[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637091":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":21,"studyPopulation":13,"armGroups":22,"interventions":34,"overallOfficials":43,"centralContacts":48,"locations":54,"responsibleParty":107,"collaborators":109,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":125,"sex":126,"minAge":127,"maxAge":13,"enrollmentInfo":128,"targetDuration":13,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":155,"whyStopped":13,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Monthly biomedical HIV prevention coverage over 6 months after enrolment","Biomedical HIV prevention coverage is defined at the person- month level as a binary indicator of whether a participant was covered by a biomedical HIV prevention method (PEP (TDF\u002F3TC\u002FDTG), oral PrEP (TDF\u002F3TC), or injectable PrEP) during a given 30-day month within the six-month observation period following enrolment in the ComBaCaL HIV prevention TwiCs .","Single assessment visit scheduled approximately six months after enrolment (180 days)",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","Cluster-randomized hybrid type 1 effectiveness- implementation trial nested within the ComBaCaL cohort following the Trials within Cohorts (TwiCs) approach. 50% of the villages being part of the overarching ComBaCaL cohort will be randomized stratified by district and access to health facility to receive the intervention. The villages randomized into the control arm will serve as comparators and follow the regular ComBaCaL cohort activities conducted by the VHWs.","HEALTH_SERVICES_RESEARCH",{"masking":20,"maskingDescription":13,"whoMasked":13},"NONE","Approximately 1.3 million new HIV infections were reported worldwide in 2024. Eastern and Southern Africa continue to bear the largest share of the HIV-related burden. To prevent lingering epidemics in these low-resource, high-prevalence regions, it is essential to intensify HIV prevention efforts, including the scale-up of effective biomedical HIV prevention, such as Pre-Exposure (PrEP) and Post- Exposure Prophylaxis (PEP). However, uptake, persistent use and adherence to biomedical HIV prevention remains low among individuals at substantial risk of HIV acquisition, especially in rural areas. Thus, there is an urgent need for scalable, integrated, cost-effective, and context-specific service delivery models that increase the utilization of biomedical HIV prevention among populations at increased risk in Southern Africa.\n\nThis cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO\\_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local lay chronic care village health workers (CC-VHWs).\n\nThe ComBaCaL HIV Preven7on (CoPrev) model is a differen7ated, community-based preven7on model, that provides eligible individuals with an alterna7ve to facility-based HIV preven7on and contracep7on. It builds on the broader ComBaCaL model of care, which extends the role of VHWs beyond educa7on, counselling, screening, and referral, to include ac7ve management of preven7on and care services for selected condi7ons. This is enabled through a tablet-based CDS applica7on, allowing VHWs to independently prescribe and deliver selected medica7ons at community level.\n\nWithin the CoPrev model, VHWs, assisted by the CDS application, deliver an integrated HIV prevention package comprising HIV prevention education and counselling; HIV and HIV risk screening; condom provision; referral to health facilities, and the prescription and delivery of PEP (TDF\u002F3TC\u002FDTG) and oral PrEP (TDF\u002F3TC) to those eligible. In addition, VHWs provide contraceptive services, including family planning education and counselling; pregnancy screening; referral to health facilities; and the delivery of refills of combined oral contraception (COC) and self-injectable contraception to those eligible.",[23,29],{"label":24,"type":25,"description":26,"interventionNames":27},"Intervention