<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/NCT03840382</url>
  </required_header>
  <id_info>
    <org_study_id>407618</org_study_id>
    <nct_id>NCT03840382</nct_id>
  </id_info>
  <brief_title>Telemedicine for PrEP Throughout Mississippi</brief_title>
  <acronym>Tele-PrEP</acronym>
  <official_title>Telemedicine for PrEP Throughout Mississippi</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rhode Island Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Mississippi Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rhode Island Hospital</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>
      This study will develop and test a program to deliver PrEP care in underserved communities in&#xD;
      Mississippi (MS) through telemedicine, distance-based, clinical care delivered in local&#xD;
      community based organizations (CBOs). The intervention will be developed in collaboration&#xD;
      with medical specialists at the University of Mississippi Medical Center (UMMC) and local CBO&#xD;
      stakeholders (providers, administrators and patients). Approximately 75 individuals will be&#xD;
      recruited from CBOs in MS. Participants will be able to receive PrEP counseling in the CBO&#xD;
      and PrEP care via telemedicine from a PrEP specialist at UMMC. Participants will complete&#xD;
      three assessments in the six months after enrolling. Our study will provide a wealth of&#xD;
      information about PrEP-related outcomes and HIV testing among MS residents living in&#xD;
      underserved communities. If successful, this program will be able to be disseminated to other&#xD;
      CBOs in the South.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Uptake of PrEP in the southern United States has been slow, especially in areas distant from&#xD;
      academic medical centers that provide PrEP care. Despite underserved populations in the South&#xD;
      having alarmingly high rates of HIV, a large percentage of at-risk individuals are not&#xD;
      engaged in PrEP care due to limited access to academic medical centers. Mississippi (MS), the&#xD;
      site of this proposed project, has the seventh highest incidence of HIV of any state and CBOs&#xD;
      that provide HIV/STI testing outside of urban areas report that very few of their at-risk&#xD;
      individuals use PrEP. Unfortunately, physicians outside of academic centers are often&#xD;
      reluctant to prescribe PrEP because they lack the expertise, training, and the support&#xD;
      necessary to provide comprehensive HIV prevention care. Those are at-risk do not seek PrEP&#xD;
      from academic centers because of stigma, travel burdens, and financial concerns. To overcome&#xD;
      these barriers, this project will develop and pilot test a program to deliver PrEP care in&#xD;
      underserved remote communities in MS through telemedicine clinical care delivered in local&#xD;
      CBOs. Telemedicine will allow specialists to provide care at a distance and while&#xD;
      simultaneously enhancing the capacity of local CBOs to provide quality HIV testing and&#xD;
      counseling, PrEP treatment, and linkage to HIV care if needed. It will allow patients to&#xD;
      receive the highest level of medical care from trusted CBOs within their local communities.&#xD;
      It will also enhance the CBO's mission by allowing it to provide a new, high-quality medical&#xD;
      service.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 19, 2019</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Appointment attendance at 3 months post-intervention (electronic medical record extraction)</measure>
    <time_frame>Assessed at 3 months</time_frame>
    <description>Attendance at a telemedicine for PrEP appointment with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Appointment attendance at 6 months post-intervention (electronic medical record extraction)</measure>
    <time_frame>Assessed at 6 months</time_frame>
    <description>Attendance at a telemedicine for PrEP appointment with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Receipt of PrEP medication prescription at 3 months (electronic medical record extraction)</measure>
    <time_frame>Assessed at 3 months</time_frame>
    <description>PrEP medication was prescribed in past 3 months, extracted for patient's electronic medical record</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Receipt of PrEP medication prescription at 6 months (electronic medical record extraction)</measure>
    <time_frame>Assessed at 6 months</time_frame>
    <description>PrEP medication was prescribed in past 3 months, extracted for patient's electronic medical record</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in adherence to PrEP (self-report)</measure>
    <time_frame>Assessed at 3 months and 6 months</time_frame>
    <description>Self-reported proportion of PrEP doses taken in past 3 months. (Change in adherence = self-reported adherence at 6 months - self-reported adherence at 3 months)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of PrEP medication refills at 3 months (electronic medical record extraction)</measure>
    <time_frame>Assessed at 3 months</time_frame>
    <description>Number of PrEP refills in past 3 months (extracted from electronic medical record)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of PrEP medication refills at 6 months (electronic medical record extraction)</measure>
    <time_frame>Assessed at 6 months</time_frame>
    <description>Number of PrEP refills in past 3 months (extracted from electronic medical record)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PrEP knowledge</measure>
    <time_frame>Assessed at Baseline, 3 months, and 6 months</time_frame>
    <description>15-item questionnaire to assess knowledge (true/false/don't know) based on facts from the CDC and the San Francisco AIDS Foundation websites concerning PrEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motivational readiness for PrEP and PrEP-related care</measure>
