NCT03642314

HIV Self-testing in Implementation PrEP Study

ImPrEP Sub-study - HIV Self-Testing to Increase Combination Prevention Demand in the ImPrEP Project: an Adaptative Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 876 (estimated)
• Sponsor: Oswaldo Cruz Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a sub-study of an ongoing PrEP study ( HIV PrEP for men who have sex with men - MSM - and transgender women - TGW: a demonstrative project in Brazil, Peru and Mexico - ImPrEP). MSM/TGW enrolled to ImPrEP Study at the selected sites, who agree to participate in this HIV Self Test (HIVST) sub-study, will be 1:1 randomized at the third study visit either to receive 5 HIVST+voucher (intervention arm) or 5 vouchers alone (control arm) to secondarily distribute into their MSM/TGW network. All vouchers are numbered invitations for priority access to individualized HIV risk assessment and combination prevention services, including PrEP, at the ImPrEP sites. Study population comprises ImPrEP participants and their referred peers. Sample size is going to be determined at an interim analysis performed when each city has enrolled 70 participants. Trial participants will be at maximum 876 (438 intervention and 438 in the control arm) MSM and TGW included in the ImPrEP Study who received PrEP for at least 6 months in the sites from Rio de Janeiro and Lima. The study is designed as a multicenter, open, adaptative, randomized trial. The main study outcome is the voucher redemption proportion by arm.

Conditions

• HIV Prevention

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	HIV self test kit	HIVST receptor will be invited to priority access to PrEP sites

Timeline

• Start date: 2018-09-01
• Primary completion: 2020-09-01
• Completion: 2022-09-01
• First posted: 2018-08-22
• Last updated: 2018-08-22