[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Malawi\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":689},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,45,0,25,[9,41,72,97,122,155,179,209,245,270,296,331,365,388,409,434,457,492,514,535,559,587,614,640,661],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100497191","building-respiratory-support-in-east-africa-through-high-flow-versus-standard-flow-oxygen-evaluation-100497191",false,"NCT05754034","Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation","BREATHE","Inclusion Criteria:\n\n* age\\>=18 years AND\n* admitted to a study site hospital within the 24 hours prior to screening AND\n* SpO2\\\u003C90% at time of first assessment OR\n* receiving oxygen at time of first assessment\n\nExclusion Criteria:\n\n* imminent death (high clinical suspicion of death within 24 hours of admission)\n* patient or caregiver refusal of study participation\n* history of chronic respiratory failure (SpO2\\\u003C90% or oxygen dependence for at least three months)\n* anatomical factors precluding the use of nasal cannula\n* intubation or non-invasive ventilation by the clinical team prior to screening for the trial\n* known hypoxemia at transferring facility for \\>48 hours\n* lack of availability of either SFO or HFO devices or supplies at the time of randomization.","ALL","18 Years",{"count":20,"type":21},1600,"ESTIMATED","INTERVENTIONAL",[24],"NA","Acute hypoxemia is common and deadly in resource variable settings. While studies in high income countries (HICs) have indicated a possible benefit to high flow oxygen as compared with standard flow oxygen, rigorous studies in low or lower middle income countries (LMICs) have not been performed. Studies in sepsis have demonstrated that interventions that improve outcomes in one context may actually be neutral or harmful in a different context.\n\nThe goal of this study is to test whether high flow oxygen results in better outcomes for hypoxemic adult patients, as compared with standard flow oxygen, in five LMIC hospitals. The main questions it aims to answer are:\n\n1. For hypoxemic adults in these LMIC study settings, does high flow oxygen or standard flow oxygen result in lower mortality?\n2. What are the facilitators and barriers to using high flow oxygen in these settings?\n3. Does high flow or standard flow oxygen use more oxygen?\n\nParticipants will be randomized to receive either high flow oxygen through a large nasal cannula, or to receive standard flow oxygen, through nasal cannulas, face masks, or non-rebreather masks. Researchers will compare the outcomes for the two groups, to see if one group of patients has better outcomes than the other.\n\nThe study will also examine how much oxygen is used by the two patient groups, as well as other factors relevant to the feasibility of implementation of high flow oxygen in these sites.",[27],"Acute Hypoxemia","RECRUITING","2026-06-30",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":32},"2023-10-11",{"date":36,"type":21},"2026-12-31",{"name":38,"class":39},"Beth Israel Deaconess Medical Center","OTHER",5,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100476037","phase-1-don-in-pediatric-cerebral-malaria-100476037","NCT05478720","DON in Pediatric Cerebral Malaria","DON in Pediatric Cerebral Malaria: A Phase I\u002FIIa Dose-Escalation Safety Study","Inclusion Criteria:\n\nFor Healthy Adults (Part 1):\n\n* 18 years and older\n* Informed consent obtained and ICF signed\n* Temperature ≤ 37.5 °C\n* BMI 18.5-25 kg\u002Fm2\n* Creatinine ≤ 110 mmol\u002FL (≤ 1.2 mg\u002FdL; males) or ≤ 90 mmol\u002FL (≤ 1.0 mg\u002FdL; females)\n* Hemoglobin ≥ 7 g\u002FdL or hematocrit\u002F packed-cell volume (PCV) ≥ 20%\n* Thick or thin blood smear negative for asexual forms of P. falciparum\n* Negative pregnancy test for persons of child-bearing potential\n\nFor Adults with Uncomplicated Malaria (Part 1):\n\n* 18 years and older\n* Informed consent obtained and ICF signed\n* Temperature ≥ 38 °C or history of fever in the past 24 hours\n* Thick or thin blood smear positive for asexual forms of P. falciparum (parasite count and speciation documented)\n* Hemoglobin ≥ 7 g\u002FdL or hematocrit\u002F PCV ≥ 20%\n* BMI 18.5-25 kg\u002Fm2\n* Creatinine ≤ 110 mmol\u002FL (≤ 1.2 mg\u002FdL; males) or ≤ 90 mmol\u002FL (≤ 1.0 mg\u002FdL; females)\n* Glasgow coma score of 15\n* Respiratory rate ≤ 20 breaths\u002F minute\n* Oxygen saturation ≥ 90% on room air\n* Negative pregnancy test for person of child-bearing potential\n\nFor Children with Cerebral Malaria (Part 2):\n\n* Age 12 months-14 years old\n* Informed consent obtained and ICF signed by parent or guardian\n* Temperature ≥ 38 °C or history of fever in the last 24 hours\n* Thick or thin blood smear positive for asexual forms of P. falciparum\n* Blantyre coma score ≤ 2\n* No other explanation for coma by history or physical exam\n* Hematocrit or PCV ≥ 18%\n* Negative pregnancy test for persons of child-bearing potential\n* Creatinine ≤ 1.5 mg\u002FdL\n* Aspartate aminotransferase (AST) \\\u003C 280 IU\u002FL\n* Alanine aminotransferase (ALT) \\\u003C 195 IU\u002FL\n\nExclusion Criteria (All Participants):\n\n* Pregnancy or lactation (participants of child-bearing potential ages 9-59 years will undergo pregnancy testing prior to administration of the intervention)\n* Participants attempting to become pregnant\n* Currently taking highly active antiretroviral therapy (HAART)\n* Currently taking anti-tuberculosis medications\n* Allergy to ondansetron or ceftriaxone\n\nAdditional Exclusion Criteria for Children with Cerebral Malaria (Part 2):\n\n* Cloudy cerebrospinal fluid (indicative of a probable bacterial central nervous system infection)\n* Severe malnutrition (\\>3 standard deviations below the mean weight for height and\u002F or mid-upper arm circumference (MUAC) ≤11.5 cm\n* Allergy to ondansetron or ceftriaxone\n* Coma for \\> 72 hours\n* Have taken a CYP3A4 inhibitor within 7 days of enrollment",true,"12 Months",{"count":51,"type":21},152,[53,54],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the safety of a single intravenous dose of DON in healthy adults, adults with uncomplicated malaria, and children 12 months-14 years old with clinically defined Cerebral Malaria. The main objectives are:\n\n* Evaluate the safety of a single intravenous dose of DON in healthy adults and adults with uncomplicated malaria ( Part 1)\n* Determine the safety of a single dose of DON in children 12 months-14 years old with World Health Organization (WHO) clinically defined CM (Part 2 :Cohort 1-4)\n* Determine the pharmacokinetic (PK) profile of a single dose of DON in healthy adults, adults with uncomplicated malaria and children with CM (Part 1, and Cohorts 1-4 of Part 2)\n* Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with CM is associated with improved intracerebral blood flow dynamics on transcranial doppler (TCD) (Part 2 :Cohort 1-4)\n* Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with CM is associated with a reduction in brain volume score on magnetic resonance imaging (MRI) (Part 2 :Cohort 1-4)\n* Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with cerebral malaria is associated with changes in electroencephalogram (EEG) pattern (Part 2 :Cohort 1-4)\n* Exploratory: Explore the metabolic mechanisms of action of adjunctive DON in children with CM\n\nHealthy adult participants will receive:\n\n* anti-emetic ondansetron\n* one dose of DON\n\nAdults with uncomplicated malaria will receive:\n\n* anti-emetic ondansetron\n* one dose of DON\n* artemisinin-combination therapies per Malawi Ministry of Health guidelines\n\nPediatric participants will receive:\n\n* one dose of DON\n* anti-emetic ondansetron and per Malawi Ministry of Health guidelines:\n* enteral lumefantrine-artemether therapy, and\n* artesunate therapy",[57],"Malaria, Cerebral",[59,60],"malaria","Plasmodium falciparum","2026-06-25",{"date":63,"type":32},"2026-06-29",{"date":65,"type":32},"2022-08-16",{"date":67,"type":21},"2026-12",{"name":69,"class":70},"Douglas Postels, MD, MS","UNKNOWN",2,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"100530851","phase-2-trial-of-novel-regimens-for-the-treatment-of-pulmonary-tuberculosis-100530851","NCT06192160","Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis","A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis","RAD-TB","Inclusion Criteria:\n\n1. Pulmonary TB (among individuals either without history of prior TB treatment or with history of TB treatment completed more than 2 years prior to study entry), identified within 7 days prior to study entry by at least one sputum specimen positive for Mtb by Xpert. Semiquantitative Mtb results of \"medium\" or \"high\" from Xpert MTB\u002FRIF Ultra are required.\n2. Pulmonary TB with documented INH susceptibility (by Line Probe Assay (LPA) or Xpert MTB\u002FXDR or other validated molecular test) and with documented RIF susceptibility (by LPA or Xpert MTB\u002FRIF or Xpert MTB\u002FRIF Ultra or other validated molecular test) within 7 days prior to study entry.\n3. Documentation of HIV-1 infection status, as below:\n\n   Presence or absence of HIV-1 infection, as documented by:\n   * Any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit, any time prior to study entry. AND for a positive result confirmation by one of the following:\n   * A second antibody test from different manufacturers or based on different principles and epitopes (combination antigen-antibody-based rapid tests may be used), or\n   * HIV-1 antigen, or\n   * Plasma HIV-1 RNA viral load, or\n   * A licensed Western blot\n4. For individuals with HIV: CD4+ cell count ≥100 cells\u002Fmm3 based on testing performed within 30 days prior to study entry.\n5. For individuals with HIV: Currently being treated with dolutegravir-based antiretroviral therapy (ART), or plan to initiate dolutegravir-based ART at or before study week 8.\n6. Individuals age ≥18 years.\n7. The following laboratory values obtained within 7 days prior to study entry at any network-approved non-U.S. laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs:\n\n   * Serum or plasma alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN)\n   * Serum or plasma total bilirubin ≤2 times ULN\n   * Serum or plasma creatinine ≤2 times ULN\n   * Serum or plasma potassium ≥3.5 mEq\u002FL\n   * Serum or plasma magnesium ≥1.0 mEq\u002FL (≥0.500 mmol\u002FL)\n   * Absolute neutrophil count (ANC) ≥1500\u002Fmm\\^3\n   * Hemoglobin ≥9.0 g\u002FdL\n   * Platelet count ≥100,000\u002Fmm\\^3\n   * Negative for, hepatitis B surface antigen (HBsAg)\n   * Negative for hepatitis C virus (HCV) antibody (or if HCV antibody positive, must have a negative HCV PCR)\n8. For female study candidates who are of reproductive potential, negative pregnancy test (urine HCG or serum β-HCG) within 3 days (72 hours) prior to entry by any network-approved non-U.S. laboratory or clinic that operates in accordance with GCLP and participates in appropriate external quality assurance programs.\n\n   Females who are of reproductive potential and who participate in sexual activity that could lead to pregnancy must agree to use at least two of the following forms of birth control while receiving TB study medications and for 12 months after stopping study medications:\n   * Male or female condoms\n   * Diaphragm or cervical cap (with spermicide, if available)\n   * Intrauterine device (IUD) or intrauterine system (IUS)\n   * Hormone-based birth control (e.g., oral contraceptives, Depo-Provera, NuvaRing, implants)\n\n   Female study candidates who are of reproductive potential, but who abstain from sexual activity that could lead to pregnancy require no additional contraception.