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POSSE Project: A Community-Level Intervention for Black YMSM

Primary Purpose

HIV/AIDS and Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
POSSE
Sponsored by
Cook County Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS and Infections

Eligibility Criteria

15 Years - 25 Years (Child, Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

POSSE Intervention

Control

Arm Description

Delayed intervention

Outcomes

Primary Outcome Measures

HIV incidence

Secondary Outcome Measures

STI incidence

Full Information

First Posted
March 7, 2017
Last Updated
June 28, 2023
Sponsor
Cook County Health
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1. Study Identification

Unique Protocol Identification Number
NCT03198663
Brief Title
POSSE Project: A Community-Level Intervention for Black YMSM
Official Title
POSSE Project: A Community-Level Intervention for Black YMSM
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cook County Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS and Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1037 (Actual)

8. Arms, Groups, and Interventions

Arm Title
POSSE Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
Other
Arm Description
Delayed intervention
Intervention Type
Behavioral
Intervention Name(s)
POSSE
Intervention Description
Popular-opinion leader
Primary Outcome Measure Information:
Title
HIV incidence
Time Frame
24 months
Secondary Outcome Measure Information:
Title
STI incidence
Time Frame
24 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
City
Chicago
State/Province
Illinois
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

POSSE Project: A Community-Level Intervention for Black YMSM

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