NCT03198663

POSSE Project: A Community-Level Intervention for Black YMSM

Completed NA Last updated 29 June 2023

What this trial tests

NA trial testing POSSE in HIV/AIDS and Infections in 1,037 participants. Completed in 1 April 2020.

Timeline

1 June 2016

Primary endpoint
1 March 2020

1 April 2020

Quick facts

Lead sponsor	Cook County Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,037
Start date	1 June 2016
Primary completion	1 March 2020
Estimated completion	1 April 2020
Sites	2 locations across United States

Drugs / interventions tested

• POSSE

Conditions studied

• HIV/AIDS and Infections — all drugs for HIV/AIDS and Infections →

Sponsor

Cook County Health — full company profile →

Who can join

Adults 15 to 25, male only, with HIV/AIDS and Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.