\n\n   Female study candidates who are not of reproductive potential are eligible without requiring the use of contraceptives. Self-reported history is acceptable documentation of menopause (i.e., at least 1 year amenorrheic), hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; these candidates are all considered not of reproductive potential.\n9. For male study candidates who engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives while the individual is on study and for 90 days after experimental treatment discontinuation.\n\n   For male study candidates who have undergone successful vasectomy with documented azoospermia or have documented azoospermia for any other reason, are eligible without requiring the use of contraceptives.\n10. For male study candidates with pregnant partners, willingness to use condoms during vaginal intercourse while on study and for 90 days after experimental treatment discontinuation.\n11. For male study candidates, willingness to refrain from sperm donation while on study and for 90 days after experimental treatment discontinuation.\n12. Documentation of Karnofsky performance score ≥60 obtained within 14 days prior to study entry.\n13. Chest x-ray obtained within 14 days prior to study entry.\n14. A verifiable address or residence readily accessible for visiting, and willingness to inform the study team of any change of address during study treatment and follow-up period.\n15. Ability and willingness of individual to provide informed consent.\n\nExclusion Criteria:\n\n1. More than cumulative 7 days of treatment directed against active TB for the current TB episode in the 60 days preceding study entry.\n2. Current extrapulmonary TB, in the opinion of the investigator.\n3. QTcF interval \\>450 ms within 7 days prior to study entry.\n4. History of or ongoing heart failure.\n5. Personal or family history of congenital QT prolongation.\n6. History of known, untreated, ongoing hypothyroidism.\n7. History of or ongoing bradyarrhythmia.\n8. History of torsades de pointes.\n9. Current Grade 2 or higher peripheral neuropathy.\n10. Other medical conditions (e.g., diabetes, liver or kidney disease, blood disorders, chronic diarrhea), in the opinion of the site investigator, in which the current clinical condition of the participant is likely to prejudice the response to, or assessment of, treatment.\n11. Pregnant or breastfeeding or planning to become pregnant within the next 12 months.\n12. Weight \\\u003C35 kg.\n13. Unable to take oral medications.\n14. Taking any of prohibited medications.\n15. Known allergy\u002Fsensitivity or any hypersensitivity to components of investigational agents or their formulation.\n16. Active drug or alcohol use or dependence; or mental illness (e.g., major depression) that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n17. Taking an investigational drug or vaccine within 30 or more days prior to study entry.",{"count":81,"type":21},315,[54],"A5409\u002FRAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB).\n\nA5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care \\[(SOC) isoniazid\u002Frifampicin\u002Fpyrazinamide\u002Fethambutol (HRZE)\\].\n\nThe study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of study treatment (experimental or SOC, based on treatment arm assignment) followed by 18 weeks of SOC continuation phase treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.",[85],"Pulmonary Tuberculosis","2026-06-22",{"date":88,"type":32},"2026-06-23",{"date":90,"type":32},"2025-03-11",{"date":92,"type":21},"2027-08-11",{"name":94,"class":95},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",29,{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"100219916","phase-1-very-early-intensive-treatment-of-infants-living-with-hiv-to-achieve-hiv-remission-100219916","NCT02140255","Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission","Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission: A Phase I\u002FII Proof of Concept Study","Maternal Inclusion Criteria\n\n1. Presumed or confirmed maternal HIV infection:\n\n   * Mothers will be eligible to enroll with EITHER:\n\n     * Presumed HIV infection defined as at least one positive rapid HIV antibody-based test result from a sample collected in the peripartum period. Presumed infection must be confirmed within 10 business days of enrollment OR\n     * Confirmed HIV infection defined as positive results from two samples collected at different timepoints\n2. Willing and able to provide written informed consent for participation of herself and her infant. The mother must be of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with IRB\u002FEC policies and procedures. Otherwise, informed consent must be obtained from a legal guardian and the mother must provide written assent.\n3. Was not previously enrolled in this study with another infant.\n4. Did not receive ARVs during the current pregnancy.\n5. Infant is eligible per inclusion criteria.\n\nInfant Inclusion Criteria for Step 1\n\n1. Less than or equal to 48 hours of age.\n2. Greater than or equal to 37 weeks gestational age at birth (assessment of gestational age will be based on the best clinical estimate determined by date of last menstrual period, antenatal ultrasound, fundal height, or Ballard Score).\n3. Greater than or equal to 2 kilograms (kg) at birth.\n4. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube.\n5. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation.\n6. Mother is eligible per inclusion criteria.\n\nInfant Inclusion Criteria for Step 2\n\n1. Enrolled in Step 1.\n2. Confirmed in utero HIV infection.\n3. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube.\n4. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation.\n5. Mother (or legal guardian if applicable) is willing and able to provide written informed consent for child's participation in Step 2.\n\nInfant Inclusion Criteria for Step 3\n\n1. Enrolled in Step 2.\n2. Has reached Step 2 Week 96.\n3. Has the following results based on testing:\n\n   * No confirmed plasma HIV RNA ≥200 copies\u002FmL at Step 2 Week 24 and up to but excluding Step 2 Week 48.\n   * No plasma HIV RNA detected at Step 2 Week 48 and thereafter, with two possible exceptions\n\n     * (i) First possible exception: If HIV RNA is detected at or after Step 2 Week 48 with a result \\\u003C200 copies\u002FmL, testing will be repeated within three weeks (specimen collection for the confirmatory test must occur within three weeks of specimen collection for the initial test).\n     * If no HIV RNA is detected on the confirmatory test, or if HIV RNA is detected with a result \\\u003C200 copies\u002FmL, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2, provided no HIV RNA is detected on any subsequent tests in Step 2.\n     * If HIV RNA is detected on the confirmatory test with a result ≥200 copies\u002FmL, the infant will not be eligible for Step 3.\n     * (ii) Second possible exception: If HIV RNA is detected after Step 2 Week 48 with a result \\\u003CLOD, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2 with no RNA detected. There is no limit on the number of times HIV RNA may be detected with a result \\\u003CLOD after Week 48. However, infants with detectable RNA with a result \\\u003CLOD after Week 48 will not be considered for entry into Step 3 until after an additional 48 weeks of no RNA detected.\n     * Participants may experience either or both exceptions at different timepoints during follow-up in Step 2.\n4. If breastfed, must have permanently ceased breastfeeding, with no exposure to breast milk for at least six weeks prior to specimen collection for the testing specified in the criterion (#5) below.\n5. Has met ALL of the following additional criteria while in Step 2, based on testing between Step 2 Week 84 and Step 2 Week 192 (inclusive):\n\n   * Two consecutive negative HIV antibody tests by fourth generation ELISA at least eight weeks apart.\n   * Two consecutive HIV DNA tests with no DNA detected in at least 850,000 PBMCs assayed at least eight weeks apart.\n   * CD4 cell percentage greater than or equal to 25% and CD4 cell absolute count greater than or equal to the lower limit of normal for age (≥1000 cells\u002FmL if 2 to less than 3 years of age; ≥750 cells\u002FmL if 3 to less than 5 years of age; ≥500 cells\u002FmL if 5 years of age or older).\n   * Infant assessed by the site investigator or designee as expected to adhere to the Step 3 Schedule of Evaluations.\n   * Mother (or legal guardian if applicable) willing and able to provide written informed consent for child's participation in Step 3 and Step 4.\n6. No plasma HIV RNA detected by testing after criteria have been confirmed, with specimen collection for the assay within 14 days prior to Step 3 Entry.\n\nInfant Inclusion Criteria for Step 4\n\n1. Enrolled in Step 3.\n2. Has met at least one of the following:\n\n   * Plasma HIV RNA ≥LOD based on two assays.\n   * Plasma HIV RNA ≥1000 copies\u002FmL in the presence of fever or other sign or symptom of acute retroviral syndrome.\n   * Confirmed or suspected diagnosis of acute retroviral syndrome.\n   * Confirmed or suspected diagnosis of a new WHO Clinical Stage 3 or 4 condition.\n   * Confirmed CD4 cell percentage less than 25% and CD4 cell absolute count less than the lower limit of normal for age (\\\u003C1000 cells\u002FmL if 2 to less than 3 years of age; \\\u003C750 cells\u002FmL if 3 to less than 5 years of age; \\\u003C500 cells\u002FmL if 5 years of age or older).\n   * Otherwise assessed by the site investigator or designee, in consultation with the Clinical Management Committee (CMC), as having an indication to re-initiate treatment.","48 Hours",{"count":106,"type":21},1120,[53,54],"The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.",[110],"HIV Infection",[112],"HIV Remission","2026-06-15",{"date":115,"type":32},"2026-06-17",{"date":117,"type":32},"2015-01-23",{"date":119,"type":21},"2031-12-31",{"name":94,"class":95},46,{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":48,"sex":129,"minAge":18,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":138,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100642577","betterinfo-on-womens-prep-choices-and-outcomes-in-malawi-100642577","NCT07579754","BetterInfo on Women's PrEP Choices and Outcomes in Malawi","BetterInfo Tracing Approach to Evaluate HIV PrEP Choices and Use Over Time Among Women in Blantyre, Malawi","Inclusion Criteria:\n\nThe population for this research includes women aged 18 years or older at risk of HIV who initiated injectable or oral PrEP at one of the 20 Blantyre sites supported through PathToScale. PathToScale supports various types of facilities including public health clinics, drop-in centers for prioritized populations (DICs), and private hospitals\u002Fclinics.