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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
2,500
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.
Human Sciences Research Council
Durban, KwaZulu-Natal, South Africa
The primary outcome is uptake of Pre-exposure prophylaxis of HIV (PrEP) .
The proportion of study participants who effectively accessed PrEP and continued use over a 12-month period.
Time frame: 36 Months
The efficacy of rapid HIV testing kits in diagnosing HIV for PrEP initiation.
To compare the safety and efficacy of HIV self-testing (HIVST) to rapid diagnostic tests (RDT) by comparing the sensitivity and specificity of each diagnostic test.
Time frame: 36 Months
Persistent use of PrEP over a 12-month period.
The proportion of study participants in the home-monitored arm who accessed and effectively/persistently used PrEP over a 12-month period compared to the community-monitored arm.
Time frame: 36 Months
Cost effectiveness per HIV incident averted.
Estimate the incremental cost-per-person receiving community-based PrEP.
Time frame: 36 Months
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