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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 |
|
| Control | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV self test kit | Diagnostic Test | HIVST receptor will be invited to priority access to PrEP sites |
|
| Measure | Description | Time Frame |
|---|---|---|
| voucher redemption proportion by arm | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
male
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valdilea Veloso, PhD | Contact | +552122707064 | valdilea.veloso@ini.fiocruz.br |
| Name | Affiliation | Role |
|---|---|---|
| Valdilea Veloso, PhD | Oswaldo Cruz Foundation | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41983677 | Derived | Hoagland B, Torres TS, Konda K, Moreira RI, Leite IC, Cunha M, Campos K, Calvo G, Pimenta C, Benedetti M, Rocha C, Grangeiro JR, Bastos E, Nazer S, Palombo C, de Vasconcellos M, Caceres CF, Grinzstejn B, Veloso VG. HIV self-testing and coupons distribution by persons using PrEP to create demand for combination HIV prevention services among men who have sex with men (MSM) and transgender women: a randomized clinical trial in the context of the ImPrEP project. J Acquir Immune Defic Syndr. 2026 Apr 15. doi: 10.1097/QAI.0000000000003887. Online ahead of print. |
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| ID | Term |
|---|---|
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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