A Multicomponent Intervention to Address Gender-based Violence in HIV

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicomponent Intervention to Address Gender-based Violence in HIV

Conditions
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Acceptability of Health Care, HIV Primary Infection

Intervention / Treatment
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* Behavioral: Kicking it with the Gurlz


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: One-arm pilot
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kicking it with the Gurlz<br>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<br>* The intervention is a multicomponent intervention, including a screening, groups, and individual sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CR-HIV | CR-HIV is a binary indicator of any HIV risk (e.g., yes=1 vs. no=0), which is an algorithm based on whether a participant reports condomless anal or vaginal sex with a HIV serodiscordant or status-unknown primary or other partner in the past 3 months. If the participant reports condomless sex with a serodiscordant or status-unknown primary or other partner, then the participant is coded as 1 if they are not adherent to PrEP and 0=if they are adherent to PrEP. | Changes from baseline to 3-month follow up | 

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 |