Status:

RECRUITING

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

Lead Sponsor:

Massachusetts General Hospital

Collaborating Sponsors:

Bill and Melinda Gates Foundation

Conditions:

HIV

Human Immunodeficiency Virus

Eligibility:

All Genders

16-30 years

Phase:

NA

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 hi...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 17 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2026

Estimated Enrollment :

2500 Patients enrolled

Trial Details

Trial ID

NCT06176859

Start Date

July 17 2023

End Date

May 1 2026

Last Update

December 20 2023

Active Locations (1)

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1

Human Sciences Research Council

Durban, KwaZulu-Natal, South Africa