xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06015581</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00003373</org_study_id>
      <nct_id>NCT06015581</nct_id>
    </id_info>
    <brief_title>Scaling Up Implementation Strategies to Improve the DIAGNOSE and PREVENT Pillars for Young MSM in Florida</brief_title>
    <acronym>YACHT</acronym>
    <official_title>Scaling Up Implementation Strategies to Improve the DIAGNOSE and PREVENT Pillars for Young MSM in Florida</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Florida State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Pennsylvania</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Nova Southeastern University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Florida State University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this study, investigators will test the YACHT package in 42 FDOH contracted Counseling,&#xD;
        Testing and Referral (CTR) agencies across Florida's seven End the HIV Epidemic (EHE)&#xD;
        counties. The study is powered on both effectiveness outcomes (number of HIV tests of Young&#xD;
        Sexual Minority Men - YSMM) and implementation outcomes, consistent with a type 2 hybrid&#xD;
        trial. It is hypothesized that YACHT will improve providers' fidelity to Tailored&#xD;
        Motivational Interviewing (TMI) when delivering risk reduction counseling (RRC) and PrEP&#xD;
        referrals (implementation outcomes) and will increase testing among YSMM (effectiveness&#xD;
        outcome). Investigators will use an innovative stepped wedge design to test the YACHT&#xD;
        package, including a second randomization to explore ongoing quality management (QM) with&#xD;
        mystery shoppers (MS) as a sustainment strategy. The study also contains a qualitative&#xD;
        component based on the Exploration, Preparation, Implementation, Sustainment (EPIS) framework&#xD;
        to further understand the context of implementation and sustainment (sequential explanatory&#xD;
        mixed methods).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary Aim: To test the effect of YACHT to improve fidelity to DIAGNOSE and PREVENT EBPs in&#xD;
        42 FDOH contracted CTR agencies in the seven Florida EHE counties. The primary effectiveness&#xD;
        outcome is the number of HIV tests among YSMM. The primary implementation outcome is&#xD;
        developmentally and culturally responsive delivery of competent EBPs (RRC, PrEP referral,&#xD;
        TMI) based on MS assessments.&#xD;
  &#xD;
        Secondary Aim 1: To assess the effect of continued QM (ongoing MS feedback) in sustaining the&#xD;
        primary outcomes.&#xD;
  &#xD;
        Secondary Aim 2: To utilize mixed methods based on the EPIS framework to understand barriers&#xD;
        and facilitators of successful implementation and sustainment of youth-specific EBPs within&#xD;
        CTR to improve the DIAGNOSE and PREVENT pillars for YSMM.&#xD;
  &#xD;
        In the proposed study, investigators will test the YACHT package in 42 FDOH contracted CTR&#xD;
        agencies across Florida's seven EHE counties. The study is powered on both effectiveness&#xD;
        outcomes (number of HIV tests of YSMM) and implementation outcomes (EBP fidelity), consistent&#xD;
        with a type 2 hybrid trial. The investigative team hypothesizes that YACHT will improve&#xD;
        providers' fidelity to TMI when delivering RRC and PrEP referrals (implementation outcomes)&#xD;
        and will increase testing among YSMM (effectiveness outcome). The study will use an&#xD;
        innovative stepped wedge design to test the YACHT package, including a second randomization&#xD;
        to explore ongoing QM with MS as a sustainment strategy.&#xD;
  &#xD;
        Primary effectiveness outcome: The primary outcome is # of tests of YSMM (ages 15-29), as&#xD;
        reported in aggregate at the agency- and county-level. Investigators expect that the YACHT&#xD;
        package will improve the number of HIV tests administered to YSMM at each agency. As an&#xD;
        exploratory outcome, FDOH has recently begun tracking PrEP uptake, defined as ≥1 day of&#xD;
        TDF/FTC prescribed for PrEP. Both the testing and PrEP data are currently reported in a&#xD;
        standardized fashion to FDOH. Data will be aggregated within agencies and will be requested&#xD;
        biannually. Data will be managed into quarterly windows to correspond to the data collection&#xD;
        intervals in the stepped wedge design.&#xD;
  &#xD;
        Primary implementation outcomes: Procedures for MS are described in C4a Exploration and&#xD;
