NCT06015581

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
12mo left

Started May 2027

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
3.7 years until next milestone

Study Start

First participant enrolled

May 1, 2027

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

July 6, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

August 23, 2023

Last Update Submit

July 1, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Testing of YMSM from FDOH Surveillance

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

    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)

Workforce Development

EXPERIMENTAL

Sites in this arm receive agency-specific guided problem solving, quality improvement planning based on Mystery Shopper feedback

Behavioral: Workforce Development (WD) strategiesBehavioral: Quality Management (QM) and Mystery Shopper (MS) Feedback

Observation

OTHER

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

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).

Interventions

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.

Workforce Development

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.

ObservationWorkforce Development

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

Sylvie Naar, PhD

CONTACT

Sara Green, MSW

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Parallel Assignment (cluster randomized)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

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

July 6, 2026

Record last verified: 2026-07

Locations