[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Eswatini\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":115},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100615098","phase-2-phase-2b-open-label-multisite-randomized-crossover-study-of-dpp-versus-2pr-100615098",false,"NCT07288190","Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR","A Multisite, Open-label, Randomized Crossover Study Comparing Adherence to a Single Daily Dual Prevention Pill (DPP) Versus FTC\u002FTDF and Combined Oral Contraception Separate Pill Dosing (2PR), Given for Pre-exposure Prophylaxis and Pregnancy Prevention in Women","Inclusion Criteria:\n\n* Age 16 through 39 years old (inclusive) at Screening.\n* Adults must be able and willing to provide informed consent. Adolescents (16- and 17-year-olds) will be consented according to applicable local guidelines, by obtaining participant assent and where applicable parental or guardian permission.\n* Able and willing to provide adequate locator information.\n* Able and willing to comply with all study procedures.\n* Must be post-menarche and pre-menopausal and could potentially become pregnant.\n* Sexually active, defined as having had penile-vaginal sex within the 3 months before Screening (per self-report)\n* Negative pregnancy test at Screening and Enrollment.\n* Does not intend to become pregnant within the next 12 months.\n* Willing to use COCs for at least 48 weeks as their method of contraception.\n* HIV negative at Screening and Enrollment.\n* Willing to use oral PrEP for at least 48 weeks.\n* Hepatitis B (HBV) surface antigen (HbsAg) negative per blood test at Screening.\n* Hepatitis C (HCV) negative at Screening.\n* Normal estimated creatinine clearance (eCrCl) ≥ 60 ml\u002Fmin per blood test at Screening.\n\nExclusion Criteria:\n\n* Intolerance, adverse reaction, or laboratory abnormality associated with PrEP use in the past.\n* Unable to become pregnant e.g., had a tubal ligation or hysterectomy or otherwise lacks a uterus, or is currently using another form of contraception.\n* Medically ineligible for combined hormonal contraception and specifically COCs per World Health Organization (WHO) medical eligibility criteria for contraceptive use or similar local medical eligibility guidelines (e.g., Centers for Disease Control and Prevention eligibility criteria).\n* Medically ineligible for PrEP based on WHO and\u002For local guidelines.\n* Using or planning to use another pregnancy prevention product other than oral contraception (condoms are permitted) during the next 48 weeks.\n* Using or planning to use another HIV prevention product other than condoms during the next 48 weeks.\n* Any other condition the clinician feels would jeopardize the health and wellbeing of the participant",true,"FEMALE","16 Years","39 Years",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","To evaluate adherence to a single dual-prevention pill (DPP) compared with a two-pill regimen (2PR) for pre-exposure prophylaxis (PrEP) and pregnancy prevention in women without HIV.",[28,29],"Pregnancy","HIV Infections",[31,32,33,34],"Pre-exposure Prophylaxis (PrEP)","Contraception","Dual Prevention Pill (DPP)","Pregnancy Prevention","NOT_YET_RECRUITING","2026-02-17",{"date":38,"type":39},"2026-02-19","ACTUAL",{"date":41,"type":22},"2026-05-15",{"date":43,"type":22},"2028-05-15",{"name":45,"class":46},"HIV Prevention Trials Network","NETWORK",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":16,"sex":55,"minAge":4,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100526409","phase-3-long-term-follow-up-of-long-acting-cabotegravir-cab-la-for-prep-pre-exposure-prophylaxis-in-participants-at-risk-of-acquiring-hiv-human-immunodeficiency-virus-100526409","NCT06134362","Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)","A Phase IIIB, Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition","PALISADE","Inclusion criteria:\n\nType of participant\n\n1. Participants must have recently completed or be currently enrolled and ongoing in one of the following studies on the CAB LA arm:\n\n   * HPTN 083 open label extension\n   * HPTN 084 open label extension (including pregnancy sub-study)\n\n   Participants that completed study participation ≥3 months ago must be discussed with the Medical Monitor prior to enrolment.\n\n   Participants who have prematurely withdrawn from prior CAB PrEP studies cannot enroll into this study.\n2. Evidence of continued benefit (HIV negative and at risk) from CAB LA during participation in the parent study\u002Fsub-study.