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NCT04799197 · ClinicalTrials.gov registry record · NA

A Multicomponent Intervention to Address Gender-based Violence in HIV

A NA study of Acceptability of Health Care and HIV Primary Infection, sponsored by University of Michigan.

Completed
Registry status
NA
Development phase
18
Enrollment target
1
Study location

NCT04799197: Completed NA study of Acceptability of Health Care and HIV Primary Infection, sponsored by University of Michigan.

NCT04799197 is a NA study of Acceptability of Health Care and HIV Primary Infection that has completed, run by University of Michigan. The registered enrollment target is 18 participants, below the 64-participant average among 3 other Acceptability of Health Care trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04799197, a NA study of Acceptability of Health Care and HIV Primary Infection, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
NA
Development phase
18 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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.

Interventions

  • BEHAVIORAL Kicking it with the Gurlz

Study Locations (1)

Michigan

  • University of Michigan - Ann Arbor

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2021-07-01
Est. Completion 2023-05-15
Phase NA
University of Michigan

1,327 total trials

What the finished NCT04799197 record still lists

NCT04799197 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 64-participant average among 3 other Acceptability of Health Care trials with a reported enrollment target (72% lower).

The record links to 2 conditions, with Acceptability of Health Care appearing as the primary indexed condition, and to 1 intervention - of which Kicking it with the Gurlz is the first listed.

NCT04799197 reports a single indexed study location in Michigan.

Frequently Asked Questions

What is clinical trial NCT04799197 about?

NCT04799197 is a clinical study titled "A Multicomponent Intervention to Address Gender-based Violence in HIV". 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 screen...

What is the current status of trial NCT04799197?

This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2021-07-01. Estimated completion is 2023-05-15.

What conditions does trial NCT04799197 study?

This clinical trial studies the following conditions: Acceptability of Health Care, HIV Primary Infection.

What interventions are being tested in trial NCT04799197?

The interventions under investigation include: Kicking it with the Gurlz (BEHAVIORAL).

Who is sponsoring clinical trial NCT04799197?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04799197 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04799197, the US trial registry maintained by the National Library of Medicine. NCT04799197 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.