HivYACHTNCT06015581
Scaling Up Implementation Strategies to Improve the DIAGNOSE and PREVENT Pillars for Young MSM in Florida
A study testing Workforce Development (WD) strategies and Quality Management (QM) and Mystery Shopper (MS) Feedback in people with Hiv, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Workforce Development (WD) strategies and Quality Management (QM) and Mystery Shopper (MS) Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2027to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Florida State University, Center for Translational Behavioral Science
Tallahassee, Florida, 32310
About this study
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.
Read the detailed description
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.
- Conditions
- Hiv
- Being tested
- Workforce Development (WD) strategies, Quality Management (QM) and Mystery Shopper (MS) Feedback
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workforce Development (WD) strategiesBehavioural
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) FeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Workforce Development | Experimental | Sites in this arm receive agency-specific guided problem solving, quality improvement planning based on Mystery Shopper feedback Receives: Behavioral: Workforce Development (WD) strategies; Behavioral: 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 Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing of YMSM from FDOH Surveillance
The outcomes will be the count of HIV tests delivered to YMSM
Measured: 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.
Measured: Quarterly from Month 7 to Month 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Jun 2027 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment (cluster randomized)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvie Naar, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015581
- Sponsor's protocol ID
- STUDY00003373
- Other IDs
- R01MH132147-05
- Acronym
- YACHT
- Status last verified
- Oct 2026
- First submitted
- 23 Aug 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39566048
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling Up Implementation Strategies to Improve the DIAGNOSE and PREVENT Pillars for Young MSM in Florida
- ClinicalTrials.gov ID
- NCT06015581
- Acronym / sponsor ID
- YACHT / STUDY00003373
- Conditions
- Hiv
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Pennsylvania
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment (cluster randomized)
| Arm | Type | Receives |
|---|---|---|
| Workforce Development | Experimental | Behavioral: Workforce Development (WD) strategies, Behavioral: Quality Management (QM) and Mystery Shopper (MS) FeedbackSites in this arm receive agency-specific guided problem solving, quality improvement planning based on Mystery Shopper feedback |
| Observation | Other | Behavioral: Quality Management (QM) and Mystery Shopper (MS) FeedbackUsual Care Sites in this arm receive final Mystery Shopper feedback report and access to ongoing voluntary monthly virtual TMI workshops |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Workforce Development (WD) strategiesWorkforce 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. | Behavioural | Workforce Development |
| Quality Management (QM) and Mystery Shopper (MS) FeedbackDuring 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. | Behavioural | Observation, Workforce Development |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 39566048Giguere 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.
Related trials for Hiv
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Workforce Development (WD) strategies and Quality Management (QM) and Mystery Shopper (MS) Feedback in people with Hiv, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvie Naar, PhD (18506442334, sylvie.naar@med.fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testing of YMSM from FDOH Surveillance (time frame: 54 months plus 12 months prior to the study start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06015581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.