HIV Self-testing in Implementation PrEP Study

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV Prevention

Intervention / Treatment
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* Diagnostic Test: HIV self test kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: individuals who were included in the ImPrEP Study performed at least 3 study visits, accepted to participate in this sub study, provide informed consent form Exclusion Criteria: Individuals included into ImPrEP as a result of HIVST secondary distribution

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Individuals receive 5 HIV Self Test kits + vouchers to secondarily distribute to MSM/TGW from their social/sexual networks. All vouchers are uniquely identified invitations for priority access to ImPrEP sites, valid to be redeemed by a 3 month period | Diagnostic Test: HIV self test kit<br>* HIVST receptor will be invited to priority access to PrEP sites<br>* Other names: HIVST;|
| No Intervention: Control<br>Individuals receive 5 vouchers to secondarily distribute to MSM/TGW from their social/sexual networks. All vouchers are uniquely identified invitations for priority access to ImPrEP sites, valid to be redeemed by a 3 month period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| voucher redemption proportion by arm |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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men who have sex with men, pre exposure prophylaxis