\n\nThose eligible for sampling are as follows:\n\n* Adult women ≥18 years; and\n* Initiated PrEP (injectable or oral) at the implementing facilities and lost to follow up within prior 2 years prior to sampling; and\n* Lost-to-follow-up (missed their PrEP visit by ≥3 months and for whom outcomes are unknown); and\n* Has a registered phone number for contact\n\nThose eligible for tracing are as follows:\n\n* Women sampled per eligibility criteria above; and\n* Women who have indicated permission for in-person follow-up\n\nHealth Care Providers, Implementing Partners, Ministry of Health (MOH) Stakeholers\n\n* providers and implementing partners from PathtoScale, and Ministry of Health stakeholders will be consented to participate in in-depth-interviews\n\nExclusion Criteria:\n\nThose excluded from sampling or tracing include:\n\n* Women who have an EMR record of a documented case of discontinuation of PrEP in consultation with a provider; or\n* Women who are known to have died; or\n* Women who have EMR documented transfers out of PathToScale supported facilities; or\n* Women refusing follow-up via phone on their ScanForm; or\n* Women refusing follow-up in person (during phone tracing); or\n* Women who do not speak Chichewa or English; or\n* Men (excluded from client interviews only)","FEMALE","110 Years",{"count":132,"type":21},384,[24],"The purpose of this study is to understand PrEP user choices, preferences and implementation impact of the roll-out of long-acting injectable PrEP alongside oral PrEP among women in Blantyre, Malawi.",[136,137],"Long-acting Injectable Cabotegravir for PrEP","Oral Pre-Exposure Prophylaxis (PrEP)",[139,140,141,142,143,144],"Implementation Science","Long-acting injectable cabotegravir for PrEP","Oral pre-exposure prophylaxis (PrEP)","HIV","pre-exposure prophylaxis (PrEP)","Lost-to-follow up (LTFU)","NOT_YET_RECRUITING","2026-06-12",{"date":113,"type":32},{"date":149,"type":21},"2026-06",{"date":151,"type":21},"2029-04",{"name":153,"class":39},"Johns Hopkins Bloomberg School of Public Health",1,{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":170,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},"100570302","phase-2-pramipexole-versus-escitalopram-to-treat-major-depressive-disorder-mdd-and-comorbid-mdd-with-mild-neurocognitive-disorder-mnd-in-persons-with-hiv-100570302","NCT06705478","Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV","An Open-Label, Randomized Controlled Trial of Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV","Inclusion Criteria:\n\n* Documented HIV-1 infection.\n* Diagnosis of MDD.\n* On current ART regimen for at least 90 days prior to study entry with no interruption in treatment greater than 7 consecutive days.\n* No plans to change ART while on study.\n* Plasma HIV-1 RNA levels of less than 200 copies\u002FmL obtained within 90 days prior to enrollment.\n* Study candidates previously treated for depression are eligible provided the study candidate's last dose of antidepressant taken is at least 4 weeks prior to study entry, with the exception of fluoxetine, which the last dose taken must have been at least 8 weeks prior to study entry.\n* Laboratory values obtained within 30 days prior to study entry that meet protocol criteria as determined by the site investigator of record.\n* Study candidates of child-bearing potential must have a negative serum or urine pregnancy test performed at screening and within 2 days prior to study entry.\n* Study candidates of child-bearing potential who are participating in sexual activity that could lead to pregnancy must agree to use at least one highly effective method for contraception.\n\nExclusion Criteria:\n\n* Active suicidality, and\u002For severe MDD, psychotic disorders, manic or hypomanic symptoms occurring in the context of bipolar disorder type I or II, or cyclothymic disorder, or another current Axis I diagnosis judged by the investigator to interfere with the trial.\n* Study candidate self-report of depressive symptoms that have persisted for over 50 percent of waking hours and for over 50 percent of days over the 24 months prior to study entry.\n* Severe, active alcohol or substance use disorder by DSM-5-TR criteria in the 6 months prior to study entry.\n* Active alcohol or substance use judged by the investigator to interfere with the trial.\n* Any acute infection within 14 days prior to study entry.\n* Acute or serious illness requiring systemic treatment and\u002For hospitalization within 90 days prior to study entry.\n* Active coronary artery disease (CAD) or myocardial infarction (MI) within 180 days prior to study entry.\n* Presence of rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus (SLE), dermatomyositis, ulcerative colitis, Crohn's disease, or other chronic inflammatory conditions.\n* Immune reconstitution inflammatory syndrome (IRIS) or a history of IRIS within 180 days prior to study entry.\n* Unstable or advanced liver disease.\n* Receipt of medications judged by the site investigator to significantly influence depression or neurocognitive function within 30 days prior to study entry.\n* Non-HIV-associated neurological disorder comorbidity.\n* Diagnosis of epilepsy with antiepileptic drug treatment.\n* Untreated HCV infection and HCV viremia.\n* Current CNS malignant tumor or CNS opportunistic infection (OI).\n* Current systemic malignant tumor or of a current systemic AIDS-defining OI.\n* History of completed treatment of CNS or systemic malignant tumor within the 5 years prior to study entry.\n* History of completed treatment of CNS OI within the 5 years prior to study entry.\n* Documented history of completed treatment of systemic AIDS-defining OI, as well as Mycobacterium Tuberculosis Infection, within the 180 days prior to study entry.\n* New diagnosis of syphilis or treatment for syphilis within the 180 days prior to study entry.\n* History of neurosyphilis.\n* Severe chronic obstructive pulmonary disease.\n* Congestive heart failure (CHF).\n* Use of systemic steroids daily (except testosterone).\n* Diseases that cause a known bleeding diathesis.\n* Immunostimulant therapies and trials of non-FDA-approved ARV medications within 30 days prior to study entry.\n* Immunosuppressive medications if judged by the investigator to affect study outcomes.\n* Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding.\n* Known allergy\u002Fsensitivity or any hypersensitivity to the study drugs or their formulations.\n* Study candidates on prohibited medications at the time of screening will be excluded from study participation.\n\nInclusion Criteria for Participants at US Sites Who Consent to the Lumbar Puncture (LP) Procedure:\n\n* Non-focal neurological examination. Study candidates with focal findings should have expert assessment for mass effect prior to the LP.\n* Laboratory values that meet LP protocol criteria as determined by the site investigator.\n\nExclusion Criteria for Participants at US Sites who Consent to the LP Procedure:\n\n* Current use of anti-coagulants.\n* Known presence of intracerebral mass or lesion that is judged to affect the safety of an LP.\n* Known presence of an active CNS infection that could alter CNS\u002FCSF inflammatory measures.\n* Known allergy to lidocaine.\n* Individuals who are unable to safely tolerate an LP due to physical limitation or condition.\n* Body mass index (BMI) greater than 40 kg\u002Fm\\^2.","70 Years",{"count":164,"type":21},186,[54],"A phase II, randomized, open-label, two-arm clinical trial evaluating the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with mild neurocognitive disorder (MND) in persons with HIV (PWH). Participants will be assessed comprehensively and briefly at intercurrent visits to monitor for toxicity, response to therapy, and to assess for dose changes.\n\nAn optional sub-study to evaluate treatment impact on the cerebrospinal fluid (CSF) profile will be conducted in a subset of 36 participants.",[168,169,142],"Major Depressive Disorder","Mild Neurocognitive Disorder",[171],"Comorbid MND",{"date":113,"type":32},{"date":174,"type":32},"2026-05-17",{"date":176,"type":21},"2026-12-02",{"name":94,"class":95},41,{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":186,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":96},"100641915","phase-2-a-trial-of-stratified-patient-centered-treatment-regimens-for-active-tb-spectra-tb-100641915","NCT07595042","A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)","A Phase 2C Trial of Stratified Patient-Centered Treatment Regimens for Active TB","Inclusion Criteria:\n\n* Has pulmonary tuberculosis (TB) that is likely to respond to standard TB medicines (drug-susceptible TB), based on sputum testing done within 7 days before entering the study. The test must show Mycobacterium tuberculosis is present, with no rifamycin resistance detected and no known resistance to isoniazid or fluoroquinolones.\n* Has a SPECTRA-TB risk score and risk group assigned during screening using the study-specific calculator.\n* Has a Karnofsky performance score of 50 or higher within 30 days before entering the study.\n* Has documented HIV-1 status (either with HIV or without HIV) based on acceptable testing.\n* If living with HIV, has a CD4+ cell count of at least 50 cells\u002Fmm3 within 60 days before study entry.\n* If living with HIV, is currently receiving or plans to start an efavirenz-based or dolutegravir-based antiretroviral therapy regimen by study week 8.\n* Has laboratory test results within 7 days before study entry that meet all of the following:\n\n  * alanine aminotransferase (ALT) no more than 3 times the upper limit of normal\n  * total bilirubin no more than 2.5 times the upper limit of normal\n  * creatinine no more than 2 times the upper limit of normal\n  * potassium between 3.5 and 5.5 mEq\u002FL\n  * absolute neutrophil count at least 1000\u002Fmm3\n  * hemoglobin at least 7.0 g\u002FdL\n  * platelet count at least 100,000\u002Fmm3\n* If able to become pregnant, has a negative blood or urine pregnancy test within 7 days before study entry.\n* If able to become pregnant and sexually active in a way that could lead to pregnancy, agrees not to try to become pregnant and agrees to use at least 1 reliable non-hormonal birth control method during study treatment and for 30 days after stopping study drugs. Acceptable methods include:\n\n  * condoms\n  * intrauterine device (IUD) or intrauterine system (IUS)\n  * cervical cap with spermicide\n  * diaphragm with spermicide\n* If not able to become pregnant, has a history or documentation of menopause, hysterectomy, bilateral removal of the ovaries, or bilateral tubal ligation.\n* Has a verifiable address or place of residence and is willing to tell the study team about any change of address during treatment and follow-up.\n* Is willing and able to give informed consent, or assent with permission from a parent or legal guardian if required.\n\nExclusion Criteria:\n\n* TB bacteria are known to be resistant to 1 or more of the following medicines: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones.\n* Received more than 5 days of treatment for active TB within the 24 weeks before study entry.\n* Received more than 5 days of treatment within the 30 days before study entry with certain TB medicines or related antibiotics, including isoniazid, rifampin, rifapentine, ethambutol, moxifloxacin, pyrazinamide, aminoglycosides, fluoroquinolones, linezolid, bedaquiline, pretomanid, and other specified anti-TB drugs.\n* Has suspected or confirmed TB involving the brain or central nervous system, bones, joints, heart lining (pericardium), or miliary TB.\n* Has a past history of suspected or confirmed drug-resistant TB of any type.\n* Is currently pregnant or breastfeeding.\n* Cannot take medicines by mouth.\n* Has an HIV\u002FAIDS-related opportunistic infection at study entry.\n* Has acute or chronic hepatitis B, unless the hepatitis B infection has cleared.