villages","ACTIVE_COMPARATOR","In the intervention villages, VHWs will follow the standard service protocol of the ComBaCaL cohort study, but in line with the CoPrev model, will also be able to additionally prescribe and deliver drugs for biomedical HIV prevention (PEP (TDF\u002F3TC\u002FDTG 300mg\u002F300mg\u002F50mg) or oral PrEP (TDF\u002F3TC 300mg\u002F300mg)) and offer refills for contraception (EE\u002FLNG 30mcg\u002F15mcg or 50mcg\u002F15mcg) or self-injectable contraception (s.c. 104mg\u002F0.65ml medroxypregosteronacetate). VHWs will provide monitoring for all dispensed drug regimens, thereby ensuring comprehensive and integrated sexual and reproductive health services within their communities.",[28],"Other: CoPrev model",{"label":30,"type":25,"description":31,"interventionNames":32},"Control villages","In the control villages, VHWs will follow the standard service protocol of the ComBaCaL cohort study. Using the tablet-based CDS application, they will be trained and supervised to educate participants on HIV prevention, screen for HIV offering oral HIV self-tests, assess HIV risk behaviour, provide risk reduction counselling and condoms, and refer participants eligible for biomedical HIV prevention to the nearest health facility. Furthermore, they will offer family planning education, pregnancy screening, and refer participants for contraception.",[33],"Other: Referral to the nearest responsible health facility",[35,39],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":13},"CoPrev model","* prescribe and deliver drugs for biomedical HIV prevenTion (PEP (TDF\u002F3TC\u002FDTG 300mg\u002F300mg\u002F50mg) or oral PrEP (TDF\u002F3TC 300mg\u002F300mg))\n* offer refills for contraception (EE\u002FLNG 30mcg\u002F15mcg or 50mcg\u002F15mcg) or self-injectable contraception (s.c. 104mg\u002F0.65ml medroxypregosteronacetate\n* monitoring for all dispensed drug regimens",[24],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":13},"Referral to the nearest responsible health facility","* refer participants eligible for biomedical HIV prevention to the nearest health facility\n* offer family planning education, pregnancy screening, and refer participants for contraception.",[30],[44],{"name":45,"affiliation":46,"role":47},"Niklaus Labhardt","Division of Clinical Epidemiology, University Hospital Basel","PRINCIPAL_INVESTIGATOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":13,"email":53},"Niklaus Labhardt, Prof. Dr.","CONTACT","+41 79 870 18 59","niklaus.labhardt@usb.ch",[55,82],{"facility":56,"status":13,"city":57,"state":13,"zip":13,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"SolidarMed Lesotho","Maseru","Lesotho","LS",{"type":61,"coordinates":62},"Point",[63,64],27.48333,-29.31667,{"lat":64,"lon":63},[67,70,71,74,76,78,80],{"name":68,"role":51,"phone":69,"phoneExt":13,"email":13},"Irene Ayakaka, MD","+266 2832 5172",{"name":68,"role":47,"phone":13,"phoneExt":13,"email":13},{"name":72,"role":73,"phone":13,"phoneExt":13,"email":13},"Ravi Gupta, MD","SUB_INVESTIGATOR",{"name":75,"role":47,"phone":13,"phoneExt":13,"email":13},"Tarumbiswa Tapiwa, MD",{"name":77,"role":73,"phone":13,"phoneExt":13,"email":13},"Nthuseng BridgeI Marake, MD",{"name":79,"role":73,"phone":13,"phoneExt":13,"email":13},"Rosina Phate, MSc",{"name":81,"role":73,"phone":13,"phoneExt":13,"email":13},"Mamotena Sekhobe, MD",{"facility":83,"status":13,"city":84,"state":13,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"University of Basel, Division of Clinical Epidemiology","Basel","4051","Switzerland","CH",{"type":61,"coordinates":89},[90,91],7.57327,47.55839,{"lat":91,"lon":90},[94,96,97,99,101,103,105],{"name":95,"role":51,"phone":52,"phoneExt":13,"email":53},"Niklaus Labhardt, Prof Dr",{"name":95,"role":47,"phone":13,"phoneExt":13,"email":13},{"name":98,"role":73,"phone":13,"phoneExt":13,"email":13},"Alain