<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/NCT03281343</url>
  </required_header>
  <id_info>
    <org_study_id>R34DA045621</org_study_id>
    <nct_id>NCT03281343</nct_id>
  </id_info>
  <brief_title>Linking Women to PrEP Care</brief_title>
  <official_title>Linkage to Community-Based HIV Pre-Exposure Prophylaxsis Care Among at Risk Women Upon Release From Incarceration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rhode Island Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rhode Island Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Pre-exposure prophylaxis (PrEP) can be very effective at preventing HIV infection among women&#xD;
      at high-risk for HIV but is underused in this population. Periods of incarceration represent&#xD;
      an opportunity to identify women at risk and link them to PrEP care as they leave jail or&#xD;
      prison. This study aims to improve linkage to community-based PrEP care to reduce HIV&#xD;
      acquisition in a high-need, underserved community.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Incarcerated women engage in high rates of sex- and drug-related behavior that place them at&#xD;
      risk for HIV. Pre-exposure prophylaxis (PrEP) is an efficacious means of reducing HIV&#xD;
      acquisition. There is a general lack of knowledge regarding PrEP among women at elevated&#xD;
      risk, and only a small percentage of at-risk women are currently engaged in PrEP care. The&#xD;
      period of incarceration represents an opportunity to identify at-risk women, initiate PrEP&#xD;
      during incarceration, and establish linkage to community-based PrEP care upon release from&#xD;
      incarceration. Further, post-release is a time period that is particularly risky, and there&#xD;
      are numerous barriers that may impede linkage to community-based care in the absence of&#xD;
      intervention.&#xD;
&#xD;
      To date, very little research has been done to improve linkage to PrEP care among US women.&#xD;
      The proposed study will examine the acceptability, feasibility, and preliminary efficacy of a&#xD;
      psychoeducation and motivational interviewing intervention to promote PrEP initiation during&#xD;
      incarceration, followed by a patient navigator intervention to facilitate linkage to&#xD;
      community-based PrEP care upon release from incarceration. The long-term goal of this line of&#xD;
      research is to disseminate an efficacious PrEP Care linkage intervention for at-risk women&#xD;
      post-release from incarceration. The present proposal seeks to develop intervention materials&#xD;
      and conduct a small randomized controlled trial (RCT) of the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 29, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2023</completion_date>
  <primary_completion_date type="Actual">October 31, 2022</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rates of linkage to community-based PrEP care</measure>
    <time_frame>3 Months post-release</time_frame>
    <description>Linkage to community-based care is operationalized as receipt of a prescription for PrEP from a community-based provider within 3 months of release from prison, confirmed through medical record data extraction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PrEP Adherence</measure>
    <time_frame>3 Months and 6 Months post-release</time_frame>
    <description>PrEP adherence will be determined by drug concentrations in urine samples collected from participants who have been prescribed PrEP at 3 and 6 months. Presence of PrEP will be assessed with immunoassay developed by UrSure Inc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PrEP Care Retention</measure>
    <time_frame>3 Month clinical appointments (+/- 1 month)</time_frame>
    <description>PrEP retention in care will be defined as attending 3-month clinical appointments (+/- 1 month) which is in accordance with current CDC guidelines. This will be verified with medical records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol and Drug Use</measure>
    <time_frame>6-months</time_frame>
    <description>The Timeline Followback (TLFB) will be used to assess alcohol and drug use behavior at baseline, as well as during the follow-up interviews.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV Risk Behavior</measure>
    <time_frame>6-months</time_frame>
    <description>The TLFB will be used to assess drug and sex risk behavior at baseline and during the follow-up interviews. In addition, the HIV Risk Assessment Battery will serve as a measure of overall sex and drug risk behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive Symptoms</measure>
    <time_frame>6-months</time_frame>
    <description>The Center for Epidemiologic Studies Depression Scale (CES-D) will be administered at baseline and follow-up interviews to assess depressive symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Received and Medications/Pregnancies</measure>
    <time_frame>6-months</time_frame>
    <description>The Treatment Services Review (TSR) and Use of Medications Questionnaire will be used to measure the number and types of treatment services utilized, medications prescribed, and pregnancies experienced during the follow-up period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Prevention</condition>
  <arm_group>
    <arm_group_label>MI-NAV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A study therapist will deliver a motivational interviewing session with participants while they are incarcerated and serve as a role of patient navigator post-release.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care (SOC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Approximates care currently provided at the prison.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Interviewing &amp; Patient Navigator</intervention_name>
    <description>The specific content, structure, and implementation approach for MI-NAV will be guided by IDIs conducted during Phase 1 and Phase 2. Our initial plan is to deliver MI-NAV in two waves. The first wave will be aimed at promoting uptake of PrEP at the prison, through the use of motivational interviewing. The second wave will be aimed at linking at-risk women to community-based PrEP care upon release from incarceration, by utilizing a patient navigator approach.</description>
    <arm_group_label>MI-NAV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of Care (SOC)</intervention_name>
    <description>SOC will consist of a pamphlet regarding PrEP during incarceration, an offer of PrEP while incarcerated, and referral to community-based PrEP care upon release.</description>
    <arm_group_label>Standard of Care (SOC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female at birth; at least 18 years of age; not currently pregnant; risk behavior prior&#xD;
             to incarceration that meets CDC indications for PrEP; likely to be incarcerated for&#xD;
             less than 6 months; able to understand and speak English and to provide written and&#xD;
             verbal informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan E Ramsey, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rhode Island Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>April 3, 2023</last_update_submitted>
  <last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PrEP</keyword>
  <keyword>Women</keyword>
  <keyword>Linkage to Care</keyword>
  <!-- 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/NCT03281343
org study id: R34DA045621
nct id: NCT03281343
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Pre-exposure prophylaxis (PrEP) can be very effective at preventing HIV infection among women
      at high-risk for HIV but is underused in this population. Periods of incarceration represent
      an opportunity to identify women at risk and link them to PrEP care as they leave jail or
      prison. This study aims to improve linkage to community-based PrEP care to reduce HIV
      acquisition in a high-need, underserved community.
