Addressing Violence and HIV Care Among Transgender Women

NCT ID: NCT04813484

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2023-05-15

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.

Conditions

Acceptability of Health Care; HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Kickin it with the Gulz

Intervention Type: BEHAVIORAL

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

Interventions

Kickin it with the Gulz

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Kristi Gamarel

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristi Gamarel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R21MH121974

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F056257

Identifier Type: -

Identifier Source: org_study_id