<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/NCT02969161</url>
  </required_header>
  <id_info>
    <org_study_id>AAAP5700</org_study_id>
    <nct_id>NCT02969161</nct_id>
  </id_info>
  <brief_title>Safe Generations Plus: Swaziland PMTCT LTF Study</brief_title>
  <acronym>SG+</acronym>
  <official_title>Safe Generations Plus: Mother Infant Retention Across the Option B-plus Cascade</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Swaziland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to understand how to improve retention in care and treatment services to HIV&#xD;
      positive pregnant women and their babies in Swaziland. The investigators will evaluate&#xD;
      outcomes of patients who are lost-to-follow-up (LTF) under a new approach for prevention of&#xD;
      mother-to-child (PMTCT) called Option B+, where all HIV positive pregnant women initiate&#xD;
      lifelong antiretroviral therapy (ART) regardless of their disease stage. The goal is to&#xD;
      understand the outcomes of patients who are LTF from care, and the reasons for disengagement&#xD;
      from care in the context of PMTCT in order to inform efforts to improve retention in care&#xD;
      among patients under Option B+.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted among approximately 1,600 women and their infants who received&#xD;
      Option B+ PMTCT services at ten facilities in Swaziland. These facilities were included in&#xD;
      another study on Option B+ called Safe Generations in which routinely collected patient-level&#xD;
      data was abstracted from medical registers. This study has three parts: the first is a review&#xD;
      of alternative patient medical records among women and their infants who were documented as&#xD;
      LTF in the Safe Generations study. The second component consists of tracing women who are LTF&#xD;
      on the phone or in the community to administer a questionnaire. Lastly, an in-depth interview&#xD;
      will be conducted among a sub-group of women to explore patterns of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>Proportion of patients who are retained in care</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Confirmation of retained status among all Option B+ mothers and their infants who are identified as LTF per the Safe Generations study through review of facility-based records - to determine maternal reasons for leaving care.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who have died</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Confirmation patients being retained in care among all Option B+ mothers and their infants who are identified as LTF per the Safe Generations study through review of facility-based records - to capture events such as fetal loss and maternal/infant deaths that are not well documented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who are in care at another facility</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Mothers and/or infants who are LTF will be traced via telephone by facility-based healthcare workers or via questionnaire/interview conducted in the community - to determine if they have transferred care to another facility (via a self-transfer of care) and therefore remain engaged in care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who have disengaged from care entirely</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Confirmation of LTF status among all Option B+ mothers and their infants who are identified as LTF per the Safe Generations study through review of facility-based records - to capture events such as fetal loss and maternal/infant deaths that are not well documented.</description>
  </secondary_outcome>
  <enrollment type="Actual">616</enrollment>
  <condition>HIV (Human Immunodeficiency Virus)</condition>
  <eligibility>
    <study_pop>
      <textblock>
        HIV-infected pregnant mothers enrolled in PMTCT care under Option B+ as part of the Safe&#xD;
        Generations study between September 16, 2013 and August 31, 2014&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mothers and their infants who were enrolled in PMTCT at Safe Generations study sites&#xD;
             after the sites transitioned to Option B+.&#xD;
&#xD;
          -  Determined to be LTF per the Safe Generations study protocol (i.e., have not attended&#xD;
             a clinic visit in the 90 days prior to their 6-month postpartum appointment and are&#xD;
             not known to be dead or transferred out, according to clinical visit data abstracted&#xD;
             to the Safe Generations study database).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mothers that are not a PMTCT client.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Reidy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ICAP at Columbia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elaine Abrams, PhD</last_name>
    <role>Study Director</role>
    <affiliation>ICAP at Columbia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Averie Gachuhi, MSc</last_name>
    <role>Study Director</role>
    <affiliation>ICAP at Columbia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Harriet Nuwagaba-Biribonwoha, MBChB, PhD</last_name>
    <role>Study Director</role>
    <affiliation>ICAP at Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Family Life Association Swaziland (FLAS) Manzini</name>
      <address>
        <city>Swaziland</city>
        <country>Swaziland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Sobhuza II Hospital</name>
      <address>
        <city>Swaziland</city>
        <country>Swaziland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Luyengo Clinic</name>
      <address>
        <city>Swaziland</city>