Amstutz, MD\u002FPhD",{"name":100,"role":73,"phone":13,"phoneExt":13,"email":13},"Felix Gerber, MD\u002FPhD",{"name":102,"role":73,"phone":13,"phoneExt":13,"email":13},"Fabian Raeber, MSc",{"name":104,"role":73,"phone":13,"phoneExt":13,"email":13},"Elis Saavedra, MSc",{"name":106,"role":73,"phone":13,"phoneExt":13,"email":13},"Palesa Agnes Mahlatsi, MSc",{"type":108,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[110,113,115],{"name":111,"class":112},"Swiss Agency for Development and Cooperation (SDC)","UNKNOWN",{"name":114,"class":112},"World Diabetes Foundation (WDF)",{"name":116,"class":6},"SolidarMed","100637091","combacal-hiv-prevention-twics-100637091",false,"NCT07581600","ComBaCaL HIV Prevention TwiCs","Community-based, Village Health Worker-led, eHealth-supported, Integrated HIV Prevention for People at Substantial Risk of HIV Acquisition in Rural Lesotho: Protocol for a Cluster-randomized Hybrid Type 1 effectiveness-implementation Trial Within the ComBaCaL Cohort Study","CoPrev","Inclusion Criteria:\n\n* Participant of the ComBaCaL cohort study (signed informed consent available)\n* Weight ≥ 35 kg\n* Negative HIV screening test\n* No potential exposure to HIV more than 72 hours ago (PEP eligibility window period) and less than 4 weeks ago (window period HIV test)\n* At substantial risk of HIV acquisition as per behavioural risk factors in the Lesotho's national HIV prevention and treatment guidelines:\n\n  * Report of serodiscordant partner who are not virally suppressed or have an unknown viral suppression status (either not on ART, initiated ART within the last 6 months, known virally unsuppressed or unknown virally suppression status but believed not to be taking treatment regularly)\n  * Report of sexual partner with unknown HIV status\n  * Report of unprotected sex with more than one partner in the last 6 months\n  * Report of STI by lab-testing or self-report of STI syndromic management in the last 6 months\n  * Report of exchanging money\u002Fgoods for sex in the last 6 months (as recipient and vice versa)\n  * Report of intravenous drug use with shared equipment in the last 6 months\n  * Request for biomedical HIV prevention\n\nExclusion Criteria:\n\n* Known allergies to PEP\u002Foral PrEP\n* Known glomerular filtration rate (GFR) \\\u003C 60 ml\u002Fmin or diagnosis of moderate\u002Fsevere kidney disease or kidney failure",true,"ALL","15 Years",{"count":129,"type":130},380,"ESTIMATED","INTERVENTIONAL",[133],"NA","This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO\\_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local lay chronic care village health workers (CC-VHWs).\n\nThis study is to evaluate the effectiveness and safety of the CoPrev model in regard to biomedical HIV prevention utilization compared with an enhanced standard of care, in which VHWs assisted by a tablet-based CDS application, perform the same activities except for the prescription and\u002For delivery of PEP, oral PrEP, COC and self-injectable contraception. Additionally, this study aims to assess the outcomes and processes related to the implementation of such a model.",[136],"Human Immunodeficiency Virus (HIV)",[138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154],"Community-Based Chronic Disease Care Lesotho (ComBaCaL) cohort study","Low- and middle-income countries (LMICs)","Clinical decision support (CDS)","Community health worker (CHW)","Adolescent girls and young women (AGYW)","Pre-Exposure Prophylaxis (PrEP)","Post-Exposure Prophylaxis (PEP)","Village health worker (VHW)","Tenofovir Disoproxil Fumarate (TDF)","Lamivudine (3TC)","Dolutegravir (DTG)","Combined oral contraception (COC)","Antiretroviral therapy (ART)","Sexually transmitted infection (STI)","Levonorgestrel (LNG)","Ethinylestradiol (EE)","Trials within Cohorts (TwiCs)","NOT_YET_RECRUITING","2026-05-18",{"date":158,"type":159},"2026-05-22","ACTUAL",{"date":161,"type":130},"2026-06",{"date":163,"type":130},"2027-06",{"name":5,"class":6},2]