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Addressing Violence and HIV Care Among Transgender Women

Not Applicable
Completed
Conditions
HIV Infections
Acceptability of Health Care
Interventions
Behavioral: Kickin it with the Gurlz
Registration Number
NCT04813484
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 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
11
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.
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Exclusion Criteria

• Evidence of severe cognitive impairment or active psychosis that may impede ability to provide fully informed consent

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Kicking it with the GurlzKickin it with the GurlzThis 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
NameTimeMethod
Acceptability Quantitative3-month follow up

Self-report viral load in the past 3 months as 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. by detectable versus undetectable.

Secondary Outcome Measures
NameTimeMethod
Acceptability Qualitative3-month follow up

Qualitative Exit Interviews where more than 80% of participants deem intervention acceptable

Trial Locations

Locations (1)

University of Michigan

🇺🇸

Ann Arbor, Michigan, United States

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