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Completed

NCT Number: NCT04813484

Addressing Violence and HIV Care Among Transgender Women

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kickin it with the Gulz

Behavioral

The intervention is a multicomponent intervention, including a screening, groups, and individual sessions.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Addressing Violence and HIV Cascade of Care Outcomes Among Transgender Women

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2021
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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