NCT03185975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

June 19, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

2.3 years

First QC Date

June 11, 2017

Last Update Submit

October 18, 2019

Conditions

HivTransgender Youth

Keywords

HIVtransgendertransyouthhome testing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Changes in Sexual Behavior

    1 year.

  • Linkage to Care

    1 year

Study Arms (2)

Control arm

PLACEBO COMPARATOR

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

Behavioral: at-home test kit

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).

Behavioral: Motivational Interviewing and Certified Testing and Referral

Interventions

at-home test kitBEHAVIORAL

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.

Control arm
Motivational Interviewing and Certified Testing and ReferralBEHAVIORAL

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.

Also known as: MICTR MI/CTR
Intervention Arm

Eligibility Criteria

Age15 Years - 24 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsmust 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.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Center for Sexuality and Health Disparities

Ann Arbor, Michigan, 49109, United States

Location

Related Publications (2)

  • 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.

    PMID: 31760536DERIVED

  • 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.

    PMID: 29183868DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Motivational InterviewingReferral and Consultation

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesProfessional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Rob Stephenson, PhD

    University of Michigan Center for Sexuality & Health Disparities

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 11, 2017

First Posted

June 14, 2017

Study Start

June 19, 2017

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

October 21, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

Locations

US(1)