<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/NCT03018002</url>
  </required_header>
  <id_info>
    <org_study_id>845695-4</org_study_id>
    <secondary_id>R01HD087994-01</secondary_id>
    <nct_id>NCT03018002</nct_id>
  </id_info>
  <brief_title>Intervention for Sustained Testing and Retention Among HIV-infected Patients</brief_title>
  <acronym>iSTAR</acronym>
  <official_title>Intervention for Sustained Testing and Retention Among HIV-infected Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nevada, Las Vegas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nevada, Las Vegas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the comparative effectiveness of a congregation,&#xD;
      clinic and integrated case management-based intervention for sustainable testing and&#xD;
      retention on linkage to care, engagement, retention and viral load suppression of women and&#xD;
      children infected with HIV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using a two-arm cluster randomized design, our proposed study will evaluate the comparative&#xD;
      effectiveness of iSTAR, a community-based social network intervention that combines trained&#xD;
      church-based Health Advisors and clinic-based staff and uses motivational interview skills&#xD;
      and clinic- quality improvement approaches (Intervention Group; IG) versus a clinic-based&#xD;
      approach (Control group; CG) on linkage, engagement, retention and viral suppression among&#xD;
      HIV-infected women and children. Eighteen health facilities in identified local government&#xD;
      areas in Benue state, north-central Nigeria will be randomly assigned to either the IG (N=9&#xD;
      health facilities) or the CG (N=9 health facilities). A total of 10,000 pregnant women will&#xD;
      be screened and 400 HIV-infected participants will be enrolled over a 24-month period. The&#xD;
      primary outcome will be the difference in the rate of linkage and engagement between the&#xD;
      groups. The secondary outcome will be the difference in rate of retention and viral&#xD;
      suppression among participants. Additionally, we will conduct network, mediation/moderation&#xD;
      analysis to examine the roles of intermediate variables such as health team cohesion,&#xD;
      turnovers, attitudes, leadership and dynamic adaptation on iSTAR implementation and&#xD;
      sustainment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">March 2020</completion_date>
  <primary_completion_date type="Anticipated">March 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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Linkage in care</measure>
    <time_frame>1 month</time_frame>
    <description>Linkage in care is defined as the percentage of participants with at least one HIV medical care visit following HIV diagnosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention in care</measure>
    <time_frame>12 months</time_frame>
    <description>Retention is defined as the percentages of participants with two or more documented viral load measurement during the 12 months following enrollment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ART Initiation</measure>
    <time_frame>1 month</time_frame>
    <description>The secondary outcome is engagement in care defined as the percentage of participants initiated on ART at 1 month following enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral Suppression</measure>
    <time_frame>12 months</time_frame>
    <description>Viral suppression is defined as the percentage of participants whose most recent two viral load are &lt;20 copies/mL.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>HIV-infected participants identified from the churches randomized to CG will be referred to PEPFAR-supported HIV clinics that provide comprehensive care including counseling, laboratory testing, ART and ongoing support during treatment as the standard of care. The study team will not be involved in their care beyond data collection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>iSTAR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HIV-infected participants identified from the churches clustered within the randomized health facilities will receive interventions from the study team.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>iSTAR</intervention_name>
    <description>Each component of the iSTAR intervention targets a specific point along the HIV continuum: confidential, onsite integrated laboratory tests during baby showers targets HIV diagnosis (b) church-based Health Advisors (CHAs) trained in motivational interviewing and quality improvement skills as promotoras target linkage, engagement and adherence by providing counseling and other support to HIV-infected women and children (c) integrated network of community and clinic case management targets reduction in loss to follow-up.&#xD;
CHAs will support participants during the study period by being available to accompany them to clinic visits, review laboratory results and medications after clinic visits. They will be available to speak with them at intervals to see how they are doing either by phone or through home visits as they prefer. At each follow-up study visit, the trained CHA will review and collect data on participants' clinic visits, treatment, and laboratory results.</description>
    <arm_group_label>iSTAR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-infected pregnant women identified during baby showers programs at participating&#xD;
             worship centers.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HIV-infected women already on treatment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Echezona Ezeanolue, MD, MPH</last_name>
    <phone>7028952687</phone>
    <email>echezona.ezeanolue@unlv.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chima Onoka, MD, PhD</last_name>
    <phone>+2348033802711</phone>
    <email>chima.onoka@unn.edu.ng</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Catholic Caritas Foundation</name>
      <address>
        <city>Makurdi</city>
        <state>Benue</state>
        <country>Nigeria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Olawepo, MD, MSc</last_name>
      <phone>+234-805 564 8788</phone>
      <email>jolawepo@ccfng.org</email>
    </contact>
    <investigator>
      <last_name>Echezona Ezeanolue, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chima Onoka, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Nigeria</country>
  </location_countries>
  <reference>
    <citation>Ezeanolue EE, Obiefune MC, Yang W, Obaro SK, Ezeanolue CO, Ogedegbe GG. Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial. Implement Sci. 2013 Jun 8;8:62. doi: 10.1186/1748-5908-8-62.</citation>
    <PMID>23758933</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nevada, Las Vegas</investigator_affiliation>
    <investigator_full_name>Echezona Ezeanolue</investigator_full_name>
    <investigator_title>Professor of Public Health and Pediatrics</investigator_title>
  </responsible_party>
  <keyword>HIV, PMTCT</keyword>
  <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/NCT03018002
org study id: 845695-4
secondary id: R01HD087994-01
nct id: NCT03018002
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the comparative effectiveness of a congregation,
      clinic and integrated case management-based intervention for sustainable testing and
      retention on linkage to care, engagement, retention and viral load suppression of women and
      children infected with HIV.
