A Multicomponent Intervention to Address Gender-based Violence in HIV

Acceptability of Health Care Clinical Trial

Official title:

A Multicomponent Intervention to Address Gender-based Violence in HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04799197
• Other study ID #: F056843
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: May 15, 2023

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acceptability of Health Care
• HIV Primary Infection

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Acceptability Qualitative	Qualitative Exit Interviews where more than 80% of participants deem intervention acceptable	3 months