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NCT Number: NCT06015581

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University, Center for Translational Behavioral Science

Tallahassee, Florida, 32310, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Agency Eligibility

  • Florida Department of Health (FDOH) contracted or direct-service Counseling, Testing, and Referral (CTR) agency.
  • Located within one of the six participating Florida End the Epidemic (EHE) counties.
  • 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

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

Exclusion criteria

-

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Green, MSW

CONTACT

[email protected]

8506442334

Sylvie Naar, PhD

CONTACT

[email protected]

18506442334

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • University of Pennsylvania

Registry information

Acronym: YACHT

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Aug 29, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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