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

NCT06015581 | Not Yet Recruiting

• 1 other identifier: STUDY00003373
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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

Hiv

Outcome Measures

Primary Outcomes (2)

• Testing of YSMM from FDOH Surveillance

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

  54 months plus 12 months prior to the study start

• Service quality via Mystery Shopper Assessments composite

  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

Study Arms (3)

Implementation Package

EXPERIMENTAL

Continuous Quality Improvement (CQI)

Behavioral: Workforce Development: Tailored Motivational Interviewing and Technical Assistance; Behavioral: Quality Management, Mystery Shopper Feedback

Observation

OTHER

Usual Care

Behavioral: Quality Management, Mystery Shopper Feedback

EPIS Qualitative

NO INTERVENTION

5 providers of 42 sites will participate in Exploration, Preparation, Implementation, Sustainment (EPIS) qualitative interviews (N=210)

Interventions

Quality Management, Mystery Shopper Feedback BEHAVIORAL

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.

Implementation Package; Observation

Workforce Development: Tailored Motivational Interviewing and Technical Assistance BEHAVIORAL

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.

Implementation Package

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Florida State University: lead
• University of Pennsylvania: collaborator
• Nova Southeastern University: collaborator

Study Sites (1)

Florida State University, Center for Translational Behavioral Science

Tallahassee, Florida, 32310, United States

Location

Related Publications (1)

• 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:e63191. doi: 10.2196/63191.

  PMID: 39566048 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Sylvie Naar, PhD

CONTACT

18506442334; sylvie.naar@med.fsu.edu

Sara Green, MSW

CONTACT

8506442334; sara.green@med.fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Stepped Wedged Design with a second randomization

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (1)