[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535336":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":39,"locations":48,"responsibleParty":64,"collaborators":28,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":28,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":28,"overallStatus":50,"whyStopped":28,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Africa Health Research Institute","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention: Choice of long-acting PrEP and PEP added to Thetha Nami ngithethe nawe","EXPERIMENTAL","Tailored peer-led psychosocial support and social mobilisation into community based SRH and differentiated HIV care and prevention, including a choice of effective PrEP or PEP.\n\nAt the mobile AYFS in the intervention clusters nurses will offer the choice of either daily oral tenofovir\u002Femtricitabine or injectable long acting cabotegravir (CAB LA) to be delivered to adolescents and young adults at risk of HIV acquisition. Those who decline will have the option of three monthly dapivarine vaginal rings or Post Exposure Prophylaxis (PEP) packs (tenofovir\u002Flamuvidine\u002Fdolutegravir) to take home.\n\nPeer navigators will promote long-acting PrEP in addition to oral PrEP. As part of the peer mentorship package, the peer naviators will remind young people of their follow-up visits.",[13,14,15,16],"Drug: APRETUDE (cabotegravir) 600 mg\\3 mL","Drug: DAPIRING (Dapivirine) 25mg Vaginal Ring","Drug: tenofovir disoproxil and emtricitabine","Drug: Tenofovir Disoproxil, Lamuvidine and Dolutegravir",{"label":18,"type":19,"description":20,"interventionNames":21},"Control (Enhanced SoC): Thetha Nami ngithethe nawe","ACTIVE_COMPARATOR","Tailored peer-led psychosocial support and social mobilisation into community based SRH and differentiated HIV care and prevention, including oral tenofovir\u002Femtricitabine PrEP.\n\nIn the mobile AYFS, young people are offered self-taken vaginal swabs or urine testing for sexually transmitted infections (STIs), family planning support and syndromic and aetiological management for STIs; HIV counselling and two POCT; immediate initiation of ART if living with HIV and oral tenofovir\u002Femtricitabine PrEP if HIV test is negative and they are suitable.\n\nPeer navigators in control clusters will promote oral PrEP during their community based health promotion activities. As part of the peer mentorship package, the peer naviators will remind young people of their follow-up visits and if required accompany young people to the mobile clinics.",[15],[23,29,33,36],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","APRETUDE (cabotegravir) 600 mg\\3 mL","choice of 2-monthly injectable long acting cabotegravir. The initial visit will be followed by planned visit for the first injection, one month visit for second injection, and then 2-monthly CAB LA injections with repeat HIV testing and pregnancy testing, and referral to peer navigators for adherence and retention support. We will conduct HIV testing, STI testing, Hep B, Hep C, and safety bloods (Full Blood Count, Creatinine, Liver Function Tests) at baseline, HIV testing two monthly, and annual safety bloods, alongside annual STI testing.",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"DAPIRING (Dapivirine) 25mg Vaginal Ring","The initial visit is followed by a 7-day phone call, 3-monthly follow-up. Each follow-up will include repeat HIV testing (POCT x2 and dry blood spots for HIV ELISA) and pregnancy testing, syndromic management of STIs, and referral to peer navigators for adherence support and PrEP\u002FART and if applicable contraception refills. Safely bloods (full blood count, creatinine, liver function tests) will follow national guidelines. Currently we aim to do baseline and annual safety bloods, alongside annual STI testing",[9],{"type":24,"name":34,"description":31,"armGroupLabels":35,"otherNames":28},"tenofovir disoproxil and emtricitabine",[18,9],{"type":24,"name":37,"description":31,"armGroupLabels":38,"otherNames":28},"Tenofovir Disoproxil, Lamuvidine and Dolutegravir",[9],[40,45],{"name":41,"role":42,"phone":43,"phoneExt":28,"email":44},"Maryam G Shahmanesh, MBBChir PhD","CONTACT","+447776185572","m.shahmanesh@ucl.ac.uk",{"name":46,"role":42,"phone":28,"phoneExt":28,"email":47},"Limakatso Lebina, MBBS PhD","l.lebina@ucl.ac.uk",[49],{"facility":5,"status":50,"city":51,"state":52,"zip":28,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Somkele","KwaZulu-Natal","South Africa","ZA",{"type":56,"coordinates":57},"Point",[58,59],32.1,-28.31667,{"lat":59,"lon":58},[62],{"name":63,"role":42,"phone":28,"phoneExt":28,"email":44},"Maryam Shahmanesh, PhD",{"type":65,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100535336","phase-3-long-acting-hiv-pre-exposure-prophylaxis-integrated-with-sexual-and-reproductive-health---crct-100535336",false,"NCT06250504","Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT","Long-acting HIV Pre-Exposure Prophylaxis Integrated With Community-based Sexual and Reproductive Health in South Africa (LAPIS): A Hybrid (1a) Cluster Randomised Controlled Phase 3B Trial of Effectiveness and Implementation","LAPIS","Inclusion Criteria:\n\nAll young men and women aged 15-30 who are residing in the 40 administrative clusters in the study district and attend any integrated SRH\u002FHIV service\n\nDocumented HIV negative test\n\nSuitable for PrEP and\u002For already on PrEP\n\nWeight \\> 35 kg\n\nUnderstand the required dosing schedule and HIV testing.\n\nAware that details can be shared with a peer navigator to support their follow-up\n\nIf pregnant or breast feeding and\u002For planning to become pregnant participant can be offered CAB LA, if risk of acquiring HIV out weighs unknown risk of CAB LA, but must understand that safety in pregnancy or breast feeding for CAB LA has not been established and oral daily PrEP is a safe alternative.\n\nExclusion Criteria:\n\nHistory or presence of allergy to the study drugs or their components\n\nInvestigator assessment find them not suitable\n\nAdditional exclusion criteria for specific products:\n\nCAB LA: Taking medication that is contraindicated (Carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Rifampin, rifapentine) and Severe mental health disorder, Hep B surface antigen positive, living with hepatitis C and not yet treated, or abnormal liver function tests (ALT more than two times the upper limit of normal)\n\nDapiRing: Pregnancy.",true,"ALL","15 Years","30 Years",{"count":79,"type":80},2052,"ESTIMATED","INTERVENTIONAL",[83],"PHASE3","The goal of this hybrid (1a) Cluster Randomised Controlled Trial phase 3B trial is to evaluate the effectiveness and implementation of offering a choice of HIV Pre-Exposure Products (PrEP) through community-based sexual and reproductive health services, on PrEP uptake and retention, and population prevalence of sexually transmissible HIV amongst adolescents and young adults living in rural South Africa.\n\nResearchers will compare adding the choice of long-acting PrEP, i.e. two monthly injectable cabotegravir (CAB LA) or dapiravine vaginal ring and HIV post exposure prophylaxis packs to daily oral PrEP integrated with community-based SRH in the 20 intervention clusters with standard of care (SoC), daily oral PrEP integrated with community-based SRH in the 20 control clusters, on uptake and retention on PrEP. We hypothesise that offering a choice of long-acting or oral PrEP and PEP within the community-based delivery of SRH services will overcome the challenges and barriers to effective use of oral daily PrEP and lead to a population-level effect on uptake and retention on PrEP and thus the prevalence of sexually transmissible HIV amongst 15-30 year olds living in rural KwaZulu-Natal, South Africa.",[86],"HIV Infections","2026-07-07",{"date":89,"type":90},"2026-07-09","ACTUAL",{"date":92,"type":90},"2024-02-27",{"date":94,"type":80},"2026-10",{"name":5,"class":6},1]