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ViolenceNCT04769492

#ChopViolence/#ChopHIV

A study testing #ChopViolence/#ChopHIV in people with Violence and HIV, run by Hektoen Institute for Medical Research at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 to 29 years, men onlyHealthy volunteers can take part
Conditions the study is for
Violence, HIV
What is being tested?
#ChopViolence/#ChopHIV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
525 participants
Where
1 siteUnited States
Study dates
30 Jul 2020to 30 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 29 years
  • Men only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting
  • Cook County Health

    Chicago, Illinois, 60612

    Chris Balthazar, MA, 312-864-8008, chris.balthazar@cookcountyhhs.org

    Sybil Hosek, PhD, 312-864-8030, shosek@cookcountyhhs.org

    Recruiting

Other trials in United States

About this study

Official title: #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.

Conditions
Violence, HIV
Being tested
#ChopViolence/#ChopHIV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • #ChopViolence/#ChopHIVOther

    Tailored, community-based violence prevention intervention

Study groups in NCT04769492
Study groupRoleWhat they receive
Pilot InterventionOtherTailored violence prevention intervention (#ChopViolence/#ChopHIV) for B-YGBMSM and B-TW in the Chicago HBC.
Receives: Other: #ChopViolence/#ChopHIV

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2021
  2. Study start30 Jul 2020
  3. Primary completion30 Aug 2024 (estimated)
  4. Study completion30 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
525 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04769492
Sponsor's protocol ID
5R34MH121968
Status last verified
Mar 2024
First submitted
17 Feb 2021
Last updated
1 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing #ChopViolence/#ChopHIV in people with Violence and HIV, run by Hektoen Institute for Medical Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trauma History Questionnaire (time frame: last 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.

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