CClinicalTrials.gg
RecruitingNCT04769492Updated Apr 1, 2024

#ChopViolence/#ChopHIV

An interventional study of #ChopViolence/#ChopHIV in Violence and HIV, sponsored by Hektoen Institute for Medical Research. Recruiting at 1 site in United States. Open to male participants aged 15 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-01.

Sponsored by Hektoen Institute for Medical Research · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Jul 2020, registered Feb 2021).
  • Started Jul 2020; still recruiting 6 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
525
Allocation
Not applicable
Ages
15 Years to 29 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Violence
  • HIV
03

In context

Lead sponsor

Hektoen Institute for Medical Research is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 29 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
525 participants (estimated)

Study arms

  • Other
    Pilot Intervention

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

    Other: #ChopViolence/#ChopHIV

Interventions

  • Other#ChopViolence/#ChopHIV

    Tailored, community-based violence prevention intervention

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: last 12 months

  2. 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.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04769492
Lead sponsor
Hektoen Institute for Medical Research
Responsible party
Sponsor
First posted
Feb 24, 2021
Start date
Jul 30, 2020
Primary completion
Aug 30, 2024 (estimated)
Completion
Aug 30, 2024 (estimated)
Last update
Apr 1, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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