    <time_frame>Assessed at Baseline, 3 months, and 6 months</time_frame>
    <description>Rollnick, S., Heather, N., Gold, R., Hall, W., 1992. Development of a short 'readiness to change' questionnaire for use in brief, opportunistic interventions among excessive drinkers. Br J Addict. 87, 743-754.&#xD;
Rollnick's Readiness Ruler will be used to assess motivation for engaging in PrEP care using two items from 1 (not ready) to 10 (ready to engage).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention acceptability (SEF)</measure>
    <time_frame>Assessed at 3 months and 6 months</time_frame>
    <description>Kennard, B., Brown, L., Hawkins, L., Risi, A., Radcliffe, J., Emslie, G. (2014). Development and implementation of health and wellness CBT for individuals with depression and HIV. Cogn Behav Pract. 21(2): 237-246.&#xD;
The Acceptability of Tele-PrEP by clients, CBO staff, administrators and UMMC physicians will be assessed with a modified version of the Session Evaluation Form (SEF).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention acceptability (CSQ-8)</measure>
    <time_frame>Assessed at 3 months and 6 months</time_frame>
    <description>Larsen, D.L., Attkisson, C.C., Hargreaves, W.A., Nguyen, T.D. Assessment of client/patient satisfaction: Development of a general scale, Evaluation and Program Planning. 1979; 2, 197-207.&#xD;
The Acceptability of Tele-PrEP by clients, CBO staff, administrators and UMMC physicians will be assessed with a modified version of the Client Satisfaction Questionnaire (CSQ-8).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>Tele-PrEP Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tele-PrEP Intervention</intervention_name>
    <description>Telemedicine conferences with PrEP-specialists</description>
    <arm_group_label>Tele-PrEP Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old or older&#xD;
&#xD;
          -  Presented at a collaborating CBO for HIV testing during trial months&#xD;
&#xD;
          -  PrEP eligible based on HIV Risk Checklist&#xD;
&#xD;
          -  Able to read and speak English&#xD;
&#xD;
          -  Able to give meaningful consent as determined by research staff&#xD;
&#xD;
          -  No known HIV infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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_official>
    <last_name>Larry K Brown, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rhode Island Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>James B Brock, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Mississippi Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Larry K Brown, MD</last_name>
    <phone>(401)-793-8808</phone>
    <email>lkbrown@lifespan.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>James B Brock, MD</last_name>
    <phone>(601) 984-5560</phone>
    <email>jbbrock@umc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James B Brock, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rhode Island Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Larry K. Brown</investigator_full_name>
    <investigator_title>Director of Research, Child and Adolescent Psychiatry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>October 14, 2022</submitted>
    <returned>August 28, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03840382
org study id: 407618
nct id: NCT03840382
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will develop and test a program to deliver PrEP care in underserved communities in
      Mississippi (MS) through telemedicine, distance-based, clinical care delivered in local
      community based organizations (CBOs). The intervention will be developed in collaboration
      with medical specialists at the University of Mississippi Medical Center (UMMC) and local CBO
      stakeholders (providers, administrators and patients). Approximately 75 individuals will be
      recruited from CBOs in MS. Participants will be able to receive PrEP counseling in the CBO
      and PrEP care via telemedicine from a PrEP specialist at UMMC. Participants will complete
      three assessments in the six months after enrolling. Our study will provide a wealth of
      information about PrEP-related outcomes and HIV testing among MS residents living in
      underserved communities. If successful, this program will be able to be disseminated to other
      CBOs in the South.
Uptake of PrEP in the southern United States has been slow, especially in areas distant from
      academic medical centers that provide PrEP care. Despite underserved populations in the South
      having alarmingly high rates of HIV, a large percentage of at-risk individuals are not
      engaged in PrEP care due to limited access to academic medical centers. Mississippi (MS), the
      site of this proposed project, has the seventh highest incidence of HIV of any state and CBOs
      that provide HIV/STI testing outside of urban areas report that very few of their at-risk
      individuals use PrEP. Unfortunately, physicians outside of academic centers are often
      reluctant to prescribe PrEP because they lack the expertise, training, and the support
      necessary to provide comprehensive HIV prevention care. Those are at-risk do not seek PrEP
      from academic centers because of stigma, travel burdens, and financial concerns. To overcome
      these barriers, this project will develop and pilot test a program to deliver PrEP care in
      underserved remote communities in MS through telemedicine clinical care delivered in local
      CBOs. Telemedicine will allow specialists to provide care at a distance and while
      simultaneously enhancing the capacity of local CBOs to provide quality HIV testing and
      counseling, PrEP treatment, and linkage to HIV care if needed. It will allow patients to
      receive the highest level of medical care from trusted CBOs within their local communities.
