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/NCT05991869</url>
    </required_header>
    <id_info>
      <org_study_id>DelSciPrEP 2021</org_study_id>
      <nct_id>NCT05991869</nct_id>
    </id_info>
    <brief_title>Leveraging Electronic Health Record Data in a Risk Prediction Model to Increase HIV PrEP Intake in Primary Care</brief_title>
    <official_title>Randomized Trial Leveraging Electronic Health Record Data in a Risk Prediction Model to Increase HIV PrEP Uptake in Primary Care.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kaiser Permanente</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kaiser Permanente</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>
        Kaiser Permanente Northern California (KPNC) has been a national leader in implementation of&#xD;
        HIV preexposure prophylaxis (PrEP), a daily antiretroviral pill that is more than 99%&#xD;
        effective in preventing HIV acquisition. However, many patients at risk for HIV at KPNC are&#xD;
        not yet using PrEP, resulting in preventable infections each year. In prior work, the study&#xD;
        team developed and validated a prediction model that used electronic health record (EHR) data&#xD;
        from 3.7 million KPNC members to identify patients at high risk of HIV acquisition but not&#xD;
        using PrEP. The model substantially outperformed models based only on CDC criteria for PrEP&#xD;
        use, particularly for Black patients, a population with high HIV incidence and lower PrEP&#xD;
        uptake. The objective of this proposal is to evaluate the feasibility of implementing this&#xD;
        EHR-based model at the point of care to increase PrEP referrals and uptake at KPNC. The&#xD;
        specific aims of this project are to 1) conduct provider focus groups to identify barriers&#xD;
        and facilitators to PrEP referrals and to optimize the delivery mechanism of our clinical&#xD;
        decision support intervention, 2) evaluate the feasibility and acceptability of a clinical&#xD;
        decision support intervention for primary care providers (PCPs) to increase PrEP referrals&#xD;
        and uptake among high-risk patients, and 3) assess patient- and provider-based&#xD;
        characteristics associated with PrEP referrals and uptake. To accomplish these aims, the&#xD;
        study team proposes a randomized controlled trial of a clinical decision support intervention&#xD;
        for PrEP, which involves alerting KP San Francisco (KPSF) Adult and Family Medicine PCPs&#xD;
        about patients identified by our prediction model as being at high risk for HIV acquisition&#xD;
        prior to in-person clinic visits. We will compare PrEP referrals and uptake among patients&#xD;
        who are seen by PCPs randomized to intervention and usual care study arms using an&#xD;
        intention-to-treat analysis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study Design This is a randomized controlled trial among PCPs at KPSF to evaluate the&#xD;
        feasibility of implementing a decision support intervention for PrEP and its impact on PrEP&#xD;
        referrals and uptake among patients predicted to be at high risk for incident HIV infections.&#xD;
        Aim 1 will consist of focus groups with PCPs to identify barriers and facilitators to PrEP&#xD;
        referrals and to optimize the intervention. After first testing the proposed study&#xD;
        intervention with two PCPs in each study arm, Aim 2 will compare PrEP referrals and uptake&#xD;
        between members who are seen by PCPs randomized to intervention and usual care study arms.&#xD;
        Aim 3 will evaluate provider- and patient-based factors associated with PrEP referrals and&#xD;
        uptake among patients in the intervention arm. The trial will randomly allocate PCPs at KP&#xD;
        San Francisco to one of two arms: 1) intervention arm that includes clinical decision support&#xD;
        for PrEP referrals prior to visits scheduled with patients flagged as high-risk by the&#xD;
        prediction model, or 2) usual care, with an estimated 50 PCPs in each arm. Eligible PCPs will&#xD;
        be contacted by the study team prior to enrollment and given an opportunity to opt out of&#xD;
        participating in this study. PCPs randomized to the usual care arm will not receive the&#xD;
        clinical decision support intervention. The intervention will be conducted over 8 months.&#xD;
  &#xD;
        Setting. KPNC is a large healthcare delivery system that provides integrated pharmacy,&#xD;
        laboratory, and medical care to more than a third of insured individuals in California. KPSF&#xD;
        has been chosen as the study site given the disproportionate burden of HIV in this KPNC&#xD;
        service area. At KPSF, there are 121 Adult and Family Medicine (AFM) PCPs serving&#xD;
        approximately 189,000 patients.&#xD;
  &#xD;
        Subjects. The study team will recruit 10-15 PCPs each from the two KPSF clinical sites in San&#xD;
        Francisco prior to randomization. Providers will be recruited at routine staff meetings and&#xD;
        through email invitations for a one-time, 60- minute, audio-recorded focus group. The study&#xD;
        team will assess what information PCPs would like to have included in the clinical decision&#xD;
        support tool. Recognizing that time constraints are a barrier to all healthcare&#xD;
        interventions, we will seek feedback from PCPs regarding their preferences for intervention&#xD;
        delivery and timing, as well as their perceptions of facilitators and barriers to acting on&#xD;
        the intervention. Open-ended questions will minimize bias and allow for unanticipated themes&#xD;
        to emerge.&#xD;
  &#xD;
        Randomization. PCPs who meet study criteria and do not opt-out will be randomized to one of&#xD;
        the two study arms in a 1:1 ratio. There are 12 providers who care for both HIV-infected and&#xD;
        uninfected patients, and allocation of this subset of providers will be balanced between the&#xD;
        trial arms. To ensure this, the study team will use simple randomization to assign the 13&#xD;
        PCPs who care for both HIV-infected and uninfected patients to intervention or usual care and&#xD;
        then use simple randomization again to assign the remaining 109 PCPs.&#xD;
  &#xD;
        Specificity of the prediction model. The prediction model acts as a screening test to be&#xD;
        followed by a provider's clinical evaluation. The study team expects that some patients with&#xD;
        scores indicating an elevated risk for HIV acquisition will not have clinical indications for&#xD;
        PrEP. The relationship between PCPs and patients is critical given the sensitive nature of&#xD;
        sexual health discussions. In addition, prior to initiation of treatment with PrEP, patients&#xD;
        will attend visits where a member of the dedicated KPSF PrEP team (NP or MD) will assess HIV&#xD;
        risk and discuss PrEP indications, follow-up, side effects, and contraindications.&#xD;
  &#xD;
        Scalability of the intervention outside KPNC. Even if the intervention is successful within&#xD;
        KPNC, other health settings outside KPNC will need to adopt technology solutions to update&#xD;
        risk scores, automate lists of patients with elevated risk scores, identify eligible&#xD;
        appointments, and successfully deliver interventions to providers. While the study team's&#xD;
        robust model that included 44 EHR variables provided the greatest predictive value for&#xD;
        incident HIV, simpler models that included only a handful of key variables also improved&#xD;
        identification of patients who may benefit from PrEP. The study results will provide a&#xD;
        roadmap for successful implementation at other institutions, even if technology and EHR&#xD;
        resources are more limited.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2021</start_date>
    <completion_date type="Actual">October 31, 2022</completion_date>
    <primary_completion_date type="Actual">November 30, 2021</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cumulative risk (%) of linkage to PrEP</measure>
      <time_frame>Within 90 days after PrEP referral.</time_frame>
      <description>linkage to PrEP care within 90 days of the first encounter, defined as first of following: PrEP discussion (ICD-10 Z29.8), referral (measured by PrEP referrals and appointments booked through e-consult, a provider-to-provider community platform embedded in the EHR ), or prescription fill for emtricitabine coformulated with tenofovir disoproxil fumarate or with tenofovir alafenamide</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cumulative risk (%) of PrEP Prescription fill only</measure>
      <time_frame>Within 90 days after first encounter</time_frame>
      <description>PrEP prescription fill within 90 days of the first encounter defined as pharmacy fills for emtricitabine coformulated with tenofovir disoproxil fumarate or with tenofovir alafenamide</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative risk (%) of HIV Testing</measure>
      <time_frame>within 90 days of first encounter</time_frame>
      <description>Physician orders for HIV testing</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative risk (%) of STI Testing</measure>
      <time_frame>within 90 days of first encounter</time_frame>
      <description>Physician orders for any testing for bacterial STIs, including chlamydia, gonorrhea, or syphilis</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">121</enrollment>
    <condition>Pre-Exposure Prophylaxis</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Point-of-care decision support intervention</intervention_name>
      <description>PCPs notified by EHR messages if they had an upcoming in-person or video visit with an eligible patient who had a predicted risk of incident HIV diagnosis of 0.2% or higher. Study team members manually sent messages marked as &quot;high priority&quot; one business day prior to scheduled visits, alerting PCPs that a patient may be at increased risk for acquiring HIV and may benefit from a conversation about PrEP. Additional information was provided about the study, the prediction model, clinical indications for PrEP, strategies for initiating discussions about HIV prevention and PrEP, and how to refer patients to KPSF's PrEP program. Messages did not include the numeric predicted HIV risk from the model. PCPs received a maximum of two messages per day; with the two patients with the highest predicted risk were selected. Patient with multiple visits were flagged no more than once monthly.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Primary care provider at Kaiser Permanente San Francisco Medical Center&#xD;
  &#xD;
            -  Provide primary care to adult patients&#xD;
  &#xD;
            -  more than 150 people without HIV on their primary care physician panel.&#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>
    <location>
      <facility>
        <name>Kaiser Permanente Northern California Division of Research</name>
        <address>
          <city>Oakland</city>
          <state>California</state>
          <zip>94612</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HIV</keyword>
    <keyword>Pre-Exposure Prophylaxis</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is no plan to make individual participant data available to other researchers.</ipd_description>
    </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/NCT05991869
  org study id: DelSciPrEP 2021
  nct id: NCT05991869
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Kaiser Permanente Northern California (KPNC) has been a national leader in implementation of
        HIV preexposure prophylaxis (PrEP), a daily antiretroviral pill that is more than 99%
        effective in preventing HIV acquisition. However, many patients at risk for HIV at KPNC are
        not yet using PrEP, resulting in preventable infections each year. In prior work, the study
        team developed and validated a prediction model that used electronic health record (EHR) data
        from 3.7 million KPNC members to identify patients at high risk of HIV acquisition but not
        using PrEP. The model substantially outperformed models based only on CDC criteria for PrEP
        use, particularly for Black patients, a population with high HIV incidence and lower PrEP
        uptake. The objective of this proposal is to evaluate the feasibility of implementing this
        EHR-based model at the point of care to increase PrEP referrals and uptake at KPNC. The
        specific aims of this project are to 1) conduct provider focus groups to identify barriers
        and facilitators to PrEP referrals and to optimize the delivery mechanism of our clinical
        decision support intervention, 2) evaluate the feasibility and acceptability of a clinical
        decision support intervention for primary care providers (PCPs) to increase PrEP referrals
        and uptake among high-risk patients, and 3) assess patient- and provider-based
        characteristics associated with PrEP referrals and uptake. To accomplish these aims, the
        study team proposes a randomized controlled trial of a clinical decision support intervention
        for PrEP, which involves alerting KP San Francisco (KPSF) Adult and Family Medicine PCPs
        about patients identified by our prediction model as being at high risk for HIV acquisition
        prior to in-person clinic visits. We will compare PrEP referrals and uptake among patients
        who are seen by PCPs randomized to intervention and usual care study arms using an
        intention-to-treat analysis.
  Study Design This is a randomized controlled trial among PCPs at KPSF to evaluate the
        feasibility of implementing a decision support intervention for PrEP and its impact on PrEP
        referrals and uptake among patients predicted to be at high risk for incident HIV infections.
        Aim 1 will consist of focus groups with PCPs to identify barriers and facilitators to PrEP
        referrals and to optimize the intervention. After first testing the proposed study
        intervention with two PCPs in each study arm, Aim 2 will compare PrEP referrals and uptake
        between members who are seen by PCPs randomized to intervention and usual care study arms.
        Aim 3 will evaluate provider- and patient-based factors associated with PrEP referrals and
        uptake among patients in the intervention arm. The trial will randomly allocate PCPs at KP
        San Francisco to one of two arms: 1) intervention arm that includes clinical decision support
        for PrEP referrals prior to visits scheduled with patients flagged as high-risk by the
        prediction model, or 2) usual care, with an estimated 50 PCPs in each arm. Eligible PCPs will
        be contacted by the study team prior to enrollment and given an opportunity to opt out of
        participating in this study. PCPs randomized to the usual care arm will not receive the
        clinical decision support intervention. The intervention will be conducted over 8 months.
  
        Setting. KPNC is a large healthcare delivery system that provides integrated pharmacy,
        laboratory, and medical care to more than a third of insured individuals in California. KPSF
        has been chosen as the study site given the disproportionate burden of HIV in this KPNC
        service area. At KPSF, there are 121 Adult and Family Medicine (AFM) PCPs serving
        approximately 189,000 patients.
  
        Subjects. The study team will recruit 10-15 PCPs each from the two KPSF clinical sites in San
        Francisco prior to randomization. Providers will be recruited at routine staff meetings and
        through email invitations for a one-time, 60- minute, audio-recorded focus group. The study
        team will assess what information PCPs would like to have included in the clinical decision
        support tool. Recognizing that time constraints are a barrier to all healthcare
        interventions, we will seek feedback from PCPs regarding their preferences for intervention
        delivery and timing, as well as their perceptions of facilitators and barriers to acting on
        the intervention. Open-ended questions will minimize bias and allow for unanticipated themes
        to emerge.
  
        Randomization. PCPs who meet study criteria and do not opt-out will be randomized to one of
        the two study arms in a 1:1 ratio. There are 12 providers who care for both HIV-infected and
        uninfected patients, and allocation of this subset of providers will be balanced between the
        trial arms. To ensure this, the study team will use simple randomization to assign the 13
        PCPs who care for both HIV-infected and uninfected patients to intervention or usual care and
        then use simple randomization again to assign the remaining 109 PCPs.
  
        Specificity of the prediction model. The prediction model acts as a screening test to be
        followed by a provider's clinical evaluation. The study team expects that some patients with
        scores indicating an elevated risk for HIV acquisition will not have clinical indications for
        PrEP. The relationship between PCPs and patients is critical given the sensitive nature of
        sexual health discussions. In addition, prior to initiation of treatment with PrEP, patients
        will attend visits where a member of the dedicated KPSF PrEP team (NP or MD) will assess HIV
        risk and discuss PrEP indications, follow-up, side effects, and contraindications.
  
        Scalability of the intervention outside KPNC. Even if the intervention is successful within
        KPNC, other health settings outside KPNC will need to adopt technology solutions to update
        risk scores, automate lists of patients with elevated risk scores, identify eligible
        appointments, and successfully deliver interventions to providers. While the study team's
        robust model that included 44 EHR variables provided the greatest predictive value for
        incident HIV, simpler models that included only a handful of key variables also improved
        identification of patients who may benefit from PrEP. The study results will provide a
        roadmap for successful implementation at other institutions, even if technology and EHR
        resources are more limited.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Cumulative risk (%) of linkage to PrEP
  time frame: Within 90 days after PrEP referral.
  description: linkage to PrEP care within 90 days of the first encounter, defined as first of following: PrEP discussion (ICD-10 Z29.8), referral (measured by PrEP referrals and appointments booked through e-consult, a provider-to-provider community platform embedded in the EHR ), or prescription fill for emtricitabine coformulated with tenofovir disoproxil fumarate or with tenofovir alafenamide
  measure: Cumulative risk (%) of PrEP Prescription fill only
  time frame: Within 90 days after first encounter
  description: PrEP prescription fill within 90 days of the first encounter defined as pharmacy fills for emtricitabine coformulated with tenofovir disoproxil fumarate or with tenofovir alafenamide
  measure: Cumulative risk (%) of HIV Testing
  time frame: within 90 days of first encounter
  description: Physician orders for HIV testing
  measure: Cumulative risk (%) of STI Testing
  time frame: within 90 days of first encounter
  description: Physician orders for any testing for bacterial STIs, including chlamydia, gonorrhea, or syphilis
  arm group label: Intervention
  arm group type: Experimental
  arm group label: Usual Care
  arm group type: No Intervention
  intervention type: Behavioral
  intervention name: Point-of-care decision support intervention
  description: PCPs notified by EHR messages if they had an upcoming in-person or video visit with an eligible patient who had a predicted risk of incident HIV diagnosis of 0.2% or higher. Study team members manually sent messages marked as "high priority" one business day prior to scheduled visits, alerting PCPs that a patient may be at increased risk for acquiring HIV and may benefit from a conversation about PrEP. Additional information was provided about the study, the prediction model, clinical indications for PrEP, strategies for initiating discussions about HIV prevention and PrEP, and how to refer patients to KPSF's PrEP program. Messages did not include the numeric predicted HIV risk from the model. PCPs received a maximum of two messages per day; with the two patients with the highest predicted risk were selected. Patient with multiple visits were flagged no more than once monthly.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: There is no plan to make individual participant data available to other researchers.