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/NCT06030557</url>
    </required_header>
    <id_info>
      <org_study_id>IN-US-412-6439</org_study_id>
      <nct_id>NCT06030557</nct_id>
    </id_info>
    <brief_title>PrEPared-RN, CAN Nurse-Led Management of High-risk Patients for Pre-Exposure Prophylaxis (PrEP)</brief_title>
    <acronym>Prep-RN</acronym>
    <official_title>PrEPared-RN, CAN Nurse-Led Management of High-risk Patients for Pre-Exposure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CAN Community Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CAN Community Health</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        During the initial encounter, the nurses will complete program enrollment forms (consents and&#xD;
        disclosures as approved by IRB), medical history, and risk assessment. If needed, the RN will&#xD;
        facilitate a 4th generation rapid HIV test or draw HIV serology. A general review of systems,&#xD;
        focused physical exam with emphasis on sexually transmitted infections and signs of&#xD;
        seroconversion is provided, including identifying signs of genitourinary infection.&#xD;
  &#xD;
        The nurse will order labs per standing order and performs blood draw. Pre-test and Post-test&#xD;
        counseling with HIV and STI testing is provided at this time. Upon receipt of a negative HIV&#xD;
        rapid or serology test, PrEP-RN provides a 7-14 day supply of samples with a 30-day&#xD;
        prescription of FTC/TDF (Truvada) or a 30-day prescription of FTC/TAF (Descovy) per standing&#xD;
        order.&#xD;
  &#xD;
        At each follow-up visit, client's self-efficacy, attitudes/beliefs about PrEP, general health&#xD;
        indicators, and social determinants of health, such as access to transportation and housing&#xD;
        status, are recorded. Process evaluation will be performed to determine relationships of&#xD;
        these variables and PrEP adherence, implementation (12 months), and&#xD;
        continuation/dissemination (year 2) phases of the study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The following study design is an alternative to the existing protocol at CAN clinics. The&#xD;
        point of care will be RN-led, as opposed to the Provider. The Provider will still retain&#xD;
        safety and protocol oversight, but the RN will make the clinical decisions. Findings of this&#xD;
        study will demonstrate the relative efficacy of the nurse-led PrEP services in comparison to&#xD;
        the traditional provider-led services.&#xD;
  &#xD;
        During the initial three months of the study period, CAN will hire and train two registered&#xD;
        nurses with licensure in the State of Florida. These nurses will work with Shannon DiPalmo,&#xD;
        MSW, CANs Vice President for Community Engagement and other staff to identify community,&#xD;
        faith-based organizations, and colleges who serve the priority populations. CAN will&#xD;
        establish memoranda of agreement with these organization to allow regular visits by nurses to&#xD;
        meet with participants in safe, private spaces where PrEP services can be provided in person&#xD;
        or through telehealth.&#xD;
  &#xD;
        When these relationships are established, the RNs will work with the partner to schedule PrEP&#xD;
        encounters. CAN plans to enroll a minimum of 210 study participants at a minimum of six&#xD;
        different locations.&#xD;
  &#xD;
        During the initial encounter, the nurses will complete program enrollment forms (consents and&#xD;
        disclosures as approved by IRB), medical history, and risk assessment. If needed, the RN will&#xD;
        facilitate a 4th generation rapid HIV test or draw HIV serology. A general review of systems,&#xD;
        focused physical exam with emphasis on sexually transmitted infections and signs of&#xD;
        seroconversion is provided, including identifying signs of genitourinary infection (e.g.,&#xD;
        discharge, lesions, or pain), rectal infection (anal pain, tenesmus, or discharge). This exam&#xD;
        also includes an inspection of the oral mucosa for signs of primary or secondary syphilis.&#xD;
        The nurse will order labs per standing order and performs blood draw. Pre-test and Post-test&#xD;
        counseling with HIV and STI testing is provided at this time. Upon receipt of a negative HIV&#xD;
        rapid or serology test, PrEP-RN provides a 7-14 day supply of samples with a 30-day&#xD;
        prescription of FTC/TDF (Truvada) or a 30-day prescription of FTC/TAF (Descovy) per standing&#xD;
        order. The RN schedules a 2-week follow-up phone call with the patient and a 4-week follow-up&#xD;
        and lab-draw visit. At the 2-week follow-up call, the RN will ensure all lab results have&#xD;
        been reviewed with the patient and discuss PrEP tolerability and adherence. At the 4-week&#xD;
        follow-up, the RN will repeat steps in the initial visit, facilitate renewal of the&#xD;
        electronic medication prescription, and review medication adherence.&#xD;
  &#xD;
        At each follow-up visit, client's self-efficacy, attitudes/beliefs about PrEP, general health&#xD;
        indicators, and social determinants of health, such as access to transportation and housing&#xD;
        status, are recorded. Process evaluation will be performed to determine relationships of&#xD;
        these variables and PrEP adherence, implementation (12 months), and&#xD;
        continuation/dissemination (year 2) phases of the study. Outcome evaluation will occur after&#xD;
        start-up and will include pre and post-enrollment rates of STI, rates of unplanned pregnancy,&#xD;
