<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/NCT01660646</url>
  </required_header>
  <id_info>
    <org_study_id>SCC 1205</org_study_id>
    <nct_id>NCT01660646</nct_id>
  </id_info>
  <brief_title>Determining the Impact of Enhanced Case Finding on Tuberculosis Notification in The Gambia</brief_title>
  <acronym>ECF</acronym>
  <official_title>A Cluster Randomised Trial to Assess the Impact of an Enhanced Case Finding Strategy on Tuberculosis Notification in The Gambia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>London School of Hygiene and Tropical Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a cluster Tuberculosis (TB) randomized trial in which enhanced case finding (ECF)&#xD;
      strategy will be compared to passive TB case reporting in The Gambia. And that the impact of&#xD;
      ECF on community and household transmission of TB will also be assessed.&#xD;
&#xD;
      The hypothesis is a cluster randomized trial of an enhanced case finding (ECF) strategy will&#xD;
      increase TB case notifications in The Gambia and reduce TB burden in the study area in a cost&#xD;
      effective manner. The impact of ECF on community and household transmission of TB will also&#xD;
      be assessed. The investigators hope this trial will contribute to this evidence base. The&#xD;
      timing alongside a nationwide TB prevalence survey is particularly of benefit as that would&#xD;
      provide a baseline for disease burden against which the investigators may be able to compare&#xD;
      case notification or case detection in selected clusters&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      TB is a chronic, transmissible disease, albeit with effective and curative combination&#xD;
      therapeutic regimens available. However insufficient case detection, delayed diagnosis of TB&#xD;
      , which prolong the duration of potential transmission, and co prevalent HIV/AIDS are the&#xD;
      major factors responsible for increasing TB incidence. The DOTs strategy, which relies on a&#xD;
      process of passive TB case finding, has helped to control TB in many parts of the world.&#xD;
      Currently, the World Health Organisation's Stop TB DOTS policy is being questioned as&#xD;
      countries that have reached and maintained targets of 70% case detection and 85% cure rates&#xD;
      are unable to demonstrate a decline in number of cases notified.&#xD;
&#xD;
      Studies in Southern Africa suggest that if the investigators want to prevent TB in&#xD;
      HIV-infected and uninfected people a major focus should be on decreasing transmission from&#xD;
      people who are HIV-negative that may transmit TB for a long time on account of delayed&#xD;
      diagnosis 5, 6. Data from studies in Ethiopia, Peru, Brazil, and Zimbabwe show different&#xD;
      strategies of intensified or active case finding (ICF or ACF) yield significantly more TB&#xD;
      cases than the standard of care-passive case finding.7-10 In the Zimbabwe study, point&#xD;
      prevalence of TB declined significantly over 2 time points and was attributed to the ICF&#xD;
      intervention. Since effective treatment for TB renders patients non-infectious within 2-4&#xD;
      weeks, it is likely that earlier diagnosis and initiation of treatment will ultimately reduce&#xD;
      the incidence of TB by interrupting TB transmission. However the quantitative effect of&#xD;
      enhanced case finding (ECF) on TB case notification rates, TB transmission, prevalence and&#xD;
      incidence remains largely unproven.&#xD;
&#xD;
      Although there is now data from Zimbabwe regarding the impact of untargeted active case&#xD;
      finding strategies, it is unclear how each case finding strategy compares to the standard&#xD;
      passive case finding and the investigators are currently unable to address the cost&#xD;
      effectiveness or otherwise of active case finding strategies in high TB burden settings with&#xD;
      low HIV prevalence which is the scenario in most West African countries including The Gambia.&#xD;
      Consequently, there is insufficient data to support a policy change and an urgent need for&#xD;
      evidence to drive the necessary review of policy.&#xD;
&#xD;
      The hypothesis is a cluster randomized trial of an enhanced case finding (ECF) strategy will&#xD;
      increase TB case notifications in The Gambia and reduce TB burden in the study area in a cost&#xD;
      effective manner. The impact of ECF on community and household transmission of TB will also&#xD;
      be assessed. The investigators hope this trial will contribute to this evidence base. The&#xD;
      timing alongside a nationwide TB prevalence survey is particularly of benefit as that would&#xD;
      provide a baseline for disease burden against which the investigators may be able to compare&#xD;
      case notification or case detection in selected clusters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The total number of successive TB cases notified in the intervention area compared to the total number of successive TB cases notified in the control areas</measure>
    <time_frame>30 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The total cost of making diagnosis and receiving treatment will be compared between ECF and passive case finding</measure>
    <time_frame>30 months</time_frame>
    <description>Residual burden of TB after intervention Proportion of TB detected through ECF vs. passive case finding in intervention areas.&#xD;
Evaluation of diagnostic delay and treatment outcome in cases detected through ECF versus passive case finding</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">650000</enrollment>
  <condition>Tuberculosis</condition>
  <arm_group>
    <arm_group_label>Behavioral: community sensitization</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Behavioral, enhanced case finding (ECF) by community sensitization via audiovisual presentation in local languages, a session for questions and answers and opportunity to provide sputum specimens for detection of TB</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral: community sensitization</intervention_name>
    <description>Behavioral, enhanced case finding (ECF) by community sensitization via audiovisual presentation in local languages, a session for questions and answers and opportunity to provide sputum specimens for detection of TB</description>
    <arm_group_label>Behavioral: community sensitization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any newly diagnosed case initiating TB therapy at any of the Gambia Government TB&#xD;
             diagnostic and treatment centres in the Greater Banjul Area.&#xD;
&#xD;
          -  All TB patients are eligible regardless of age, residency, HIV status, or type of TB&#xD;
&#xD;
          -  All settlements randomised to the intervention arm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to understand the implications of study participation, whether through&#xD;
             cognitive impairment or insurmountable language barrier.&#xD;
&#xD;
          -  Communities that refuse to accept intervention through decision conveyed by the alkalo&#xD;
             and other recognised community leaders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ifedayo Adetifa, FWACP, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Research Council Unit, The Gambia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Research Council Unit, The Gambia</name>
      <address>
        <city>Fajara,</city>
        <state>Near Banjul</state>
        <country>Gambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Gambia</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 26, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>March 20, 2018</last_update_submitted>
  <last_update_submitted_qc>March 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tuberculosis case finding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT01660646
org study id: SCC 1205
nct id: NCT01660646
lead sponsor: 
has dmc: No
This is a cluster Tuberculosis (TB) randomized trial in which enhanced case finding (ECF)
      strategy will be compared to passive TB case reporting in The Gambia. And that the impact of
      ECF on community and household transmission of TB will also be assessed.

