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Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT - Trial NCT06250504

Access comprehensive clinical trial information for NCT06250504 through Pure Global AI's free database. This Phase 3 trial is sponsored by Africa Health Research Institute and is currently Not yet recruiting. The study focuses on HIV Infections. Target enrollment is 2000 participants.

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NCT06250504
Phase 3
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06250504
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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

Study Focus

HIV Infections

APRETUDE (cabotegravir) 600 mg\3 mL

Interventional

drug

Sponsor & Location

Africa Health Research Institute

Timeline & Enrollment

Phase 3

Feb 01, 2024

Mar 01, 2026

2000 participants

Primary Outcome

Uptake PrEP,Retention on PrEP

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.

ICD-10 Classifications

HIV disease resulting in other viral infections
HIV disease resulting in other bacterial infections
HIV disease resulting in multiple infections
Acute HIV infection syndrome
HIV disease resulting in other infectious and parasitic diseases

Data Source

ClinicalTrials.gov

NCT06250504

Non-Device Trial