[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Lesotho\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":143},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,60,91,121],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"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":21,"type":22},380,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Human Immunodeficiency Virus (HIV)",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"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":50,"type":51},"2026-05-22","ACTUAL",{"date":53,"type":22},"2026-06",{"date":55,"type":22},"2027-06",{"name":57,"class":58},"University Hospital, Basel, Switzerland","OTHER",2,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":59},"100485108","community-based-chronic-disease-care-in-rural-lesotho-100485108","NCT05596773","Community-Based Chronic Disease Care in Rural Lesotho","Community-Based Chronic Disease Care in Rural Lesotho: The ComBaCaL Cohort Study","ComBaCaL","Inclusion Criteria village level:\n\n* Village size of 40 to 100 households\n* Village consent obtained from village chief\n* Possibility to identify or recruit a CC-VHW from the village population meeting the following requirements which are largely in line with the criteria of the Lesotho VHW Program Policy:\n\n  o Criteria of the Lesotho Village Health Program Policy:\n* Having primary residence in the village (according to village chief)\n* Having a proven record of trustworthiness in the resident village\n* Having proven ability to maintain confidentiality on public matters\n* Being aged between 20 and 50 years\n* Being able to provide written reports and being able to do basic mathematical calculations\n* Having at least educational level equivalent to high school leaving certificate (Junior Certificate)\n\n  o Additional ComBaCaL criteria:\n* Having the ability and willingness to work with a tablet-based eHealth tool\n* Having good social and communication skills\n* Having the ability and willingness to interact with health professionals and the village population\n* Being able to speak, understand and write in English-\n* Having successfully completed the ComBaCaL CC-VHW training including final assessment\n\nInclusion criteria individual level:\n\n* Having primary residence in the village (self-reported at time of enrolment)\n* Being able and willing to consent to participation or in case of individuals aged below 18",{"count":69,"type":22},17500,"OBSERVATIONAL","This ComBaCaL cohort study is to assess the impact of community-based, lay-led chronic disease screening and care interventions in rural Lesotho. It aims to establish a prospective research and service delivery platform in rural Lesotho that is managed by eHealth-supported Chronic Care Village Health Worker (CC-VHWs) providing regular chronic disease screening, monitoring and referral services. The implementation outcomes of the cohort as well as the effect of the cohort activities on disease-specific care cascades will be assessed. Subsequently, nested trials to assess the effectiveness of specific chronic disease control interventions will be developed. Measurements and data entry will be conducted by CC-VHWs. The CC-VHWs will be equipped with the essential tools required for chronic disease monitoring in the community (i.e. BP machines, scales, measuring band, glucometers, and urine dipsticks). They will undergo a theoretical and practical training covering all aspects required for correct data collection and chronic disease screening, diagnosing, referral and counselling services. At every visit, the CC-VHW will screen participants for warning signs and symptoms (i.e. shortness of breath, severe headache, chest pain, new-onset confusion, impaired consciousness, severely impaired general state of health) and refer participants to the closest health centre in case of any danger-sign. The CC-VHWs will be continuously monitored and supervised by health centre nurses of the respective village's catchment area, mainly through direct interaction during monthly VHW meetings and by CC nurses through field visits, remote interaction via phone calls or messages sent via the ComBaCaL app and through direct contact during the monthly VHW meetings at the health centre. The CC-VHWs are embedded within the Lesotho MoH VHW program and may during the project period be trained and equipped to provide further routine services in their communities.",[73],"Non-communicable Diseases (NCDs)",[75,76,77,78,79,80,81],"Community-Based Chronic Disease