A Multicomponent Intervention to Address Gender-based Violence in HIV
- Conditions
- HIV Primary InfectionAcceptability of Health Care
- Interventions
- Behavioral: Kicking it with the Gurlz
- Registration Number
- NCT04799197
- Lead Sponsor
- University of Michigan
- 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 prevention 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. We 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 prevention intervention to improve HIV prevention 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." We 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 PrEP use, and exit interviews with participants and staff at program conclusion). We 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 prevention 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 27
- 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-negative or unknown HIV status
- 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.
• Evidence of severe cognitive impairment or active psychosis that may impede ability to provide fully informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Kicking it with the Gurlz Kicking it with the Gurlz This multicomponent intervention includes a violence and gender affirmation screening tool, a peer delivered adaptation of the group-level Seeking Safety Program, and individual-level peer navigation sessions.
- Primary Outcome Measures
Name Time Method Acceptability Qualitative 3 months Qualitative Exit Interviews where more than 80% of participants deem intervention acceptable
Acceptability Quantitative 3 months The Client Satisfaction Questionnaire (CSQ-8) will be used to assess intervention satisfaction. This is an 8-item scale where each individual item is scored separately with a range of 1 to 4 and a score of 3 or 4 on each item will be considered indicative of acceptable.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States