RecruitingPhase 3NCT06250504

Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT

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

Sponsor

Africa Health Research Institute

Enrollment

2,000 participants

Start Date

Feb 27, 2024

Study Type

INTERVENTIONAL

Conditions

HIV Infections

Summary

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.

Eligibility

Min Age: 15 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether offering long-acting injectable HIV prevention (PrEP) medications through sexual and reproductive health services reduces new HIV infections in young people. You may be eligible if... - You are between 15 and 30 years old and live in the study district - You attend an integrated sexual/reproductive health or HIV service in the study area - You have tested HIV-negative - You are suitable for PrEP or already on PrEP - You weigh more than 35 kg - You understand the dosing schedule and HIV testing requirements You may NOT be eligible if... - You have an allergy to the study drugs - Your investigator finds you unsuitable for the study - For the CAB LA injection: you take certain seizure or TB medications, have severe mental health conditions, hepatitis B, untreated hepatitis C, or abnormal liver function - For the DapiRing: you are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAPRETUDE (cabotegravir) 600 mg\3 mL

choice of 2-monthly injectable long acting cabotegravir. The initial visit will be followed by planned visit for the first injection, one month visit for second injection, and then 2-monthly CAB LA injections with repeat HIV testing and pregnancy testing, and referral to peer navigators for adherence and retention support. We will conduct HIV testing, STI testing, Hep B, Hep C, and safety bloods (Full Blood Count, Creatinine, Liver Function Tests) at baseline, HIV testing two monthly, and annual safety bloods, alongside annual STI testing.

DRUGDAPIRING (Dapivirine) 25mg Vaginal Ring

The initial visit is followed by a 7-day phone call, 3-monthly follow-up. Each follow-up will include repeat HIV testing (POCT x2 and dry blood spots for HIV ELISA) and pregnancy testing, syndromic management of STIs, and referral to peer navigators for adherence support and PrEP/ART and if applicable contraception refills. Safely bloods (full blood count, creatinine, liver function tests) will follow national guidelines. Currently we aim to do baseline and annual safety bloods, alongside annual STI testing

DRUGtenofovir disoproxil and emtricitabine

DRUGTenofovir Disoproxil, Lamuvidine and Dolutegravir