Care Lesotho (ComBaCaL)","Chronic Care Village Health Worker (CC-VHWs)","eHealth application (ComBaCaL app)","Lesotho","low- and middle-income countries (LMICs)","Arterial hypertension (aHT)","Diabetes mellitus (DM)","RECRUITING","2026-02-10",{"date":85,"type":51},"2026-02-13",{"date":87,"type":51},"2023-02-22",{"date":89,"type":22},"2027-12-31",{"name":57,"class":58},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":18,"minAge":98,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":120},"100574651","investigating-the-optimal-management-of-dolutegravir-resistance-100574651","NCT06762054","Investigating the Optimal Management of Dolutegravir Resistance","Investigating the Optimal Management of Dolutegravir Resistance: a Multi-country Cohort Study","Inclusion Criteria:\n\n* Able and willing to provide informed consent (assent as appropriate and legal guardian consent if \\\u003C 18 years)\n* Age ≥ 1 years\n* Documented HIV-1 infection as confirmed by national HIV testing standards at the respective study sites\n* On a DTG-based ART regimen for at least six months\n* Most recent HIV-1 RNA ≥ 1,000 copies\u002FmL within 3 months prior to enrolment, taken after at least 6 months on current ART regimen\n\nExclusion Criteria:\n\n* Has switched ART regimen for confirmed or suspected HIV treatment failure while on a PI- or INSTI-based regimen\n* Any reason which, in the investigator's opinion, will significantly prevent the collection of viral load levels such as relocation to another area outside of the trial sites or imminent death\n* Concomitant NNRTI or PI while on DTG","1 Year",{"count":100,"type":22},6600,"The goal of this study is to address the gap in published data on viral suppression among people meeting the criteria for virologic failure on dolutegravir (DTG)-based ART regimens without a change in regimen. The study will also assess the emergence of DTG-associated drug-resistant mutations and their impact on viral suppression.",[103],"HIV-1-infection",[105,106,107,108,109,110],"HIV","Dolutegravir","Treatment failure","Drug resistant mutations","Dolutegravir resistance","Re-suppression","2025-09-04",{"date":113,"type":51},"2025-09-05",{"date":115,"type":51},"2025-03-03",{"date":117,"type":22},"2026-10",{"name":119,"class":58},"University of Nairobi",9,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":18,"minAge":128,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":23,"phases":131,"briefSummary":133,"conditions":134,"keywords":135,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":120},"100573532","phase-3-ndovu-rct-investing-the-optimal-management-of-dolutegravir-resistance-100573532","NCT06747507","Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance","Investigating the Optimal Management of Dolutegravir Resistance: an Open-label Randomised Controlled Trial of Maintaining Dolutegravir or Switch to Ritonavir-boosted Darunavir","Inclusion Criteria:\n\n* Enrolled in the Ndovu cohort study\n* Able and willing to understand and comply with the protocol requirements, instructions and restrictions\n* Able and willing to provide informed consent for the nested clinical trial (assent as appropriate and legal guardian consent if \\\u003C 18 years)\n* Age ≥ 3 years\n* Most recent HIV-1 RNA ≥ 200 copies\u002FmL\n* At least one major DTG-associated DRM (substitution at codon 66K, 92Q, 118R, 138K\u002FA\u002FT, 140S\u002FA\u002FC, 148H\u002FR\u002FK, 155H or 263K)\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Using any concomitant therapy disallowed as per the reference safety information and product labelling for the study drugs\n* WHO stage 3 or 4 opportunistic infection which would prevent randomisation to either arm (e.g. due to drug interactions or significant liver or renal injury) within 4 weeks prior to RCT screening\n* Investigator opinion that the potential participant should discontinue DTG immediately for clinical reasons\n* Investigator opinion that the potential participant should not switch to DRV\u002Fr for clinical reasons","3 Years",{"count":130,"type":22},392,[132],"PHASE3","This clinical trial will address the gap in published data on the effect of dolutegravir (DTG)-associated drug-resistant mutations on viral suppression among people remaining on DTG-based antiretroviral therapy. It will also address the gap in the optimal management strategy for this population.",[103],[105,106,107,108,109,110],{"date":137,"type":51},"2025-09-11",{"date":139,"type":51},"2025-09-01",{"date":141,"type":22},"2027-07",{"name":119,"class":58},""]