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: May 6, 2019
• Est. completion date: July 11, 2023

Study information

• Verified date: May 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: 163
• Est. completion date: July 11, 2023
• Est. primary completion date: March 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 17 Years to 60 Years

Eligibility

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

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)

Tobin KE, Heidari O, Winiker A, Pollock S, Rothwell MD, Alexander K, Owczarzak J, Latkin C. Peer Approaches to Improve HIV Care Cascade Outcomes: a Scoping Review Focused on Peer Behavioral Mechanisms. Curr HIV/AIDS Rep. 2022 Aug;19(4):251-264. doi: 10.1007/s11904-022-00611-3. Epub 2022 Jul 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Session Attendance	number of participants who completed 80%	3 month
Primary	Number of Index Participants Who Requested Test Kits	Number of Index participants who requested test kits is reported	3 months
Primary	Number of Participants Who Return Kits for Testing	Number of participants who returned kits to lab for testing is reported.	3 month