Clinical trial 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)
Official title: Pilot Peer Mentor Intervention to Train Black MSM to Use and Promote Home-based HIV and STI Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Sexually Transmitted Diseases
Keywords: Black MSM
Social network
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-10-10
Enrollment: 163
Sex: MALE
Minimum age (years): 17
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Session Attendance
timeFrame: 3 month
measure: Number of Index Participants Who Requested Test Kits
timeFrame: 3 months
measure: Number of Participants Who Return Kits for Testing
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Lighthouse Studies @ Peer Point
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Karin E Tobin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.