\n* Has acute or chronic hepatitis C, unless the hepatitis C infection has cleared or has been successfully treated.\n* Has alcohol-related liver disease.\n* Has liver cirrhosis.\n* Has a history of aortic aneurysm or aortic dissection.\n* Has a known history of long QT syndrome, a first-degree relative with long QT syndrome, or a screening ECG showing QTcF greater than 470 ms that does not correct with treatment of contributing factors.\n* Is taking other medicines that can prolong the QT interval and cannot safely switch to an alternative medicine.\n* Has a known history of acute intermittent porphyria.\n* Weighs less than 30 kg.\n* Is currently using, or is expected to need within 24 weeks after enrollment, 1 or more medicines that are not allowed during the study.\n* Has a known allergy, sensitivity, or hypersensitivity to any of the study drugs or their ingredients.\n* Has active drug or alcohol use, dependence, mental illness, or another serious infection that, in the opinion of the site investigator, could make it hard to follow the study requirements.\n* Is currently taking part in another interventional clinical trial.","13 Years",{"count":188,"type":21},900,[54],"The A5414 study will evaluate whether treatment for drug-susceptible pulmonary tuberculosis (TB) can be tailored according to a participant's risk of an unfavorable outcome. Participants will be assigned to lower-risk or higher-risk groups using baseline characteristics and then randomized within each group to receive either standard TB treatment or an investigational rifapentine- and moxifloxacin-containing regimen. The study will evaluate whether shorter treatment durations may be used in lower-risk participants and whether the investigational regimen may improve outcomes in higher-risk participants. Safety and tolerability will also be evaluated.",[192],"Tuberculosis",[192,194,195,196,197,198,199,200,201],"Pulmonary tuberculosis","Drug-susceptible tuberculosis","Rifampin-susceptible tuberculosis","Rifapentine","Moxifloxacin","HIV coinfection","Treatment shortening","Risk-stratified treatment","2026-06-11",{"date":113,"type":32},{"date":205,"type":21},"2026-07-31",{"date":207,"type":21},"2029-10-22",{"name":94,"class":95},{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":129,"minAge":4,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":221,"conditions":222,"keywords":228,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":154},"100625608","phase-2-xylitol-and-the-prevention-of-periodontal-disease-and-preterm-birth-trial-100625608","NCT07424846","Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial","Xylitol and the Prevention of Periodontal Disease and Preterm Birth (XaPPP) Trial","XaPPP","Inclusion Criteria:\n\n* Able to provide informed consent. For those under 18 years of age, an approval will additionally be sought from the parent or guardian\n* Less than 20 weeks' gestation (by best obstetric estimate)\n* At least 20 natural teeth\n* Planning to deliver at one of the health facilities within the XaPPP trial\n* Receiving antenatal obstetric care at one of the 8 health districts\n* Willing to chew two pieces of gum thrice daily for 5 minutes after the morning, day and evening meals throughout pregnancy\n* Willing to attend all study visits\n* Willing to provide biospecimens (oral, vaginal, placental, breast milk)\n* Willing to undergo at least two dental exams including oral microbiota sampling at study enrolment \\\u003C20 weeks of pregnancy, 28-30 weeks of pregnancy, and 6-8 weeks after giving birth\n* Willing to have their child undergo follow up through at least 12 months after birth including neurodevelopmental examination(s)\n* Speaks Chichewa or English\n\nAll patients who meet inclusion criteria will be approached without regard to sex, race, ethnicity, parents' country of origin, or religious preferences.\n\nExclusion Criteria:\n\n* Those who upon screening and enrolment but dislike the taste of the gum and state they will not chew the gum throughout pregnancy\n* Gravidae with known or suspected non-viable pregnancy (including life threatening congenital anomalies such as cardiac, neurological or others)\n* Pregnant individual has a life-threatening diagnosis such as cancer requiring treatment during pregnancy\n* Pregnant women with a known or suspected morbidly adherent placenta (such as placenta accrete, increta and percreta)\n* Known allergy to xylitol",{"count":218,"type":21},6000,[54,220],"PHASE3","The ground-breaking Prevention of Prematurity and Xylitol (PPaX) cluster randomized controlled clinical trial was conducted in Lilongwe, Malawi and enrolled approximately 10,069 pregnant individuals seeking to evaluate the impact of xylitol-containing chewing gum compared to no chewing gum on reducing the occurrence of maternal periodontal disease, preterm birth, and low birthweight offspring. The premise of this study centers upon the numerous publications supporting a strong association between maternal periodontal disease and preterm birth. Given that xylitol-containing chewing gum is considered a prebiotic and known to reduce cariogenic and periodontopathic bacteria, the study evaluated and discovered a statistically significant reduction in maternal periodontal disease, preterm birth, and low birthweight offspring among pregnant individuals who chewed xylitol-containing chewing gum.\n\nWhile PPaX demonstrated the efficacy of xylitol to reduce preterm birth (PTB), the study had important limitations: (a) PPaX was an unblinded cluster-randomized study with only 8 clusters, 4 with xylitol-containing chewing gum and 4 without any gum (not placebo-controlled); (b) PPaX used a suboptimal dose of 2 grams of xylitol daily which may have reduced the effectiveness of the intervention given that recent literature suggests 5-10 grams\u002Fday more effectively improve oral health; and (c) PPaX did not evaluate infant mortality nor early neurodevelopmental outcomes. Notably, reducing fetal exposure to periodontal disease (PD) as well as PTB may improve neurodevelopmental outcomes for offspring as both prematurity and fetal exposure to inflammation are well-documented risk factors for neurodevelopmental delay (NDD) and infant mortality.\n\nThe investigators will conduct a double-blind, placebo-controlled, individually randomized clinical trial with 3 arms among Malawian pregnant individuals (n=6000) at \\\u003C20 weeks of pregnancy with the co-primary outcomes being the incidence of PTB and low birthweight offspring. The 3 study arms (n=2000 each) will be (a) an optimized dose of xylitol-containing chewing gum (6.4 grams\u002Fday), (b) the PPaX trial xylitol dose (2.1 grams\u002Fday), or (c) flavored sorbitol gum base (placebo control). This trial overcomes the PPaX trial's limitations and will definitively answer whether xylitol prevents PTB in Malawi. The investigators will additionally collect biospecimens from a random sampling of the participants for biobanking for later analysis of inflammatory and microbiome alterations that may occur with xylitol exposure compared with placebo. The investigators hypothesize that pregnant individuals who chew xylitol-containing chewing gum will have a significant reduction in periodontal disease metrics at 28-30 weeks' gestation (e.g. bleeding on probing) as well as offspring with improved neurodevelopmental outcomes as assessed by the Bayley Scales of Infant and Toddler Development 4th edition and reduced risk of adverse pregnancy outcomes including preterm birth.",[223,224,225,226,227],"Preterm Birth","Low Birthweight Neonate","Periodontitis","Gingivitis","Developmental Delay",[229,230,231,232,233,234,235],"xylitol","preterm birth","prematurity","pregnancy","periodontitis","periodontal disease","chewing gum","2026-06-05",{"date":238,"type":32},"2026-06-09",{"date":240,"type":32},"2026-03-26",{"date":242,"type":21},"2030-09-30",{"name":244,"class":39},"University of Washington",{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":17,"minAge":186,"maxAge":252,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":255,"briefSummary":256,"conditions":257,"keywords":259,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":269},"100575270","suicide-assessment-and-feasible-evidence-based-treatments-for-youth-living-with-hiv-in-lilongwe-100575270","NCT06770101","Suicide Assessment and Feasible Evidence-based Treatments for Youth Living With HIV in Lilongwe","Suicide Assessment and Feasible Evidence-based Treatments for Youth Living With HIV in Lilongwe: SAFETY Planning Pilot Trial","Inclusion Criteria:\n\n* Age 13-19\n* Diagnosed with HIV\n* Report current or historical suicidal ideation and behaviors (SIBs) on question 9 of the Patient Health Questionnaire modified for adolescents (PHQ-9-A) and the Ask Suicide-Screening questionnaire (ASQ)\n* Living in the clinic's catchment area with intention to remain for more than 1 year\n* Willing to provide consent (age 18+ or 16-17 years old and married and thereby considered emancipated minors per Malawi law) or assent with parental consent (age 13-17).\n\nExclusion Criteria:\n\n* Refuse to participate\n* Refuse to be audio-taped for in-depth interviews","19 Years",{"count":254,"type":21},60,[24],"The overall aim of this study is to determine the feasibility, fidelity, acceptability, and preliminary effectiveness of the Friendship Bench +Safety Planning intervention in reducing suicidal ideation and behaviors (SIBs) and improving HIV engagement amongst adolescents living with HIV (ALWH) when compared to augmented usual care.",[142,258],"Suicide",[142,258,260],"Suicidal Ideation","2026-06-04",{"date":236,"type":32},{"date":264,"type":32},"2025-07-01",{"date":266,"type":21},"2026-09",{"name":268,"class":39},"University of Pennsylvania",4,{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":17,"minAge":277,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":284,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":295},"100468742","phase-2-trial-of-a-six-month-regimen-of-high-dose-rifampicin-high-dose-isoniazid-linezolid-and-pyrazinamide-versus-a-standard-nine-month-regimen-for-the-treatment-of-adults-and-adolescents-with-tuberculous-meningitis-100468742","NCT05383742","Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis","A Phase II, Randomized, Open-Label Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis: Improved Management With Antimicrobial AGents Isoniazid rifampiciN LinEzolid for TBM (IMAGINE-TBM)","Inclusion Criteria:\n\n* Definite, probable, or possible TBM diagnosis wherein the participant is being committed to a full course of SOC anti-TB treatment for TBM in the setting of routine care. CSF, imaging, laboratory, and other results used to determine definite, probable, or possible TBM can be from testing performed as part of routine care, as long as obtained within 21 days prior to study entry\n* Absence of HIV-1 infection, as documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit, within 30 days prior to study entry, OR\n* HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 E\u002FCIA test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and\u002For E\u002FCIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load. Two or more HIV-1 RNA viral loads of \\>1,000 copies\u002FmL are also acceptable as documentation of HIV-1 infection, or documentation of HIV diagnosis in the medical record by a healthcare provider\n* Documentation within 3 days prior to study entry of stage of disease using BMRC TBM grade.