NCT04813484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

April 24, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

2.3 years

First QC Date

March 21, 2021

Results QC Date

January 8, 2025

Last Update Submit

April 4, 2025

Conditions

Acceptability of Health CareHIV Infections

Outcome Measures

Primary Outcomes (1)

  • Acceptability Quantitative

    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.

    3-month follow up

Study Arms (1)

Kicking it with the Gurlz

EXPERIMENTAL

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: Kickin it with the Gulz

Interventions

Kickin it with the GulzBEHAVIORAL

The intervention is a multicomponent intervention, including a screening, groups, and individual sessions.

Kicking it with the Gurlz

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsAll participants will identify their gender as a female, transgender woman, or another feminine gender identity.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Patient Acceptance of Health CareHIV Infections

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Kristi Gamarel
Organization
University of Michigan
kgamarel@umich.edu
7346473178

Study Officials

  • Kristi Gamarel, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: One-arm pilot
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 21, 2021

First Posted

March 24, 2021

Study Start

January 15, 2021

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

April 24, 2025

Results First Posted

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)