<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/NCT04494516</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00237243</org_study_id>
    <nct_id>NCT04494516</nct_id>
  </id_info>
  <brief_title>Qualitative Understanding of Community TB Services Pre and Post the CHIP-TB Trial</brief_title>
  <official_title>A Qualitative Study to Optimize a Community-Based Pediatric TB/HIV Prevention Intervention and Implementation Strategy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UNITAID</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aurum Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>KNCV Tuberculosis Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins 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 qualitative study is designed to elicit the perspectives of relevant stakeholders to&#xD;
      adapt a community-based TB/HIV intervention aimed on providing home-based TB prevention&#xD;
      treatment (TPT) initiation for child TB contacts, to design its implementation strategy and,&#xD;
      post intervention, to assess lessons learned for future scale up. Participants will include&#xD;
      policy makers and health system managers, nurse and physician providers, community health&#xD;
      team members, and child caregivers of TB-exposed children. Stakeholders will be asked to&#xD;
      participate in two interviews, one prior to the cluster randomized trial assessing this&#xD;
      intervention and one after the cluster randomized trial. Trained interviewers will conduct&#xD;
      1-hour semi-structured in-depth interviews that will be audio-recorded, translated and&#xD;
      transcribed for thematic analysis using a priori and emergent domains of interest.&#xD;
      Free-listing, ranking exercises and cultural consensus will be used to identify&#xD;
      context-specific intervention adaptations and implementation strategies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tuberculosis (TB) remains a top 10 cause of child mortality in sub-Saharan Africa.&#xD;
      Short-course combination TB preventive therapy (TPT) regimens are highly effective with high&#xD;
      completion rates and therefore hold promise to reduce the 1 million pediatric TB patients and&#xD;
      233,000 child TB deaths annually. TPT effectiveness requires improvement in access to&#xD;
      pediatric TB preventive care. The World Health Organization (WHO) estimates only 23% of the&#xD;
      1.3 million TB-exposed children under 5 years old initiated TPT in 2017. The investigators'&#xD;
      previous data suggest 50-75% of TB-exposed children under 5 years old fail to be either&#xD;
      identified or linked to TB preventive care. Children under 5 years are at exceptionally high&#xD;
      risk of TB disease due to not only immature immune systems, but also HIV infection and HIV&#xD;
      exposure. Guidelines have long recommended TPT for children under 5 years, but have recently&#xD;
      been expanded to children under 15 years. Developing and testing innovative health care&#xD;
      delivery models to accompany new WHO-endorsed short-course combination TPT regimens is&#xD;
      essential to reduce TB-associated global child morbidity and mortality.&#xD;
&#xD;
      Integrated community case management (iCCM) is a cost-effective intervention that increases&#xD;
      child survival by bringing curative therapies to at risk children in the community. Recently,&#xD;
      algorithms for screening pediatric patients with household exposure to TB have been&#xD;
      simplified to include symptom screening only, eliminating costly laboratory and radiographic&#xD;
      evaluations that are barriers to treatment and do not improve sensitivity and specificity of&#xD;
      the assessment. The CHIP-TB Trial plans to assess whether integrated community-based&#xD;
      pediatric TB/HIV prevention services is feasible, acceptable and effective in increasing TPT&#xD;
      uptake among child TB contacts under 15 years in a cluster-randomized trial in South Africa&#xD;
      and Ethiopia, two high-burden, resource-limited settings.&#xD;
&#xD;
      Nested within this larger trial, the investigators will use qualitative research to (1)&#xD;
      describe the social context in which the community health teams perform the team's duties,&#xD;
      (2) make context-specific adaptations to the intervention to maximize its effectiveness, (3)&#xD;
      define a context-specific implementation strategy and evaluation plan, and (4) learn&#xD;
      important lessons for the future scale up and dissemination of the community-based&#xD;
      intervention.&#xD;
&#xD;
      The investigators will conduct 10-15 paired semi-structured individual in-depth interviews&#xD;
      (IDI) for each of the four key stakeholder groups: (1) caregivers of TB-exposed children, (2)&#xD;
      community health team members, (3) clinic-based nurse and clinic or hospital-based physician&#xD;
      providers, and (4) health system managers and policy makers, for a total of ~120 IDIs (~60 in&#xD;
      South Africa and ~60 in Ethiopia) both pre and post trial. Before the intervention the&#xD;