\n* The following laboratory values obtained within 3 days prior to study entry:\n\n  * Serum creatinine ≤1.8 times upper limit of normal (ULN)\n  * Hemoglobin ≥8.0 g\u002FdL for men, ≥7.5 g\u002FdL for women\n  * Absolute neutrophil count ≥600\u002Fmm3\n  * Platelet count ≥60,000\u002Fmm3\n  * Alanine aminotransferase (ALT) ≤3 x ULN\n  * Total bilirubin ≤2 x ULN\n* For participants of reproductive potential who have not been post-menopausal for at least 24 consecutive months (i.e., no menses within the preceding 24 months), or participants who have not undergone surgical sterilization, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation, documentation of a serum or urine pregnancy test result (positive or negative; see protocol for test sensitivity requirement) within 21 days prior to study entry\n* Participants with documentation of a positive pregnancy test will be consented using the consent form for pregnant participants.\n\nParticipants of reproductive potential with documentation of a negative pregnancy test must agree to use at least one acceptable form of contraception, or abstain from sexual activity that could lead to pregnancy while receiving study treatment and for 30 days after stopping study treatment.\n\nParticipants who are not of reproductive potential or whose partner(s) has documented azoospermia are not required to use contraception. Any statement of self-reported sterility or that of the partner's must be entered in the source documents\n\n* Ability and willingness of participant or parent or legally authorized representative (for adolescents or participants unable to provide consent) to provide informed consent\u002Fassent\n* Ability to comply with the protocol requirements in the opinion of the site investigator\n\nExclusion Criteria:\n\n* More than 14 cumulative days of first-line TB medications, including but not limited to INH, RIF, EMB, and PZA, received within 90 days prior to study entry\n* Known current or previous drug resistant TB infection (i.e., resistance to one or more first-line TB medications, including but not limited to INH, RIF, EMB, LZD and PZA)\n* Known allergy\u002Fsensitivity or any hypersensitivity to components of study TB drugs (INH, RIF, LZD, PZA, and EMB) or their formulation\n* For participants who are able to undergo the Brief Peripheral Neuropathy Screen (BPNS) within 21 days prior to study entry, Grade 3 subjective peripheral neuropathy score on the BPNS AND EITHER vibratory loss OR absent ankle jerks\n* Expected concomitant use or use up to 21 days prior to study entry of monoamine oxidase inhibitors or selective serotonin reuptake inhibitors, or concomitant use of any other drug with significant interaction with the study drugs (See protocol)\n* For participants with HIV who are ART-naïve or who are not regularly taking ART, planned initiation or reinitiation of ART during screening or during the first 4 weeks after initiation of TB therapy\n* For participants with HIV and on ART that includes a protease inhibitor, nevirapine, or other prohibited ART (see protocol), contraindication to switching to an acceptable alternative regimen (e.g., efavirenz, high-dose raltegravir or dolutegravir with nucleoside reverse transcriptase inhibitors, as per local SOC) prior to randomization. TB treatment, including study drugs, should be started as soon as possible\n* Contraindication to LP at discretion of treating clinician (e.g., unequal pressures between intracranial compartments due to mass lesion, non-communicating hydrocephalus)\n* Positive cryptococcal antigen, gram stain, bacterial culture, or other test result obtained from a CSF specimen collected within 21 days prior to entry as part of routine care indicating CNS infection with a pathogen other than Mtb (e.g., cryptococcal meningitis, bacterial meningitis).","15 Years",{"count":279,"type":21},330,[54],"The purpose of this study is to compare a 6-month regimen of high-dose rifampicin (RIF), high-dose isoniazid (INH), linezolid (LZD), and pyrazinamide (PZA) versus the World Health Organization (WHO) standard of care (SOC) treatment for tuberculosis meningitis (TBM).",[283],"Tuberculous Meningitis",[285,192,286],"Tuberculosis, meningeal","CNS Disease","2026-06-01",{"date":289,"type":32},"2026-06-02",{"date":291,"type":32},"2023-12-07",{"date":293,"type":21},"2029-09-15",{"name":94,"class":95},18,{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":17,"minAge":303,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":307,"phases":4,"briefSummary":308,"conditions":309,"keywords":312,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":71},"100514023","covid-19-transmission-and-morbidity-in-malawi-100514023","NCT05973084","COVID-19 Transmission and Morbidity in Malawi","COVID-TMM","Inclusion Criteria Index Cases\n\n1. Presents with symptoms of COVID-19 and has infection confirmed through RT-PCR or a rapid antigen test;\n2. Aged 5 years to 75 years and plans to live in Blantyre, in the catchment area of the target research health centers for the following 6 months;\n3. Confirmed SARS-CoV-2 infection and share a household with 1 or more individuals of eligible age;\n4. Has not received a SARS-CoV-2 vaccine in the previous 3 months\n5. Willingness to comply with study procedures and visits, and provides informed consent.\n\nHousehold Contacts of the Confirmed SARS-CoV-2 Case\n\n1. Aged 5 years to 75 years and plans to live in Blantyre, in the catchment area of the target research health centers in the following 6 months;\n2. Willingness to comply with study procedures and follow-up visits and provides informed consent.\n3. Has not received a SARS-CoV-2 vaccine in the previous 3 months\n\nVaccinees\n\n1\\) Aged 18 years to 75 years; 2) Willingness to receive the primary regimen of the AZ and\u002For JJ vaccines 2) Not in the other 2 cohorts; 4) Willingness to comply with study procedures and follow-up visits and provides informed consent.\n\n5\\) Has not received a prior dose of a SARS-CoV-2 vaccine\n\nExclusion Criteria Index Cases\n\n1. Conditions that precludes from adherence to the visit schedule;\n2. 50% or more of household members decline to participate.\n3. Pregnancy at the enrollment visit\n4. Long term use of cotrimoxazole prophylaxis\n\nHousehold Contacts of the Confirmed SARS-CoV-2 Case\n\n1. Conditions that preclude adherence to the visit schedule.\n2. Participants with 2 consecutive negative SARS-CoV-2 RT-PCRs will be excluded from visits after M1.\n3. Pregnancy at the enrollment visit\n4. Long term use of cotrimoxazole prophylaxis\n\nVaccinees\n\n1. Conditions that preclude adherence to the visit schedule.\n2. Pregnancy at the enrollment visit\n3. Long term use of cotrimoxazole prophylaxis","5 Years","75 Years",{"count":306,"type":21},1500,"OBSERVATIONAL","SARS-CoV-2 transmission was expected to have a devastating impact in sub-Saharan African countries. Instead, morbidity and mortality rates in nearly the whole region are an order of magnitude lower than in Europe and the Americas. To identify what is different requires a better understanding of the underlying immunological substrate of the population, and how these factors affect susceptibility to infection, progression of symptoms, transmission, and responses to SARS-CoV-2 vaccination.\n\nStudy objectives\n\n1. Determine the risk and predictors of infection and disease among contacts of SARS-CoV-2 infection subjects in Malawi\n2. Determine whether innate immune responses lower the risk of SARS-CoV-2 infection and disease, and acquisition and duration of vaccine responses.\n3. Assess whether alterations in innate immune responses relevant to SARS-CoV-2 are associated with malaria or intestinal parasite infections.\n4. Assess the acquisition and longevity of antibodies (Ab) and cellular adaptive responses elicited by SARS-CoV-2 infection and vaccination.\n5. Assess whether malaria and intestinal parasite infections, chronic\u002Fmild undernutrition, and anemia mediate alterations in Ab and other adaptive cellular responses to SARS-CoV-2 through innate immune responses or a different unknown mechanism.",[310,311],"SARS CoV 2 Infection","SARS CoV 2 Vaccination",[313,314,315,316,317,318,319,320,321],"Natural infection","Immune phenotypes","Innate immunity","SARS CoV 2 adaptive immunity","SARS CoV 2 antibody response","Vacinees","Household contacts","Malawi","Sub Saharan Africa","2026-05-26",{"date":324,"type":32},"2026-05-28",{"date":326,"type":32},"2023-01-17",{"date":328,"type":21},"2028-03",{"name":330,"class":39},"Boston University",{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":48,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":339,"targetDuration":341,"studyType":307,"phases":4,"briefSummary":342,"conditions":343,"keywords":347,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":364},"100580181","preparing-for-maternal-gbs-vaccine-trials-in-africa-100580181","NCT06833957","Preparing for Maternal GBS Vaccine Trials in Africa","PReparing for OptimalPhase III\u002FIV maTErnal Group B StreptococCal Vaccine Trials in Africa (PROTECT)","PROTECT","Inclusion Criteria:\n\n* WP2 Pregnancy Exposure Registries inclusion criteria:\n\nAll women and their infants attending for antenatal and\u002For delivery and postpartum services at the study sites in Uganda, Malawi, Mozambique, and Kenya.\n\nWP3 GBS Surveillance inclusion criteria:\n\n* Infants aged less than 90 days old with laboratory-confirmed GBS infection admitted at participating health facilities in Uganda, Malawi, Mozambique, and Kenya.\n* Infants whose parents or guardians provided written informed consent for their participation.\n* Residents in the catchment area of participating health facilities.\n\nWP4 Vaccine Confidence inclusion criteria:\n\n* In Uganda, Kenya and Mozambique, pregnant women at any gestation period aged 18 years and above (reproductive age).\n* In Malawi, pregnant women aged 16 years are eligible to be included in the study because they are considered emancipated minors.\n* Pregnant women who consent to the study and give written consent.\n* Stakeholders who include pregnant women, health workers, women leaders, community leaders, national stakeholders, cultural and religious leaders who are willing to take part and can give written informed consent.\n\nExclusion Criteria:\n\nWP4 Vaccine Confidence exclusion criteria:\n\n* Pregnant women who are visiting\u002Fnon-resident in the research area.\n* Those who may be unwell and unable to consent to take part in the study.",{"count":340,"type":21},18100,"8 Months","Infections are one of the key causes of newborn deaths. Among them, Group B Streptococcus (GBS) is the leading cause of sepsis and bacterial meningitis in the first 90 days of life.\n\nFortunately, GBS vaccines for pregnant women, a powerful tool for fighting infections, are currently in development. Once vaccine trials are completed, these vaccines can stop preventable newborn deaths.\n\nThe PReparing for Optimal Phase III\u002FIV maTErnal Group B StreptococCal vaccine Trials in Africa (PROTECT) project, funded by the European \\& Developing Countries Clinical Trials Partnership (EDCTP) and European Commission, is supporting medical sites in Kenya, Malawi, Mozambique, and Uganda to establish uniform pregnancy and infant health data collection processes. It is also establishing surveillance of GBS in newborns to determine incidence rates and measure the burden of disease. With better reporting systems, medical sites can participate in vaccine trials and monitor vaccine safety. At the same time, the consortium is working to understand the drivers of vaccine hesitancy and to develop culturally appropriate communication tools to facilitate engagement with vaccines.