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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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 fina

Первичные конечные точки

• Testing of YMSM from FDOH Surveillance [Срок оценки: 54 months plus 12 months prior to the study start]
• Service quality via Mystery Shopper Assessments composite [Срок оценки: Quarterly from Month 7 to Month 54]

Критерии участия

Критерии включения

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.

Критерии исключения

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Florida State University, Center for Translational Behavioral Science — Tallahassee

Публикации

• Giguere R, Fernandez MI, Bauermeister JA, Balan IC, Aryal S, Cheshure A, Green S, Lin W, Morgan J, Naar S. The Young Adult Centered Healthforce Training (YACHT) Program to Increase HIV Testing and Pre-Exposure Prophylaxis Referrals Among Young Sexual Minority Men in Florida: Protocol for a Type 2 Implementation-Effectiveness Hybrid Trial With a Stepped Wedge Design. JMIR Res Protoc. 2024 Nov 20;13 PMID 39566048

Идентификаторы

NCT: NCT06015581 · STUDY00003373

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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