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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04121962
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Sexually Transmitted Diseases Behavioral: Peer Mentor Behavioral: Website only Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot Peer Mentor Intervention to Train Black MSM to Use and Promote Home-based HIV and STI Testing
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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

  2. 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. 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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   17 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Biologic male who identifies as male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04121962

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Contact: Karin E Tobin, PhD 410-502-5368
Contact: Melissa Davey-Rothwell, PhD 410-502-5368

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United States, Maryland
Lighthouse Studies @ Peer Point Recruiting
Baltimore, Maryland, United States, 21205
Contact: Karin E Tobin, PhD    410-502-5368   
Sub-Investigator: Melissa Davey-Rothwell, PhD         
Sub-Investigator: Charlotte Gaydos, PhD         
Sub-Investigator: Joyce Jones, PhD         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health

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Responsible Party: Johns Hopkins Bloomberg School of Public Health Identifier: NCT04121962     History of Changes
Other Study ID Numbers: 1R34MH118178 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 12 months after data collection is over

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Black MSM
Social network
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female