Using a two-arm cluster randomized design, our proposed study will evaluate the comparative
      effectiveness of iSTAR, a community-based social network intervention that combines trained
      church-based Health Advisors and clinic-based staff and uses motivational interview skills
      and clinic- quality improvement approaches (Intervention Group; IG) versus a clinic-based
      approach (Control group; CG) on linkage, engagement, retention and viral suppression among
      HIV-infected women and children. Eighteen health facilities in identified local government
      areas in Benue state, north-central Nigeria will be randomly assigned to either the IG (N=9
      health facilities) or the CG (N=9 health facilities). A total of 10,000 pregnant women will
      be screened and 400 HIV-infected participants will be enrolled over a 24-month period. The
      primary outcome will be the difference in the rate of linkage and engagement between the
      groups. The secondary outcome will be the difference in rate of retention and viral
      suppression among participants. Additionally, we will conduct network, mediation/moderation
      analysis to examine the roles of intermediate variables such as health team cohesion,
      turnovers, attitudes, leadership and dynamic adaptation on iSTAR implementation and
      sustainment.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Linkage in care
time frame: 1 month
description: Linkage in care is defined as the percentage of participants with at least one HIV medical care visit following HIV diagnosis.
measure: Retention in care
time frame: 12 months
description: Retention is defined as the percentages of participants with two or more documented viral load measurement during the 12 months following enrollment.
measure: ART Initiation
time frame: 1 month
description: The secondary outcome is engagement in care defined as the percentage of participants initiated on ART at 1 month following enrollment.
measure: Viral Suppression
time frame: 12 months
description: Viral suppression is defined as the percentage of participants whose most recent two viral load are <20 copies/mL.
arm group label: Control group
arm group type: No Intervention
description: HIV-infected participants identified from the churches randomized to CG will be referred to PEPFAR-supported HIV clinics that provide comprehensive care including counseling, laboratory testing, ART and ongoing support during treatment as the standard of care. The study team will not be involved in their care beyond data collection.
arm group label: iSTAR
arm group type: Experimental
description: HIV-infected participants identified from the churches clustered within the randomized health facilities will receive interventions from the study team.
intervention type: Other
intervention name: iSTAR
description: Each component of the iSTAR intervention targets a specific point along the HIV continuum: confidential, onsite integrated laboratory tests during baby showers targets HIV diagnosis (b) church-based Health Advisors (CHAs) trained in motivational interviewing and quality improvement skills as promotoras target linkage, engagement and adherence by providing counseling and other support to HIV-infected women and children (c) integrated network of community and clinic case management targets reduction in loss to follow-up.
CHAs will support participants during the study period by being available to accompany them to clinic visits, review laboratory results and medications after clinic visits. They will be available to speak with them at intervals to see how they are doing either by phone or through home visits as they prefer. At each follow-up study visit, the trained CHA will review and collect data on participants' clinic visits, treatment, and laboratory results.
arm group label: iSTAR
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Echezona Ezeanolue, MD, MPH
phone: 7028952687
email: echezona.ezeanolue@unlv.edu
last name: Chima Onoka, MD, PhD
phone: +2348033802711
email: chima.onoka@unn.edu.ng
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Nigeria
citation: Ezeanolue EE, Obiefune MC, Yang W, Obaro SK, Ezeanolue CO, Ogedegbe GG. Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial. Implement Sci. 2013 Jun 8;8:62. doi: 10.1186/1748-5908-8-62.
PMID: 23758933
responsible party type: Principal Investigator
investigator affiliation: University of Nevada, Las Vegas
investigator full name: Echezona Ezeanolue
investigator title: Professor of Public Health and Pediatrics
sharing ipd: No