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) (STAR)

February 29, 2024 updated by: Johns Hopkins Bloomberg School of Public Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Lighthouse Studies @ Peer Point

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer Mentor
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
Participants will be trained to be Peer Mentors and promote home-based testing to their social network
Active Comparator: Control
Participants will receive information on how to use the website to request at-home test kits
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who completed at least 80% of the training sessions.
Time Frame: 3 month
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.
Time Frame: 3 month
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.
Time Frame: 3 month
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)
Time Frame: baseline and 3 month
Assessment of changes to willingness and intention to initiate PrEP
baseline and 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Karin E Tobin, PhD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Actual)

July 30, 2022

Study Completion (Actual)

July 30, 2022

Study Registration Dates

First Submitted

October 4, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R34MH118178 (U.S. NIH Grant/Contract)
  • IRB00009216 (Other Identifier: JHSPH IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Investigators will share data in a way that will protect participant confidentiality. Within 12 months of publication of the primary papers for this study, a dataset of aggregate values will be made available. Due to the highly sensitive nature of the data collected and the characteristics of this often stigmatized population, no client-level data will be shared until the entire cohort is accrued and completed, even that which is de-identified; this will reduce the risk of small numbers resulting in deductive identification.

IPD Sharing Time Frame

12 months after data collection is over

IPD Sharing Access Criteria

To Be Determined

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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