Incarcerated women engage in high rates of sex- and drug-related behavior that place them at
      risk for HIV. Pre-exposure prophylaxis (PrEP) is an efficacious means of reducing HIV
      acquisition. There is a general lack of knowledge regarding PrEP among women at elevated
      risk, and only a small percentage of at-risk women are currently engaged in PrEP care. The
      period of incarceration represents an opportunity to identify at-risk women, initiate PrEP
      during incarceration, and establish linkage to community-based PrEP care upon release from
      incarceration. Further, post-release is a time period that is particularly risky, and there
      are numerous barriers that may impede linkage to community-based care in the absence of
      intervention.

      To date, very little research has been done to improve linkage to PrEP care among US women.
      The proposed study will examine the acceptability, feasibility, and preliminary efficacy of a
      psychoeducation and motivational interviewing intervention to promote PrEP initiation during
      incarceration, followed by a patient navigator intervention to facilitate linkage to
      community-based PrEP care upon release from incarceration. The long-term goal of this line of
      research is to disseminate an efficacious PrEP Care linkage intervention for at-risk women
      post-release from incarceration. The present proposal seeks to develop intervention materials
      and conduct a small randomized controlled trial (RCT) of the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Rates of linkage to community-based PrEP care
time frame: 3 Months post-release
description: Linkage to community-based care is operationalized as receipt of a prescription for PrEP from a community-based provider within 3 months of release from prison, confirmed through medical record data extraction.
measure: PrEP Adherence
time frame: 3 Months and 6 Months post-release
description: PrEP adherence will be determined by drug concentrations in urine samples collected from participants who have been prescribed PrEP at 3 and 6 months. Presence of PrEP will be assessed with immunoassay developed by UrSure Inc.
measure: PrEP Care Retention
time frame: 3 Month clinical appointments (+/- 1 month)
description: PrEP retention in care will be defined as attending 3-month clinical appointments (+/- 1 month) which is in accordance with current CDC guidelines. This will be verified with medical records.
measure: Alcohol and Drug Use
time frame: 6-months
description: The Timeline Followback (TLFB) will be used to assess alcohol and drug use behavior at baseline, as well as during the follow-up interviews.
measure: HIV Risk Behavior
time frame: 6-months
description: The TLFB will be used to assess drug and sex risk behavior at baseline and during the follow-up interviews. In addition, the HIV Risk Assessment Battery will serve as a measure of overall sex and drug risk behavior.
measure: Depressive Symptoms
time frame: 6-months
description: The Center for Epidemiologic Studies Depression Scale (CES-D) will be administered at baseline and follow-up interviews to assess depressive symptoms
measure: Treatment Received and Medications/Pregnancies
time frame: 6-months
description: The Treatment Services Review (TSR) and Use of Medications Questionnaire will be used to measure the number and types of treatment services utilized, medications prescribed, and pregnancies experienced during the follow-up period.
arm group label: MI-NAV
arm group type: Experimental
description: A study therapist will deliver a motivational interviewing session with participants while they are incarcerated and serve as a role of patient navigator post-release.
arm group label: Standard of Care (SOC)
arm group type: Active Comparator
description: Approximates care currently provided at the prison.
intervention type: Behavioral
intervention name: Motivational Interviewing & Patient Navigator
description: The specific content, structure, and implementation approach for MI-NAV will be guided by IDIs conducted during Phase 1 and Phase 2. Our initial plan is to deliver MI-NAV in two waves. The first wave will be aimed at promoting uptake of PrEP at the prison, through the use of motivational interviewing. The second wave will be aimed at linking at-risk women to community-based PrEP care upon release from incarceration, by utilizing a patient navigator approach.
arm group label: MI-NAV
intervention type: Behavioral
intervention name: Standard of Care (SOC)
description: SOC will consist of a pamphlet regarding PrEP during incarceration, an offer of PrEP while incarcerated, and referral to community-based PrEP care upon release.
arm group label: Standard of Care (SOC)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susan E Ramsey, Ph.D.
role: Principal Investigator
affiliation: Rhode Island Hospital
facility: 
country: United States
responsible party type: Sponsor