        domains are described in Preliminary Studies (section C1c). Using the pre-established MS&#xD;
        domains, investigators will compute an overall agency score using the pooled scores from the&#xD;
        two MS conducted each quarter. Pooled scores will be presented to reduce potential selection&#xD;
        bias and confounding based on whether the same or a different provider interacted with the&#xD;
        shoppers at either agency visit, and to account for the variability across shoppers. Domain&#xD;
        sub-scores will also be created using psychometrically tested subscales for: 1) LGBT&#xD;
        visibility, 2) medical form inclusivity, 3) perceived clinic environment, 4) privacy and&#xD;
        confidentiality, 5) relationship context, 6) RRC, 7) safer sex education, 8) PrEP information&#xD;
        and referral, 9) perceived provider competency, and 10) patient-provider interactions. For&#xD;
        ease of interpretability across domains, investigators will normalize the pooled average&#xD;
        scores into percentiles.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">June 2024</start_date>
    <completion_date type="Anticipated">May 2026</completion_date>
    <primary_completion_date type="Anticipated">May 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>Stepped Wedged Design with a second randomization</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Testing of YSMM from FDOH Surveillance</measure>
      <time_frame>54 months plus 12 months prior to the study start</time_frame>
      <description>The outcomes will be the count of HIV tests delivered to YSMM</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Service quality via Mystery Shopper Assessments composite</measure>
      <time_frame>Quarterly from Month 7 to Month 54</time_frame>
      <description>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.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">210</enrollment>
    <condition>Hiv</condition>
    <arm_group>
      <arm_group_label>Implementation Package</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Continuous Quality Improvement (CQI)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Observation</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Usual Care</description>
    </arm_group>
    <arm_group>
      <arm_group_label>EPIS Qualitative</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>5 providers of 42 sites will participate in Exploration, Preparation, Implementation, Sustainment (EPIS) qualitative interviews (N=210)</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Workforce Development: Tailored Motivational Interviewing and Technical Assistance</intervention_name>
      <description>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.</description>
      <arm_group_label>Implementation Package</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Quality Management, Mystery Shopper Feedback</intervention_name>
      <description>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.</description>
      <arm_group_label>Implementation Package</arm_group_label>
      <arm_group_label>Observation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Site inclusion: All Florida Department of Health (FDOH) contracted or direct service&#xD;
               agencies (k=42) across all seven EHE counties that meet eligibility criteria: 1)&#xD;
               provide HIV CTR, and 2) tested a minimum of 24 tests to YSMM in the last year.&#xD;
  &#xD;
            -  Provider Inclusion: Provide CTR at eligible sites.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sylvie Naar, PhD</last_name>
      <phone>18506442334</phone>
      <email>sylvie.naar@med.fsu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sara Green, MSW</last_name>
      <phone>8506442334</phone>
      <email>sara.green@med.fsu.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Florida State University</investigator_affiliation>
      <investigator_full_name>Sylvie Naar</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06015581
  org study id: STUDY00003373
  nct id: NCT06015581
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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).
  Primary Aim: To test the effect of YACHT to improve fidelity to DIAGNOSE and PREVENT EBPs in
        42 FDOH contracted CTR agencies in the seven Florida EHE counties. The primary effectiveness
        outcome is the number of HIV tests among YSMM. The primary implementation outcome is
        developmentally and culturally responsive delivery of competent EBPs (RRC, PrEP referral,
        TMI) based on MS assessments.
  
        Secondary Aim 1: To assess the effect of continued QM (ongoing MS feedback) in sustaining the
        primary outcomes.
  
        Secondary Aim 2: To utilize mixed methods based on the EPIS framework to understand barriers
        and facilitators of successful implementation and sustainment of youth-specific EBPs within
        CTR to improve the DIAGNOSE and PREVENT pillars for YSMM.
  
        In the proposed study, investigators will test the YACHT package in 42 FDOH contracted CTR
        agencies across Florida's seven EHE counties. The study is powered on both effectiveness
        outcomes (number of HIV tests of YSMM) and implementation outcomes (EBP fidelity), consistent
        with a type 2 hybrid trial. The investigative team hypothesizes that YACHT will improve
        providers' fidelity to TMI when delivering RRC and PrEP referrals (implementation outcomes)
        and will increase testing among YSMM (effectiveness outcome). The study will use an
        innovative stepped wedge design to test the YACHT package, including a second randomization
        to explore ongoing QM with MS as a sustainment strategy.
  
        Primary effectiveness outcome: The primary outcome is # of tests of YSMM (ages 15-29), as
        reported in aggregate at the agency- and county-level. Investigators expect that the YACHT
        package will improve the number of HIV tests administered to YSMM at each agency. As an
        exploratory outcome, FDOH has recently begun tracking PrEP uptake, defined as ≥1 day of
        TDF/FTC prescribed for PrEP. Both the testing and PrEP data are currently reported in a
        standardized fashion to FDOH. Data will be aggregated within agencies and will be requested
        biannually. Data will be managed into quarterly windows to correspond to the data collection
        intervals in the stepped wedge design.
  
        Primary implementation outcomes: Procedures for MS are described in C4a Exploration and
        domains are described in Preliminary Studies (section C1c). Using the pre-established MS
        domains, investigators will compute an overall agency score using the pooled scores from the
        two MS conducted each quarter. Pooled scores will be presented to reduce potential selection
        bias and confounding based on whether the same or a different provider interacted with the
        shoppers at either agency visit, and to account for the variability across shoppers. Domain
        sub-scores will also be created using psychometrically tested subscales for: 1) LGBT
        visibility, 2) medical form inclusivity, 3) perceived clinic environment, 4) privacy and
        confidentiality, 5) relationship context, 6) RRC, 7) safer sex education, 8) PrEP information
        and referral, 9) perceived provider competency, and 10) patient-provider interactions. For
        ease of interpretability across domains, investigators will normalize the pooled average
        scores into percentiles.
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: Stepped Wedged Design with a second randomization
  primary purpose: Health Services Research
  masking: Single (Outcomes Assessor)
  measure: Testing of YSMM from FDOH Surveillance
  time frame: 54 months plus 12 months prior to the study start
  description: The outcomes will be the count of HIV tests delivered to YSMM
  measure: Service quality via Mystery Shopper Assessments composite
  time frame: Quarterly from Month 7 to Month 54
  description: 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.
  arm group label: Implementation Package
  arm group type: Experimental
  description: Continuous Quality Improvement (CQI)
  arm group label: Observation
  arm group type: Other
  description: Usual Care
  arm group label: EPIS Qualitative
  arm group type: No Intervention
  description: 5 providers of 42 sites will participate in Exploration, Preparation, Implementation, Sustainment (EPIS) qualitative interviews (N=210)
  intervention type: Behavioral
  intervention name: Workforce Development: Tailored Motivational Interviewing and Technical Assistance
  description: 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.
  arm group label: Implementation Package
  intervention type: Behavioral
  intervention name: Quality Management, Mystery Shopper Feedback
  description: 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.
  arm group label: Implementation Package
  arm group label: Observation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sylvie Naar, PhD
  phone: 18506442334
  email: sylvie.naar@med.fsu.edu
  last name: Sara Green, MSW
  phone: 8506442334
  email: sara.green@med.fsu.edu
  responsible party type: Principal Investigator
  investigator affiliation: Florida State University
  investigator full name: Sylvie Naar
  investigator title: Principal Investigator