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临床试验/NCT06015581
NCT06015581尚未招募不适用

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

Florida State University1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2027年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
81
试验地点
1
主要终点
Testing of YSMM from FDOH Surveillance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

研究组 & 干预措施

EPIS Qualitative

No Intervention

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).

结局指标

主要结局

Testing of YSMM from FDOH Surveillance

时间窗: 54 months plus 12 months prior to the study start

The outcomes will be the count of HIV tests delivered to YSMM

Service quality via Mystery Shopper Assessments composite

时间窗: 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.

Testing of YMSM from FDOH Surveillance

时间窗: 54 months plus 12 months prior to the study start

The outcomes will be the count of HIV tests delivered to YMSM

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sylvie Naar

Principal Investigator

Florida State University

研究点 (1)

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