<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/NCT04470011</url>
  </required_header>
  <id_info>
    <org_study_id>H-40488</org_study_id>
    <secondary_id>OPP1136158</secondary_id>
    <nct_id>NCT04470011</nct_id>
  </id_info>
  <brief_title>Survey of Procedures and Resources for Initiating Treatment of HIV in Africa-Zambia</brief_title>
  <acronym>SPRINT-Zambia</acronym>
  <official_title>Survey of Procedures and Resources for Initiating Treatment of HIV in Africa: The SPRINT Study in Zambia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Witwatersrand, South Africa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Clinton Health Access Initiative Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston 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>
      In its 2017 revision of the global guidelines for HIV care and treatment, the World Health&#xD;
      Organization (WHO) called for rapid or same-day initiation of antiretroviral treatment (ART)&#xD;
      for eligible patients testing positive for HIV. However, to date neither the WHO nor the&#xD;
      Zambia Ministry of Health has provided detailed guidance on how to implement this&#xD;
      recommendation.&#xD;
&#xD;
      In sub-Saharan Africa, where most HIV patients are located, studies continue to document high&#xD;
      losses of treatment-eligible patients from care before they receive their first dose of&#xD;
      antiretroviral medications (ARVs). Among facility-level reasons for these losses are&#xD;
      treatment initiation protocols that require multiple clinic visits and long waiting times&#xD;
      before a patient who tests positive for HIV is dispensed an initial supply of medications.&#xD;
      There is very little published evidence on the practical details of the process and the&#xD;
      extent to which it varies by facility, setting, or country. Without a robust baseline&#xD;
      evidence base, it is challenging to identify opportunities for making improvements. The&#xD;
      SPRINT (Survey of Procedures and Resources for Initiating Treatment of HIV in Africa) study&#xD;
      will begin to develop this evidence base. SPRINT will combine a facility-level description of&#xD;
      the standard of care with a retrospective record review of patients who recently initiated&#xD;
      ART at the study sites. Data will be collected from 12 health facilities in Zambia. The&#xD;
      survey will elicit detailed information about current procedures through structured&#xD;
      interviews with clinic staff at the selected health facilities. The record review for a&#xD;
      retrospective cohort of patients eligible for ART will estimate actual numbers of clinic&#xD;
      visits, services provided, and duration of the steps for treatment initiation from start to&#xD;
      finish. SPRINT is expected to identify differences in approaches to treatment initiation and&#xD;
      potential opportunities for improvement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Average numbers of visits required to start ART</measure>
    <time_frame>Up to 6 months after treatment eligibility determined</time_frame>
    <description>Number of health system interactions required between HIV diagnosis and first dispensing of ARVs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to ART initiation</measure>
    <time_frame>Up to 6 months after treatment eligibility determined</time_frame>
    <description>Average number of days required between HIV diagnosis and first dispensing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who initiate by specified time intervals</measure>
    <time_frame>Up to 6 months after treatment eligibility determined</time_frame>
    <description>Proportion of patients who initiate ART within 0, 7, 14, and 28 days and 3 and 6 months of determination of treatment eligibility</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Procedures for ART initiation</measure>
    <time_frame>Up to 6 months after treatment eligibility determined</time_frame>
    <description>Detailed descriptive information addressing such topics as patient flow, number of required clinic visits, intervals between visits, services provided, staffing cadres involved, and record keeping systems</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2189</enrollment>
  <condition>HIV</condition>
  <condition>Antiretroviral Therapy</condition>
  <arm_group>
    <arm_group_label>Patients who initiated HIV treatment</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Service providers at study facilities</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Routine medical record data collection</intervention_name>
    <description>The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.</description>
    <arm_group_label>Patients who initiated HIV treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interviews with service providers</intervention_name>
    <description>Clinicians and lay staff will be interviewed regarding the ART initiation process.</description>
    <arm_group_label>Service providers at study facilities</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who became eligible for ART at a study facility between 1 July 2018 and 30 June&#xD;
        2019.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years old&#xD;
&#xD;
          -  HIV-positive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Sydney B Rosen, MPA</last_name>
    <role>Principal Investigator</role>
    <affiliation>BU School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health Economics and Epidemiology Research Office</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2193</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinton Health Access Initiative</name>
      <address>
        <city>Lusaka</city>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
    <country>Zambia</country>
  </location_countries>
  <reference>
    <citation>Huber A, Hirasen K, Brennan AT, Phiri B, Tcherini T, Mulenga L, Haimbe P, Shakwelele H, Nyirenda R, Wilson Matola B, Gunda A, Rosen S. Uptake of same-day initiation of HIV treatment in Malawi, South Africa, and Zambia as reported in routinely collected data: the SPRINT retrospective cohort study. Gates Open Res. 2023 May 2;7:42. doi: 10.12688/gatesopenres.14424.2. eCollection 2023.</citation>
    <PMID>37153118</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>February 14, 2023</last_update_submitted>
  <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04470011
org study id: H-40488
secondary id: OPP1136158
nct id: NCT04470011
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In its 2017 revision of the global guidelines for HIV care and treatment, the World Health
      Organization (WHO) called for rapid or same-day initiation of antiretroviral treatment (ART)
      for eligible patients testing positive for HIV. However, to date neither the WHO nor the
      Zambia Ministry of Health has provided detailed guidance on how to implement this
      recommendation.

      In sub-Saharan Africa, where most HIV patients are located, studies continue to document high
      losses of treatment-eligible patients from care before they receive their first dose of
      antiretroviral medications (ARVs). Among facility-level reasons for these losses are
      treatment initiation protocols that require multiple clinic visits and long waiting times
      before a patient who tests positive for HIV is dispensed an initial supply of medications.
      There is very little published evidence on the practical details of the process and the
      extent to which it varies by facility, setting, or country. Without a robust baseline
      evidence base, it is challenging to identify opportunities for making improvements. The
      SPRINT (Survey of Procedures and Resources for Initiating Treatment of HIV in Africa) study
      will begin to develop this evidence base. SPRINT will combine a facility-level description of
      the standard of care with a retrospective record review of patients who recently initiated
      ART at the study sites. Data will be collected from 12 health facilities in Zambia. The
      survey will elicit detailed information about current procedures through structured
      interviews with clinic staff at the selected health facilities. The record review for a
      retrospective cohort of patients eligible for ART will estimate actual numbers of clinic
      visits, services provided, and duration of the steps for treatment initiation from start to
      finish. SPRINT is expected to identify differences in approaches to treatment initiation and
      potential opportunities for improvement.
observational model: Cohort
time perspective: Retrospective
measure: Average numbers of visits required to start ART
time frame: Up to 6 months after treatment eligibility determined
description: Number of health system interactions required between HIV diagnosis and first dispensing of ARVs
measure: Time to ART initiation
time frame: Up to 6 months after treatment eligibility determined
description: Average number of days required between HIV diagnosis and first dispensing
measure: Proportion of patients who initiate by specified time intervals
time frame: Up to 6 months after treatment eligibility determined
description: Proportion of patients who initiate ART within 0, 7, 14, and 28 days and 3 and 6 months of determination of treatment eligibility
measure: Procedures for ART initiation
time frame: Up to 6 months after treatment eligibility determined
description: Detailed descriptive information addressing such topics as patient flow, number of required clinic visits, intervals between visits, services provided, staffing cadres involved, and record keeping systems
arm group label: Patients who initiated HIV treatment
arm group label: Service providers at study facilities
intervention type: Other
intervention name: Routine medical record data collection
description: The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
arm group label: Patients who initiated HIV treatment
intervention type: Other
intervention name: Interviews with service providers
description: Clinicians and lay staff will be interviewed regarding the ART initiation process.
arm group label: Service providers at study facilities
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Sydney B Rosen, MPA
role: Principal Investigator
affiliation: BU School of Public Health
facility: 
facility: 
country: South Africa
country: Zambia
citation: Huber A, Hirasen K, Brennan AT, Phiri B, Tcherini T, Mulenga L, Haimbe P, Shakwelele H, Nyirenda R, Wilson Matola B, Gunda A, Rosen S. Uptake of same-day initiation of HIV treatment in Malawi, South Africa, and Zambia as reported in routinely collected data: the SPRINT retrospective cohort study. Gates Open Res. 2023 May 2;7:42. doi: 10.12688/gatesopenres.14424.2. eCollection 2023.
PMID: 37153118
responsible party type: Sponsor
sharing ipd: No