Providing Online Counseling for Home-Based HIV Testing With Transgender Youth
Verified July 2017 by Robert Stephenson, University of Michigan
University of Michigan
Information provided by (Responsible Party)
Robert Stephenson, University of Michigan
First received: June 11, 2017
Last updated: July 6, 2017
Last Verified: July 2017
History of Changes
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.
Behavioral : at-home test kit
Behavioral : Motivational Interviewing and Certified Testing and Referral
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.
- 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.
|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)|
Each participant will receive an at-home test kit and will be asked to test and return results to investigator.
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.
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).
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
|Ages Eligible for Study:||15 Years to 24 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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)
- 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 LocationsChoosing 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
|Contact: Erin C Riley, MPHfirstname.lastname@example.org|
|Contact: Rob Stephenson, PhDemail@example.com|
Locations Show More
|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  firstname.lastname@example.org
Principal Investigator: Robert B Stephenson, PhD
Sponsors and CollaboratorsUniversity of Michigan
|Principal Investigator:||Rob Stephenson, PhD||University of Michigan Center for Sexuality & Health Disparities|
|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|
|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
ClinicalTrials.gov processed this data on July 20, 2018
This information is provided by ClinicalTrials.gov.