Providing Online Counseling for Home-Based HIV Testing With Transgender Youth
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03185975|
Recruitment Status : Active, not recruiting
First Posted : June 14, 2017
Last Update Posted : June 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hiv Transgender Youth||Behavioral: at-home test kit Behavioral: Motivational Interviewing and Certified Testing and Referral||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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.
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
|United States, Michigan|
|University of Michigan Center for Sexuality and Health Disparities|
|Ann Arbor, Michigan, United States, 49109|
|Principal Investigator:||Rob Stephenson, PhD||University of Michigan Center for Sexuality & Health Disparities|