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
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 30
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
South Africa
Human Sciences Research Council
RECRUITING
Durban
Contact Information
Primary
Francesca Caramazza
IDCRU@mgh.harvard.edu
617-724-4160
Time Frame
Start Date: 2023-07-17
Estimated Completion Date: 2026-05
Participants
Target number of participants: 2500
Treatments
Experimental: Home-based PrEP
In the home-based PrEP arm, participants will complete the HIV self-test at home with support received through telemedicine or over the phone. Confirmation of HIV test result will be shared with the provider through a photograph of the test. PrEP refills will be delivered to participants at home by courier.
Active_comparator: Community-based PrEP
In the community-based PrEP arm, participants will be tested using rapid diagnostic tests (RDT) in person (at a community venue) or through telemedicine (at a community venue) where they will be linked by counsellor telephonically to nurse or clinician. PrEP refills will be collected by participants at a community venue.
Related Therapeutic Areas
Sponsors
Collaborators: Bill and Melinda Gates Foundation
Leads: Massachusetts General Hospital