A Multicomponent Intervention to Address Gender-based Violence in HIV

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.

• Kicking it with the Gurlz (Behavioral): The intervention is a multicomponent intervention, including a screening, groups, and individual sessions.

Primary outcomes

• Acceptability Quantitative [3 months]: 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.

Sex: Male, ages: 18 Years to any, accepts healthy volunteers

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

Participant flow

Outcome results

• Acceptability Quantitative (Primary), Mean, score on a scale: Kickin it With the Gurlz 3.5 (0 to 4)

Adverse events

Time frame: 6 months

• Study Protocol (PDF, 2021-06-22)
• Informed Consent Form (PDF, 2021-06-29)

• Kristi Gamarel, PhD, Principal investigator, University of Michigan

NIH grants: R21MH123218