HIV Self-testing in Implementation PrEP Study

NCT03642314 | Unknown

• 1 other identifier: HIV-ST
• Study Type: interventional
• Target: 876
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

pre exposure prophylaxis; men who have sex with men

Outcome Measures

Primary Outcomes (1)

• voucher redemption proportion by arm

  2 years

Study Arms (2)

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

Diagnostic Test: HIV self test kit

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

Interventions

HIV self test kit DIAGNOSTIC_TEST

HIVST receptor will be invited to priority access to PrEP sites

Also known as: HIVST

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Individuals included into ImPrEP as a result of HIVST secondary distribution

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead

MeSH Terms

Conditions

Homosexuality

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior

Study Officials

• Valdilea Veloso, PhD

  Oswaldo Cruz Foundation

  STUDY CHAIR

Central Study Contacts

Valdilea Veloso, PhD

CONTACT

+552122707064; valdilea.veloso@ini.fiocruz.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2022
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share