- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04769492
#ChopViolence/#ChopHIV
March 29, 2024 updated by: Hektoen Institute for Medical Research
#ChopViolence/#ChopHIV: A Tailored Violence Prevention Intervention for Black Young MSM and Transgender Women From the House Ball Community to Improve HIV Outcomes and Decrease Exposure to Violence
Black young gay, bisexual and other men who have sex with men (B-YGBMSM) and transgender women (B-YTW) are disproportionately affected by HIV/AIDS in the U.S. Youth in the House Ball Community (HBC), a subculture of the Black gay community that offers a social network to freely express diverse sexual and gender identities, are among the most at-risk for HIV infection and loss to care, but barriers exist to the provision of HIV services within this community.
One barrier is the increasing rates of violence.
Interventions are needed that will interrupt the cycle of violence within the HBC to allow for adequate provision of HIV services and increased access to HIV care.
The investigators propose to tailor the Cure Violence model for violence prevention for developmental-appropriateness, cultural-specificity and HIV relevance, then pilot test the new intervention (#ChopViolence/#ChopHIV) with B-YGBMSM and B-TW in the Chicago HBC.
The proposed research activities will take place in six steps.
In Step 1, the investigators will hold Youth Advisory Board meetings, finalize our assessment battery and conduct multiple baseline assessments (months 3, 9 & 15; n=75 per assessment point) at HBC venues to track trends in violence (i.e., intimate partner, HBC and neighborhood violence), HIV stigma, substance use, mental health, sexual risk and HIV care engagement.
In Step 2, the investigators will employ ADAPT-ITT strategies for adapting evidence-based interventions including conducting a series of focus groups (n=32) with youth and leaders from the HBC in order to identify persuasive messaging around decreasing violence and improving HIV outcomes.
Based on the focus group data as well as consultation with community experts, the investigators will then tailor the intervention to be relevant for the Chicago HBC and develop training materials along with standard operating procedures.
In Step 3, the investigators will identify, recruit and train trusted members of the HBC to work as Violence Interrupters (VI) or Outreach Workers (OW).
VI and OW will undergo training over the course of several weeks.
Training activities include didactic seminars, webinars from the Cure Violence team, HIV education, conflict mediation skills and mock interruption and outreach activities.
In Step 4, the investigators will pilot test the tailored intervention.
VI will monitor HBC events as well as social media venues for potential violence and intervene.
OW will build their client caseload with HIV+ youth identified as of highest-risk for violence and schedule sessions, phone calls, and assist with HIV care linkage.
In Step 5, the investigators will conduct follow-up assessments (months 21, 27 & 33; n=75 per assessment point) at HBC events to continue to monitor trends in violence, HIV stigma, substance use, mental health, sexual risk and HIV care engagement.
Qualitative interviews will be conducted with VI, OW and HIV+ intervention clients to explore the processes and strategies of intervention implementation, with a focus on implementation barriers and facilitators.
Finally, in Step 6, the investigators will conduct data analysis, disseminate findings and produce scientific publications.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
525
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Recruiting
- Cook County Health
-
Contact:
- Sybil Hosek, PhD
- Phone Number: 312-864-8030
- Email: shosek@cookcountyhhs.org
-
Contact:
- Chris Balthazar, MA
- Phone Number: 312-864-8008
- Email: chris.balthazar@cookcountyhhs.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 29 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- self-identified as Black,
- ages 15-29
- in attendance at a HBC event at the time of the assessment.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Pilot Intervention
Tailored violence prevention intervention (#ChopViolence/#ChopHIV) for B-YGBMSM and B-TW in the Chicago HBC.
|
Tailored, community-based violence prevention intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trauma History Questionnaire
Time Frame: last 12 months
|
The Trauma History Questionnaire measures history of exposure to potentially traumatic events with 18 yes/no items addressing the occurrence of traumatic events in three categories: crime, general trauma, and sexual and physical assault experiences.
We will adapt this measure for participants to identify if event occurred within HBC or within neighborhood.
|
last 12 months
|
|
Intimate Partner Violence
Time Frame: 12 months
|
Intimate partner violence will be measured using a questionnaire developed for a multi-national study that consists of 4 questions that assess physical, emotional and sexual harm experienced by the participant.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 30, 2020
Primary Completion (Estimated)
August 30, 2024
Study Completion (Estimated)
August 30, 2024
Study Registration Dates
First Submitted
February 17, 2021
First Submitted That Met QC Criteria
February 23, 2021
First Posted (Actual)
February 24, 2021
Study Record Updates
Last Update Posted (Actual)
April 1, 2024
Last Update Submitted That Met QC Criteria
March 29, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 5R34MH121968 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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