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Trial Outcomes & Findings for A Multicomponent Intervention to Address Gender-based Violence in HIV (NCT NCT04799197)

NCT ID: NCT04799197

Last Updated: 2025-03-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

3 months

Results posted on

2025-03-25

Participant Flow

Participant milestones

Participant milestones
Measure
Kickin it With the Gurlz
Group sessions
Overall Study
STARTED
18
Overall Study
COMPLETED
18
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Multicomponent Intervention to Address Gender-based Violence in HIV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Kicking it With the Gurlz
n=18 Participants
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. Kicking it with the Gurlz: The intervention is a multicomponent intervention, including a screening, groups, and individual sessions.
Age, Continuous
29 years
n=5 Participants
Sex: Female, Male
Female
18 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
18 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
18 participants
n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Descriptive analyses examining the mean.

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.

Outcome measures

Outcome measures
Measure
Kickin it With the Gurlz
n=18 Participants
Group sessions
Acceptability Quantitative
3.5 score on a scale
Interval 0.0 to 4.0

Adverse Events

Kickin it With the Gurlz

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kristi Gamarel

University of Michigan

Phone: 7346473178

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place