A Multicomponent Intervention to Address Gender-based Violence in HIV

NCT04799197 | Completed Results

• 2 other identifiers: F056843R21MH123218
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Acceptability of Health Care; HIV Primary Infection

Outcome Measures

Primary Outcomes (1)

• Acceptability Quantitative

  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.

  3 months

Study Arms (1)

Kicking it with the Gurlz

EXPERIMENTAL

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.

Behavioral: Kicking it with the Gurlz

Interventions

Kicking it with the Gurlz BEHAVIORAL

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

Kicking it with the Gurlz

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All participants will identify their gender as a female, transgender woman, or another feminine gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Kristi Gamarel
• Organization: University of Michigan

kgamarel@umich.edu

7346473178

Study Officials

• Kristi Gamarel, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: One-arm pilot

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 16, 2021
• Study Start: July 1, 2021
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: March 25, 2025
• Results First Posted: February 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)