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ComBaCaL HIV Prevention TwiCs (CoPrev)

11. september 2026 oppdatert av: University Hospital, Basel, Switzerland

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

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.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

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).

The 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.

Within 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/3TC/DTG) and oral PrEP (TDF/3TC) 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.

Studietype

Intervensjonell

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Lesotho
      • Maseru, Lesotho
        • SolidarMed Lesotho
  • Sveits
      • Basel, Sveits, 4051
        • University of Basel, Division of Clinical Epidemiology

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Intervention villages
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.
Annen: CoPrev model
  • 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
Aktiv komparator: 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.
Annen: Referral to the nearest responsible health facility
  • refer participants eligible for biomedical HIV prevention to the nearest health facility
  • offer family planning education, pregnancy screening, and refer participants for contraception.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Monthly biomedical HIV prevention coverage over 6 months after enrolment
Tidsramme: Single assessment visit scheduled approximately six months after enrolment (180 days)
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Basel, Switzerland

Samarbeidspartnere

SolidarMed
The World Diabetes Foundation
Swiss Agency for Development and Cooperation

Etterforskere

  • Hovedetterforsker: Niklaus Labhardt, Division of Clinical Epidemiology, University Hospital Basel

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

5. mai 2026

Først innsendt som oppfylte QC-kriteriene

5. mai 2026

Først lagt ut (Faktiske)

12. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ub26Labhardt2

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

An anonymized key dataset necessary for reproducing the primary and key secondary endpoints will be made freely available in an appropriate repository, such as zenodo.org, alongside the publication of the study results. Besides removal of variables not required for key analysis, we will remove participant identifier, study site and exact date information. Requests for access to more detailed data may be made to the corresponding author by submitting a proposal, which will be reviewed by the trial consortium.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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