NCT04210271

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. 1.To conduct qualitative formative research to adapt couples testing for self-testing with a buddy;
  2. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Status
completed

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

June 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
Last Updated

December 24, 2019

Status Verified

December 1, 2019

Enrollment Period

2.5 years

First QC Date

January 29, 2018

Last Update Submit

December 20, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

HIV Self-testing

EXPERIMENTAL

brief intervention to teach and support consistent self-testing with a friend

Behavioral: Buddy self-testing condition

Generic Self-screening

ACTIVE COMPARATOR

time and attention control providing basic self-screening education on a range of health outcomes

Behavioral: Control self-screening condition

Interventions

HIV Self-testing
Generic Self-screening

Eligibility Criteria

Age18 Years - 34 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2018

First Posted

December 24, 2019

Study Start

June 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 24, 2019

Record last verified: 2019-12