        <country>Swaziland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mankayane PHU</name>
      <address>
        <city>Swaziland</city>
        <country>Swaziland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mbikwakhe Clinic</name>
      <address>
        <city>Swaziland</city>
        <country>Swaziland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Médecins sans Frontières (MSF) Matsapha</name>
      <address>
        <city>Swaziland</city>
        <country>Swaziland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raleigh Fitkin Memorial Hospital</name>
      <address>
        <city>Swaziland</city>
        <country>Swaziland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siphofaneni Clinc</name>
      <address>
        <city>Swaziland</city>
        <country>Swaziland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siteki PHU</name>
      <address>
        <city>Swaziland</city>
        <country>Swaziland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lamvelase</name>
      <address>
        <city>Zombodze</city>
        <country>Swaziland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Swaziland</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>January 23, 2018</last_update_submitted>
  <last_update_submitted_qc>January 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>William Reidy</investigator_full_name>
    <investigator_title>Associate Research Scientist, ICAP</investigator_title>
  </responsible_party>
  <keyword>PMTCT (Prevention of Mother-to-Child Transmission)</keyword>
  <keyword>HIV (Human Immunodeficiency Virus)</keyword>
  <keyword>Loss to follow-up (LTF)</keyword>
  <keyword>Option B+ (B+)</keyword>
  <keyword>ART (antiretroviral therapy)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
  </condition_browse>
  <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/NCT02969161
org study id: AAAP5700
nct id: NCT02969161
lead sponsor: 
collaborator: 
has dmc: No
This study is to understand how to improve retention in care and treatment services to HIV
      positive pregnant women and their babies in Swaziland. The investigators will evaluate
      outcomes of patients who are lost-to-follow-up (LTF) under a new approach for prevention of
      mother-to-child (PMTCT) called Option B+, where all HIV positive pregnant women initiate
      lifelong antiretroviral therapy (ART) regardless of their disease stage. The goal is to
      understand the outcomes of patients who are LTF from care, and the reasons for disengagement
      from care in the context of PMTCT in order to inform efforts to improve retention in care
      among patients under Option B+.
The study will be conducted among approximately 1,600 women and their infants who received
      Option B+ PMTCT services at ten facilities in Swaziland. These facilities were included in
      another study on Option B+ called Safe Generations in which routinely collected patient-level
      data was abstracted from medical registers. This study has three parts: the first is a review
      of alternative patient medical records among women and their infants who were documented as
      LTF in the Safe Generations study. The second component consists of tracing women who are LTF
      on the phone or in the community to administer a questionnaire. Lastly, an in-depth interview
      will be conducted among a sub-group of women to explore patterns of care.
observational model: Cohort
time perspective: Retrospective
measure: Proportion of patients who are retained in care
time frame: Up to 24 months
description: Confirmation of retained status among all Option B+ mothers and their infants who are identified as LTF per the Safe Generations study through review of facility-based records - to determine maternal reasons for leaving care.
measure: Proportion of patients who have died
time frame: Up to 24 months
description: Confirmation patients being retained in care among all Option B+ mothers and their infants who are identified as LTF per the Safe Generations study through review of facility-based records - to capture events such as fetal loss and maternal/infant deaths that are not well documented.
measure: Proportion of patients who are in care at another facility
time frame: Up to 24 months
description: Mothers and/or infants who are LTF will be traced via telephone by facility-based healthcare workers or via questionnaire/interview conducted in the community - to determine if they have transferred care to another facility (via a self-transfer of care) and therefore remain engaged in care.
measure: Proportion of patients who have disengaged from care entirely
time frame: Up to 24 months
description: Confirmation of LTF status among all Option B+ mothers and their infants who are identified as LTF per the Safe Generations study through review of facility-based records - to capture events such as fetal loss and maternal/infant deaths that are not well documented.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 50 Years
healthy volunteers: No
last name: William Reidy, PhD
role: Principal Investigator
affiliation: ICAP at Columbia University
last name: Elaine Abrams, PhD
role: Study Director
affiliation: ICAP at Columbia University
last name: Averie Gachuhi, MSc
role: Study Director
affiliation: ICAP at Columbia University
last name: Harriet Nuwagaba-Biribonwoha, MBChB, PhD
role: Study Director
affiliation: ICAP at Columbia University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Swaziland
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: William Reidy
investigator title: Associate Research Scientist, ICAP
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Immunologic Deficiency Syndromes
sharing ipd: No