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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185975
• Other study ID #: HUM00123412
• Status: Completed
• Phase: N/A
• Start date: June 19, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Hiv
• Transgender Youth

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Center for Sexuality and Health Disparities	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase uptake of HIV testing for transgender youth	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.	1 year
Secondary	Changes in Sexual Behavior	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.	1 year.
Secondary	Linkage to Care	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.	1 year