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)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV/AIDS, Sexually Transmitted Diseases

Intervention / Treatment
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* Behavioral: Peer Mentor
* Behavioral: Website only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: self-report male sex condomless anal sex with >1 male in the prior 6 months self-report Black race aged 17 to 45 internet use at least once a week. Exclusion Criteria: younger than 17 or older than 45 years

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer Mentor<br>Peer Mentor Training is 5 groups with a 30 day reunion session. This condition is focused on training participants with communication skills to promote HIV and STI home-based testing and treatment and pre-exposure prophylaxis (PrEP) to individuals in their social networks. Participants will also learn how to use the Star website to request home-based testing kits. Peer Mentor training is conducted by a two health educators. The sessions are held once a week and will last approximately 90 minutes. | Behavioral: Peer Mentor<br>* Participants will be trained to be Peer Mentors and promote home-based testing to their social network<br>|
| Active Comparator: Control<br>Participants will receive information on how to use the website to request at-home test kits | Behavioral: Website only<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who completed at least 80% of the training sessions. | Session attendance will be calculated as the ratio of number of sessions attended divided by the total number of sessions. We will consider greater than 80% attendance to indicate feasibility | 3 month | 
| Risk characteristics of social network alters who request home-based testing kits. | Assessment of sexual and drug/alcohol risk behaviors of social network alters who request the kits. | 3 month | 
| Number of individuals who request home-based testing kits. | Compare the number of participants in each condition who request and return test kits | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Willingness and intention to initiate pre-exposure prophalaxis (PrEP) | Assessment of changes to willingness and intention to initiate PrEP | baseline and 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Black MSM, Social network