<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/NCT03288246</url>
  </required_header>
  <id_info>
    <org_study_id>1708018474</org_study_id>
    <nct_id>NCT03288246</nct_id>
  </id_info>
  <brief_title>Point-of-care Viral Load Testing Among HIV-infected Adolescents in Haiti</brief_title>
  <official_title>Point-of-care Viral Load Testing Among HIV-infected Adolescents in Haiti</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed as an individual randomized trial among 150 HIV-infected adolescents&#xD;
      aged 10-24 years who have been on ART for &gt;6 months and will be randomized in a 1:1 fashion&#xD;
      to one of two arms: 1) the intervention arm (POC) will receive a POC VL test with adherence&#xD;
      counseling informed by the VL result the same day as testing vs. 2) the standard-of-care arm&#xD;
      (SOC) will receive a standard laboratory-based test with adherence counseling informed by the&#xD;
      VL result 1 month later. The study tests an intervention, POC VL testing, which reduces the&#xD;
      time between sample collection and participant receipt of results, thus decreasing the number&#xD;
      of steps in the HIV treatment cascade. This intervention was developed to addresses health&#xD;
      systems-based barriers which delay clinic, laboratory, and data management processes for VL&#xD;
      monitoring for HIV-infected adolescents. Our results will contribute to research on whether&#xD;
      POC VL testing is a feasible testing method which could be incorporated into health systems&#xD;
      in similar resource-limited settings and whether it can improve outcomes among HIV-infected&#xD;
      adolescents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed as an individual randomized trial among 150 HIV-infected adolescents&#xD;
      aged 10-24 years who have been on ART for &gt;6 months and will be randomized in a 1:1 fashion&#xD;
      to one of two arms: 1) the intervention arm (POC) - receiving a POC VL test with adherence&#xD;
      counseling informed by the VL result the same day as testing vs. 2) the standard-of-care arm&#xD;
      (SOC) - receiving a standard laboratory-based test with adherence counseling informed by the&#xD;
      VL result 1 month later. The study tests an intervention, POC VL testing, which reduces the&#xD;
      time between sample collection and participant receipt of results, thus decreasing the number&#xD;
      of steps in the HIV treatment cascade. This intervention was developed to addresses health&#xD;
      systems-based barriers which delay clinic, laboratory, and data management processes for VL&#xD;
      monitoring for HIV-infected adolescents. The results will contribute to research on whether&#xD;
      POC VL testing is a feasible testing method which could be incorporated into health systems&#xD;
      in similar resource-limited settings and whether it can improve outcomes among HIV-infected&#xD;
      adolescents. The two study arms are described below.&#xD;
&#xD;
      Standard-of-care (SOC): At the first visit after enrollment and randomization, participants&#xD;
      in the SOC arm receive a standard laboratory-based VL test. Steps in the standard&#xD;
      laboratory-based VL testing process include: sample collection at a phlebotomy clinic&#xD;
      adjacent to the adolescent HIV clinic, labeling and daily storage, transportation (1 hr&#xD;
      drive) to the central laboratory, arrival and intake at the laboratory, processing in the&#xD;
      fully automated Abbott system, manual entry of the printed results into an excel spreadsheet&#xD;
      by laboratory staff, and manual entry of results on the spreadsheet into the EMR by data&#xD;
      management staff. This process - from sample collection to patient return of results - varies&#xD;
      depending on the volume of samples collected each day and on laboratory and data management&#xD;
      staffing. Average time from blood collection to availability of the result in the EMR is 2-3&#xD;
      weeks. Per standard clinical care at the adolescent HIV clinic, adolescents return for&#xD;
      monthly visits, and the patient receives the VL result and adherence counseling which is&#xD;
      informed by the VL result 1 month after providing the blood sample. The primary endpoint is&#xD;
      return of the VL result within 6 weeks of sample collection to allow for a short time buffer&#xD;
      for appointments that are not scheduled exactly 1 month from the previous visit for reasons&#xD;
      related to school, work, family obligations, or holidays.&#xD;
&#xD;
      These standard laboratory procedures were developed to meet the high demand for VL testing&#xD;
      when the Haitian national guidelines switched from recommending routine CD4 testing to&#xD;
      routine VL testing. Since the Abbott systems are fully automated and can batch large&#xD;
      quantities of samples together, this approach is appropriate for a routine nation-wide health&#xD;
      system testing protocol. However, the need for transportation, cold-chain storage, and manual&#xD;
      entry of thousands of results every year may not be the optimal structure for HIV-infected&#xD;
      adolescents who are more likely to have high VL results and are more likely to be lost from&#xD;
      care in between visits. This study will test the POC VL test vs. this standard&#xD;
      laboratory-based test to determine if reducing the time between sample collection and patient&#xD;
      receipt of results (removing a step in the HIV treatment cascade), can increase the impact of&#xD;
      VL testing on clinical management and adolescent patient outcomes. The study will test if&#xD;
      implementation of the POC VL test, in collaboration with clinicians and laboratory staff, and&#xD;
      accompanied by patient education, can address many of the logistical barriers to&#xD;
      laboratory-based VL testing in a resource-limited setting such as Haiti.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2018</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of steps in the HIV care cascade involved with viral load testing.</measure>
    <time_frame>1 day of clinic visit</time_frame>
    <description>The number of steps within the HIV care cascade involved with viral load testing will be measured comparing standard laboratory-based testing to POC testing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants who demonstrate comprehension of the correlation between ART adherence and viral level</measure>
    <time_frame>1 month</time_frame>
    <description>The proportion of participants who demonstrate comprehension of the correlation between ART adherence and viral level 1 month after receiving their VL test result will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants who achieve or sustain a viral level &lt;1000 cells/ml</measure>
    <time_frame>6 months</time_frame>
    <description>The proportion of participants who achieve or sustain a viral level &lt;1000 cells/ml 6 months from the index VL test will be measured.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Standard-of-care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the standard-of-care arm will receive a standard laboratory-based viral load test at baseline, 3, and 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Point-of-care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the point-of-care arm will receive a point-of-care viral load test at baseline, 3, and 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>point-of-care viral load test</intervention_name>
    <description>A point-of-care viral load test returns viral load test results within 90 minutes.</description>
    <arm_group_label>Point-of-care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 10-24 years&#xD;
&#xD;
          -  HIV-infected&#xD;
&#xD;
          -  On ART for &gt; 6 months&#xD;
&#xD;
          -  Permanent residence in Port-au-Prince&#xD;
&#xD;
          -  Able to provide informed consent/assent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Requires urgent VL test the day of enrollment/randomization&#xD;
&#xD;
          -  Requires ART regimen change&#xD;
&#xD;
          -  Currently pregnant&#xD;
&#xD;
          -  Co-infected with tuberculosis&#xD;
&#xD;
          -  Severe co-morbidities including cognitive impairment, bipolar disorder, psychosis, or&#xD;
             current need for inpatient psychiatric hospitalization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Fitzgerald, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GHESKIO</name>
      <address>
        <city>Port-au-Prince</city>
        <country>Haiti</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Haiti</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adolescent</keyword>
  <keyword>HIV</keyword>
  <keyword>point-of-care</keyword>
  <keyword>viral load</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be shared once the trial is complete</ipd_description>
  </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/NCT03288246
org study id: 1708018474
nct id: NCT03288246
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed as an individual randomized trial among 150 HIV-infected adolescents
      aged 10-24 years who have been on ART for >6 months and will be randomized in a 1:1 fashion
      to one of two arms: 1) the intervention arm (POC) will receive a POC VL test with adherence
      counseling informed by the VL result the same day as testing vs. 2) the standard-of-care arm
      (SOC) will receive a standard laboratory-based test with adherence counseling informed by the
      VL result 1 month later. The study tests an intervention, POC VL testing, which reduces the
      time between sample collection and participant receipt of results, thus decreasing the number
      of steps in the HIV treatment cascade. This intervention was developed to addresses health
      systems-based barriers which delay clinic, laboratory, and data management processes for VL
      monitoring for HIV-infected adolescents. Our results will contribute to research on whether
      POC VL testing is a feasible testing method which could be incorporated into health systems
      in similar resource-limited settings and whether it can improve outcomes among HIV-infected
      adolescents.
This study is designed as an individual randomized trial among 150 HIV-infected adolescents
      aged 10-24 years who have been on ART for >6 months and will be randomized in a 1:1 fashion
      to one of two arms: 1) the intervention arm (POC) - receiving a POC VL test with adherence
      counseling informed by the VL result the same day as testing vs. 2) the standard-of-care arm
      (SOC) - receiving a standard laboratory-based test with adherence counseling informed by the
      VL result 1 month later. The study tests an intervention, POC VL testing, which reduces the
      time between sample collection and participant receipt of results, thus decreasing the number
      of steps in the HIV treatment cascade. This intervention was developed to addresses health
      systems-based barriers which delay clinic, laboratory, and data management processes for VL
      monitoring for HIV-infected adolescents. The results will contribute to research on whether
      POC VL testing is a feasible testing method which could be incorporated into health systems
      in similar resource-limited settings and whether it can improve outcomes among HIV-infected
      adolescents. The two study arms are described below.

      Standard-of-care (SOC): At the first visit after enrollment and randomization, participants
      in the SOC arm receive a standard laboratory-based VL test. Steps in the standard
      laboratory-based VL testing process include: sample collection at a phlebotomy clinic
      adjacent to the adolescent HIV clinic, labeling and daily storage, transportation (1 hr
      drive) to the central laboratory, arrival and intake at the laboratory, processing in the
      fully automated Abbott system, manual entry of the printed results into an excel spreadsheet
      by laboratory staff, and manual entry of results on the spreadsheet into the EMR by data
      management staff. This process - from sample collection to patient return of results - varies
      depending on the volume of samples collected each day and on laboratory and data management
      staffing. Average time from blood collection to availability of the result in the EMR is 2-3
      weeks. Per standard clinical care at the adolescent HIV clinic, adolescents return for
      monthly visits, and the patient receives the VL result and adherence counseling which is
      informed by the VL result 1 month after providing the blood sample. The primary endpoint is
      return of the VL result within 6 weeks of sample collection to allow for a short time buffer
      for appointments that are not scheduled exactly 1 month from the previous visit for reasons
      related to school, work, family obligations, or holidays.

      These standard laboratory procedures were developed to meet the high demand for VL testing
      when the Haitian national guidelines switched from recommending routine CD4 testing to
      routine VL testing. Since the Abbott systems are fully automated and can batch large
      quantities of samples together, this approach is appropriate for a routine nation-wide health
      system testing protocol. However, the need for transportation, cold-chain storage, and manual
      entry of thousands of results every year may not be the optimal structure for HIV-infected
      adolescents who are more likely to have high VL results and are more likely to be lost from
      care in between visits. This study will test the POC VL test vs. this standard
      laboratory-based test to determine if reducing the time between sample collection and patient
      receipt of results (removing a step in the HIV treatment cascade), can increase the impact of
      VL testing on clinical management and adolescent patient outcomes. The study will test if
      implementation of the POC VL test, in collaboration with clinicians and laboratory staff, and
      accompanied by patient education, can address many of the logistical barriers to
      laboratory-based VL testing in a resource-limited setting such as Haiti.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: The number of steps in the HIV care cascade involved with viral load testing.
time frame: 1 day of clinic visit
description: The number of steps within the HIV care cascade involved with viral load testing will be measured comparing standard laboratory-based testing to POC testing.
measure: The proportion of participants who demonstrate comprehension of the correlation between ART adherence and viral level
time frame: 1 month
description: The proportion of participants who demonstrate comprehension of the correlation between ART adherence and viral level 1 month after receiving their VL test result will be measured.
measure: The proportion of participants who achieve or sustain a viral level <1000 cells/ml
time frame: 6 months
description: The proportion of participants who achieve or sustain a viral level <1000 cells/ml 6 months from the index VL test will be measured.
arm group label: Standard-of-care
arm group type: No Intervention
description: Participants in the standard-of-care arm will receive a standard laboratory-based viral load test at baseline, 3, and 6 months.
arm group label: Point-of-care
arm group type: Experimental
description: Participants in the point-of-care arm will receive a point-of-care viral load test at baseline, 3, and 6 months.
intervention type: Diagnostic Test
intervention name: point-of-care viral load test
description: A point-of-care viral load test returns viral load test results within 90 minutes.
arm group label: Point-of-care
criteria: 
gender: All
minimum age: 10 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Fitzgerald, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
country: Haiti
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Data will be shared once the trial is complete