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NCT03642314 Clinical Trial

HIV Self-testing in Implementation PrEP Study

HIV Prevention Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03642314
Other study ID # HIV-ST
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2018
Est. completion date September 2022

Study information
Verified date August 2018
Source Oswaldo Cruz Foundation
Contact Valdilea Veloso, PhD
Phone +552122707064
Email valdilea.veloso@ini.fiocruz.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 876
Est. completion date September 2022
Est. primary completion date September 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• HIV self test kit
HIVST receptor will be invited to priority access to PrEP sites

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Oswaldo Cruz Foundation

Outcome
Type Measure Description Time frame Safety issue
Primary voucher redemption proportion by arm 2 years
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