Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2017 by Robert Stephenson, University of Michigan

Sponsor
University of Michigan


Information provided by (Responsible Party)
Robert Stephenson, University of Michigan

ClinicalTrials.gov Identifier
NCT03185975

First received: June 11, 2017
Last updated: July 6, 2017
Last Verified: July 2017
History of Changes
Purpose

Purpose

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 Intervention
Hiv
Transgender Youth

Behavioral : at-home test kit
Behavioral : Motivational Interviewing and Certified Testing and Referral

Study Type: Interventional
Study Design: 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

Further study details as provided by Robert Stephenson, University of Michigan:

Primary Outcome Measures

  • 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:
  • 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.
  • 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.

Estimated Enrollment: 200
Study Start Date: June 19, 2017
Estimated Study Completion Date: May 31, 2018
Estimated Primary Completion Date: May 31, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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
Eligibility

Eligibility

Ages Eligible for Study: 15 Years to 24 Years  
Sexes Eligible for Study: All  
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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03185975

Contacts

Contact:   Erin C Riley, MPH 734647-5610 ecriley@umich.edu
Contact:   Rob Stephenson, PhD 404-727-2038 rbsteph@med.umich.edu

Locations

United States, Michigan
University of Michigan Center for Sexuality and Health Disparities Recruiting
Ann Arbor, Michigan, United States, 49109
Contact: Erin C Riley, MPH    734-647-5610    ecriley@umich.edu
Principal Investigator: Robert B Stephenson, PhD

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator: Rob Stephenson, PhD University of Michigan Center for Sexuality & Health Disparities
More Information

More Information


Responsible Party: Robert Stephenson, Professor, University of Michigan  
ClinicalTrials.gov Identifier: NCT03185975   History of Changes  
Other Study ID Numbers: HUM00123412  
Study First Received: June 11, 2017  
Last Updated: July 6, 2017  

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

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.