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

Mass General Brigham

Status: Enrolling

Conditions: Human Immunodeficiency Virus; HIV; ART

Treatments: Other: HIV PrEP Delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT06176859

2022P003023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 16 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 16 years - 30 years old,
• Men in serodifferent relationships or those reporting male to male sex,
• Heterosexual cis-gender females
• Interested in use of PrEP for HIV prevention
• Able and willing to provide informed consent for study procedures

Exclusion criteria

• HIV infection based on negative HIV rapid tests
• Clinically ineligible for PrEP
• The participant doesn't reside in the study community for the duration of follow-up

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,500 participants in 2 patient groups

Home-based PrEP

Experimental group

Description:

In the home-based PrEP arm, participants will complete the HIV self-test at home with support received through telemedicine or over the phone. Confirmation of HIV test result will be shared with the provider through a photograph of the test. PrEP refills will be delivered to participants at home by courier.

Treatment:

Other: HIV PrEP Delivery

Community-based PrEP

Active Comparator group

Description:

In the community-based PrEP arm, participants will be tested using rapid diagnostic tests (RDT) in person (at a community venue) or through telemedicine (at a community venue) where they will be linked by counsellor telephonically to nurse or clinician. PrEP refills will be collected by participants at a community venue.

Treatment:

Other: HIV PrEP Delivery