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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)

Primary Purpose

HIV/AIDS, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Mentor
Website only
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring Black MSM, Social network

Eligibility Criteria

17 Years - 45 Years (Child, Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Lighthouse Studies @ Peer Point

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peer Mentor

Control

Arm Description

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.

Participants will receive information on how to use the website to request at-home test kits

Outcomes

Primary Outcome Measures

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
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.
Number of individuals who request home-based testing kits.
Compare the number of participants in each condition who request and return test kits

Secondary Outcome Measures

Willingness and intention to initiate pre-exposure prophalaxis (PrEP)
Assessment of changes to willingness and intention to initiate PrEP

Full Information

First Posted
October 4, 2019
Last Updated
July 3, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT04121962
Brief Title
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)
Acronym
STAR
Official Title
Pilot Peer Mentor Intervention to Train Black MSM to Use and Promote Home-based HIV and STI Testing
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Sexually Transmitted Diseases
Keywords
Black MSM, Social network

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer Mentor
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants will receive information on how to use the website to request at-home test kits
Intervention Type
Behavioral
Intervention Name(s)
Peer Mentor
Intervention Description
Participants will be trained to be Peer Mentors and promote home-based testing to their social network
Intervention Type
Behavioral
Intervention Name(s)
Website only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants who completed at least 80% of the training sessions.
Description
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
Time Frame
3 month
Title
Risk characteristics of social network alters who request home-based testing kits.
Description
Assessment of sexual and drug/alcohol risk behaviors of social network alters who request the kits.
Time Frame
3 month
Title
Number of individuals who request home-based testing kits.
Description
Compare the number of participants in each condition who request and return test kits
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Willingness and intention to initiate pre-exposure prophalaxis (PrEP)
Description
Assessment of changes to willingness and intention to initiate PrEP
Time Frame
baseline and 3 month

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Biologic male who identifies as male
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Lighthouse Studies @ Peer Point
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
30820988
Citation
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.
Results Reference
background

Learn more about this trial

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)

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