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Trial record 23 of 83929 for:    testing

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

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ClinicalTrials.gov Identifier: NCT02834572
Recruitment Status : Unknown
Verified April 2017 by Beryl Koblin, Ph, D., New York Blood Center.
Recruitment status was:  Active, not recruiting
First Posted : July 15, 2016
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Beryl Koblin, Ph, D., New York Blood Center

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.

Condition or disease Intervention/treatment Phase
HIV Testing Behavioral: All About Me Behavioral: Control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Using Technology to Match Young Black Men and Transwomen Who Have Sex With Men or Transwomen to HIV Testing Options
Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of participants reporting having an HIV test as assessed by questionnaire [ Time Frame: 3 months ]
    Self-reported HIV test in the prior 3 months assessed by questionnaire


Secondary Outcome Measures :
  1. Number of participants who are aware of HIV self-testing and couples based voluntary counseling and testing as assessed by questionnaire [ Time Frame: 3 months ]
    Self-reported awareness of HIV self-testing and couples based voluntary counseling and testing assessed by questionnaire

  2. Number of intervention participants recommended a self-test who use a self-test as assessed by questionnaire [ Time Frame: 3 months ]
    Self-reported use of self test among those recommended a self test - Intervention participants only

  3. Number of intervention participants recommended testing at a clinic who test at a clinic as assessed by questionnaire [ Time Frame: 3 months ]
    Self-reported use of testing at a clinic among those recommended to test at a clinic - Intervention participants

  4. Number of intervention participants recommended couples testing who test using couples testing as assessed by questionnaire [ Time Frame: 3 months ]
    Self-reported use of couples testing among those recommended to test using couples testing - Intervention only



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834572


Locations
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United States, New York
New York Blood Center
New York, New York, United States, 10065
Sponsors and Collaborators
New York Blood Center
Investigators
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Principal Investigator: Beryl Koblin, PhD NY Blood Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Beryl Koblin, Ph, D., Principal Investigator, New York Blood Center
ClinicalTrials.gov Identifier: NCT02834572     History of Changes
Other Study ID Numbers: 473699-41
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided