<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/NCT04424524</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00007949</org_study_id>
    <secondary_id>R00MH118134</secondary_id>
    <nct_id>NCT04424524</nct_id>
  </id_info>
  <brief_title>Streamlining the Efficiency of PrEP Implementation</brief_title>
  <acronym>Efficiency</acronym>
  <official_title>An Implementation Project to Improve the Efficiency of PrEP Delivery in Public Health HIV Care Clinics in Kenya</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</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>
      This is a pilot facility-based direct-to-pharmacy PrEP refill delivery to streamline care&#xD;
      pathway in Kenyan public health HIV facilities implementing PrEP. Data on up to 500 PrEP&#xD;
      users will be evaluated to understand delivery efficiency and in-depth interview with users&#xD;
      and delivery key informants will be conducted to identify barriers and facilitators of&#xD;
      implementation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, pilot implementation evaluation of patient-centered differentiated care&#xD;
      service. The core components of the multifaceted implementation strategy include: 1)&#xD;
      3-monthly refills, 2) direct-to-pharmacy refill visits, 3) HIV self-testing (HIVST) while&#xD;
      waiting for refills, 4) Rapid risk assessment for ongoing risk, adherence, side effect, and&#xD;
      acute HIV symptoms. Clinics will implement either: 1) current PrEP patient flow without any&#xD;
      change or 2) a pilot differentiated pharmacy-based follow up PrEP care pathway. Clinics will&#xD;
      implement only one delivery model thus eliminating risk for confusion in the clinic about&#xD;
      delivery models and permitting a full-scale test of the system, since the efficiency in PrEP&#xD;
      delivery is in part at the system level, above and beyond the individual client encounter.&#xD;
      For this pilot project designed to primarily test delivery efficiency, feasibility and&#xD;
      acceptability of direct-to-pharmacy care pathway at systems level using existing public&#xD;
      health infrastructure, pilot and control clinics will be of comparable size selected to&#xD;
      reflect the implementation nature of the design.&#xD;
&#xD;
      The specific aims are:&#xD;
&#xD;
      Aim 1: To evaluate whether a differentiated care model improves the efficiency of PrEP&#xD;
      delivery while resulting in equivalent or better: 1) patient waiting time, 2) early PrEP&#xD;
      continuation, and 3) adherence.&#xD;
&#xD;
      Aim 2: Conduct mixed-methods study to understand patient and provider perception, experiences&#xD;
      , feasibility and acceptability of a differentiated PrEP delivery model.&#xD;
&#xD;
      Aim 3: Assess the efficiency, cost and cost-effectiveness of a facility-based differentiated&#xD;
      PrEP care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2022</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>Patient wait time</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Total waiting time at the clinic and contact time with providers measured by time and motion studies</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PrEP continuation</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Measured by return to clinic for PrEP refill</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PrEP adherence</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Measured objectively through tenofovir levels in dried blood spots at random subset of PrEP visits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of direct-to-pharmacy PrEP care pathway</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Assessed by the Acceptability of Intervention Psychometric Measure (AIM)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of user HIV self-testing for PrEP care pathway</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Assessed by the Acceptability of Intervention Psychometric Measure (AIM)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of direct-to-pharmacy PrEP care pathway</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Assessed by the Feasibility of Intervention Psychometric Measure (FIM)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Barriers to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Evaluated through in-depth and key informants qualitative interviews</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Facilitators to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Evaluated through in-depth and key informants qualitative interviews</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fidelity of implementing of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Extent to which core components of the direct-to-pharmacy PrEP care pathway are implemented as intended will be evaluated through checklists and surveys with clinic managers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of HIV self-testing</measure>
    <time_frame>up to 6 moths</time_frame>
    <description>Accuracy of HIV self-testing measured by frequency false negative and positive tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for PrEP discontinuation</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Measured through in-depth qualitative interviews and surveys with persons who discontinue PrEP use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of implementing direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Measured through micro-activity costing and time and motion studies</description>
  </secondary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>HIV Prevention</condition>
  <condition>HIV Preexposure Prophylaxis</condition>
  <condition>Implementation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        HIV uninfected men and women accessing PrEP services at public health HIV clinics in Kenya.&#xD;
        Data on up to 500 persons who initiate PrEP will be evaluated, both newly initiating PrEP&#xD;
        and those continuing on PrEP (up to 250 at up clinics implementing current practice and up&#xD;
        to 250 at clinics implementing direct-to-pharmacy PrEP refill visits). PrEP is standard of&#xD;
        care at these clinics, recommended by Kenyan guidelines, and demand creation, PrEP&#xD;
        eligibility assessment and provision are all performed by the facility staff following the&#xD;
        Kenya Ministry of Health PrEP guidelines.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For HIV-negative participants:&#xD;
&#xD;
          -  Of legal age (≥18 years)&#xD;
&#xD;
          -  Able and willing to provide written informed consent for research component of the&#xD;
             project (blood draw for adherence, brief surveys and in-depth qualitative interviews)&#xD;
&#xD;
          -  HIV uninfected based on negative HIV tests, per Kenya national guidelines&#xD;
&#xD;
          -  Currently or previously accessed PrEP at participating HIV clinic&#xD;
&#xD;
        For Key delivery informants:&#xD;
&#xD;
          -  Able willing and able to provide consent in order to participate in the survey and&#xD;
             qualitative interviews.&#xD;
&#xD;
          -  Works at any of the clinics implementing PrEP delivery. Key informants may include HIV&#xD;
             testing service nurses, counselors, clinicians, social workers, or clinic managers.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not meeting any of the inclusion criteria listed above.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth Mugwanya, MBChB, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Justice Quame-Amaglo</last_name>
    <phone>206-520-3866</phone>
    <email>quamaglo@uw.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Partners in Health Research and Development</name>
      <address>
        <city>Thika</city>
        <country>Kenya</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Irungu, MBChB, MPH</last_name>
    </contact>
    <contact_backup>
      <email>eirungu@uw.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Kenneth K Mugwanya</investigator_full_name>
    <investigator_title>Assistant Professor, School of Medicine: Global Health</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data from Streamlining Efficiency of PrEP Implementation Study will be available by contacting the International Clinical Research Center at the University of Washington (icrc@uw.edu)</ipd_description>
    <ipd_time_frame>After primary results are reported</ipd_time_frame>
  </patient_data>
  <!-- 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/NCT04424524
org study id: STUDY00007949
secondary id: R00MH118134
nct id: NCT04424524
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a pilot facility-based direct-to-pharmacy PrEP refill delivery to streamline care
      pathway in Kenyan public health HIV facilities implementing PrEP. Data on up to 500 PrEP
      users will be evaluated to understand delivery efficiency and in-depth interview with users
      and delivery key informants will be conducted to identify barriers and facilitators of
      implementation.
A prospective, pilot implementation evaluation of patient-centered differentiated care
      service. The core components of the multifaceted implementation strategy include: 1)
      3-monthly refills, 2) direct-to-pharmacy refill visits, 3) HIV self-testing (HIVST) while
      waiting for refills, 4) Rapid risk assessment for ongoing risk, adherence, side effect, and
      acute HIV symptoms. Clinics will implement either: 1) current PrEP patient flow without any
      change or 2) a pilot differentiated pharmacy-based follow up PrEP care pathway. Clinics will
      implement only one delivery model thus eliminating risk for confusion in the clinic about
      delivery models and permitting a full-scale test of the system, since the efficiency in PrEP
      delivery is in part at the system level, above and beyond the individual client encounter.
      For this pilot project designed to primarily test delivery efficiency, feasibility and
      acceptability of direct-to-pharmacy care pathway at systems level using existing public
      health infrastructure, pilot and control clinics will be of comparable size selected to
      reflect the implementation nature of the design.

