[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"long-acting-injectable-cabotegravir-for-prep\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:long-acting-injectable-cabotegravir-for-prep":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,83],{"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":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100642577","betterinfo-on-womens-prep-choices-and-outcomes-in-malawi-100642577",false,"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)",true,"FEMALE","18 Years","110 Years",{"count":21,"type":22},384,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29],"Long-acting Injectable Cabotegravir for PrEP","Oral Pre-Exposure Prophylaxis (PrEP)",[31,32,33,34,35,36],"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":40,"type":41},"2026-06-15","ACTUAL",{"date":43,"type":22},"2026-06",{"date":45,"type":22},"2029-04",{"name":47,"class":48},"Johns Hopkins Bloomberg School of Public Health","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":49},"100632658","pharmacokinetic-study-of-long-acting-antiretrovirals-and-contraceptives-in-hiv-100632658","NCT07516548","Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV","Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptive Options in HIV Prevention","PHARAOH","Parent Tshireletso Study Inclusion Criteria:\n\n1. Female 18 years of age or older and willing and able to provide an informed consent\n2. \\\u003C 14 days after delivery (calendar day of birth = day 0)\n3. Negative HIV screening test (conducted at the time of enrolment)\n4. Female \\\u003C30 years old or has had \\\u003C 3 prior pregnancies (Gravida 1, 2, or 3 including this pregnancy)\n5. Plan to stay and receive postpartum and pediatric care in the Gaborone or Molepolole region for 24 months\n\nParent Tshireletso Study Exclusion Criteria\n\n1. Receiving carbamazepine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (\\>1 dose oral\u002FIV), or St. John's wort\n2. Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampicin)\n3. Previous hypersensitivity reaction to CAB or other INSTI\n4. Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 2 months\n5. Plan for pediatric and post-partum care outside the government system (private clinics)\n6. Inflammatory skin condition that compromises the safety of the intramuscular injection\n7. Weight \\\u003C35kg\n\nParent Doris Duke Study Inclusion Criteria Post-partum females included;\n\n1. if HIV-uninfected or unknown HIV status, willing to be tested for HIV\n2. if HIV-infected, documented to be on DTG as part of an antiretroviral treatment regimen\n3. maternal age \\>18 years,\n4. ability to speak English or Setswana\n5. intend to be available for follow up in Molepolole, Gaborone or Mochudi for 18 months post-delivery\n6. have access to a cell phone (including phone of friend or relative)\n\nParent Doris Duke Study Exclusion Criteria Post-partum females excluded if\n\n1. did not attend antenatal care or were not included in Tsepamo surveillance\n2. maternal age \\\u003C18,\n3. females who do not speak English or Setswana,\n4. unable or unwilling to give consent\n5. will not be able to attend follow up at a study site\n6. do not have access to any cell phone for follow up calls\n\nAdditional Inclusion Criteria for this PK Study\n\n1. For DMPA and ETG implant groups, intends to initiate or continue use of DMPA or ETG implant for at least another three or six months, respectively,\n2. For the CAB-LA groups, have received at least three consecutive CAB injections on time, including the one administered concurrently while starting a contraceptive method,\n3. Willing to undergo phlebotomy every 4 weeks for the duration of the sub-study period Additional Exclusion Criteria for this PK Study\n\n1\\) Use or anticipated use of nicotine-containing products (e.g., cigarettes or hookahs) known to interact with CAB-LA for the duration of the sub-study period 2) Use within the previous 90 days, current use, or planned future concomitant use of other hormonal contraceptives, including oral contraceptive methods 3) BMI≥35 4) Has any of the following laboratory abnormalities within the last year:\n\n1. Serum ALT\\>5x ULN at the time of screening,\n2. Serum creatinine \\>2.5x ULN at the time of screening. 5) Has any other condition that, in the opinion of the sub-study PI\u002Fdesignee, would preclude informed consent, make study participation unsafe, or complicate interpretation of study outcome 6) HIV infected females on the Doris Duke parent study",{"count":59,"type":22},105,"OBSERVATIONAL","This study is being done to understand how long-acting injectable cabotegravir (CAB-LA) used for HIV pre-exposure prophylaxis (PrEP) and hormonal contraceptive methods affect each other when used at the same time. Women who are already using CAB-LA or not using PrEP will choose to join one of several groups based on whether they use injectable contraceptive (IM DMPA), an etonogestrel implant, or no hormonal contraceptive. Participants will have study visits every 4 to 12 weeks for up to 12 or 24 weeks after starting a contraceptive method to collect blood samples and measure levels of CAB-LA and hormone concentrations. The study will compare these levels to see if taking CAB-LA changes hormone concentrations or if using hormonal contraception changes CAB-LA drug levels. Safety, side effects, satisfaction, and continuation of CAB-LA PrEP and contraceptive methods will also be evaluated.",[63,64,65,66,28],"HIV Infections","Contraception","Drug-drug Interaction","PrEP",[68,69,70,71,72,66,73],"Adolescent girls and young women","Injectable cabotegravir","Botswana","Long-acting injectable cabotegravir","Pharmacokinetic study","HIV prevention","2026-05-06",{"date":76,"type":41},"2026-05-08",{"date":78,"type":22},"2026-06-01",{"date":80,"type":22},"2026-12-31",{"name":82,"class":48},"University of Alabama at Birmingham",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":16,"sex":90,"minAge":91,"maxAge":19,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":49},"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.","ALL","15 Years",{"count":93,"type":22},9900,[25],"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.",[97,28],"Oral Pre-exposure Prophylaxis (PrEP)","RECRUITING","2026-03-02",{"date":101,"type":41},"2026-03-04",{"date":103,"type":41},"2026-02-16",{"date":105,"type":22},"2026-11",{"name":107,"class":48},"Georgetown University"]