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

University of Michigan

Status: Completed

Conditions: Transgender Youth; Hiv

Treatments: Behavioral: Motivational Interviewing and Certified Testing and Referral; Behavioral: at-home test kit

Study type: Interventional

Funder types: Other

Identifiers

NCT03185975

HUM00123412

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 15 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

Control arm

Placebo Comparator group

Description:

Each participant will receive an at-home test kit and will be asked to test and return results to investigator.

Treatment:

Behavioral: at-home test kit

Intervention Arm

Active Comparator group

Description:

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).

Treatment:

Behavioral: Motivational Interviewing and Certified Testing and Referral