Using Technology to Match Young Black Men and Transwomen Who Have Sex With Men or Transwomen to HIV Testing Options

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.

Study Overview

• Status: Unknown
• Conditions: HIV Testing
• Intervention / Treatment: Behavioral: All About Me; Behavioral: Control

Detailed Description

We are conducting a pilot study among 240 young Black MSM and transgender women randomized to the Intervention Arm (assessment and algorithm to deliver a tailored recommendation) or Control (assessment and standard HIV testing information) and followed for 6 months to estimate the intervention's potential efficacy in increasing HIV testing. After informed consent, participants are asked to provide contact information on the locator form. Then, participants complete a brief quantitative assessment including basic demographics, HIV testing history and other factors related to HIV testing. All participants, regardless of study arm, then receive information about each HIV testing method including how the tests are conducted (blood, oral sample), and availability of counseling and support. Participants then are randomized into 1 of the 2 study arms. A computer program will randomly assign each participant using randomly ordered block sizes of 4 and 6 and stratified by age (16-23, 24-29 years) to balance groups.

Participants assigned to the Intervention Arm will complete a brief quantitative assessment lasting approximately 2-3 minutes to assess those factors associated with HIV testing and thus are needed to complete the algorithm. They then receive the results of the HIV testing algorithm, presented as their personalized HIV testing approach. All participants will receive information on resources in New York City to test by all of these methods. The control participants are provided with the above information about each testing approach but without a recommended approach.

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • New York Blood Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 29 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: All About Me; assessment and algorithm to provide participants with a tailored recommendation of their optimal HIV testing approach	Behavioral: All About Me; Assessment and algorithm to determine recommended HIV testing approach
ACTIVE_COMPARATOR: Control; HIV testing information	Behavioral: Control; HIV testing information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who are aware of HIV self-testing and couples based voluntary counseling and testing as assessed by questionnaire	Self-reported awareness of HIV self-testing and couples based voluntary counseling and testing assessed by questionnaire	3 months
Number of intervention participants recommended a self-test who use a self-test as assessed by questionnaire	Self-reported use of self test among those recommended a self test - Intervention participants only	3 months
Number of intervention participants recommended testing at a clinic who test at a clinic as assessed by questionnaire	Self-reported use of testing at a clinic among those recommended to test at a clinic - Intervention participants	3 months
Number of intervention participants recommended couples testing who test using couples testing as assessed by questionnaire	Self-reported use of couples testing among those recommended to test using couples testing - Intervention only	3 months

Collaborators and Investigators

• Sponsor: New York Blood Center
• Investigators: Principal Investigator: Beryl Koblin, PhD, NY Blood Center

Publications and helpful links

General Publications

• 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 record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: July 14, 2016
• First Posted (ESTIMATE): July 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 473699-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED