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HIV Self-testing in Implementation PrEP Study

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ClinicalTrials.gov Identifier: NCT03642314
Recruitment Status : Not yet recruiting
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Oswaldo Cruz Foundation

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.

Condition or disease Intervention/treatment Phase
HIV Prevention Diagnostic Test: HIV self test kit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 876 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: ImPrEP Sub-study - HIV Self-Testing to Increase Combination Prevention Demand in the ImPrEP Project: an Adaptative Randomized Trial
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 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
Diagnostic Test: HIV self test kit
HIVST receptor will be invited to priority access to PrEP sites
Other Name: HIVST

No Intervention: 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



Primary Outcome Measures :
  1. voucher redemption proportion by arm [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642314


Contacts
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Contact: Valdilea Veloso, PhD +552122707064 valdilea.veloso@ini.fiocruz.br

Sponsors and Collaborators
Oswaldo Cruz Foundation
Investigators
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Study Chair: Valdilea Veloso, PhD Oswaldo Cruz Foundation

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Responsible Party: Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT03642314     History of Changes
Other Study ID Numbers: HIV-ST
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oswaldo Cruz Foundation:
pre exposure prophylaxis
men who have sex with men