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Completed

NCT Number: NCT04121962

A Pilot Peer Mentor Intervention That Trains Black Men Who Have Sex With Men (BMSM) to Use and Promote Uptake of HIV/STI Self-Testing to Peers and Sex Partners: STAR Study (Self-Testing at Your Residence)

The objectives of the study are to assess the feasibility, reach and preliminary efficacy of a brief intervention that trains Black men who have sex with men [referred to as Index] (a) to use home-based testing for HIV and sexually transmitted infections and (b) promote home-based testing to their peers and sexual partners.

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Key information

About this study

Sexually transmitted infections (STIs) increase one's risk of HIV infection, are serious co-infections that affect HIV clinical outcomes, and remain a risk for individuals using PrEP. Self-testing methods address barriers to clinic-based testing by offering convenience and privacy and have been shown to be well accepted by MSM. Therefore, use of self-testing is a potential approach through which to improve HIV and STI testing rates in MSM. Internet-based distribution (herein: web-based) of STI self-test kits enables an individual to request sampling kits via a website, mail biological specimens (e.g. urethral swabs) to a laboratory for testing, and view test results through a web-based account. Web-based self-HIV oral testing enables an individual to request a test kit, collect an oral specimen, and receive results within 20 minutes. Despite these potential benefits and reports of willingness to use free self-testing, uptake has been low due to barriers such as concerns about accuracy of the tests, apprehension to collect specimens, low risk perception, and the desire for counseling. In the proposed study, investigators will pilot test an intervention that address these barriers by training BMSM with information about the accuracy of the HIV rapid oral test kit, demonstrating how to properly collect specimens for HIV and STIs (gonorrhea, chlamydia and syphilis) self-testing, and providing resources for linkage to HIV and STI treatment and PrEP services. Study participants will utilize a secure website to request test kits.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • self-report male sex
  • condomless anal sex with >1 male in the prior 6 months
  • self-report Black race
  • aged 18 or older
  • internet use at least once a week.

Exclusion criteria

  • younger than 17

Treatment and study plan

Peer Mentor

Behavioral

Participants will be trained to be Peer Mentors and promote home-based testing to their social network

Website only

Behavioral

Participants will be given instructions on how to use the project website to request kits to test for HIV at home and collect specimens for lab testing.

Primary outcomes

  1. Session Attendance

    Time frame: 3 month

    number of participants who completed 80%

  2. Number of Index Participants Who Requested Test Kits

    Time frame: 3 months

    Number of Index participants who requested test kits is reported

  3. Number of Participants Who Return Kits for Testing

    Time frame: 3 month

    Number of participants who returned kits to lab for testing is reported.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Pilot Peer Mentor Intervention to Train Black MSM to Use and Promote Home-based HIV and STI Testing

Acronym: STAR

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Oct 10, 2019
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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