      investigators will conduct a one-hour interview that will explore the inner setting of the&#xD;
      community health team's environment from each stakeholder perspective and will develop and&#xD;
      decide upon key intervention adaptations and implementation strategies for the&#xD;
      community-based TB/HIV prevention program that will be assessed with a one-year&#xD;
      cluster-randomized trial. Upon trial completion, the investigators will conduct another 10-15&#xD;
      semi-structured IDIs with each stakeholder group in each country (total ~120 IDIs) to&#xD;
      identify key facilitators and barriers to the implementation. Thematic content analysis with&#xD;
      an inductive approach will be used to analyze transcripts for both a priori and emergent&#xD;
      domains of interest. A coding scheme will be adapted from Consolidated Framework for&#xD;
      Implementation Research (CFIR) constructs. Free listing, ranking, and cultural consensus will&#xD;
      be used to identify intervention adaptations and implementation strategies that are context&#xD;
      specific. The investigators will use Smith's Saliency Index to analyze the free listed data,&#xD;
      mean rank order to assess ranking exercises, and the Eigenvalue to evaluate consensus across&#xD;
      groups all using the ANTHROPAC ® 4.0 software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2021</start_date>
  <completion_date type="Actual">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">June 30, 2023</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Perception of intervention adaptations as assessed by an in-depth interview</measure>
    <time_frame>Within six months prior to CHIP-TB trial initiation</time_frame>
    <description>In-depth, semi-structured interviews will explore perceptions of context-specific adaptations to the community-based TB prevention intervention needed for success.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perception of implementation strategies as assessed by an in-depth interview</measure>
    <time_frame>Within six months prior to CHIP-TB trial initiation</time_frame>
    <description>In-depth, semi-structured interviews will explore perceptions of context-specific implementation strategies for the community-based TB prevention intervention needed for success.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perception of the social context of the community-based health teams as assessed by an in-depth interview</measure>
    <time_frame>Within six months prior to CHIP-TB trial initiation</time_frame>
    <description>In-depth, semi-structured interviews will explore the social context and inner setting of the community health teams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perception of the lessons learned as assessed by an in-depth interview</measure>
    <time_frame>Within four months after CHIP-TB Trial completion</time_frame>
    <description>In-depth, semi-structured interviews will explore lessons learned for the future scale up and dissemination of the community-based TB prevention intervention.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">183</enrollment>
  <condition>Tuberculosis Infection</condition>
  <condition>Tuberculosis Prevention</condition>
  <arm_group>
    <arm_group_label>Pre-trial</arm_group_label>
    <description>This cohort of participants will be recruited preceding evaluation of the community-based pediatric TB prevention intervention (CHIP-TB; NCT04369326) to assist with design of the intervention and implementation strategy. Participants will include four stakeholder groups including: (1) policy makers, program managers, (2) nurse and physician clinicians, (3) community health team members, and (4) caregivers of child contacts from both South African and Ethiopian sites.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-trial</arm_group_label>
    <description>This cohort of participants will be recruited after evaluation of the community-based pediatric TB prevention intervention (CHIP-TB; NCT04369326) to assist with future scale up and dissemination of the intervention. Participants will include four stakeholder groups including: (1) policy makers, program managers, (2) nurse and physician clinicians, (3) community health team members, and (4) caregivers of child contacts from both South African and Ethiopian sites.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include key stakeholders from the target communities in South&#xD;
        Africa (Ekurhuleni, Gauteng Province) and Ethiopia (East Shewa Zone of the Oromia regional&#xD;
        state), including caregivers of TB-exposed children, community health teams including&#xD;
        nurses and community health workers, clinic-based nurse and clinic/hospital-based physician&#xD;
        providers, program managers and policy makers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for Interview 1:&#xD;
&#xD;
          -  Adult caregiver (18 years of age or older) of a child (&lt;15 years of age) who was&#xD;
             exposed to TB in the last two years where at least one child was evaluated for and&#xD;
