<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/NCT03820323</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY000004861</org_study_id>
    <secondary_id>R34MH115769</secondary_id>
    <nct_id>NCT03820323</nct_id>
  </id_info>
  <brief_title>Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy</brief_title>
  <acronym>Opt4Kids</acronym>
  <official_title>Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy</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>
    <collaborator>
      <agency>Kenya Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</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>
      Among nearly 1 million HIV-infected children receiving antiretroviral treatment (ART), as&#xD;
      many as 40% of those living in resource limited settings have not achieved virologic&#xD;
      suppression. Kenya, a The Joint United Nations Programme on HIV/AIDS (UNAIDS) fast-track and&#xD;
      The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) priority country, has an&#xD;
      estimated 98,000 children aged 0-14 years living with HIV. Virologic suppression is achieved&#xD;
      by only 65% of Kenyan children on ART translating to only 38% of the final UNAIDS 90-90-90&#xD;
      goal for population-level viral suppression. Feasible, scalable and cost-effective approaches&#xD;
      to maximizing durability of first-line ART and ensuring viral load (VL) suppression in&#xD;
      HIV-infected children are urgently needed. This pilot study will evaluate two critical&#xD;
      components related to viral suppression in children via: 1) Point-of-care (POC) VL testing&#xD;
      (Aim 1) and 2) targeted drug resistance mutation (DRM) testing (Aim 2) among children on&#xD;
      first-line ART at three facilities within a PEPFAR-funded HIV care and treatment program in&#xD;
      Kenya. The hypotheses are: 1) viral suppression rates will be higher among children with&#xD;
      access to POC VL testing and time to suppression shorter compared to children with standard&#xD;
      VL testing and 2) DRM testing will shorten time to viral suppression and that the&#xD;
      investigators will observe high levels of 1st line antiretroviral DRMs among children on ART&#xD;
      without viral suppression. This proposal directly addresses the urgent need to find&#xD;
      interventions to maximize viral suppression among children on ART and achieve the UNAIDS&#xD;
      90-90-90 goals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design will be a randomized, controlled study to pilot the use of POC VL and DRM&#xD;
      testing in children aged 1-14 years on first-line ART. Children enrolling at each site will&#xD;
      be randomized 1:1 to two study arms.&#xD;
&#xD;
      Standard of Care Arm:&#xD;
&#xD;
      Participants in the Standard-of-Care (SOC) control arm will receive the standard-of-care VL&#xD;
      and DRM testing based on the existing Kenyan national guidelines. VL testing will be 6 months&#xD;
      after ART initiation (then every 3 months if unsuppressed, otherwise every 12 months) with&#xD;
      DRM testing only if failing second-line ART. Children who have a high lab-based HIV VL&#xD;
      (≥1,000 copies/mL) will receive intensive adherence counseling and be asked to return to the&#xD;
      clinic in 3 months for repeat HIV VL testing. If the HIV VL remains high (≥1,000 copies/mL),&#xD;
      the children will be managed per Kenya national guidelines.&#xD;
&#xD;
      Intervention Arm:&#xD;
&#xD;
      Children in the intervention arm will undergo POC VL testing every 3 months for a total of 12&#xD;
      months. &quot;Targeted&quot; DRM testing will include DRM testing for each child on the first detection&#xD;
      of lack of viral suppression (VL &gt; 1000 copies/mL) and in children newly initiating ART.&#xD;
&#xD;
      The investigators will follow the viral outcomes 12 months after the implementation of POC VL&#xD;
      testing and compare VL suppression rates, defined as VL &lt;1000 copies/mL by the Kenyan&#xD;
      national guidelines, among intervention vs. control arms, accounting for pre-intervention VL&#xD;
      suppression rates.&#xD;
&#xD;
      The primary outcome for Aim 1 is rates of viral suppression (defined as VL &lt;1000 copies/mL)&#xD;
      at 12 months after POC VL testing implementation at the three facilities. The secondary&#xD;
      outcome for Aim 1 is time to viral suppression among those children without viral suppression&#xD;
      at their 1st POC VL testing or newly initiating ART after POC VL testing implementation. In&#xD;
      Aim 2, the investigators intend to evaluate the impact of targeted HIV DRM testing on viral&#xD;
      suppression in the intervention arm only. The investigators will also explore how&#xD;
      sociodemographic, behavioral, clinical, and facility factors may be contributing to the DRM&#xD;
      patterns they observe.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 7, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>
    <intervention_model_description>Randomized control trial of two study arms</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Investigators and those conducting the analysis will be blinded to arm allocation</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Viral Suppression</measure>
    <time_frame>12 months after enrollment</time_frame>
    <description>Viral Load &lt;1000 copies/mL at 12 months after enrollment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Virological Suppression at 12 Months Among Children Newly Initiating ART or Initially Virologically Unsuppressed</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>Among children newly initiating ART or initially virologically unsuppressed, we then evaluated the virological suppression status at 12 months post-enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Underwent POC VL Testing</measure>
