Clinical trial NCT06176859: Delivery Optimization for Pre-Exposure Prophylaxis (DO PrEP) Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Human Immunodeficiency Virus
ART
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2023-12-20
Enrollment: 2500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, interventional, and randomized study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome is uptake of Pre-exposure prophylaxis of HIV (PrEP) .
timeFrame: 36 Months
Secondary outcomes:
measure: The efficacy of rapid HIV testing kits in diagnosing HIV for PrEP initiation.
timeFrame: 36 Months
measure: Persistent use of PrEP over a 12-month period.
timeFrame: 36 Months
measure: Cost effectiveness per HIV incident averted.
timeFrame: 36 Months
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: Human Sciences Research Council
state: KwaZulu-Natal
Study officials:
affiliation: Human Sciences Research Council of South Africa
name: Zaynab Essack, PhD
role: PRINCIPAL_INVESTIGATOR
References: