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

Not Applicable

Completed

• Conditions: Hiv; Transgender Youth
• Interventions: Behavioral: Motivational Interviewing and Certified Testing and Referral; Behavioral: at-home test kit

• Registration Number: NCT03185975
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-11
• Study First Submitted QC: 2017-06-11
• Study First Posted: 2017-06-14
• Study Start: 2017-06-19
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Motivational Interviewing and Certified Testing and Referral	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).
Control arm	at-home test kit	Each participant will receive an at-home test kit and will be asked to test and return results to investigator.

Primary Outcome Measures

Name	Time	Method
Increase uptake of HIV testing for transgender youth	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

Name	Time	Method
Changes in Sexual Behavior	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	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.

Trial Locations

Locations (1)

University of Michigan Center for Sexuality and Health Disparities; 🇺🇸 Ann Arbor, Michigan, United States