NCT04769492

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
525

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

4.1 years

First QC Date

February 17, 2021

Last Update Submit

March 29, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Trauma History Questionnaire

    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

    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

Study Arms (1)

Pilot Intervention

OTHER

Tailored violence prevention intervention (#ChopViolence/#ChopHIV) for B-YGBMSM and B-TW in the Chicago HBC.

Other: #ChopViolence/#ChopHIV

Interventions

Tailored, community-based violence prevention intervention

Pilot Intervention

Eligibility Criteria

Age15 Years - 29 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailscis-gender male or transgender female
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • self-identified as Black,
  • ages 15-29
  • in attendance at a HBC event at the time of the assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cook County Health

Chicago, Illinois, 60612, United States

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 24, 2021

Study Start

July 30, 2020

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

April 1, 2024

Record last verified: 2024-03

Locations