      The specific aims are:

      Aim 1: To evaluate whether a differentiated care model improves the efficiency of PrEP
      delivery while resulting in equivalent or better: 1) patient waiting time, 2) early PrEP
      continuation, and 3) adherence.

      Aim 2: Conduct mixed-methods study to understand patient and provider perception, experiences
      , feasibility and acceptability of a differentiated PrEP delivery model.

      Aim 3: Assess the efficiency, cost and cost-effectiveness of a facility-based differentiated
      PrEP care.
observational model: Other
time perspective: Prospective
measure: Patient wait time
time frame: up to 6 months
description: Total waiting time at the clinic and contact time with providers measured by time and motion studies
measure: PrEP continuation
time frame: up to 6 months
description: Measured by return to clinic for PrEP refill
measure: PrEP adherence
time frame: up to 6 months
description: Measured objectively through tenofovir levels in dried blood spots at random subset of PrEP visits
measure: Acceptability of direct-to-pharmacy PrEP care pathway
time frame: up to 6 months
description: Assessed by the Acceptability of Intervention Psychometric Measure (AIM)
measure: Acceptability of user HIV self-testing for PrEP care pathway
time frame: up to 6 months
description: Assessed by the Acceptability of Intervention Psychometric Measure (AIM)
measure: Feasibility of direct-to-pharmacy PrEP care pathway
time frame: up to 6 months
description: Assessed by the Feasibility of Intervention Psychometric Measure (FIM)
measure: Barriers to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
time frame: up to 6 months
description: Evaluated through in-depth and key informants qualitative interviews
measure: Facilitators to implementation of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
time frame: up to 6 months
description: Evaluated through in-depth and key informants qualitative interviews
measure: Fidelity of implementing of direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
time frame: up to 6 months
description: Extent to which core components of the direct-to-pharmacy PrEP care pathway are implemented as intended will be evaluated through checklists and surveys with clinic managers
measure: Safety of HIV self-testing
time frame: up to 6 moths
description: Accuracy of HIV self-testing measured by frequency false negative and positive tests.
measure: Reasons for PrEP discontinuation
time frame: up to 6 months
description: Measured through in-depth qualitative interviews and surveys with persons who discontinue PrEP use
measure: Cost of implementing direct-to-pharmacy PrEP care pathway in Kenyan public health HIV clinics
time frame: up to 6 months
description: Measured through micro-activity costing and time and motion studies
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kenneth Mugwanya, MBChB, PhD
role: Principal Investigator
affiliation: University of Washington
last name: Justice Quame-Amaglo
phone: 206-520-3866
email: quamaglo@uw.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: Kenya
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Kenneth K Mugwanya
investigator title: Assistant Professor, School of Medicine: Global Health
sharing ipd: Yes
ipd description: Data from Streamlining Efficiency of PrEP Implementation Study will be available by contacting the International Clinical Research Center at the University of Washington (icrc@uw.edu)
ipd time frame: After primary results are reported