Addressing Violence and HIV Cascade of Care Outcomes Among Transgender Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- Acceptability Quantitative
Study Overview
Brief Summary
This project seeks to adapt and pilot a trauma-informed combination intervention named 'Kickin' it with the Gurlz' that was designed with, for, and by transgender women of color to improve HIV care continuum outcomes. The intervention components include a violence and gender affirmation screening tool, a peer-led adaptation of Seeking Safety, and individual-level peer navigation sessions. The project will examine the feasibility, acceptability, and preliminary promise of the multicomponent by conducting a one-arm pilot with 30 transgender women of color who have a history of trauma. Participants will complete baseline, immediate post-intervention, and 3-month follow up assessments.
Detailed Description
This project seeks to evaluate the feasibility and acceptability of the trauma-informed combination care intervention to improve HIV care continuum outcomes including the development of community-informed strategies for subsequent RCTs. We will conduct a one-arm pilot of the adapted multicomponent trauma-informed intervention named "Kickin it with the Gurlz." This project will collect feasibility and acceptability data related to identifying, recruiting, enrolling, intervening with, and retaining participants (i.e. recruitment length, screening procedures, feasibility of conducting sessions, intervention acceptability, retention rates, feasibility of verifying self-reported and medical chart review data on viral load and exit interviews with participants and staff at program conclusion). The study will recruit 30 participants into the pilot study. Participants will complete baseline, end of program, and 3-month post-intervention follow-up surveys. Exit interviews and interviews with key stakeholders will identify strategies for implementing trauma-informed HIV treatment efficacy trials with transgender women of color within close-knit communities, such as acceptable and feasible control conditions, acceptable and feasible violence and gender affirmation screening, biomedical confirmation methods, contamination concerns, and potential changes needed within existing health care systems.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
No masking
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •At least 18 years old
- •Assigned male at birth; identifies as female, transgender woman, or another feminine gender identity
- •Self-identifies as a person of color (any racial/ethnic identity except non-Hispanic white)
- •Self-reports as HIV-positive
- •History of trauma (i.e., endorses at least 2 items on the adapted Trauma History Screener which includes IPV and experiencing or witnessing other forms of violence for transgender women
- •Living or willing to travel to Detroit
- •English-speaking
- •Willing and able to provide informed consent.
Exclusion Criteria
- •Evidence of severe cognitive impairment or active psychosis that may impede ability to provide fully informed consent
Outcomes
Primary Outcomes
Acceptability Quantitative
Time Frame: 3-month follow up
The Client Satisfaction Questionnaire (CSQ-8) will be used to assess intervention satisfaction. Scores are averaged across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 0 to 4, with the higher number indicating greater satisfaction.
Secondary Outcomes
No secondary outcomes reported
Investigators
Kristi Gamarel
Associate Professor
University of Michigan