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Providing Online Counseling for Home-Based HIV Testing With Transgender Youth

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ClinicalTrials.gov Identifier: NCT03185975
Recruitment Status : Active, not recruiting
First Posted : June 14, 2017
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Stephenson, University of Michigan

Brief Summary:
This research study will recruit 200 transgender youths between the ages of 15-24. There are two arms to the research study: the control and the intervention arm. Each eligible participant will be randomized into either arm. The control arm participants receive an OraQuick HIV testing kit sent to an address of their choice and instructions of how to conduct the test. They will enter their results on the research study website and complete surveys at 3 month intervals until an entire year has passed. Participants in the intervention arm will receive an OraQuick HIV testing kit sent to them and will receive video-based counseling called Motivational Interviewing and Certified Testing and Referral. After this counseling session, the results from the OraQuick HIV test will be logged by study staff. Then, participants in the intervention arm will fill out surveys at 3 month intervals until a year has passed.

Condition or disease Intervention/treatment Phase
Hiv Transgender Youth Behavioral: at-home test kit Behavioral: Motivational Interviewing and Certified Testing and Referral Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Providing Online Counseling for Home-Based HIV Testing With Transgender Youth
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control arm
Each participant will receive an at-home test kit and will be asked to test and return results to investigator.
Behavioral: at-home test kit
Transgender youth in the control arm will receive test kits, but will not receive any testing intervention. Once individual results are reported, participants will be contacted via phone or email by study staff with options for referrals to services. Participants will complete follow-up surveys at 3, 6, 9, and 12 months post-testing.

Active Comparator: Intervention Arm
Each participant will receive an at-home test kit and will be asked to take the test in conjunction with an online Motivational interviewing/certified testing and referral (MI/CTR).
Behavioral: Motivational Interviewing and Certified Testing and Referral
Transgender individuals randomized to the experimental group (MI/CTR) will receive HIV counseling and testing via an online, HIPPA-compliant videoconferencing service. The session will last less than one hour and focus on HIV testing, prevention strategies, and/or linkage to HIV care, depending on the individual's test results. Participants will complete follow up surveys at 3, 6, 9 and 12 months.
Other Name: MICTR MI/CTR




Primary Outcome Measures :
  1. Increase uptake of HIV testing for transgender youth [ Time Frame: 1 year ]
    Assess differences and changes in TY's sexual-risk behaviors between those who receive the home-testing with video-based MI/CTR (intervention arm) compared to those who receive the home-testing alone (control arm). 200 TY (100 male: 100 female) will be randomized to either the intervention or control arm and followed for 6 months with surveys taken at baselines and months 3, 6, 9 and 12 months.


Secondary Outcome Measures :
  1. Changes in Sexual Behavior [ Time Frame: 1 year. ]
    We measure changes in sexual behavior using behavioral measures based on information collected from the baseline survey, MI/CTR session for the intervention arm participants, and subsequent surveys each 3 months until one year from the initial survey has occurred.

  2. Linkage to Care [ Time Frame: 1 year ]
    We will measure linkage to care with the following outcomes as indicators per the recent recommendations of the Institute of Medicine and CDC: within 3 months of HIV diagnosis, attending at least one clinical care appointment, having at least one CD4 test performed and having at least one viral load test performed.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   must have a differing gender identity than what was reported as the sex assigned at birth, intersex, agender, genderqueer, and genderfluid individuals are also eligible regardless of their sex assigned at birth.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male sex at birth, identifies as female, trans feminine, trans woman, female
  • female sex at birth, identifies as male, trans male, trans masculine, male
  • agender, genderfluid, genderqueer
  • between the ages of 15-24,
  • negative or unknown HIV status and not having tested in the least 3 months
  • willingness to have HIV test kit delivered to an address they provide
  • wilingness to be tested for HIV
  • willingness to be randomized to either study arm
  • willingness and ability to participate in video-based counseling (must have a computer or tablet with video and audio capabilities, internet access)

Exclusion Criteria:

  • same sex assigned at birth and currently identifies as that same sex
  • aged 14 years or younger, or 25 years or older
  • reports having a positive HIV status during the baseline survey or screener survey before testing unwillingness to have HIV test kit delivered to an address they provide
  • unwillingness to test for HIV
  • unwillingness to be randomized
  • unwillingness or inability to participate in video-based counseling

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): NCT03185975


Locations
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United States, Michigan
University of Michigan Center for Sexuality and Health Disparities
Ann Arbor, Michigan, United States, 49109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Rob Stephenson, PhD University of Michigan Center for Sexuality & Health Disparities

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert Stephenson, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03185975     History of Changes
Other Study ID Numbers: HUM00123412
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert Stephenson, University of Michigan:
HIV
transgender
trans
youth
home testing