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)

HIV/AIDS Clinical Trial

— STAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04121962
• Other study ID #: 1R34MH118178
• Secondary ID: IRB00009216
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: July 30, 2022

Study information

• Verified date: February 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 17 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV/AIDS
• Sexually Transmitted Diseases

Intervention

Behavioral:
• Peer Mentor
Participants will be trained to be Peer Mentors and promote home-based testing to their social network
• Website only
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.

Locations

Country	Name	City	State
United States	Lighthouse Studies @ Peer Point	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Winiker AK, Tobin KE, Davey-Rothwell M, Latkin C. An examination of grit in black men who have sex with men and associations with health and social outcomes. J Community Psychol. 2019 Jun;47(5):1095-1104. doi: 10.1002/jcop.22176. Epub 2019 Mar 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Willingness and intention to initiate pre-exposure prophalaxis (PrEP)	Assessment of changes to willingness and intention to initiate PrEP	baseline and 3 month