HIV Self-testing in Implementation PrEP Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

876 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2022-09-30

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.

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Detailed Description

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Conditions

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HIV Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

HIV self test kit

Intervention Type DIAGNOSTIC_TEST

HIVST receptor will be invited to priority access to PrEP sites

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HIV self test kit

HIVST receptor will be invited to priority access to PrEP sites

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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HIVST

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