This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 2 of 21 for:    Recruiting, Not yet recruiting, Available Studies | "Transgendered Persons"

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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified June 2017 by Robert Stephenson, University of Michigan
Sponsor:
Information provided by (Responsible Party):
Robert Stephenson, University of Michigan
ClinicalTrials.gov Identifier:
NCT03185975
First received: June 11, 2017
Last updated: NA
Last verified: June 2017
History: No changes posted
  Purpose
This application is for an Administrative Supplement in response to PA-14-077. The parent grant is a NICHD-funded R01 (1R01HD078131) "Providing online counseling for home-based HIV testing". The parent R01 is currently in its second year, and involves the implementation of a RCT of 600 male couples to examine whether the provision of a video-based counseling session for home-based HIV testing can lead to increased relationship functioning for management of HIV risk among male couples. The abstract for the parent grant is shown below. In this administrative supplement we propose to add an additional sample of 200 transgender youth (15-24, 100 children and 100 adults), to be randomized (50:50) to the control and experimental conditions. Study staff is in the process of applying for a Certificate of Confidentialty due to the sensitive nature of data collection.

Condition Intervention
Transgender Individual 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: Participant
Primary Purpose: Prevention
Official Title: Providing Online Counseling for Home-Based HIV Testing With Transgender Youth

Resource links provided by NLM:


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
Anticipated Study Start Date: June 15, 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 MI/CTR session.
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

  Show Detailed Description

  Eligibility

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
  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 Not yet 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

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: June 11, 2017
Individual Participant Data  
Plan to Share IPD: Yes

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 record on June 23, 2017