\n\nThe end goal is to set up a network of sites that can monitor vaccine safety for current and future vaccines.",[344,345,346],"Group B Streptococcus","Invasive Bacterial Diseases (IBD)","Maternal Immunization",[348,349,350,351,344,352,353,354],"Child health","Clinical research","Clinical trials","Infectious diseases","vaccines","maternal immunisation","maternal health","2026-05-19",{"date":357,"type":32},"2026-05-20",{"date":359,"type":32},"2025-03-01",{"date":361,"type":21},"2027-02-28",{"name":363,"class":39},"Barcelona Institute for Global Health",10,{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":48,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":154},"100544320","an-economic-and-relationship-strengthening-intervention-to-reduce-alcohol-use-in-malawi-100544320","NCT06367348","An Economic and Relationship-strengthening Intervention to Reduce Alcohol Use in Malawi","Mlambe: A Randomized Controlled Trial of an Economic and Relationship-Strengthening Intervention to Reduce Alcohol Use in Malawi","Inclusion Criteria:\n\n1. In a married or cohabitating union\n2. Have at least one partner with a positive AUDIT-C screen in prior 3 months\n3. Must also currently be on ART for at least 6 months\n4. Must have disclosed their HIV status to their partner\n\nExclusion Criteria:\n\n1\\) Severe intimate partner violence reported in previous 3 months and\u002For fear that safety would be at risk by participation in the study (reported at screening). Couples who participated in Mlambe's pilot study will also be excluded.",{"count":373,"type":21},500,[24],"With a full-scale randomized control trial, the investigators will evaluate the efficacy and cost effectiveness of Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty around drinking, strengthen couple support and communication, and reduce heavy drinking among HIV-affected married couples with a partner who drinks alcohol in Malawi.",[377,378],"HIV\u002FAIDS","Alcohol Abuse","2026-05-11",{"date":381,"type":32},"2026-05-14",{"date":383,"type":32},"2025-02-14",{"date":385,"type":21},"2028-05",{"name":387,"class":39},"University of California, San Francisco",{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":129,"minAge":18,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":307,"phases":4,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":71},"100419588","blood-and-urine-hpvdna-as-minimally-invasive-biomarkers-for-cervical-cancer-detection-and-surveillance-following-treatment-100419588","NCT04743674","Blood and Urine HPVDNA as Minimally Invasive Biomarkers for Cervical Cancer Detection and Surveillance Following Treatment","Plasma Circulating Tumor HPVDNA and Transrenal HPVDNA as Minimally Invasive Biomarkers for Cervical Cancer Detection and Surveillance Following Definitive Treatment","Inclusion Criteria:\n\n* 18 years of age or older on day of signing informed consent\n* New diagnosis of cervical cancer\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee\n\nExclusion Criteria:\n\n* Women who are pregnant",{"count":396,"type":21},30,"The purpose of this study is to determine if ctHPVDNA (circulating tumor HPV DNA) can be used as a non-invasive biomarker for identification and treatment monitoring of cervical cancer by characterizing correlation between plasma ctHPVDNA, urine transrenal HPVDNA (TrHPVDNA) levels and presence of cervical cancer at diagnosis and following definitive intent management.",[399],"Cervical Cancer","2026-05-08",{"date":402,"type":32},"2026-05-12",{"date":404,"type":32},"2024-05-03",{"date":406,"type":21},"2027-01-15",{"name":408,"class":39},"UNC Lineberger Comprehensive Cancer Center",{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":48,"sex":17,"minAge":416,"maxAge":304,"enrollmentInfo":417,"targetDuration":4,"studyType":22,"phases":419,"briefSummary":420,"conditions":421,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":433},"100624843","group-postpartum-and-well-child-care-for-maternal-and-infant-health-100624843","NCT07414901","Group Postpartum and Well-Child Care for Maternal and Infant Health","Evaluating the Effectiveness of an Integrated Group Postpartum and Well-child Care Model on Maternal and Child Health Outcomes","Inclusion Criteria:\n\nAims 1\\&2:\n\n* Women presenting for their 1-week postnatal care visit with their infant at a study site clinic.\n* Over age 15.\n* One infant is less than 4 weeks old.\n* Able to speak and understand Chichewa.\n* Adolescents 15-17 must bring parent\u002Fguardian for consent\u002Fassent. Infants included as part of mother-infant dyad.\n\nAim 3:\n\n* Midwife or HSA serving as group care co-facilitator or key stakeholders in MoH\u002FZomba District\u002Fclinical administration\n* Able to speak Chichewa and\u002For English.\n\nExclusion Criteria:\n\nAim 1\\&2\n\n* Under age 15.\n* Serious physical or mental illness or marked cognitive impairment preventing informed consent.\n* Inability to participate in full intervention\n* Multiple infants (e.g. twins, triplets)\n\nAim 3\n\n-Serious physical or mental illness or marked cognitive impairment preventing informed consent.","1 Week",{"count":418,"type":21},1125,[24],"The proposed study will evaluate the effectiveness of an integrated group postpartum and well-child care model, compared to individual (usual) postnatal and well-child care, on maternal and child health outcomes. Results will provide clinical evidence for improved maternal and infant health care in the first year postpartum. The study will inform and provide lessons learned to advance maternal and infant health service delivery models in low resource settings.",[422,423],"Postpartum Health","Infant Health","2026-05-06",{"date":426,"type":32},"2026-05-07",{"date":428,"type":32},"2026-03-30",{"date":430,"type":21},"2030-01-30",{"name":432,"class":39},"Johns Hopkins University",16,{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":17,"minAge":441,"maxAge":442,"enrollmentInfo":443,"targetDuration":4,"studyType":22,"phases":445,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":456},"100586886","phase-2-comprehensive-ambulatory-antibiotics-for-the-treatment-of-congenital-syphilis-100586886","NCT06921213","Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis","Cares-1","Inclusion Criteria:\n\n1. Infants at risk of congenital syphilis at birth defined as:\n\n   1. an infant born to a mother who tests positive for syphilis in pregnancy using registered and licensed locally-available diagnostic tests for example but not limited to a Treponemal rapid POCT, an RPR or both.\n\n      AND\n   2. the mother is untreated in the current pregnancy defined as:\n\n   i. she tested positive at antenatal care and received no treatment OR ii. she was never tested during antenatal care OR iii. she tested negative at antenatal care and positive on re-testing at delivery\n\n   OR c. the mother is inadequately treated in the current pregnancy defined as:\n\n   i. Having received a non-penicillin based treatment regimen; and\u002For ii. Does not have documentation of 3 doses of IM Benzathine Penicillin, given 7-10 days apart, with the last dose given \\> 30 days prior to delivery OR b. The mother was adequately treated in the current pregnancy BUT considers herself at risk of re-infection following a midwife delivered explanation of risk (partner treatment, multiple partners etc).\n2. Infants who are asymptomatic for a diagnosis of congenital syphilis following application of a clinical proforma by the study team (Appendix 1)\n3. Infants who are less than \\\u003C= 7 days of life AND with a post-menstrual age (PMA) of 34-42 weeks (Appendix 2).\n4. Infants who are tolerating enteral feeds, including if they are being administered by an NG tube.\n\nExclusion Criteria:\n\n\\- 1. The infant's clinical condition at birth or prior to randomisation requires ongoing (\\> 48 hours) treatment with antibiotics with the potential for anti-treponemal activity i.e. B-lactams, Cephalosporins, Carbapenems.\n\n2\\. They have a birthweight \\\u003C2kg 3. They are nil by mouth. 4. They have a life-limiting congenital anomaly","0 Days","7 Days",{"count":444,"type":21},90,[54],"CARES-1 is a randomised, open-label, phase II pharmacokinetic (PK) and safety study of ambulatory antibiotics for the treatment of neonates with \"all-risk\" asymptomatic congenital syphilis.",[448],"Syphilis, Congenital",{"date":379,"type":32},{"date":451,"type":32},"2026-05-04",{"date":453,"type":21},"2027-06-30",{"name":455,"class":39},"London School of Hygiene and Tropical Medicine",3,{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":48,"sex":129,"minAge":277,"maxAge":465,"enrollmentInfo":466,"targetDuration":4,"studyType":22,"phases":468,"briefSummary":470,"conditions":471,"keywords":475,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":154},"100528235","phase-4-uncpm-22314---pregnancy-infant-and-maternal-health-outcomes-study-100528235","NCT06158126","UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study","UNCPM 22314 - Evaluating the Safety of Pregnancy, Infant and Maternal Health Outcomes Among PrEP Users in Malawi","PrIMO","Inclusion Criteria:\n\nMaternal participants:\n\n* Confirmed pregnancy by urine pregnancy test or ultrasound.\n* Aged 15 years or older\n* PrEP-eligible by Malawi local guidelines\n* Confirmed HIV-negative based on the local HIV testing algorithm\n* Hepatitis B surface antigen (HBsAg) negative\n* Weight \\>35 kg\n* Provided informed consent and expressed willingness to participate in study activities with their infants.\n\nInfant participants: Infant participants will enter the study with their mother as unborn infants. There are no specific eligibility criteria for infant participation otherwise.\n\nExclusion Criteria:\n\nMaternal participants will not be eligible to enter the prospective cohort study if any of the following conditions are identified during the screening process:\n\n* Known to be living with HIV\n* Known allergies to CAB-LA, TDF\u002F3TC or FTC\u002FTDF\n* Other current significant disease process (active or chronic), substance use, or social circumstances that, in the judgment of the site investigator would make participation in the study unsafe.\n* Intention to leave the study site's catchment area of Bwaila before scheduled study exit.","55 Years",{"count":467,"type":21},621,[469],"PHASE4","The primary purpose of this study is to assess the safety of long-acting injectable cabotegravir (CAB-LA) and oral pre-expose prophylaxis (PrEP) (FTC\u002FTDF or 3TC\u002FTDF) for the prevention of HIV during pregnancy and breastfeeding among pregnant women and their infants in Malawi. The main question the study aims to answer is:\n\n\\- Do composite adverse pregnancy events, maternal health outcomes, and\u002For infant health outcomes differ between individuals taking oral PrEP and those taking CAB-LA?\n\nWomen who are already using PrEP at the time of pregnancy diagnosis or those who initiate PrEP during pregnancy will enroll into a Safety Cohort where they will be closely followed up during pregnancy while optimizing their antenatal care (ANC) per the Malawi ANC package. Women will have access to either CAB-LA or oral PrEP and will be given an opportunity to choose one option. Women and their infants will attend a series of follow-up visits through pregnancy, birth, and the postnatal period.