        and post enrollment HIV seroconversion. The demographics characteristics of clients enrolled&#xD;
        in the study will be compared to CANs existing PrEP populations served in traditional&#xD;
        clinical settings. Qualitative information on barriers to PrEP initiation, barriers to&#xD;
        adherence, and rationale for participation interruption/termination will be obtained by the&#xD;
        PrEP nurses during monthly check-in appointments and telephone interviews. A portion of the&#xD;
        study nurses' FTE will be dedicated to rapid analysis and reporting. This work will be&#xD;
        managed in-kind by the Principal Investigator, Dr. Laura Armas-Kolostroubis, MD with 5% of&#xD;
        FTE, with co-investigators Aleida Torres, DHSc., APRN with 30% FTE and Katy Wendel R.N., BSN&#xD;
        with 15% FTE. Additional statistical analysis will be provided by Max Wilson, Ph.D. Final&#xD;
        study publications will be completed by a panel of CAN stakeholders, including medical and&#xD;
        prevention subject-matter experts (SMEs) and priority population members.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 16, 2023</start_date>
    <completion_date type="Anticipated">July 10, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 10, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Outcome 1</measure>
      <time_frame>18 months</time_frame>
      <description>Demonstrate an increase of at least 10% (n=30) of target population members enrolled in pre-exposure prophylaxis services compared to baseline (n=300)</description>
    </primary_outcome>
    <enrollment type="Anticipated">210</enrollment>
    <condition>Hiv Prevention</condition>
    <condition>Pre-Exposure Prophylaxis (PrEP)</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Truvada</intervention_name>
      <description>Participants will receive either Truvada or Descovy (based on prescription guidelines).</description>
      <other_name>Descovy</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Those who are aged 18-65 at the time of consent who are high risk patients for PrEP&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Gay and bisexual men of color, cisgender women of color, and transgender women,&#xD;
               transgender men, heterosexual men, Caucasian cisgender men and women individuals at&#xD;
               risk for HIV and STI's, Individuals completing nPEP services. Between the ages of 18&#xD;
               and 65.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Minors younger than age 18, individuals not at risk for HIV, HIV positive status, HIV&#xD;
               seroconversion, current or historical Hepatitis B virus infection, patients who are&#xD;
               candidates for Truvada; patient has a history of renal dysfunction or eGFR values are&#xD;
               below 60 mL/min, patients who are candidates for Descovy; patient has advanced CKD or&#xD;
               an eGFR less than 30 mL/min, Patient is taking contraindicated medications*, patient&#xD;
               has a positive pregnancy test or is breastfeeding. Any other clinical or psychosocial&#xD;
               condition or prior therapy that, in the opinion of the Investigator, would make the&#xD;
               participant unsuitable for the study or unable to comply with dosing requirements&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>CAN Community Health</name>
        <address>
          <city>Fort Lauderdale</city>
          <state>Florida</state>
          <zip>33316</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gabby Brito</last_name>
        <phone>754-701-6920</phone>
        <email>gbrito@cancommunityhealth.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>CAN Community Health</name>
        <address>
          <city>Lake Worth</city>
          <state>Florida</state>
          <zip>33460</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Abra Khan</last_name>
        <phone>561-867-9991</phone>
        <email>Akhan@cancommunityhealth.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>CAN Community Health</name>
        <address>
          <city>Miami Beach</city>
          <state>Florida</state>
          <zip>33139</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mark Kinkel</last_name>
        <phone>305-514-0813</phone>
        <email>Mkinkel@cancommunityhealth.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>CAN Community Health</name>
        <address>
          <city>Miami Gardens</city>
          <state>Florida</state>
          <zip>33055</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Abra Khan</last_name>
        <phone>786-800-5631</phone>
        <email>Akhan@cancommunityhealth.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>CAN Community Health</name>
        <address>
          <city>Plantation</city>
          <state>Florida</state>
          <zip>33317</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gabby Brito</last_name>
        <phone>754-701-6911</phone>
        <email>gbrito@cancommunityhealth.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>February 2023</verification_date>
    <study_first_submitted>February 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06030557
  org study id: IN-US-412-6439
  nct id: NCT06030557
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  During the initial encounter, the nurses will complete program enrollment forms (consents and
        disclosures as approved by IRB), medical history, and risk assessment. If needed, the RN will
        facilitate a 4th generation rapid HIV test or draw HIV serology. A general review of systems,
        focused physical exam with emphasis on sexually transmitted infections and signs of
        seroconversion is provided, including identifying signs of genitourinary infection.
  