      It will also enhance the CBO's mission by allowing it to provide a new, high-quality medical
      service.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Appointment attendance at 3 months post-intervention (electronic medical record extraction)
time frame: Assessed at 3 months
description: Attendance at a telemedicine for PrEP appointment with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record
measure: Appointment attendance at 6 months post-intervention (electronic medical record extraction)
time frame: Assessed at 6 months
description: Attendance at a telemedicine for PrEP appointment with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record
measure: Receipt of PrEP medication prescription at 3 months (electronic medical record extraction)
time frame: Assessed at 3 months
description: PrEP medication was prescribed in past 3 months, extracted for patient's electronic medical record
measure: Receipt of PrEP medication prescription at 6 months (electronic medical record extraction)
time frame: Assessed at 6 months
description: PrEP medication was prescribed in past 3 months, extracted for patient's electronic medical record
measure: Change in adherence to PrEP (self-report)
time frame: Assessed at 3 months and 6 months
description: Self-reported proportion of PrEP doses taken in past 3 months. (Change in adherence = self-reported adherence at 6 months - self-reported adherence at 3 months)
measure: Number of PrEP medication refills at 3 months (electronic medical record extraction)
time frame: Assessed at 3 months
description: Number of PrEP refills in past 3 months (extracted from electronic medical record)
measure: Number of PrEP medication refills at 6 months (electronic medical record extraction)
time frame: Assessed at 6 months
description: Number of PrEP refills in past 3 months (extracted from electronic medical record)
measure: PrEP knowledge
time frame: Assessed at Baseline, 3 months, and 6 months
description: 15-item questionnaire to assess knowledge (true/false/don't know) based on facts from the CDC and the San Francisco AIDS Foundation websites concerning PrEP
measure: Motivational readiness for PrEP and PrEP-related care
time frame: Assessed at Baseline, 3 months, and 6 months
description: Rollnick, S., Heather, N., Gold, R., Hall, W., 1992. Development of a short 'readiness to change' questionnaire for use in brief, opportunistic interventions among excessive drinkers. Br J Addict. 87, 743-754.
Rollnick's Readiness Ruler will be used to assess motivation for engaging in PrEP care using two items from 1 (not ready) to 10 (ready to engage).
measure: Intervention acceptability (SEF)
time frame: Assessed at 3 months and 6 months
description: Kennard, B., Brown, L., Hawkins, L., Risi, A., Radcliffe, J., Emslie, G. (2014). Development and implementation of health and wellness CBT for individuals with depression and HIV. Cogn Behav Pract. 21(2): 237-246.
The Acceptability of Tele-PrEP by clients, CBO staff, administrators and UMMC physicians will be assessed with a modified version of the Session Evaluation Form (SEF).
measure: Intervention acceptability (CSQ-8)
time frame: Assessed at 3 months and 6 months
description: Larsen, D.L., Attkisson, C.C., Hargreaves, W.A., Nguyen, T.D. Assessment of client/patient satisfaction: Development of a general scale, Evaluation and Program Planning. 1979; 2, 197-207.
The Acceptability of Tele-PrEP by clients, CBO staff, administrators and UMMC physicians will be assessed with a modified version of the Client Satisfaction Questionnaire (CSQ-8).
arm group label: Tele-PrEP Intervention
arm group type: Experimental
description: The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care.
intervention type: Behavioral
intervention name: Tele-PrEP Intervention
description: Telemedicine conferences with PrEP-specialists
arm group label: Tele-PrEP Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Larry K Brown, MD
role: Principal Investigator
affiliation: Rhode Island Hospital
last name: James B Brock, MD
role: Principal Investigator
affiliation: University of Mississippi Medical Center
last name: Larry K Brown, MD
phone: (401)-793-8808
email: lkbrown@lifespan.org
last name: James B Brock, MD
phone: (601) 984-5560
email: jbbrock@umc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rhode Island Hospital
investigator full name: Dr. Larry K. Brown
investigator title: Director of Research, Child and Adolescent Psychiatry
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
submitted: October 14, 2022
returned: August 28, 2023