Addressing Violence and HIV Care Among Transgender Women
Primary Purpose
Acceptability of Health Care, HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kickin it with the Gurlz
Sponsored by

About this trial
This is an interventional prevention trial for Acceptability of Health Care
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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Kicking it with the Gurlz
Arm Description
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.
Outcomes
Primary Outcome Measures
Self-report past 3 months viral load
Self-report viral load in the past 3 months as measured by detectable versus undetectable.
Secondary Outcome Measures
PTSD Checklist for DSM-4 (PLC-5)
PTSD Checklist for DSM-5 (PLC-5) is a self-report measure that assesses PTSD symptoms where higher scores indicate greater PTSD symptoms.
Generalized Anxiety Disorder (GAD-7)
Generalized Anxiety Disorder-7 (GAD-7) is a self-report measure that assesses anxious symptoms where higher scores indicate greater anxious symptoms
Patient Health Questionnaire (PHQ-9)
Patient Health Questionnaire (PHQ-9) is a self-report measure that assesses depressive symptoms where higher scores indicated greater depressive symptoms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04813484
Brief Title
Addressing Violence and HIV Care Among Transgender Women
Official Title
Addressing Violence and HIV Cascade of Care Outcomes Among Transgender Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acceptability of Health Care, HIV Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One-arm pilot
Masking
None (Open Label)
Masking Description
No masking
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kicking it with the Gurlz
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Kickin it with the Gurlz
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-report past 3 months viral load
Description
Self-report viral load in the past 3 months as measured by detectable versus undetectable.
Time Frame
Changes from baseline to 3-month follow up
Secondary Outcome Measure Information:
Title
PTSD Checklist for DSM-4 (PLC-5)
Description
PTSD Checklist for DSM-5 (PLC-5) is a self-report measure that assesses PTSD symptoms where higher scores indicate greater PTSD symptoms.
Time Frame
Changes from baseline to 3-month follow up
Title
Generalized Anxiety Disorder (GAD-7)
Description
Generalized Anxiety Disorder-7 (GAD-7) is a self-report measure that assesses anxious symptoms where higher scores indicate greater anxious symptoms
Time Frame
Changes from baseline to 3-month follow up
Title
Patient Health Questionnaire (PHQ-9)
Description
Patient Health Questionnaire (PHQ-9) is a self-report measure that assesses depressive symptoms where higher scores indicated greater depressive symptoms.
Time Frame
Changes from baseline to 3-month follow up
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
All participants will identify their gender as a female, transgender woman, or another feminine gender identity.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristi Gamarel, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Addressing Violence and HIV Care Among Transgender Women
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