Optimizing delivery of HIV prevention medication
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
This study is testing a new way to deliver HIV prevention medication to see if it helps young women and sexual minority men in South Africa access and stick with the treatment better than going to a clinic.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2500 (estimated) |
| Ages | 16 Years to 30 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Durban, KwaZulu-Natal) |
| Trial ID | NCT06176859 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness, safety, acceptability, and cost-effectiveness of a decentralized delivery service for pre-exposure prophylaxis (PrEP) compared to traditional facility-based delivery. It focuses on priority populations, particularly young women and sexual minority men, to enhance access and persistent use of PrEP in South Africa. The study addresses barriers to PrEP access, such as clinic-level factors and individual logistics, to develop scalable strategies for HIV prevention. Participants will be monitored for their engagement with the PrEP delivery system over time.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 16 to 30 who are at risk for HIV and interested in using PrEP for prevention.
Not a fit: Patients who are already HIV positive or clinically ineligible for PrEP will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase access to and sustained use of PrEP, thereby reducing HIV incidence in high-risk populations.
How similar studies have performed: Other studies have shown success with community-based strategies for HIV prevention, indicating potential for this decentralized approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Durban, KwaZulu-Natal
- Human Sciences Research Council — Durban, KwaZulu-Natal, South Africa (Recruiting)
Study contacts
- Principal investigator: Zaynab Essack, PhD — Human Sciences Research Council of South Africa
- Study coordinator: Francesca Caramazza
- Email: IDCRU@mgh.harvard.edu
- Phone: 617-724-4160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.