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

HIV Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06176859
• Other study ID #: 2022P003023
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: May 2026

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: Francesca Caramazza
• Phone: 617-724-4160
• Email: IDCRU[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• ART
• HIV
• HIV Infections
• Human Immunodeficiency Virus

Intervention

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.

Locations

Country	Name	City	State
South Africa	Human Sciences Research Council	Durban	KwaZulu-Natal

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 Months
Secondary	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.	36 Months
Secondary	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.	36 Months
Secondary	Cost effectiveness per HIV incident averted.	Estimate the incremental cost-per-person receiving community-based PrEP.	36 Months