<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/NCT02234908</url>
  </required_header>
  <id_info>
    <org_study_id>H-33047</org_study_id>
    <secondary_id>M140529</secondary_id>
    <secondary_id>1U01AI100015-01</secondary_id>
    <nct_id>NCT02234908</nct_id>
  </id_info>
  <brief_title>Rewards for Tuberculosis Contact Screening</brief_title>
  <acronym>RECON</acronym>
  <official_title>Rewards for Tuberculosis Contact Screening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Witwatersrand, South Africa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>City of Johannesburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helen Joseph Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</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>
      This pilot project is an evaluation of the feasibility, acceptability, and cost of offering&#xD;
      an economic reward, in the form of a shopping voucher, to the household contacts of index&#xD;
      patients (outpatient drug-susceptible and drug-resistant TB patients) who present at the&#xD;
      study clinic for TB screening and optional HIV testing, providing a reward to the index&#xD;
      patients for participating, and entering index patients whose contacts do present into a&#xD;
      lottery to win a prize.The effectiveness of the intervention in screening a high proportion&#xD;
      of contacts will be compared to existing published data from studies of active case-finding&#xD;
      through home visits and of the status quo passive case finding. If successful, this pilot&#xD;
      project will create a demand for screening among high risk patients, who will be rewarded for&#xD;
      identifying themselves to the healthcare system, and could prove to be an affordable&#xD;
      alternative to resource-intensive home visits. It will also shift responsibility for contact&#xD;
      tracing from overburdened clinic staff to those who have the most to gain from early case&#xD;
      detection-the patients and their families.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the success of antiretroviral treatment (ART) programs in reaching &gt; 10 million&#xD;
      HIV-infected patients in resource-limited countries over the past decade, HIV and&#xD;
      tuberculosis (TB), continue to take a heavy toll on survival and health in southern Africa.&#xD;
      In South Africa, where 6.4 million people are estimated to be HIV-positive and up to 2.1&#xD;
      million are on ART, TB incidence is the second highest in the world (after Swaziland), 65% of&#xD;
      TB patients are HIV-infected, and TB remains the leading natural cause of death.&#xD;
      Drug-resistant TB (DR-TB) is even more concerning, with more than 15,000 South African&#xD;
      patients diagnosed with multidrug-resistant TB (MDR-TB) in 2012, nearly a fifth of the global&#xD;
      total, and very high mortality among those receiving standard MDR-TB treatment.&#xD;
&#xD;
      Because of the high risk of both TB and HIV among the household contacts of TB patients and&#xD;
      the importance of early case detection for both diseases and especially for DR-TB, improving&#xD;
      TB case finding is a high priority. Recent studies have shown that having healthcare workers&#xD;
      make multiple visits to the homes of TB patients in order to screen household contacts is a&#xD;
      logistically challenging and resource- intensive strategy, and it is not routinely undertaken&#xD;
      in most public sector settings in South Africa. One alternative to home visits that could&#xD;
      prove effective and affordable is to offer small economic rewards to the household contacts&#xD;
      of TB patients who voluntarily present at a healthcare facility for TB symptom screening and&#xD;
      optional HIV testing. Economic incentives have been successful in increasing demand for&#xD;
      healthcare in a variety of settings, but they have not been tried before as a way to increase&#xD;
      uptake of services among patients' contacts, rather than among the diagnosed patients&#xD;
      themselves.&#xD;
&#xD;
      This pilot project is an evaluation of the feasibility and results of offering an economic&#xD;
      reward, in the form of a shopping voucher, to the household contacts of index patients&#xD;
      (outpatient drug-susceptible and drug-resistant TB patients) who present at the study clinic&#xD;
      for TB screening and optional HIV testing, providing a reward to the index patients for&#xD;
      participating, and entering index patients whose contacts do present into a lottery to win a&#xD;
      prize. The effectiveness of the intervention in screening a high proportion of contacts will&#xD;
      be compared to existing published data from studies of active case-finding through home&#xD;
      visits and of the status quo passive case finding. If successful, this pilot project will&#xD;
