ComBaCaL HIV Prevention TwiCs

NCT07581600 | Not Yet Recruiting

• 1 other identifier: ub26Labhardt2
• Study Type: interventional
• Target: 380
• Locations: 2 countries
• Sites: 2

Brief Summary

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). This 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/or 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.

Conditions

Human Immunodeficiency Virus (HIV)

Keywords

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)

Outcome Measures

Primary Outcomes (1)

• 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/3TC/DTG), oral PrEP (TDF/3TC), 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)

Study Arms (2)

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/3TC/DTG 300mg/300mg/50mg) or oral PrEP (TDF/3TC 300mg/300mg)) and offer refills for contraception (EE/LNG 30mcg/15mcg or 50mcg/15mcg) or self-injectable contraception (s.c. 104mg/0.65ml medroxypregosteronacetate). VHWs will provide monitoring for all dispensed drug regimens, thereby ensuring comprehensive and integrated sexual and reproductive health services within their communities.

Other: CoPrev model

Control villages

ACTIVE COMPARATOR

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.

Other: Referral to the nearest responsible health facility

Interventions

CoPrev model OTHER

* prescribe and deliver drugs for biomedical HIV prevenTion (PEP (TDF/3TC/DTG 300mg/300mg/50mg) or oral PrEP (TDF/3TC 300mg/300mg)) * offer refills for contraception (EE/LNG 30mcg/15mcg or 50mcg/15mcg) or self-injectable contraception (s.c. 104mg/0.65ml medroxypregosteronacetate * monitoring for all dispensed drug regimens

Intervention villages

Referral to the nearest responsible health facility OTHER

* refer participants eligible for biomedical HIV prevention to the nearest health facility * offer family planning education, pregnancy screening, and refer participants for contraception.

Control villages

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant of the ComBaCaL cohort study (signed informed consent available)
• Weight ≥ 35 kg
• Negative HIV screening test
• No potential exposure to HIV more than 72 hours ago (PEP eligibility window period) and less than 4 weeks ago (window period HIV test)
• At substantial risk of HIV acquisition as per behavioural risk factors in the Lesotho's national HIV prevention and treatment guidelines:
• 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)
• Report of sexual partner with unknown HIV status
• Report of unprotected sex with more than one partner in the last 6 months
• Report of STI by lab-testing or self-report of STI syndromic management in the last 6 months
• Report of exchanging money/goods for sex in the last 6 months (as recipient and vice versa)
• Report of intravenous drug use with shared equipment in the last 6 months
• Request for biomedical HIV prevention

You may not qualify if:

• Known allergies to PEP/oral PrEP
• Known glomerular filtration rate (GFR) \< 60 ml/min or diagnosis of moderate/severe kidney disease or kidney failure

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss Agency for Development and Cooperation (SDC): collaborator
• World Diabetes Foundation (WDF): collaborator
• SolidarMed: collaborator

Study Sites (2)

SolidarMed Lesotho

Maseru, Lesotho

Location

University of Basel, Division of Clinical Epidemiology

Basel, 4051, Switzerland

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Niklaus Labhardt

  Division of Clinical Epidemiology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niklaus Labhardt, Prof. Dr.

CONTACT

+41 79 870 18 59; niklaus.labhardt@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

LE (1); CH (1)