MedPath

A Multicomponent Intervention to Address Gender-based Violence in HIV

Not Applicable
Completed
Conditions
HIV Primary Infection
Acceptability 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
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-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.
Read More
Exclusion Criteria

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

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Kicking it with the GurlzKicking 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 Qualitative3 months

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

Acceptability Quantitative3 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
NameTimeMethod

Trial Locations

Locations (1)

University of Michigan

🇺🇸

Ann Arbor, Michigan, United States

© Copyright 2025. All Rights Reserved by MedPath