      create a demand for screening among high risk patients, who will be rewarded for identifying&#xD;
      themselves to the healthcare system, and could prove to be an affordable alternative to&#xD;
      resource-intensive home visits. It will also shift responsibility for contact tracing from&#xD;
      overburdened clinic staff to those who have the most to gain from early case detection-the&#xD;
      patients and their families.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of household contacts volunteering for TB symptom screening</measure>
    <time_frame>30 days</time_frame>
    <description>The primary quantitative outcome is uptake of TB symptom screening, defined as the proportion of reported household contacts who complete TB symptom screening within 1 month of index subject enrollment.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">301</enrollment>
  <condition>Tuberculosis</condition>
  <condition>Drug-resistant Tuberculosis</condition>
  <arm_group>
    <arm_group_label>Contacts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Contacts are the household contacts of confirmed TB and drug-resistant TB patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Index</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Index subjects are confirmed TB and drug-resistant TB patients who distribute referral cards to their household contacts.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Contacts</intervention_name>
    <description>Household contacts who come to the study clinic, present a referral card, and complete TB symptom screening will receive a shopping voucher of $5-10 value.</description>
    <arm_group_label>Contacts</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Index</intervention_name>
    <description>Index subjects will be entered in a prize lottery if any of their contacts complete TB symptom screening at the study clinic.</description>
    <arm_group_label>Index</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for index cases:&#xD;
&#xD;
          -  Adult patients (&gt;18 years)&#xD;
&#xD;
          -  Newly diagnosed with pulmonary TB (drug-susceptible or drug-resistant) or initiating&#xD;
             treatment for TB at one of the study sites&#xD;
&#xD;
        Exclusion criteria for index cases:&#xD;
&#xD;
          -  Resident outside the site's permissible catchment area for service delivery&#xD;
&#xD;
          -  No household contacts (live alone)&#xD;
&#xD;
          -  Admitted for inpatient care immediately following their TB diagnosis, and thus not&#xD;
             readily able to distribute the referral cards&#xD;
&#xD;
          -  Not physically, mentally, or emotionally able to participate in the study, in the view&#xD;
             of study staff&#xD;
&#xD;
          -  Previously enrolled in the same study&#xD;
&#xD;
          -  Declines to provide written informed consent to participate&#xD;
&#xD;
          -  Unable to speak any of the languages for which consent documents are available and not&#xD;
             accompanied by person who can&#xD;
&#xD;
        Inclusion criteria for contacts:&#xD;
&#xD;
          -  Usually spend at least 4 nights per week in the same household as an index case&#xD;
&#xD;
          -  Can provide referral card given to contact by index patient&#xD;
&#xD;
        Exclusion criteria for contacts:&#xD;
&#xD;
          -  Currently on any type of TB treatment&#xD;
&#xD;
          -  Not able to present any form of identification that matches the information on the&#xD;
             referral card&#xD;
&#xD;
          -  Previously enrolled in the same study&#xD;
&#xD;
          -  Declines to provide written informed consent to participate&#xD;
&#xD;
          -  Unable to speak any of the languages for which consent documents are available and not&#xD;
             accompanied by person who can&#xD;
&#xD;
        Inclusion criteria for interview respondents:&#xD;
&#xD;
          -  Experience with the intervention as provider or patient&#xD;
&#xD;
          -  Written informed consent to be interviewed&#xD;
&#xD;
        Exclusion criteria for contacts:&#xD;
&#xD;
        • None&#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>Sydney Rosen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Helen Joseph Hospital</name>
      <address>
        <city>Johannesburg</city>
        <zip>2193</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OR Tambo Clinic</name>
      <address>
        <city>Johannesburg</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>January 7, 2021</last_update_submitted>
  <last_update_submitted_qc>January 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tuberculosis</keyword>
  <keyword>Drug-resistant tuberculosis</keyword>
  <keyword>Incentives</keyword>
  <keyword>Symptom screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Tuberculosis, Multidrug-Resistant</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02234908