      The hypothesis is a cluster randomized trial of an enhanced case finding (ECF) strategy will
      increase TB case notifications in The Gambia and reduce TB burden in the study area in a cost
      effective manner. The impact of ECF on community and household transmission of TB will also
      be assessed. The investigators hope this trial will contribute to this evidence base. The
      timing alongside a nationwide TB prevalence survey is particularly of benefit as that would
      provide a baseline for disease burden against which the investigators may be able to compare
      case notification or case detection in selected clusters
TB is a chronic, transmissible disease, albeit with effective and curative combination
      therapeutic regimens available. However insufficient case detection, delayed diagnosis of TB
      , which prolong the duration of potential transmission, and co prevalent HIV/AIDS are the
      major factors responsible for increasing TB incidence. The DOTs strategy, which relies on a
      process of passive TB case finding, has helped to control TB in many parts of the world.
      Currently, the World Health Organisation's Stop TB DOTS policy is being questioned as
      countries that have reached and maintained targets of 70% case detection and 85% cure rates
      are unable to demonstrate a decline in number of cases notified.

      Studies in Southern Africa suggest that if the investigators want to prevent TB in
      HIV-infected and uninfected people a major focus should be on decreasing transmission from
      people who are HIV-negative that may transmit TB for a long time on account of delayed
      diagnosis 5, 6. Data from studies in Ethiopia, Peru, Brazil, and Zimbabwe show different
      strategies of intensified or active case finding (ICF or ACF) yield significantly more TB
      cases than the standard of care-passive case finding.7-10 In the Zimbabwe study, point
      prevalence of TB declined significantly over 2 time points and was attributed to the ICF
      intervention. Since effective treatment for TB renders patients non-infectious within 2-4
      weeks, it is likely that earlier diagnosis and initiation of treatment will ultimately reduce
      the incidence of TB by interrupting TB transmission. However the quantitative effect of
      enhanced case finding (ECF) on TB case notification rates, TB transmission, prevalence and
      incidence remains largely unproven.

      Although there is now data from Zimbabwe regarding the impact of untargeted active case
      finding strategies, it is unclear how each case finding strategy compares to the standard
      passive case finding and the investigators are currently unable to address the cost
      effectiveness or otherwise of active case finding strategies in high TB burden settings with
      low HIV prevalence which is the scenario in most West African countries including The Gambia.
      Consequently, there is insufficient data to support a policy change and an urgent need for
      evidence to drive the necessary review of policy.

      The hypothesis is a cluster randomized trial of an enhanced case finding (ECF) strategy will
      increase TB case notifications in The Gambia and reduce TB burden in the study area in a cost
      effective manner. The impact of ECF on community and household transmission of TB will also
      be assessed. The investigators hope this trial will contribute to this evidence base. The
      timing alongside a nationwide TB prevalence survey is particularly of benefit as that would
      provide a baseline for disease burden against which the investigators may be able to compare
      case notification or case detection in selected clusters.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The total number of successive TB cases notified in the intervention area compared to the total number of successive TB cases notified in the control areas
time frame: 30 months
measure: The total cost of making diagnosis and receiving treatment will be compared between ECF and passive case finding
time frame: 30 months
description: Residual burden of TB after intervention Proportion of TB detected through ECF vs. passive case finding in intervention areas.
Evaluation of diagnostic delay and treatment outcome in cases detected through ECF versus passive case finding
arm group label: Behavioral: community sensitization
arm group type: Other
description: Behavioral, enhanced case finding (ECF) by community sensitization via audiovisual presentation in local languages, a session for questions and answers and opportunity to provide sputum specimens for detection of TB
arm group label: control
arm group type: No Intervention
intervention type: Behavioral
intervention name: Behavioral: community sensitization
description: Behavioral, enhanced case finding (ECF) by community sensitization via audiovisual presentation in local languages, a session for questions and answers and opportunity to provide sputum specimens for detection of TB
arm group label: Behavioral: community sensitization
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ifedayo Adetifa, FWACP, MSc
role: Principal Investigator
affiliation: Medical Research Council Unit, The Gambia
facility: 
country: Gambia
responsible party type: Sponsor
mesh term: Tuberculosis