\n3. Participants must have nonreactive HIV tests at Screening (rapid test, immunoassay \\[antigen\u002Fantibody\\] test and HIV-1 RNA results must all be available and nonreactive) and Day 1 (at least one of rapid test and immunoassay \\[antigen\u002Fantibody test\\] results must be available and nonreactive). Participants who have one or more reactive or positive HIV test result(s) will not be enrolled, even if subsequent confirmatory testing indicates they are not HIV-infected.\n\n   Sex\n4. Males and Females:\n\n   All participants who are engaging in sexual activity should be counselled on safer sexual practices including the use and benefit\u002Frisk of effective barrier methods (e.g., male condom) and on the risk of acquiring HIV and other STIs.\n\n   Females:\n\n   Cisgender female participants who are of childbearing potential and who are engaging in sexual activity that could lead to pregnancy, must talk to the investigator about recommended contraception options. Contraception will be optional in this study. Condoms are recommended in addition, because their appropriate use is the only contraception method effective for preventing HIV-1 transmission.\n\n   Pregnant participants from the HPTN 084 study are eligible to enroll into this study if they meet all eligibility criteria.\n\n   Informed consent\n5. Participant or caregiver\u002Flegal guardian is able and willing to provide signed informed consent as described in Protocol Section 11.1.5, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Where applicable, participants must provide written assent.\n\nExclusion Criteria:\n\nConcurrent conditions\u002Fmedical history (includes liver function)\n\n1. Participants who are currently enrolled in the eligible studies on the TDF\u002FFTC arm are not eligible to enroll into this study. Participants receiving short-term oral TDF\u002FFTC bridging may be enrolled following consultation with the Medical Monitor.\n2. Previous premature discontinuation from IP in the parent study\u002Fsub-study.\n3. ALT \\>5 × ULN; or ALT\\>3 × ULN and bilirubin \\>1.5 × ULN (with \\>35% direct bilirubin) in the screening liver chemistry test result.\n4. Participants with known active hepatitis B infection (as indicated by a positive HBsAg and\u002For quantifiable HBV DNA). Participants negative for HBsAg but positive for anti-HBc and positive for anti-HBs (past and\u002For current evidence) are immune to HBV and are not excluded.\n5. Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator).\n6. Known history of cirrhosis with or without viral hepatitis co-infection.\n7. Participant is currently participating in or has participated in a study (other than the studies listed in Inclusion Criteria 1) with a compound or device that is not commercially available within 30 days prior to signing informed consent, unless permission from the Medical Monitor is granted.\n8. Presence of or any history of allergy\u002Fsensitivity to the study drug or its components.\n9. Inflammatory skin conditions that compromise the safety of IM injections, per the discretion of the investigator. Mild skin conditions may not be exclusionary at the discretion of the investigator or designee.\n10. Participant has a gluteal implant, tattoo or other dermatological condition overlying the buttock region which in the opinion of the investigator or designee may interfere with the injection or interpretation of ISRs.\n11. Coagulopathy (primary or iatrogenic) which would contraindicate IM injection. Concomitant medications\n12. Participant is receiving any protocol-defined prohibited medication and is unwilling or unable to switch to an alternate medication.\n13. Anticipated need for HCV therapy with interferon or any drugs that have potential for adverse drug: drug interactions with study treatment throughout the entire study period.\n\n    Relevant habits\n14. Participant is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.\n15. Any condition (i(including but not limited to substance use disorder) that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol.\n\n    Other\n16. Participant has in the last 14 days prior to screening presented with signs and symptoms, which, in the opinion of the investigator, are suggestive of acute HIV infection. Participants may only be enrolled if clinical suspicion of HIV is ruled out with non-reactive results using appropriate HIV tests as per Inclusion Criterion #3.