    <time_frame>Every 3 months within the 12 months study period</time_frame>
    <description>The number of children undergoing VL testing within each group (POC VL testing or SOC VL testing) at the scheduled intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Turn-around Time for the VL Testing Results</measure>
    <time_frame>Every 3 months within the 12 months study period</time_frame>
    <description>The time it takes for viral load results to be received by health care providers and participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Children With Any or Major Drug Resistance Mutations (DRMs)</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>The number of children tested for DRMs with any or major mutations within each class of HIV drugs.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">704</enrollment>
  <condition>Chronic HIV Infection</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in the Standard-of-Care control arm will receive laboratory based VL testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). DRM testing is usually done if there is a failing 2nd line ART regimen based on the current Kenyan guideline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>POC VL and targeted DRM testing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>POC VL and targeted DRM testing.</intervention_name>
    <description>Point-of-care Viral Load Testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of ART and when viremia (VL&gt;1000 copies/mL) is detected.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>SOC VL testing</intervention_name>
    <description>SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.</description>
    <arm_group_label>Standard of Care</arm_group_label>
    <other_name>Kenyan National guidelines for viral load testing</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 1-14 years living with HIV (documented HIV positive)&#xD;
&#xD;
          -  On first-line ART per Kenyan National Guideline or&#xD;
&#xD;
          -  Newly initiating ART&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  On second-line, third-line, or non-standard first-line ART&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rena Patel, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lisa L Abuogi, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rtcp-Faces</name>
      <address>
        <city>Kisumu</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <results_first_submitted>October 11, 2022</results_first_submitted>
  <results_first_submitted_qc>December 5, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 27, 2022</results_first_posted>
  <disposition_first_submitted>December 17, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>December 27, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 28, 2021</disposition_first_posted>
  <last_update_submitted>December 5, 2022</last_update_submitted>
  <last_update_submitted_qc>December 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Rena Patel</investigator_full_name>
    <investigator_title>Assistant Professor, Division of Allergy and Infectious Disease, Department of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for all outcome measures will be made available after study completion</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>After primary outcomes results are published.</ipd_time_frame>
    <ipd_access_criteria>Contact PIs of the study and obtain institutional ethic review approvals.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 2, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03820323/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 11, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03820323/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted in Kisumu County, western Kenya, with the second-highest prevalence of pediatric HIV infections in Kenya. The study was implemented at five low-resource, high-HIV burden public sector facilities from March 2019 to December 2020. We chose the study facilities to leverage existing POC technologies, specifically the GeneXpert® platform.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Standard of Care</title>
          <description>Participants in the Standard-of-Care control arm will receive laboratory based VL testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). DRM testing is usually done if there is a failing 2nd line ART regimen based on the current Kenyan guideline.&#xD;
SOC VL testing: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.</description>
        </group>
        <group group_id="P2">
          <title>Intervention</title>
          <description>POC VL and targeted DRM testing.&#xD;
POC VL and targeted DRM testing.: Point-of-care Viral Load Testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of ART and when viremia (VL&gt;1000 copies/mL) is detected.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="355"/>
                <participants group_id="P2" count="349"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="315"/>
                <participants group_id="P2" count="313"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missed 12-month visit</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Transferred out</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Terminated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard of Care</title>
          <description>Participants in the Standard-of-Care control arm will receive laboratory based VL testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). DRM testing is usually done if there is a failing 2nd line ART regimen based on the current Kenyan guideline.&#xD;
SOC VL testing: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.</description>
        </group>
        <group group_id="B2">
          <title>Intervention</title>
          <description>POC VL and targeted DRM testing.&#xD;
POC VL and targeted DRM testing.: Point-of-care Viral Load Testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of ART and when viremia (VL&gt;1000 copies/mL) is detected.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="355"/>
            <count group_id="B2" value="349"/>
            <count group_id="B3" value="704"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="355"/>
                    <measurement group_id="B2" value="349"/>
                    <measurement group_id="B3" value="704"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9" lower_limit="7" upper_limit="12"/>
                    <measurement group_id="B2" value="9" lower_limit="6" upper_limit="12"/>
                    <measurement group_id="B3" value="9" lower_limit="7" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="160"/>
                    <measurement group_id="B2" value="184"/>
                    <measurement group_id="B3" value="344"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="195"/>
                    <measurement group_id="B2" value="165"/>
                    <measurement group_id="B3" value="360"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="355"/>
                    <measurement group_id="B2" value="349"/>
                    <measurement group_id="B3" value="704"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="355"/>
                    <measurement group_id="B2" value="349"/>
                    <measurement group_id="B3" value="704"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Kenya</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="355"/>
                    <measurement group_id="B2" value="349"/>
                    <measurement group_id="B3" value="704"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Virological suppression at enrollment</title>
          <description>Viral load &lt;1000 copier per mL at enrollment or most recent up to 2 years prior</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes (viral load &lt;1000 copies per mL)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="274"/>
                    <measurement group_id="B2" value="262"/>
                    <measurement group_id="B3" value="536"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No (viral load &gt;=1000 copies per mL)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No viral load recorded or missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Viral Suppression</title>
        <description>Viral Load &lt;1000 copies/mL at 12 months after enrollment</description>
        <time_frame>12 months after enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>Participants in the Standard-of-Care (SOC) control arm will receive laboratory based viral load (VL) testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). Drug resistance mutation (DRM) testing is usually done if there is a failing 2nd line antiretroviral therapy (ART) regimen based on the current Kenyan guideline.&#xD;
SOC VL testing: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>Point-of-care (POC) viral load (VL) and targeted Drug resistance mutation (DRM) testing.&#xD;
POC VL and targeted DRM testing: POC VL testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of antiretroviral (ART) and when viremia (VL&gt;1000 copies/mL) is detected.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Viral Suppression</title>
          <description>Viral Load &lt;1000 copies/mL at 12 months after enrollment</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="289"/>
                    <measurement group_id="O2" value="283"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.55</p_value>
            <method>Modified Poisson regression</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.94</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Virological Suppression at 12 Months Among Children Newly Initiating ART or Initially Virologically Unsuppressed</title>
        <description>Among children newly initiating ART or initially virologically unsuppressed, we then evaluated the virological suppression status at 12 months post-enrollment.</description>
        <time_frame>12 months post enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>Participants in the Standard-of-Care (SOC) control arm will receive laboratory based viral load (VL) testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). Drug resistance mutation (DRM) testing is usually done if there is a failing 2nd line antiretroviral therapy (ART) regimen based on the current Kenyan guideline.&#xD;
SOC VL testing: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>Point-of-care (POC) viral load (VL) and targeted Drug resistance mutation (DRM) testing.&#xD;
POC VL and targeted DRM testing: POC VL testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of antiretroviral (ART) and when viremia (VL&gt;1000 copies/mL) is detected.</description>
          </group>
        </group_list>
        <measure>
          <title>Virological Suppression at 12 Months Among Children Newly Initiating ART or Initially Virologically Unsuppressed</title>
          <description>Among children newly initiating ART or initially virologically unsuppressed, we then evaluated the virological suppression status at 12 months post-enrollment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.28</p_value>
            <method>Modified Poission regression</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>1.13</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Underwent POC VL Testing</title>
        <description>The number of children undergoing VL testing within each group (POC VL testing or SOC VL testing) at the scheduled intervals.</description>
        <time_frame>Every 3 months within the 12 months study period</time_frame>
        <population>Of note, during the 6- and 9-month study visits, COVID-19 related restrictions in travel and routine care greatly affected our ability to obtain samples for VL testing leading to varying numbers analyzed per month.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>Participants in the Standard-of-Care (SOC) control arm will receive laboratory based viral load (VL) testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). Drug resistance mutation (DRM) testing is usually done if there is a failing 2nd line antiretroviral therapy (ART) regimen based on the current Kenyan guideline.&#xD;
SOC VL testing: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>Point-of-care (POC) viral load (VL) and targeted Drug resistance mutation (DRM) testing.&#xD;
POC VL and targeted DRM testing: POC VL testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of antiretroviral (ART) and when viremia (VL&gt;1000 copies/mL) is detected.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Underwent POC VL Testing</title>
          <description>The number of children undergoing VL testing within each group (POC VL testing or SOC VL testing) at the scheduled intervals.</description>
          <population>Of note, during the 6- and 9-month study visits, COVID-19 related restrictions in travel and routine care greatly affected our ability to obtain samples for VL testing leading to varying numbers analyzed per month.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="355"/>
                <count group_id="O2" value="349"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="351"/>
                    <count group_id="O2" value="349"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="167"/>
                    <measurement group_id="O2" value="349"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="351"/>
                    <count group_id="O2" value="329"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185"/>
                    <measurement group_id="O2" value="301"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="351"/>
                    <count group_id="O2" value="321"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131"/>
                    <measurement group_id="O2" value="177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="351"/>
                    <count group_id="O2" value="335"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143"/>
                    <measurement group_id="O2" value="186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="351"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135"/>
                    <measurement group_id="O2" value="286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Turn-around Time for the VL Testing Results</title>
        <description>The time it takes for viral load results to be received by health care providers and participants.</description>
        <time_frame>Every 3 months within the 12 months study period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>Participants in the Standard-of-Care (SOC) control arm will receive laboratory based viral load (VL) testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). Drug resistance mutation (DRM) testing is usually done if there is a failing 2nd line antiretroviral therapy (ART) regimen based on the current Kenyan guideline.&#xD;
SOC VL testing: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>Point-of-care (POC) viral load (VL) and targeted Drug resistance mutation (DRM) testing.&#xD;
POC VL and targeted DRM testing: POC VL testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of antiretroviral (ART) and when viremia (VL&gt;1000 copies/mL) is detected.</description>
          </group>
        </group_list>
        <measure>
          <title>Turn-around Time for the VL Testing Results</title>
          <description>The time it takes for viral load results to be received by health care providers and participants.</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="355"/>
                <count group_id="O2" value="349"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" lower_limit="10" upper_limit="21"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Children With Any or Major Drug Resistance Mutations (DRMs)</title>
        <description>The number of children tested for DRMs with any or major mutations within each class of HIV drugs.</description>
        <time_frame>12 months post enrollment</time_frame>
        <population>Of 120 samples in the intervention group in which we requested a DRM test, 13 (11%) failed to amplify. We are not able to elucidate reasons why five of the samples in the Standard of Care group were selected for DRM testing or why three of the five requested DRM tests were not performed successfully.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>Participants in the Standard-of-Care (SOC) control arm will receive laboratory based viral load (VL) testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). Drug resistance mutation (DRM) testing is usually done if there is a failing 2nd line antiretroviral therapy (ART) regimen based on the current Kenyan guideline.&#xD;
SOC VL testing: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>Point-of-care (POC) viral load (VL) and targeted Drug resistance mutation (DRM) testing.&#xD;
POC VL and targeted DRM testing: POC VL testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of antiretroviral (ART) and when viremia (VL&gt;1000 copies/mL) is detected.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Children With Any or Major Drug Resistance Mutations (DRMs)</title>
          <description>The number of children tested for DRMs with any or major mutations within each class of HIV drugs.</description>