\n\nIn addition, the study will contribute to the development of a national PrEP Pregnancy Registry which will be initially rolled out in Lilongwe and Blantyre -the two most populous cities in Malawi-before a nationwide roll out begins under the guidance of the Malawi Ministry of Health.",[472,473,474],"Pre-exposure Prophylaxis","HIV Prevention","Pregnancy Related",[476,477,478,479,480,481,482],"PrEP","Pregnancy","Breastfeeding","Infant health","HIV prevention","Maternal health","Eliminating mother-to-child transmission (EMTCT)","2026-05-01",{"date":485,"type":32},"2026-05-05",{"date":487,"type":32},"2024-04-17",{"date":489,"type":21},"2027-12",{"name":491,"class":39},"University of North Carolina, Chapel Hill",{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":48,"sex":17,"minAge":498,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":22,"phases":501,"briefSummary":502,"conditions":503,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":154},"100594170","phase-4-kupewa-optimizing-implementation-strategies-for-cervical-cancer-prevention-100594170","NCT07015957","Kupewa: Optimizing Implementation Strategies for Cervical Cancer Prevention","Inclusion Criteria:\n\n* Health workers: People who provide medical care and counseling (typically medical assistants, clinical officers, and nurses), and interact with adolescent girls and young women aged 9-24 and\u002For their parents\u002Fcaregivers.\n* Clients: Non-pregnant females aged 9-24 (for those aged 9-17, their male or female parent\u002Fguardian will also be eligible for participation) who present for HIV care at a participating health facility during the study period.\n\nExclusion Criteria:\n\n* Health workers: Less than 18 years of age, or not an active and regular provider of medical care or counseling at the facility, or unable or unwilling to provide informed consent.\n* Clients: \\\u003C9 or \\>24 years old, or pregnancy, or unable or unwilling to provide informed consent.","9 Years",{"count":500,"type":21},7000,[469],"The goal of this clinical trial is identify an effective and implementable set of implementation strategies to increase cervical cancer prevention in Malawi. The main questions it aims to answer are:\n\n1. Which implementation strategies produce the greatest increase in provider recommendation for, and uptake of, cervical cancer prevention tools among people receiving HIV care.\n2. What is the acceptability, appropriateness, feasibility, and cost of these implementation strategies.\n3. What is the sustained effect of these implementation strategies. The implementation strategies will be conducted with health workers (clinical officers, nurses, and medical assistants): training, coaching, and a reminder system.",[504],"Cervical Cancer Prevention","2026-04-29",{"date":507,"type":32},"2026-04-30",{"date":509,"type":32},"2025-07-08",{"date":511,"type":21},"2029-08",{"name":513,"class":39},"New York University",{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":129,"minAge":18,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":22,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":40},"100570090","enhanced-problem-solving-therapy-and-hiv-engagement-support-to-improve-perinatal-mental-health--hiv-outcomes-in-malawi-100570090","NCT06702722","Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health & HIV Outcomes in Malawi","Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health and HIV Outcomes in Malawi: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Presenting for antenatal care at one of our 5 recruitment sites\n* ≥ 18 years of age\n* ≤ 34 weeks gestation\n* HIV-positive, based on medical records\n* Initiating, re-initiating, or on established ART during index pregnancy\n* Elevated depressive symptoms as indicated by a EPDS score ≥10. The EPDS is widely used to assess perinatal mood disorders that has been validated in perinatal populations in Malawi with this cut point to identify probable perinatal depression\n\nExclusion Criteria:\n\n* Suicidal ideation evaluated as acute risk.\n* Other health concerns requiring emergent response.",{"count":522,"type":21},400,[24],"The main objective of the proposed study is to evaluate the effectiveness of the Enhanced Friendship Bench intervention to improve perinatal depression, HIV care engagement, and infant health outcomes among pregnant women with HIV and depression in Malawi.",[142,526,527],"Depression","Depression, Postpartum","2026-04-28",{"date":505,"type":32},{"date":531,"type":32},"2025-02-26",{"date":533,"type":21},"2028-06",{"name":491,"class":39},{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":543,"targetDuration":4,"studyType":307,"phases":4,"briefSummary":544,"conditions":545,"keywords":547,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":154},"100587478","leukemia-adapted-protocol-100587478","NCT06928909","Leukemia Adapted Protocol","Evaluating the Feasibility of an Intensity-Adapted Pediatric Acute Myeloid Leukemia Treatment Guideline in Malawi","LEAP","Inclusion Criteria:\n\n1. Age Patients must be \\\u003C18 years of age at time of study enrollment.\n2. Diagnosis\n\n   Patients must be diagnosed with de novo AML according to 2022 WHO 5th Edition classification with or without extramedullary disease. Patients must have one of the following:\n   * Bone marrow myeloblasts ≥20%. In cases of dry taps due to fibrosis, myeloblast percentage can be estimated from a bone marrow biopsy core specimen. Due to unavailable molecular\u002Fcytogenetic diagnostics in Malawi, patients with \\\u003C20% bone marrow myeloblasts can be included in the study at the discretion of the treating oncologist with rationale documented.\n   * In cases where a bone marrow evaluation is not safe\u002Ffeasible, a peripheral blood sample may be used with a documented absolute myeloblast percentage of ≥1000\u002FμL calculated based on a total white blood cell count and percentage circulating blasts.\n3. Therapy Patients must begin treatment according to the 2023 KCH AML therapy CPG.\n\nExclusion Criteria:\n\n1. Patients with any of the following conditions or criteria will be excluded from the study:\n\n   * Juvenile myelomonocytic leukemia\n   * Transient myeloproliferative disorder\n   * Acute promyelocytic leukemia\n   * Mixed phenotype acute leukemia\n   * Trisomy 21\n   * Current pregnancy\n   * Previous or concurrent malignancy\n   * Isolated myeloid sarcoma\n2. Patients previously treated with antineoplastic therapy with the following exceptions:\n\n   * Hydroxyurea\n   * Corticosteroids\n   * Intrathecal chemotherapy at diagnosis",{"count":396,"type":21},"In resource-constrained settings such as Malawi, survival rates for pediatric acute myeloid leukemia (AML) are dismally low compared to high-resource environments. This disparity highlights the urgent need for feasible treatment protocols tailored to the realities of these regions where most children with cancer are treated. In 2023, after reviewing favorable clinical trials results in other resource-limited settings, the Kamuzu Central Hospital (KCH) pediatric cancer unit adopted an evidence-based intensity-adapted clinical practice guideline (CPG) developed by the International Society of Paediatric Oncology (SIOP) as its standard of care for the treatment of pediatric AML, aiming to balance curative intent with manageable toxicity. The current study is a prospective evaluation of outcomes of standard of care in Malawi using the SIOP CPG in a real-world setting.\n\nThe LEAP study aims to assess the implementation of the SIOP AML guidelines at KCH in an effort to continually improve outcomes in Malawi. The study is an observational-implementation design with a composite effectiveness-implementation outcome called Implementation Success. Implementation Success combines feasibility, the ability of patients to complete all aspects of the CPG, with effectiveness, the ability to maintain historical rates of complete remission of 40% at the treatment center.\n\nThis prospective cohort study will enroll children under 18 years diagnosed with de novo AML at KCH. Implementation Success will be the primary endpoint, with secondary endpoints including CPG fidelity, long-term survival, adverse events, and hematologic recovery times. Patient-reported outcomes will also be collected to assess the impact of treatment on quality of life.\n\nThis will be the first prospective study of pediatric AML in sub-Saharan Africa, providing critical data on the management of AML in low-resource settings. By assessing the implementation of a context-adapted CPG, the study will contribute to the global effort to improve pediatric AML outcomes in resource-constrained environments. The findings will serve to guide practitioners in Malawi and similar settings, and the data generated will be invaluable for future clinical decisions and CPG development.",[546],"Acute Myeloid Leukaemia",[548,549],"Pediatric Acute Myeloid Treatment","Acute myeloid leukemia (AML)","2026-03-31",{"date":552,"type":32},"2026-04-06",{"date":554,"type":32},"2025-01-01",{"date":556,"type":21},"2030-12-31",{"name":558,"class":39},"Baylor College of Medicine",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":129,"minAge":18,"maxAge":567,"enrollmentInfo":568,"targetDuration":4,"studyType":22,"phases":570,"briefSummary":571,"conditions":572,"keywords":576,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":154},"100631553","what-works-to-prevent-violence---malawi-moyo-olemekeza-100631553","NCT07502183","What Works to Prevent Violence - Malawi Moyo Olemekeza","What Works to Prevent Violence Against Women and Girls: Impact at Scale: A Cluster Randomized Controlled Trial to Assess the Effectiveness of a Community-mobilisation Intervention to Prevent Violence Against Women in Malawi","WW-M-MO","Inclusion Criteria:\n\n1. The household has a woman aged 18-49 who are in monogamous relationships\n2. The household is food insecure, where food insecurity is scored on a scale of (0-7) and constructed from responses on 3 questions related to the household's food sufficiency (a) How does the household meet its food needs (b) How often does the household has food surplus and (c) How many times do you eat a full meal on a typical day over a year.\n3. The primary decision maker of the household is male\n4. Household is willing to participate in community meetings","49 Years",{"count":569,"type":21},1700,[24],"Violence against women is complex and must be addressed at multiple levels, with leadership from women themselves on how to bring about positive change to free women and girls from daily experiences of violence and to promote their rights. It is in this context that the Pamodzi Kuthetsa Nkhanza (PKN) consortium will implement a programme to facilitate the prevention of intimate partner violence (IPV) in Malawi as one of the most common forms of VAW experienced in Malawi. The programme takes a whole community approach and uses gender transformative approaches at different levels of society to address the root causes of IPV. It will draw primarily on two existing, evidence-based prevention models, namely SASA! Together (community mobilisation model) and Moyo Olemekeza (MO) (gender norms and behaviour change and economic empowerment approach). The institutional strengthening component of these evaluations is meant to create an enabling environment.