             offered either TB preventive therapy or TB treatment.&#xD;
&#xD;
        or&#xD;
&#xD;
          -  Community health team members from one of the Ethiopian or South African clinics in&#xD;
             which the CHIP-TB trial will be conducted.&#xD;
&#xD;
        or&#xD;
&#xD;
          -  TB nurse from one of the 16 Ethiopian or South African clinics in which the study will&#xD;
             be conducted&#xD;
&#xD;
        or&#xD;
&#xD;
          -  Pediatrician or medical officer working in pediatrics at the relevant Ethiopian or&#xD;
             South African District Hospital who sees outpatient pediatric consultations including&#xD;
             TB-exposed children&#xD;
&#xD;
        or&#xD;
&#xD;
          -  Program manager or policy maker in the relevant Ethiopian or South African district or&#xD;
             provincial office who manages TB, PMTCT, and/or other pediatric programming&#xD;
&#xD;
        Exclusion Criteria for Interview 1:&#xD;
&#xD;
          -  Any adult caregivers, community health team members, TB nurses, medical officers or&#xD;
             pediatricians, program managers or policy makers who are unable or unwilling to&#xD;
             provide informed consent for both the interview and audio-recording&#xD;
&#xD;
        Inclusion Criteria for Interview 2:&#xD;
&#xD;
          -  Any community health team members, TB nurses, medical officers or pediatricians,&#xD;
             program managers or policy makers who participated in the program for at least 3&#xD;
             months&#xD;
&#xD;
          -  Any adult caregiver whose child participated in the community-based TB prevention&#xD;
             program&#xD;
&#xD;
        Exclusion Criteria for Interview 2:&#xD;
&#xD;
          -  Any adult caregivers, community health team members, TB nurses, medical officers or&#xD;
             pediatricians, program managers or policy makers who are unable or unwilling to&#xD;
             provide informed consent for both the interview and audio-recording&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicole Salazar-Austin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KNCV Tuberculosis Foundation</name>
      <address>
        <city>Addis Ababa</city>
        <country>Ethiopia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Aurum Institute</name>
      <address>
        <city>Johannesburg</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ethiopia</country>
    <country>South Africa</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 10, 2023</last_update_submitted>
  <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Latent Tuberculosis</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/NCT04494516
org study id: IRB00237243
nct id: NCT04494516
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This qualitative study is designed to elicit the perspectives of relevant stakeholders to
      adapt a community-based TB/HIV intervention aimed on providing home-based TB prevention
      treatment (TPT) initiation for child TB contacts, to design its implementation strategy and,
      post intervention, to assess lessons learned for future scale up. Participants will include
      policy makers and health system managers, nurse and physician providers, community health
      team members, and child caregivers of TB-exposed children. Stakeholders will be asked to
      participate in two interviews, one prior to the cluster randomized trial assessing this
      intervention and one after the cluster randomized trial. Trained interviewers will conduct
      1-hour semi-structured in-depth interviews that will be audio-recorded, translated and
      transcribed for thematic analysis using a priori and emergent domains of interest.
      Free-listing, ranking exercises and cultural consensus will be used to identify
      context-specific intervention adaptations and implementation strategies.
Tuberculosis (TB) remains a top 10 cause of child mortality in sub-Saharan Africa.
      Short-course combination TB preventive therapy (TPT) regimens are highly effective with high
      completion rates and therefore hold promise to reduce the 1 million pediatric TB patients and
      233,000 child TB deaths annually. TPT effectiveness requires improvement in access to
      pediatric TB preventive care. The World Health Organization (WHO) estimates only 23% of the
      1.3 million TB-exposed children under 5 years old initiated TPT in 2017. The investigators'
      previous data suggest 50-75% of TB-exposed children under 5 years old fail to be either
      identified or linked to TB preventive care. Children under 5 years are at exceptionally high
      risk of TB disease due to not only immature immune systems, but also HIV infection and HIV
      exposure. Guidelines have long recommended TPT for children under 5 years, but have recently
      been expanded to children under 15 years. Developing and testing innovative health care
      delivery models to accompany new WHO-endorsed short-course combination TPT regimens is
      essential to reduce TB-associated global child morbidity and mortality.

      Integrated community case management (iCCM) is a cost-effective intervention that increases
      child survival by bringing curative therapies to at risk children in the community. Recently,
      algorithms for screening pediatric patients with household exposure to TB have been
      simplified to include symptom screening only, eliminating costly laboratory and radiographic
      evaluations that are barriers to treatment and do not improve sensitivity and specificity of
      the assessment. The CHIP-TB Trial plans to assess whether integrated community-based
      pediatric TB/HIV prevention services is feasible, acceptable and effective in increasing TPT
      uptake among child TB contacts under 15 years in a cluster-randomized trial in South Africa
      and Ethiopia, two high-burden, resource-limited settings.

      Nested within this larger trial, the investigators will use qualitative research to (1)
      describe the social context in which the community health teams perform the team's duties,
      (2) make context-specific adaptations to the intervention to maximize its effectiveness, (3)
      define a context-specific implementation strategy and evaluation plan, and (4) learn
      important lessons for the future scale up and dissemination of the community-based
      intervention.

      The investigators will conduct 10-15 paired semi-structured individual in-depth interviews
      (IDI) for each of the four key stakeholder groups: (1) caregivers of TB-exposed children, (2)
      community health team members, (3) clinic-based nurse and clinic or hospital-based physician
      providers, and (4) health system managers and policy makers, for a total of ~120 IDIs (~60 in
      South Africa and ~60 in Ethiopia) both pre and post trial. Before the intervention the
      investigators will conduct a one-hour interview that will explore the inner setting of the
      community health team's environment from each stakeholder perspective and will develop and
      decide upon key intervention adaptations and implementation strategies for the
      community-based TB/HIV prevention program that will be assessed with a one-year
      cluster-randomized trial. Upon trial completion, the investigators will conduct another 10-15
      semi-structured IDIs with each stakeholder group in each country (total ~120 IDIs) to
      identify key facilitators and barriers to the implementation. Thematic content analysis with
      an inductive approach will be used to analyze transcripts for both a priori and emergent
      domains of interest. A coding scheme will be adapted from Consolidated Framework for
      Implementation Research (CFIR) constructs. Free listing, ranking, and cultural consensus will
      be used to identify intervention adaptations and implementation strategies that are context
      specific. The investigators will use Smith's Saliency Index to analyze the free listed data,
      mean rank order to assess ranking exercises, and the Eigenvalue to evaluate consensus across
      groups all using the ANTHROPAC ® 4.0 software.
observational model: Cohort
time perspective: Prospective
measure: Perception of intervention adaptations as assessed by an in-depth interview
time frame: Within six months prior to CHIP-TB trial initiation
description: In-depth, semi-structured interviews will explore perceptions of context-specific adaptations to the community-based TB prevention intervention needed for success.
measure: Perception of implementation strategies as assessed by an in-depth interview
time frame: Within six months prior to CHIP-TB trial initiation
description: In-depth, semi-structured interviews will explore perceptions of context-specific implementation strategies for the community-based TB prevention intervention needed for success.
measure: Perception of the social context of the community-based health teams as assessed by an in-depth interview
time frame: Within six months prior to CHIP-TB trial initiation
description: In-depth, semi-structured interviews will explore the social context and inner setting of the community health teams.
measure: Perception of the lessons learned as assessed by an in-depth interview
time frame: Within four months after CHIP-TB Trial completion
description: In-depth, semi-structured interviews will explore lessons learned for the future scale up and dissemination of the community-based TB prevention intervention.
arm group label: Pre-trial
description: This cohort of participants will be recruited preceding evaluation of the community-based pediatric TB prevention intervention (CHIP-TB; NCT04369326) to assist with design of the intervention and implementation strategy. Participants will include four stakeholder groups including: (1) policy makers, program managers, (2) nurse and physician clinicians, (3) community health team members, and (4) caregivers of child contacts from both South African and Ethiopian sites.
arm group label: Post-trial
description: This cohort of participants will be recruited after evaluation of the community-based pediatric TB prevention intervention (CHIP-TB; NCT04369326) to assist with future scale up and dissemination of the intervention. Participants will include four stakeholder groups including: (1) policy makers, program managers, (2) nurse and physician clinicians, (3) community health team members, and (4) caregivers of child contacts from both South African and Ethiopian sites.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nicole Salazar-Austin, MD
role: Principal Investigator
affiliation: Johns Hopkins School of Medicine
facility: 
facility: 
country: Ethiopia
country: South Africa
country: United States
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Latent Tuberculosis
sharing ipd: No