          <population>Of 120 samples in the intervention group in which we requested a DRM test, 13 (11%) failed to amplify. We are not able to elucidate reasons why five of the samples in the Standard of Care group were selected for DRM testing or why three of the five requested DRM tests were not performed successfully.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any DRM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NRTI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NNRTI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protease Inhibitor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any major DRM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Major NRTI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Major NNRTI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Major protease Inhibitor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The adverse events were reported from enrollment to approximately 12 months after enrollment for each participant.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Standard of Care</title>
          <description>Participants in the Standard-of-Care control arm will receive laboratory based VL testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). DRM testing is usually done if there is a failing 2nd line ART regimen based on the current Kenyan guideline.&#xD;
SOC VL testing: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.</description>
        </group>
        <group group_id="E2">
          <title>Intervention</title>
          <description>POC VL and targeted DRM testing.&#xD;
POC VL and targeted DRM testing.: Point-of-care Viral Load Testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of ART and when viremia (VL&gt;1000 copies/mL) is detected.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="355"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="349"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="355"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="349"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization</sub_title>
                <description>Malnutrition</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="355"/>
                <counts group_id="E2" subjects_at_risk="349"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="355"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="349"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>First, it is possible we had sample biased towards higher levels of viral suppression (VS). Second, though our package of POC VL testing, DRM testing, and clinical decision support was only offered to intervention group, the same providers cared for participants in intervention and control groups. Third, VS was assessed on different schedules for intervention and control, the intervention group participants had a greater number of opportunities to act on their test results and detect viremia.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Rena C. Patel</name_or_title>
      <organization>University of Washington</organization>
      <phone>206-520-3800</phone>
      <email>rcpatel@uw.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03820323
org study id: STUDY000004861
secondary id: R34MH115769
nct id: NCT03820323
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Among nearly 1 million HIV-infected children receiving antiretroviral treatment (ART), as
      many as 40% of those living in resource limited settings have not achieved virologic
      suppression. Kenya, a The Joint United Nations Programme on HIV/AIDS (UNAIDS) fast-track and
      The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) priority country, has an
      estimated 98,000 children aged 0-14 years living with HIV. Virologic suppression is achieved
      by only 65% of Kenyan children on ART translating to only 38% of the final UNAIDS 90-90-90
      goal for population-level viral suppression. Feasible, scalable and cost-effective approaches
      to maximizing durability of first-line ART and ensuring viral load (VL) suppression in
      HIV-infected children are urgently needed. This pilot study will evaluate two critical
      components related to viral suppression in children via: 1) Point-of-care (POC) VL testing
      (Aim 1) and 2) targeted drug resistance mutation (DRM) testing (Aim 2) among children on
      first-line ART at three facilities within a PEPFAR-funded HIV care and treatment program in
      Kenya. The hypotheses are: 1) viral suppression rates will be higher among children with
      access to POC VL testing and time to suppression shorter compared to children with standard
      VL testing and 2) DRM testing will shorten time to viral suppression and that the
      investigators will observe high levels of 1st line antiretroviral DRMs among children on ART
      without viral suppression. This proposal directly addresses the urgent need to find
      interventions to maximize viral suppression among children on ART and achieve the UNAIDS
      90-90-90 goals.
The study design will be a randomized, controlled study to pilot the use of POC VL and DRM
      testing in children aged 1-14 years on first-line ART. Children enrolling at each site will
      be randomized 1:1 to two study arms.

      Standard of Care Arm:

      Participants in the Standard-of-Care (SOC) control arm will receive the standard-of-care VL
      and DRM testing based on the existing Kenyan national guidelines. VL testing will be 6 months
      after ART initiation (then every 3 months if unsuppressed, otherwise every 12 months) with
      DRM testing only if failing second-line ART. Children who have a high lab-based HIV VL
      (≥1,000 copies/mL) will receive intensive adherence counseling and be asked to return to the
      clinic in 3 months for repeat HIV VL testing. If the HIV VL remains high (≥1,000 copies/mL),
      the children will be managed per Kenya national guidelines.

      Intervention Arm:

      Children in the intervention arm will undergo POC VL testing every 3 months for a total of 12
      months. "Targeted" DRM testing will include DRM testing for each child on the first detection
      of lack of viral suppression (VL > 1000 copies/mL) and in children newly initiating ART.

      The investigators will follow the viral outcomes 12 months after the implementation of POC VL
      testing and compare VL suppression rates, defined as VL <1000 copies/mL by the Kenyan
      national guidelines, among intervention vs. control arms, accounting for pre-intervention VL
      suppression rates.

      The primary outcome for Aim 1 is rates of viral suppression (defined as VL <1000 copies/mL)
      at 12 months after POC VL testing implementation at the three facilities. The secondary
      outcome for Aim 1 is time to viral suppression among those children without viral suppression
      at their 1st POC VL testing or newly initiating ART after POC VL testing implementation. In
      Aim 2, the investigators intend to evaluate the impact of targeted HIV DRM testing on viral
      suppression in the intervention arm only. The investigators will also explore how
      sociodemographic, behavioral, clinical, and facility factors may be contributing to the DRM
      patterns they observe.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized control trial of two study arms
primary purpose: Diagnostic
masking: Double (Investigator, Outcomes Assessor)
masking description: Investigators and those conducting the analysis will be blinded to arm allocation
measure: Number of Participants With Viral Suppression
time frame: 12 months after enrollment
description: Viral Load <1000 copies/mL at 12 months after enrollment
measure: Virological Suppression at 12 Months Among Children Newly Initiating ART or Initially Virologically Unsuppressed
time frame: 12 months post enrollment
description: Among children newly initiating ART or initially virologically unsuppressed, we then evaluated the virological suppression status at 12 months post-enrollment.
measure: Number of Participants Who Underwent POC VL Testing
time frame: Every 3 months within the 12 months study period
description: The number of children undergoing VL testing within each group (POC VL testing or SOC VL testing) at the scheduled intervals.
measure: Turn-around Time for the VL Testing Results
time frame: Every 3 months within the 12 months study period
description: The time it takes for viral load results to be received by health care providers and participants.
measure: Number of Children With Any or Major Drug Resistance Mutations (DRMs)
time frame: 12 months post enrollment
description: The number of children tested for DRMs with any or major mutations within each class of HIV drugs.
arm group label: Standard of Care
arm group type: Other
description: Participants in the Standard-of-Care control arm will receive laboratory based VL testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). DRM testing is usually done if there is a failing 2nd line ART regimen based on the current Kenyan guideline.
arm group label: Intervention
arm group type: Experimental
description: POC VL and targeted DRM testing.
intervention type: Diagnostic Test
intervention name: POC VL and targeted DRM testing.
description: Point-of-care Viral Load Testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of ART and when viremia (VL>1000 copies/mL) is detected.
arm group label: Intervention
intervention type: Diagnostic Test
intervention name: SOC VL testing
description: SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.
arm group label: Standard of Care
other name: Kenyan National guidelines for viral load testing
criteria: 
gender: All
minimum age: 1 Year
maximum age: 14 Years
healthy volunteers: No
last name: Rena Patel, MD, MPH
role: Principal Investigator
affiliation: University of Washington
last name: Lisa L Abuogi, MD, MSc
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: Kenya
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Rena Patel
investigator title: Assistant Professor, Division of Allergy and Infectious Disease, Department of Medicine
mesh term: HIV Infections
sharing ipd: Yes
ipd description: De-identified individual participant data for all outcome measures will be made available after study completion
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: After primary outcomes results are published.
ipd access criteria: Contact PIs of the study and obtain institutional ethic review approvals.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: First, it is possible we had sample biased towards higher levels of viral suppression (VS). Second, though our package of POC VL testing, DRM testing, and clinical decision support was only offered to intervention group, the same providers cared for participants in intervention and control groups. Third, VS was assessed on different schedules for intervention and control, the intervention group participants had a greater number of opportunities to act on their test results and detect viremia.
point of contact: 