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

NCT06250504 Phase 3 UNKNOWN

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. Researchers 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.

Details

Lead sponsor	Africa Health Research Institute
Phase	Phase 3
Status	UNKNOWN
Enrolment	2000
Start date	2024-02-27
Completion	2026-03

Conditions

• HIV Infections

Interventions

• APRETUDE (cabotegravir) 600 mg\3 mL
• DAPIRING (Dapivirine) 25mg Vaginal Ring
• tenofovir disoproxil and emtricitabine
• Tenofovir Disoproxil, Lamuvidine and Dolutegravir

Primary outcomes

• Uptake PrEP — This will be evaluated among participants aged 16-30 years in the cross-sectional surveys at 14 months
  Defined as the proportion of young people who have taken up any PrEP (oral, injectable, ring, or PEP).
• Retention on PrEP — This will be measured in the clinical cohort of consenting clinic attendeeswho start or are on PrEP/PEP during the first 10 months of the trial.
  Defined as attending at least one follow-up appointment after PrEP/PEP initiation, including for HIV testing.

Countries

South Africa