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

July 1, 2026 updated by: Sylvie Naar, Florida State University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Young men who have sex with men (YMSM) continue to experience a disproportionate burden of HIV infection and remain less likely than other populations to engage in HIV testing, prevention services, and pre-exposure prophylaxis (PrEP). Counseling, Testing, and Referral (CTR) agencies play a critical role in improving the DIAGNOSE and PREVENT pillars of the Ending the HIV Epidemic initiative by providing culturally and developmentally responsive HIV prevention services. Previous mystery shopper evaluations of CTR agencies identified important gaps in provider delivery of evidence-based practices (EBPs), including risk reduction counseling, PrEP referrals, and culturally responsive care.

The purpose of this study is to evaluate the effectiveness of the Young Adult Centered HealthForce Training (YACHT) package for improving providers' fidelity to youth-focused EBPs and increasing HIV testing among YMSM in Florida CTR agencies. The study will be conducted in 41 Florida Department of Health contracted or direct-service CTR agencies located across six Florida End the Epidemic (EHE) counties.

This is a Type 2 hybrid implementation-effectiveness, cluster stratified randomized trial involving 41 agencies distributed across three blocks. Agencies will be randomized within blocks, with 20 assigned to receive the YACHT intervention and 21 serving as the comparison group.

The YACHT package consists of two complementary implementation strategies:

Workforce Development (WD), which provides agency-tailored guided problem solving and development of quality improvement strategies based on mystery shopper feedback reports; and Quality Management (QM) using standardized mystery shopper assessments that evaluate clinic environment, provider delivery of evidence-based practices, and culturally responsive care. Mystery shoppers will visit each participating agency twice per quarter, and aggregate agency-level feedback will be used to support quality improvement.

The primary effectiveness outcome is the number of HIV tests administered to YMSM using agency-level aggregate data obtained from the Florida Department of Health. The primary implementation outcome is providers' fidelity to evidence-based practices, including risk reduction counseling and PrEP referrals, as assessed through standardized mystery shopper evaluations across multiple domains. Secondary objectives include identifying barriers and facilitators to successful implementation of youth-specific EBPs through qualitative interviews with agency representatives using a mixed-methods approach.

Both intervention and comparison agencies will receive a final mystery shopper feedback report at the conclusion of the study and will have access to ongoing voluntary virtual Tailored Motivational Interviewing (TMI) workshops. Qualitative interviews will be conducted with representatives from both intervention and comparison agencies following completion of study activities.

Study Type

Interventional

Enrollment (Estimated)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32310
        • Florida State University, Center for Translational Behavioral Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Agency Eligibility

  1. Florida Department of Health (FDOH) contracted or direct-service Counseling, Testing, and Referral (CTR) agency.
  2. Located within one of the six participating Florida End the Epidemic (EHE) counties.
  3. Provides HIV counseling, testing, and referral services. 4 Conducted HIV testing for a minimum of 24 young men who have sex with men (YMSM) during the previous year.

Provider/Staff Eligibility

  1. Employed by a participating CTR agency.
  2. Age 18 years or older.
  3. Able to understand and speak English.
  4. Willing and able to provide informed consent.
  5. Selected to participate in the qualitative interview component of the study.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Workforce Development
Sites in this arm receive agency-specific guided problem solving, quality improvement planning based on Mystery Shopper feedback
Behavioral: Workforce Development (WD) strategies
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.
Behavioral: Quality Management (QM) and Mystery Shopper (MS) Feedback
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.
Other: Observation
Usual Care Sites in this arm receive final Mystery Shopper feedback report and access to ongoing voluntary monthly virtual TMI workshops
Behavioral: Quality Management (QM) and Mystery Shopper (MS) Feedback
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Service quality via Mystery Shopper Assessments composite
Time Frame: Quarterly from Month 7 to Month 54
Two mystery shoppers visit each agency once per quarter. Using the pre-established MS domains (Session Speed, LGBT Visibility, Medical Forms, Clinic Environment, Privacy and Confidentiality, PrEP-specific Indicators, Relationship Context, Counseling Session, Safer Sex Education, Perceived Provoder Competency, Provider Interactions), we will compute an overall agency score using the pooled scores from the two MS conducted each quarter.
Quarterly from Month 7 to Month 54
Testing of YMSM from FDOH Surveillance
Time Frame: 54 months plus 12 months prior to the study start
The outcomes will be the count of HIV tests delivered to YMSM
54 months plus 12 months prior to the study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Collaborators

University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2027

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

August 29, 2023

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003373

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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