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

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.

Study Overview

• Status: Completed
• Conditions: HIV Testing
• Intervention / Treatment: Behavioral: Buddy self-testing condition; Behavioral: Control self-screening condition

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.

• Study Type: Interventional
• Enrollment (Actual): 402
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consistent HIV self-testing	One or more HIV self-test in past three months	12 months
Consistent HIV testing	One or more HIV test (any type) in past three months	12 months

Collaborators and Investigators

• Sponsor: New York Blood Center

Publications and helpful links

General Publications

• Frye V, Nandi V, Paige MQ, McCrossin J, Lucy D, Gwadz M, Sullivan PS, Hoover DR, Wilton L; TRUST Study Team. TRUST: Assessing the Efficacy of an Intervention to Increase HIV Self-Testing Among Young Black Men Who have Sex with Men (MSM) and Transwomen. AIDS Behav. 2021 Apr;25(4):1219-1235. doi: 10.1007/s10461-020-03091-x. Epub 2020 Nov 15.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): December 24, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 648283

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No