ART, HIV, Human Immunodeficiency Virus
Conditions
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.
Interventions
OTHERHIV 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.
Sponsors
Massachusetts General Hospital
Bill and Melinda Gates Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
A prospective, interventional, and randomized study
Eligibility
Sex/Gender
ALL
Age
16 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 16 years - 30 years old, * Self-report living without HIV or unknown status. * Persons who have been sexually active within the last 3 months * Interested in the use of PrEP for HIV prevention. * Able and willing to provide informed consent for study procedures. * Access to a cellphone for study related communication * Reside in the study community for the duration of follow-up.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome is uptake of Pre-exposure prophylaxis of HIV (PrEP) . | 36 Months | The proportion of study participants who effectively accessed PrEP and continued use over a 12-month period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy of rapid HIV testing kits in diagnosing HIV for PrEP initiation. | 36 Months | 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. |
| Persistent use of PrEP over a 12-month period. | 36 Months | 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. |
| Cost effectiveness per HIV incident averted. | 36 Months | Estimate the incremental cost-per-person receiving community-based PrEP. |
Countries
South Africa
Contacts
PRINCIPAL_INVESTIGATORZaynab Essack, PhD
Human Sciences Research Council of South Africa
Outcome results
None listed