Clinical trial NCT03185975: Providing Online Counseling for Home-Based HIV Testing With Transgender Youth
Official title: Providing Online Counseling for Home-Based HIV Testing With Transgender Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Transgender Youth
Keywords: HIV
transgender
trans
youth
home testing
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Increase uptake of HIV testing for transgender youth
timeFrame: 1 year
Secondary outcomes:
measure: Changes in Sexual Behavior
timeFrame: 1 year.
measure: Linkage to Care
timeFrame: 1 year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Center for Sexuality and Health Disparities
state: Michigan
Study officials:
affiliation: University of Michigan Center for Sexuality & Health Disparities
name: Rob Stephenson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stephenson R, Todd K, Kahle E, Sullivan SP, Miller-Perusse M, Sharma A, Horvath KJ. Project Moxie: Results of a Feasibility Study of a Telehealth Intervention to Increase HIV Testing Among Binary and Nonbinary Transgender Youth. AIDS Behav. 2020 May;24(5):1517-1530. doi: 10.1007/s10461-019-02741-z.
citation: Stephenson R, Metheny N, Sharma A, Sullivan S, Riley E. Providing Home-Based HIV Testing and Counseling for Transgender Youth (Project Moxie): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2017 Nov 28;6(11):e237. doi: 10.2196/resprot.8562.