NCT02834572

Brief Summary

Young Black men who have sex with men (MSM) and transwomen in the US are affected by HIV at severely disproportionate rates. A key component of HIV prevention for communities at risk is diagnosing HIV infections through regular HIV testing. A significant proportion of young Black MSM and transwomen have not tested in the prior year. This research study seeks to address low HIV testing rates among young Black MSM and transwomen by testing a brief Internet-based HIV testing intervention optimized for mobile devices. The intervention takes advantage of the variety of HIV testing options now available, including the HIV self testing, couples-based HIV counseling and testing and traditional clinic-based testing and will provide men and transwomen with a tailored recommendation of their optimal HIV testing approach. The investigators are conducting a pilot randomized study among young Black MSM and transwomen followed for 6 months to estimate the intervention's potential efficacy in increasing HIV testing.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

May 23, 2016

Last Update Submit

April 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants reporting having an HIV test as assessed by questionnaire

    Self-reported HIV test in the prior 3 months assessed by questionnaire

    3 months

Secondary Outcomes (4)

  • Number of participants who are aware of HIV self-testing and couples based voluntary counseling and testing as assessed by questionnaire

    3 months

  • Number of intervention participants recommended a self-test who use a self-test as assessed by questionnaire

    3 months

  • Number of intervention participants recommended testing at a clinic who test at a clinic as assessed by questionnaire

    3 months

  • Number of intervention participants recommended couples testing who test using couples testing as assessed by questionnaire

    3 months

Study Arms (2)

All About Me

EXPERIMENTAL

assessment and algorithm to provide participants with a tailored recommendation of their optimal HIV testing approach

Behavioral: All About Me

Control

ACTIVE COMPARATOR

HIV testing information

Behavioral: Control

Interventions

ControlBEHAVIORAL

HIV testing information

Control
All About MeBEHAVIORAL

Assessment and algorithm to determine recommended HIV testing approach

All About Me

Eligibility Criteria

Age16 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • male at birth;
  • self-identify as Black, African American, Caribbean Black, African Black or multiethnic Black;
  • able to read and respond in English;
  • between 16-29 years of age;
  • known to be HIV-infected;
  • insertive or receptive anal intercourse with a man or transwoman in the last 12 months;
  • reside in the New York City metropolitan area

You may not qualify if:

  • enrolled in any other HIV research study involving HIV testing
  • participant in an HIV vaccine trial
  • currently taking pre-exposure prophylaxis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Blood Center

New York, New York, 10065, United States

Location

Related Publications (2)

  • Frye V, Nandi V, Hirshfield S, Chiasson MA, Wilton L, Usher D, Hoover DR, Koblin BA. Brief Report: Randomized Controlled Trial of an Intervention to Match Young Black Men and Transwomen Who Have Sex With Men or Transwomen to HIV Testing Options in New York City (All About Me). J Acquir Immune Defic Syndr. 2020 Jan 1;83(1):31-36. doi: 10.1097/QAI.0000000000002223.

  • Koblin B, Hirshfield S, Chiasson MA, Wilton L, Usher D, Nandi V, Hoover DR, Frye V. Intervention to Match Young Black Men and Transwomen Who Have Sex With Men or Transwomen to HIV Testing Options (All About Me): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Dec 19;6(12):e254. doi: 10.2196/resprot.8856.

Study Officials

  • Beryl Koblin, PhD

    NY Blood Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2016

First Posted

July 15, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations