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Trial record 3 of 90771 for:    testing

Testing an Intervention to Increase HIV Self-Testing Among Young, Black MSM (TRUST)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04210271
Recruitment Status : Completed
First Posted : December 24, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
New York Blood Center

Brief Summary:

The investigators propose a study to design and test a brief intervention to increase uptake of consistent HIV self-testing among YBMSM using a novel and culturally-relevant "buddy system" approach. In the model, peer educators train pairs of YBMSM (or "buddies") to initiate self-testing and support each other in consistent self-testing (past 3 months) and sexual and AOD use risk reduction.

The specific aims of this developmental R01 study are:

  1. To conduct qualitative formative research to adapt couples testing for self-testing with a buddy;
  2. To assess the preliminary efficacy of the intervention to increase the proportion of YBMSM who self-test regularly over 12 months using a 2-arm randomized, controlled study design.

Condition or disease Intervention/treatment Phase
HIV Testing Behavioral: Buddy self-testing condition Behavioral: Control self-screening condition Not Applicable

Detailed Description:

Increasing HIV testing rates among young, Black men who have sex with men (YBMSM) is critical to reducing the disproportionate disease burden in the Black community. MSM comprised almost two-thirds of new HIV diagnoses in the United States (US) in 2010. We propose a study to design and test a brief intervention to increase uptake of consistent HIV self-testing among YBMSM using a novel and culturally-relevant "buddy system" approach. In our model, peer educators train pairs of YBMSM (or "buddies") to initiate self-testing and support each other in consistent self-testing (past 3 months) and sexual and AOD use risk reduction. We propose a study to design and test a brief intervention to increase uptake of consistent HIV self-testing among YBMSM using a novel and culturally-relevant "buddy system" approach. In the model, peer educators train pairs of YBMSM (or "buddies") to initiate self-testing and support each other in consistent self-testing (past 3 months) and sexual and AOD use risk reduction.

The specific aims of this developmental R01 study are:

  1. To conduct qualitative formative research to adapt couples testing for self-testing with a buddy;
  2. To assess the preliminary efficacy of the intervention to increase the proportion of YBMSM who self-test regularly (i.e., past three months) over 12 months using a 2-arm randomized, controlled study design.

The investigators will achieve the aims of the study in three phases, recruiting YBMSM using web- and app-based approaches. In Phase 1, the investigators conducted 30 in-depth interviews to identify barriers to, facilitators of, perceptions of and preferences for regular HIV self-testing, describe how AOD use and sexual behavior influence HIV self-testing behaviors, and assess participant perspectives on the proposed buddy intervention. In Phase 2, based on the formative research, the investigators adapted couples testing, integrating enhanced motivational interviewing techniques to create a brief, peer educator-delivered, face-to-face intervention. In Phase 3, for which the investigators currently seek IRB approval, the investigators will use web- and app-based, face-to-face and word-of-mouth approaches to recruit 376 HIV-negative, BMSM aged 18 to 34 who will be randomized as pairs to either the intervention arm (HIV testing together, HIV self-testing screening information and skills training; free test kits on demand; tailored booster messages) or the control arm (HIV testing separately, generic health screening information; free test kits on demand) and followed for 12 months to estimate the intervention's efficacy in increasing regular HIV self-testing according to self-report. If demonstrated to be efficacious, this innovative and efficient approach can be adapted easily for widespread distribution, with the potential to diffuse along naturally occurring, social networks among YBMSM.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Testing an Intervention to Increase HIV Self-Testing Among Young, Black MSM
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: HIV Self-testing
brief intervention to teach and support consistent self-testing with a friend
Behavioral: Buddy self-testing condition
Active Comparator: Generic Self-screening
time and attention control providing basic self-screening education on a range of health outcomes
Behavioral: Control self-screening condition



Primary Outcome Measures :
  1. Consistent HIV self-testing [ Time Frame: 12 months ]
    One or more HIV self-test in past three months

  2. Consistent HIV testing [ Time Frame: 12 months ]
    One or more HIV test (any type) in past three months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • biological male at birth
  • between 18 and 34 years of age
  • self-identify Black, African American, Caribbean Black, African Black, multiethnic Black OR Latino/Hispanic
  • reside in the NYC metropolitan area
  • not HIV-infected (self-report)
  • report insertive or receptive anal intercourse with another man in the past year
  • ability to communicate in English
  • provide informed consent for the study.
  • willing to participate in the study with a friend or buddy.

Exclusion Criteria:

  • currently enrolled in any other HIV research study involving HIV testing or an HIV vaccine trial

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Responsible Party: New York Blood Center
ClinicalTrials.gov Identifier: NCT04210271    
Other Study ID Numbers: 648283
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019