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POSSE Project: A Community-Level Intervention for Black YMSM

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ClinicalTrials.gov Identifier: NCT03198663
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Sybil Hosek, John H. Stroger Hospital

Brief Summary:
Black young men who have sex with men (BYMSM) are at high risk for contracting and transmitting HIV, and represent a priority population for developing effective interventions. Within the House Ball community (HBC), a clandestine subculture of the Black gay community, HIV is highly stigmatized. This stigma, coupled with high HIV prevalence rates and elevated levels of undiagnosed/untreated HIV infection, places BYMSM in HBCs at incredible risk for HIV infection. Community-level interventions that target social norms, behavior, and stigma in the HBC are sorely needed in order to make a broader impact among BYMSM. Building on prior work in the community, this study proposes to launch an innovative Effectiveness-Implementation Hybrid Type 2 trial to examine the effectiveness and implementation of a community-level HIV prevention intervention (called POSSE) based on popular opinion leader (POL) models across two cities with similar HBCs, Chicago and Philadelphia. The proposed study has two specific aims: 1) To determine the effectiveness of a POL intervention, POSSE, to decrease sexual risk behavior (UAI), STIs and HIV stigma among BYMSM in the HBC; and 2) To evaluate the processes, strategies, barriers and facilitators for the implementation of POSSE delivered across two distinct metropolitan areas with high HIV prevalence among BYMSM and similar House Ball Communities. To examine these aims, the investigators will first use social network strategies to identify, screen, and recruit POLs (n=75) from the Philadelphia HBC. The investigators will then gather baseline behavioral and biological (HIV/STI testing) data in both Chicago and Philadelphia (n=100 BYMSM per city) and train the Philadelphia POLs to implement the POSSE intervention. The investigators will conduct an implementation-focused process evaluation to assess fidelity to the POSSE intervention; number, content, spread, and acceptability of risk reduction messages; age appropriateness of the messages; acceptability of the overall intervention; and barriers/facilitators to implementation. Next, the investigators will complete follow-up assessments every 6 months post- intervention in both cities (n=100 BYMSM per city at each assessment point). The investigators will also assess behavior change in those delivering the intervention (POLs) at each assessment point. The investigators will conduct implementation-focused qualitative interviews with POLs (n=15) and community participants (n=30) from Philadelphia. Last, the investigators will implement POSSE in Chicago by repeating the steps outlined above, continuing assessments in both cities, and conducting qualitative interviews in Chicago.

Condition or disease Intervention/treatment Phase
HIV/AIDS and Infections Behavioral: POSSE Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: POSSE Project: A Community-Level Intervention for Black YMSM
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: POSSE Intervention Behavioral: POSSE
Popular-opinion leader

Control
Delayed intervention
Behavioral: POSSE
Popular-opinion leader




Primary Outcome Measures :
  1. HIV incidence [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. STI incidence [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • self-identified as Black,
  • between the ages of 15 - 24 (inclusive), and
  • in attendance at a HBC event at the time of the assessment.

Exclusion Criteria:

  • intoxicated or otherwise unable to consent at time of enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198663


Contacts
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Contact: Sybil Hosek, PhD 312-864-8030 shosek@cookcountyhhs.org
Contact: Christopher Balthazar, MA 312-864-8012 cbalthazar@cookcountyhhs.org

Locations
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United States, Illinois
Recruiting
Chicago, Illinois, United States
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
John H. Stroger Hospital

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Responsible Party: Sybil Hosek, Clinical Psychologist, John H. Stroger Hospital
ClinicalTrials.gov Identifier: NCT03198663     History of Changes
Other Study ID Numbers: R01MH104106 ( U.S. NIH Grant/Contract )
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No