\n\nThe cRCT described in this protocol will assess the added value of the women's social and economic empowerment programme (MO) when layered on top of SASA! Together for eligible at-risk households.",[573,574,575],"Intimate Partner Violence (IPV)","Earning Outcomes","Norms, Social",[577,578],"Intimate Partner Violence","Economic Empowerment",{"date":580,"type":32},"2026-04-03",{"date":582,"type":32},"2025-10-15",{"date":584,"type":21},"2029-01",{"name":586,"class":39},"George Washington University",{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":22,"phases":596,"briefSummary":597,"conditions":598,"keywords":603,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":154},"100566756","prevention-of-mother-to-child-transmission-pmtct-among-women-experiencing-depression-in-malawi-100566756","NCT06659315","Prevention of Mother-to-child Transmission (PMTCT) Among Women Experiencing Depression in Malawi","Addressing Perinatal Depression and PMTCT Adherence in Malawi: A Couple-Based Approach","Inclusion Criteria:\n\n* In a marriage or cohabitating union for at least 6 months.\n* One member of the couple is a woman in the second or third trimester of pregnancy who is living with HIV and screens positive for depression (\\>10 on the PHQ9).\n* Have revealed their HIV status to their partner if living with HIV\\>\n\nExclusion Criteria:\n\n* Fear their safety would be at risk.\n* Report incidents of severe intimate partner violence (IPV) in the past three months using the WHO IPV measure.",{"count":595,"type":21},180,[24],"Prevention of mother-to-child transmission (PMTCT) of HIV virtually eliminates transmission of HIV from mothers to their infants. Adherence to PMTCT (i.e., to antiretroviral therapy, infant prophylaxis, and exclusive breastfeeding) during pregnancy and the postpartum period is challenging, with evidence from sub-Saharan Africa (SSA) showing suboptimal adherence and persistent viremia among perinatal women. Perinatal depression (PD) is a major driver of women's poor adherence to PMTCT. Interventions that involve male partners to provide social and food\u002Feconomic support could be a promising approach for addressing PD and PMTCT, yet few interventions have intervened with couples to improve systems of support, communication, and other dyadic processes. The investigators propose to develop and test a couple-based approach to intervene on the mother's perinatal depressive symptoms and to strengthen the relationship and support system for partners to work together around depression to improve PMTCT adherence. The study will take place in antenatal and HIV care settings in Zomba, Malawi. The specific aims are: (1) to develop a couple-based intervention to target perinatal depression (PD) based on an evidence-based approach using problem-solving therapy (PST), augmented with content on couple communication and problem-solving skills; and (2) to assess the feasibility and acceptability (F\\&A) of the intervention via a pilot randomized controlled trial (RCT). Our short-term goal is the produce a couple-focused PST intervention that can be added to the global health toolkit for treating depression in perinatal women. Our long-term goal is to produce a high-impact and sustainable intervention leveraging the couple relationship that can be scaled-up to address depression, PMTCT adherence, and family health.",[599,600,601,602],"HIV Antiretroviral Therapy (ART) Adherence","Perinatal Mental Health","Depression During Pregnancy","PMTCT",[604,605,606,602,607],"Perinatal depression","Couples","Problem-solving","ART adherence",{"date":428,"type":32},{"date":610,"type":32},"2025-11-11",{"date":612,"type":21},"2027-07-01",{"name":387,"class":39},{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":618,"acronym":619,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":17,"minAge":621,"maxAge":622,"enrollmentInfo":623,"targetDuration":4,"studyType":22,"phases":624,"briefSummary":625,"conditions":626,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":364},"100527931","choline-to-improve-malnutrition-and-enhance-cognition-100527931","NCT06154174","Choline to Improve Malnutrition and Enhance Cognition","CHIME-SAM","Inclusion Criteria:\n\n* 6-59 months of age\n* mid-upper arm circumference \\\u003C 11.5 cm and\u002For weight-for-length z-score \\\u003C -3 and\u002For presence of bilateral pedal pitting edema\n* willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic\n\nExclusion Criteria:\n\n* features of complicated SAM: inability to tolerate a 30g test dose of RUTF, breathing difficulties, mental status changes, sepsis, or physician\u002Fnursing clinical assessment that the child needs immediate hospitalization\n* participation in a separate feeding program within the past month\n* known allergy to study food ingredient (peanut, milk, fish)\n* intention to move away from catchment area within 9 months\n* developmental delay\n* presence of a chronic severe medical condition (other than TB and HIV), such as congenital heart disease","6 Months","59 Months",{"count":306,"type":21},[24],"The goal of this clinical trial is to test adding choline to ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition (SAM) in Malawi. The main question it aims to answer is:\n\n\\- Will the addition of a 500mg daily dose of choline to RUTF during treatment for SAM improve cognitive development among 6-59-month-old Malawian children compared with standard RUTF without added choline?",[627,628,629,630],"Severe Acute Malnutrition","Cognitive Impairment","Wasting","Kwashiorkor","2026-03-16",{"date":633,"type":32},"2026-03-17",{"date":635,"type":32},"2023-12-05",{"date":637,"type":21},"2026-11",{"name":639,"class":39},"Washington University School of Medicine",{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":4,"eligibilityCriteria":646,"healthyVolunteers":48,"sex":17,"minAge":277,"maxAge":130,"enrollmentInfo":647,"targetDuration":4,"studyType":22,"phases":649,"briefSummary":650,"conditions":651,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":659,"locationsCount":154},"100609989","pathtoscale-the-persist-trial-100609989","NCT07221747","PathToScale: The PERSIST Trial","ACCELERATING THE PATH TO SCALE FOR INJECTABLE HIV PRE-EXPOSURE PROPHYLAXIS (PrEP) in MALAWI: THE PERSIST TRIAL","Inclusion Criteria:\n\n•Inclusion criteria for long-acting injectable cabotegravir for pre-exposure prophylaxis will be applied per Ministry of Health guidelines. Per Ministry of Health guidelines, the following populations will be prioritized for long-acting injectable cabotegravir for pre-exposure prophylaxis distribution, following individual risk assessment:\n\nIndividuals who are 15+ years old AND either\n\n1. Female sex workers (FSW) OR\n2. Men who have sex with men (MSM) OR\n3. Transgender individuals (TG) OR\n4. Women and adolescent girls and young women (AGYW) presenting at STI services and\u002For family planning and\u002For HIV testing services OR\n5. Breastfeeding women (BFW) OR\n6. Male partners of female sex workers and\u002For Men at high risk for HIV and\u002For men presenting with a syndromic or lab-confirmed sexually transmitted infections. All individuals initiated on long-acting injectable cabotegravir for pre-exposure prophylaxis 15 years or above will be included in the passively enrolled sample.\n\nExclusion Criteria:\n\n* Per Ministry of Health guidelines, exclusion criteria for long-acting injectable cabotegravir for pre-exposure prophylaxis includes:\n\nThose living with HIV-1 or evidence of possible acute HIV infection OR Those with a prior Hepatitis B diagnosis OR Those with a known history of severe side effects to Cabotegravir Long Acting OR Those unwilling or unable to return for 3-monthly HIV testing or 2-monthly counseling and safety monitoring visits OR Clients currently on multi-drug resistance tuberculosis (MDR-TB) medications OR Clients currently taking post-exposure prophylaxis.",{"count":648,"type":21},9900,[24],"The purpose of this study is to identify the effectiveness of a bundle of strategies to support continuation of clients on pre-exposure prophylaxis, including long-acting injectable cabotegravir and oral pre-exposure prophylaxis to high priority groups.",[652,136],"Oral Pre-exposure Prophylaxis (PrEP)","2026-03-02",{"date":655,"type":32},"2026-03-04",{"date":657,"type":32},"2026-02-16",{"date":637,"type":21},{"name":660,"class":39},"Georgetown University",{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":667,"eligibilityCriteria":668,"healthyVolunteers":48,"sex":17,"minAge":18,"maxAge":567,"enrollmentInfo":669,"targetDuration":4,"studyType":22,"phases":671,"briefSummary":672,"conditions":673,"keywords":675,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":681,"lastUpdatePostDateStruct":682,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":688,"locationsCount":154},"100576292","what-works---malawi-sasa-together-100576292","NCT06783400","What Works - Malawi SASA! Together","What Works to Prevent Violence Against Women and Girls: Impact at Scale: A Cluster Randomized Controlled Trial to Assess the Effectiveness of a Community-mobilisation Intervention to Prevent Violence Against Women in Malawi - SASA! Together","WW-M-SASA!","Inclusion Criteria:\n\n* Women and men aged 18-49 who have ever been in an intimate (romantic) relationship.\n* Living in selected Group Village Heads (GVHs) in Lilongwe or Balaka districts for at least a year. The specific Traditional Authorities (TAs) in Lilongwe are: Kalolo, Chimutu, Kabudula; The TAs in Balaka are: Msamala and Nyanyala.\n\nExclusion Criteria:\n\n* Women and men younger than 18 years or older than 49 years old\n* Women who have never had an intimate relationship.\n* Not living in selected TAs and GVHs in Lilongwe or Balaka districts, or living in selected GVHs for less than one year\n* Paid employees of the PKN programme (any element), including SASA! Together community activists who deliver the programme activities.",{"count":670,"type":21},4800,[24],"Violence against women is complex and must be addressed at multiple levels, with leadership from women themselves on how to bring about positive change to free women and girls from daily experiences of violence and to promote their rights. It is in this context that the Pamodzi Kuthetsa Nkhanza (PKN) consortium will implement a programme to facilitate the prevention of intimate partner violence (IPV) in Malawi as one of the most common forms of VAW experienced in Malawi. The programme takes a whole community approach and uses gender transformative approaches at different levels of society to address the root causes of IPV. It will draw primarily on two existing, evidence-based prevention models, namely SASA! Together (community mobilisation model) and Moyo Olemekeza (MO) (gender norms and behaviour change and economic empowerment approach).\n\nA cluster randomised controlled trial (cRCT) will evaluate the effectiveness of the PKN programme, assessing the effectiveness of the SASA! Together programme at shifting individual behaviours and reducing violence in intimate relationships while also tackling community norms that drive these forms of violence against women. The cRCT will also assess the added value of combining SASA! Together and a women's social and economic empowerment programme (MO) for most at-risk households.\n\nThis protocol focuses on the evaluation of the SASA! Together programme.",[573,575,674],"Gender Inequitable Behavior",[676,677,678,679,680],"intimate partner violence","gender","social norms","community mobilization","behavior change","2026-02-10",{"date":683,"type":32},"2026-02-12",{"date":685,"type":32},"2024-08-27",{"date":687,"type":21},"2029-12",{"name":586,"class":39},""]