        The nurse will order labs per standing order and performs blood draw. Pre-test and Post-test
        counseling with HIV and STI testing is provided at this time. Upon receipt of a negative HIV
        rapid or serology test, PrEP-RN provides a 7-14 day supply of samples with a 30-day
        prescription of FTC/TDF (Truvada) or a 30-day prescription of FTC/TAF (Descovy) per standing
        order.
  
        At each follow-up visit, client's self-efficacy, attitudes/beliefs about PrEP, general health
        indicators, and social determinants of health, such as access to transportation and housing
        status, are recorded. Process evaluation will be performed to determine relationships of
        these variables and PrEP adherence, implementation (12 months), and
        continuation/dissemination (year 2) phases of the study.
  The following study design is an alternative to the existing protocol at CAN clinics. The
        point of care will be RN-led, as opposed to the Provider. The Provider will still retain
        safety and protocol oversight, but the RN will make the clinical decisions. Findings of this
        study will demonstrate the relative efficacy of the nurse-led PrEP services in comparison to
        the traditional provider-led services.
  
        During the initial three months of the study period, CAN will hire and train two registered
        nurses with licensure in the State of Florida. These nurses will work with Shannon DiPalmo,
        MSW, CANs Vice President for Community Engagement and other staff to identify community,
        faith-based organizations, and colleges who serve the priority populations. CAN will
        establish memoranda of agreement with these organization to allow regular visits by nurses to
        meet with participants in safe, private spaces where PrEP services can be provided in person
        or through telehealth.
  
        When these relationships are established, the RNs will work with the partner to schedule PrEP
        encounters. CAN plans to enroll a minimum of 210 study participants at a minimum of six
        different locations.
  
        During the initial encounter, the nurses will complete program enrollment forms (consents and
        disclosures as approved by IRB), medical history, and risk assessment. If needed, the RN will
        facilitate a 4th generation rapid HIV test or draw HIV serology. A general review of systems,
        focused physical exam with emphasis on sexually transmitted infections and signs of
        seroconversion is provided, including identifying signs of genitourinary infection (e.g.,
        discharge, lesions, or pain), rectal infection (anal pain, tenesmus, or discharge). This exam
        also includes an inspection of the oral mucosa for signs of primary or secondary syphilis.
        The nurse will order labs per standing order and performs blood draw. Pre-test and Post-test
        counseling with HIV and STI testing is provided at this time. Upon receipt of a negative HIV
        rapid or serology test, PrEP-RN provides a 7-14 day supply of samples with a 30-day
        prescription of FTC/TDF (Truvada) or a 30-day prescription of FTC/TAF (Descovy) per standing
        order. The RN schedules a 2-week follow-up phone call with the patient and a 4-week follow-up
        and lab-draw visit. At the 2-week follow-up call, the RN will ensure all lab results have
        been reviewed with the patient and discuss PrEP tolerability and adherence. At the 4-week
        follow-up, the RN will repeat steps in the initial visit, facilitate renewal of the
        electronic medication prescription, and review medication adherence.
  
        At each follow-up visit, client's self-efficacy, attitudes/beliefs about PrEP, general health
        indicators, and social determinants of health, such as access to transportation and housing
        status, are recorded. Process evaluation will be performed to determine relationships of
        these variables and PrEP adherence, implementation (12 months), and
        continuation/dissemination (year 2) phases of the study. Outcome evaluation will occur after
        start-up and will include pre and post-enrollment rates of STI, rates of unplanned pregnancy,
        and post enrollment HIV seroconversion. The demographics characteristics of clients enrolled
        in the study will be compared to CANs existing PrEP populations served in traditional
        clinical settings. Qualitative information on barriers to PrEP initiation, barriers to
        adherence, and rationale for participation interruption/termination will be obtained by the
        PrEP nurses during monthly check-in appointments and telephone interviews. A portion of the
        study nurses' FTE will be dedicated to rapid analysis and reporting. This work will be
        managed in-kind by the Principal Investigator, Dr. Laura Armas-Kolostroubis, MD with 5% of
        FTE, with co-investigators Aleida Torres, DHSc., APRN with 30% FTE and Katy Wendel R.N., BSN
        with 15% FTE. Additional statistical analysis will be provided by Max Wilson, Ph.D. Final
        study publications will be completed by a panel of CAN stakeholders, including medical and
        prevention subject-matter experts (SMEs) and priority population members.
  observational model: Other
  time perspective: Prospective
  measure: Outcome 1
  time frame: 18 months
  description: Demonstrate an increase of at least 10% (n=30) of target population members enrolled in pre-exposure prophylaxis services compared to baseline (n=300)
  intervention type: Drug
  intervention name: Truvada
  description: Participants will receive either Truvada or Descovy (based on prescription guidelines).
  other name: Descovy
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
  sharing ipd: No