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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | Placebo Comparator | Each participant will receive an at-home test kit and will be asked to test and return results to investigator. |
|
| Intervention Arm | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| at-home test kit | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Linkage to Care |
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Inclusion Criteria:
Exclusion Criteria:
must have a differing gender identity than what was reported as the sex assigned at birth, intersex, agender, genderqueer, and genderfluid individuals are also eligible regardless of their sex assigned at birth.
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| Name | Affiliation | Role |
|---|---|---|
| Rob Stephenson, PhD | University of Michigan Center for Sexuality & Health Disparities | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Center for Sexuality and Health Disparities | Ann Arbor | Michigan | 49109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31760536 | Derived | 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. | |
| 29183868 | Derived |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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|
| Motivational Interviewing and Certified Testing and Referral | Behavioral | 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. |
|
|
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 |
| 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. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |