NCT06176859

Delivery Optimization for Pre-Exposure Prophylaxis (DO PrEP) Study

Delivery Optimization for Pre-Exposure Prophylaxis (DO PrEP) Study: A Prospective, Interventional, Randomized Study of Community-based PrEP Initiation, Delivery, and Monitoring in South Africa

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,500 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 30 Years
• Healthy volunteers: Accepted

Summary

The overall goal is to determine whether an end-to-end decentralized delivery service for PrEP is more effective, safe, acceptable, and cost-effective than facility-based PrEP delivery.

Detailed description

Optimizing pre-exposure prophylaxis (PrEP) delivery with a focus on priority populations is critical to realize the enormous potential of PrEP for HIV prevention. HIV incidence remains relentlessly high among young women and sexual minority men and primary prevention is critical to achieving control of the HIV epidemic. With effective and persistent use, oral pre-exposure prophylaxis (PrEP) for HIV prevents 75%-100% of HIV cases among cisgender women and men, gay and bisexual men, and transgender women. Despite the high efficacy, uptake throughout the PrEP prevention cascade remains low. South Africa is expanding PrEP provision but requires evidence-based strategies on how to achieve access, effective use, and persistence. The current clinic-based requirement of PrEP to persons at risk for HIV acquisition requires that clients self-identify their exposure to HIV and visit the clinic regularly for initiation, monitoring and refills. Barriers to PrEP access include clinic level factors (i.e. staff training, brief visits) and individual level factors including logistics such as transportation for clinic visits. The priority is to determine how to deliver PrEP in a scalable way and achieve high PrEP access and effective, persistent use. PrEP is a highly efficacious HIV prevention strategy but requires effective strategies that streamline delivery and engage users for scale-up. Community-based strategies for HIV testing, ART initiation, and monitoring successfully reach people living with HIV for treatment and have made marked improvements to viral suppression. This protocol describes a randomized clinical study to test an end-to-end decentralized delivery service for PrEP. It aims to safely increase PrEP access and use among priority populations in South Africa. Participants will include 16-30 year old HIV negative women and sexual minority men at high risk for acquiring HIV. As a critical component of decentralized delivery, we will also evaluate the safety and efficacy of HIV self-testing compared to rapid diagnostic tests.

Conditions

• HIV
• Human Immunodeficiency Virus
• ART

Interventions

Type	Name	Description
OTHER	HIV PrEP Delivery	To test an end-to-end decentralized delivery service for pre-exposure prophylaxis (PrEP) to safely increase PrEP access and use among priority populations in South Africa.

Timeline

• Start date: 2023-07-17
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2023-12-20
• Last updated: 2026-01-12

Locations

1 site across 1 country: South Africa