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

NCT06015581 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-02-06

No results posted yet for this study

Summary

In this study, investigators will test the YACHT package in 42 FDOH contracted Counseling, Testing and Referral (CTR) agencies across Florida's seven End the HIV Epidemic (EHE) counties. The study is powered on both effectiveness outcomes (number of HIV tests of Young Sexual Minority Men - YSMM) and implementation outcomes, consistent with a type 2 hybrid trial. It is hypothesized that YACHT will improve providers' fidelity to Tailored Motivational Interviewing (TMI) when delivering risk reduction counseling (RRC) and PrEP referrals (implementation outcomes) and will increase testing among YSMM (effectiveness outcome). Investigators will use an innovative stepped wedge design to test the YACHT package, including a second randomization to explore ongoing quality management (QM) with mystery shoppers (MS) as a sustainment strategy. The study also contains a qualitative component based on the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to further understand the context of implementation and sustainment (sequential explanatory mixed methods).

Conditions

Interventions

BEHAVIORAL

Workforce Development: Tailored Motivational Interviewing and Technical Assistance

TMI training includes an initial 12 hour virtual workshop, standard patient interaction with feedback, group coaching, and a final standard patient interaction and feedback. TMI relies on experiential activities developed by the network while minimizing didactic presentations. Stigma-reducing communication is emphasized by practicing autonomy supportive and empathic statements and improving cultural humility practices. Role plays map on to the Mystery Shopper domains focusing on risk reduction counseling and PrEP referral. TA addresses factors in the EPIS framework.

BEHAVIORAL

Quality Management, Mystery Shopper Feedback

Mystery shoppers visit each agency two times per quarter to systematically examine testing clinics' environmental characteristics and their experiences with clinic staff (e.g., quality of testing session, safer sex discussions, perceived provider competency, PrEP discussions and referral). The investigator team meets with each agency once per quarter to review the data and provide technical assistance.

Sponsors & Collaborators

  • University of Pennsylvania

    collaborator OTHER

  • Nova Southeastern University

    collaborator OTHER

  • Florida State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2027-05-01
Primary Completion
2028-04-30
Completion
2028-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06015581 on ClinicalTrials.gov