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
Pilot Peer Mentor Intervention to Train Black MSM to Use and Promote Home-based HIV and STI Testing
2 other identifiers
interventional
163
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 6, 2019
CompletedFirst Submitted
Initial submission to the registry
October 4, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2023
CompletedResults Posted
Study results publicly available
May 20, 2024
CompletedMay 20, 2024
May 1, 2024
2.8 years
October 4, 2019
April 4, 2024
May 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Session Attendance
number of participants who completed 80%
3 month
Number of Index Participants Who Requested Test Kits
Number of Index participants who requested test kits is reported
3 months
Number of Participants Who Return Kits for Testing
Number of participants who returned kits to lab for testing is reported.
3 month
Study Arms (2)
Peer Mentor
EXPERIMENTALPeer Mentor Training is 5 individual sessions with a 30 day check-in session. This condition is focused on training Index with communication skills to promote HIV and STI testing and treatment and pre-exposure prophalaxis (PrEP) to individuals in their social networks. Peer Mentor training is conducted by a one health educator. The sessions are held once a week and will last approximately 60 minutes.
Control
ACTIVE COMPARATORIs one individual-based session which will be conducted by sending a video about the website of a health educator.
Interventions
Participants will be trained to be Peer Mentors and promote home-based testing to their social network
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- younger than 17
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lighthouse Studies @ Peer Point
Baltimore, Maryland, 21205, United States
Related 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.
PMID: 35798989BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study occurred during the COVID-19 pandemic and amid the stay at home orders. Therefore recruitment was interrupted and the delivery of the intervention and control were remote. The stay-at home orders also disrupted the follow-up activities.
Results Point of Contact
- Title
- Dr. Karin Tobin
- Organization
- Johns Hopkins Bloomberg School of Public Health
Study Officials
- PRINCIPAL INVESTIGATOR
Karin E Tobin, PhD
Johns Hopkins Bloomberg School of Public Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2019
First Posted
October 10, 2019
Study Start
May 6, 2019
Primary Completion
March 9, 2022
Study Completion
July 11, 2023
Last Updated
May 20, 2024
Results First Posted
May 20, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 12 months after data collection is over
- Access Criteria
- To Be Determined
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.