\n17. Participant is a ward of the state (e.g. child in care).","ALL",{"count":57,"type":22},3508,[59],"PHASE3","The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN 083 and HPTN 084 and associated sub-studies. Participants will continue receiving CAB LA and be followed for new HIV diagnosis, SAEs (serious adverse events), Grade 3 and Grade 4 ISRs (injection site reactions), and AEs (adverse events) leading to withdrawal.",[29],[63,64,65,66,67,68,69,70,71],"HIV","Human Immunodeficiency Virus","CAB LA","Cabotegravir","Apretude","PrEP","HPTN 083","HPTN 084","DAIDS","RECRUITING","2025-12-19",{"date":75,"type":39},"2025-12-22",{"date":77,"type":39},"2024-05-14",{"date":79,"type":22},"2029-01-01",{"name":81,"class":82},"ViiV Healthcare","INDUSTRY",34,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":16,"sex":55,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"100605678","the-eswatini-study-on-neurocognitive-performance-in-adolescents-living-with-hiv-100605678","NCT07165639","The Eswatini Study on Neurocognitive Performance in Adolescents Living With HIV","Association Between Inflammation Biomarkers and Neurocognitive Performance Among Adolescents Living With HIV in Eswatini","Inclusion Criteria:\n\n* Cases\n\n  * Adolescents aged 13-19 years\n  * HIV-positive\n  * Undergoing antiretroviral therapy at Baylor Clinic\n  * Providing consent or assent to participate\n\nControls\n\n* Adolescents aged 13-19 years\n* HIV-negative\n* Providing consent or assent to participate\n\nExclusion Criteria:\n\n* Exclusion Criteria\n\n  * Recent (within 2 months) acute conditions: influenza, COVID-19, TB, acute gastroenteritis (as these conditions elevate CRP levels)\n  * Chronic conditions: diabetes, hypertension, asthma\n  * Neurological disorders: epilepsy, cerebrovascular accident, neurodegenerative diseases\n  * History of significant cranial trauma or perinatal complications\n  * All the aforementioned conditions will be identified through self-reported data and medical records.","13 Years","19 Years",{"count":94,"type":22},80,"OBSERVATIONAL","This study explores the link between inflammatory biomarkers and neurocognitive performance in adolescents living with HIV (ALHIV) in Eswatini. Persistent HIV infection during adolescence has been associated with ongoing systemic inflammation and subsequent neurocognitive dysfunction. However, the exact nature of this relationship is not well-defined, especially in resource-limited settings where epidemiological and mechanistic data are scarce.\n\nobjectives\n\n* To determine the prevalence of cognitive impairment among a sample of adolescents living with HIV, compared to HIV-negative adolescents in Eswatini\n* To assess the relationship between neurocognitive performance and current viral load status in adolescent living with HIV (ALHIV).\n* To examine the association between inflammation biomarkers and viral load suppression status in ALHIV.\n* To investigate whether adolescents with HIV experiencing neurocognitive decline exhibit a high inflammatory status.\n\nA case-control design will be employed, involving 80 adolescents aged 13-19 years: 50 who are HIV-positive and 30 HIV-negative controls. Participants will be recruited from Baylor Manzini and Mbabane, as well as Raleigh Fitkin Memorial Hospital. Neurocognitive function will be evaluated using the Symbol Digit Modalities Test, focusing on areas such as processing speed, motor coordination, attention, and visual scanning.\n\nBlood samples will be collected to measure key inflammatory biomarkers, including C-reactive protein (CRP), soluble CD14 (sCD14), lipopolysaccharide (LPS), soluble CD163 (sCD163), and monocyte chemoattractant protein-1 (MCP-1). Sociodemographic and clinical data will be gathered through questionnaires and medical record reviews.\n\nPrimary outcomes will include neurocognitive performance scores, while secondary outcomes will involve biomarker levels and their correlation with cognitive function. Multivariate regression models will assess associations, adjusting for confounders such as age, sex, education, and HIV disease severity. Structural equation modeling will be used to explore potential mediators in the inflammation-cognition pathway.",[98],"HIV (Human Immunodeficiency Virus)",[100,64,101,102,103],"adolescent","inflammation biomarkers","neurocognitive performance","Eswatini","2025-09-09",{"date":106,"type":39},"2025-09-15",{"date":108,"type":22},"2025-11-30",{"date":110,"type":22},"2026-05-31",{"name":112,"class":113},"Eswatini Nazarene Health Institutions","OTHER",1,""]