A Multicomponent Intervention to Address Gender-based Violence in HIV

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.

Study Overview

• Status: Completed
• Conditions: Acceptability of Health Care; HIV Primary Infection
• Intervention / Treatment: Behavioral: Kicking it with the Gurlz

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Kicking it with the Gurlz; The intervention is a multicomponent intervention, including a screening, groups, and individual sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability Qualitative	Qualitative Exit Interviews where more than 80% of participants deem intervention acceptable	3 months
Acceptability Quantitative	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Checklist for DSM-4 (PLC-5)	PTSD Checklist for DSM-5 (PLC-5) is a self-report measure that assesses PTSD symptoms	Changes from baseline to 3-month follow up
Generalized Anxiety Disorder (GAD-7)	General Anxiety Disorder-7 (GAD-7) is a self-report measure that assesses anxious symptoms	Changes from baseline to 3-month follow up
Patient Health Questionnaire-9 (PHQ-9)	Patient Health Questionnaire-9 (PHQ-9) is self-report measure that assesses depressive symptoms	Changes from baseline to 3-months

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Kristi Gamarel, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: F056843

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Our team is committed to collaboration with NIH officials, other researchers, the health and social services community, and other entities for rapid dissemination of data and sharing of materials. We will make our results available to the community of researchers and general public interested in transgender health to avoid unintentional duplication of research, as well as to others in the health and social services community, including HIV clinics, LGBT community based organizations, and AIDS service organizations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No