Scaling Up Implementation Strategies to Improve the DIAGNOSE and PREVENT Pillars for Young MSM in Florida

Part of paid clinical trials in Tallahassee, Florida.

Sponsor: Florida State University
Study ID: NCT06015581
Status: Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Accepted

Interventions

Workforce Development (WD) strategies — BEHAVIORAL
Workforce Development (WD) strategies includes agency-tailored problem-solving and development of quality improvement strategies based on MS feedback reports. The effectiveness of workforce development within the provider population will be assessed through qualitative interviews. Agencies will have access to ongoing virtual TMI training and final MS feedback at the end of the study.
Quality Management (QM) and Mystery Shopper (MS) Feedback — BEHAVIORAL
During this intervention, mystery shoppers will visit each agency twice per quarter to systematically examine testing clinics' environmental characteristics and their experiences with clinic staff on a variety of domains. The mystery shopper agency assessment outcomes will be measured through agency specific, aggregate data requested from FDOH that addresses the primary effectiveness outcome of the number of HIV tests among YMSM. Agencies will have access to ongoing virtual TMI training and final MS feedback at the end of the study.

Study Details

The purpose of this study is to evaluate the Young Adult Centered HealthForce Training (YACHT) package in 41 Florida Department of Health (FDOH) contracted Counseling, Testing, and Referral (CTR) agencies across six Florida End the Epidemic (EHE) counties. Agencies will be cluster-stratified and randomized to either the YACHT intervention (20 agencies) or a comparison group (21 agencies). The primary effectiveness outcome is the number of HIV tests administered to young men who have sex with men (YMSM), and the primary implementation outcome is providers' fidelity to evidence-based practices (EBPs), including risk reduction counseling and PrEP referrals, as measured through mystery shopper assessments and agency-level data obtained from the Florida Department of Health. The study also includes qualitative interviews with agency representatives to identify barriers and facilitators to successful implementation of youth-specific EBPs within HIV CTR settings.

Key Dates

First listed: Aug 29, 2023
Start date: May 1, 2027
Status verified: Jul 2026
Primary completion: Apr 30, 2028
Completion: Apr 30, 2028

Study Design

Enrollment: 81 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Arms

Experimental: Workforce Development
Sites in this arm receive agency-specific guided problem solving, quality improvement planning based on Mystery Shopper feedback
Other: Observation
Usual Care Sites in this arm receive final Mystery Shopper feedback report and access to ongoing voluntary monthly virtual TMI workshops
No Intervention: EPIS Qualitative
Providers will participate in Exploration, Preparation, Implementation, Sustainment (EPIS) qualitative interviews. 3 providers per each agency in the intervention group (N=60) and 1 provider per agency in the control group (N=21).