org study id: H-33047
secondary id: M140529
secondary id: 1U01AI100015-01
nct id: NCT02234908
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot project is an evaluation of the feasibility, acceptability, and cost of offering
      an economic reward, in the form of a shopping voucher, to the household contacts of index
      patients (outpatient drug-susceptible and drug-resistant TB patients) who present at the
      study clinic for TB screening and optional HIV testing, providing a reward to the index
      patients for participating, and entering index patients whose contacts do present into a
      lottery to win a prize.The effectiveness of the intervention in screening a high proportion
      of contacts will be compared to existing published data from studies of active case-finding
      through home visits and of the status quo passive case finding. If successful, this pilot
      project will create a demand for screening among high risk patients, who will be rewarded for
      identifying themselves to the healthcare system, and could prove to be an affordable
      alternative to resource-intensive home visits. It will also shift responsibility for contact
      tracing from overburdened clinic staff to those who have the most to gain from early case
      detection-the patients and their families.
Despite the success of antiretroviral treatment (ART) programs in reaching > 10 million
      HIV-infected patients in resource-limited countries over the past decade, HIV and
      tuberculosis (TB), continue to take a heavy toll on survival and health in southern Africa.
      In South Africa, where 6.4 million people are estimated to be HIV-positive and up to 2.1
      million are on ART, TB incidence is the second highest in the world (after Swaziland), 65% of
      TB patients are HIV-infected, and TB remains the leading natural cause of death.
      Drug-resistant TB (DR-TB) is even more concerning, with more than 15,000 South African
      patients diagnosed with multidrug-resistant TB (MDR-TB) in 2012, nearly a fifth of the global
      total, and very high mortality among those receiving standard MDR-TB treatment.

      Because of the high risk of both TB and HIV among the household contacts of TB patients and
      the importance of early case detection for both diseases and especially for DR-TB, improving
      TB case finding is a high priority. Recent studies have shown that having healthcare workers
      make multiple visits to the homes of TB patients in order to screen household contacts is a
      logistically challenging and resource- intensive strategy, and it is not routinely undertaken
      in most public sector settings in South Africa. One alternative to home visits that could
      prove effective and affordable is to offer small economic rewards to the household contacts
      of TB patients who voluntarily present at a healthcare facility for TB symptom screening and
      optional HIV testing. Economic incentives have been successful in increasing demand for
      healthcare in a variety of settings, but they have not been tried before as a way to increase
      uptake of services among patients' contacts, rather than among the diagnosed patients
      themselves.

      This pilot project is an evaluation of the feasibility and results of offering an economic
      reward, in the form of a shopping voucher, to the household contacts of index patients
      (outpatient drug-susceptible and drug-resistant TB patients) who present at the study clinic
      for TB screening and optional HIV testing, providing a reward to the index patients for
      participating, and entering index patients whose contacts do present into a lottery to win a
      prize. The effectiveness of the intervention in screening a high proportion of contacts will
      be compared to existing published data from studies of active case-finding through home
      visits and of the status quo passive case finding. If successful, this pilot project will
      create a demand for screening among high risk patients, who will be rewarded for identifying
      themselves to the healthcare system, and could prove to be an affordable alternative to
      resource-intensive home visits. It will also shift responsibility for contact tracing from
      overburdened clinic staff to those who have the most to gain from early case detection-the
      patients and their families.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Proportion of household contacts volunteering for TB symptom screening
time frame: 30 days
description: The primary quantitative outcome is uptake of TB symptom screening, defined as the proportion of reported household contacts who complete TB symptom screening within 1 month of index subject enrollment.
arm group label: Contacts
arm group type: Experimental
description: Contacts are the household contacts of confirmed TB and drug-resistant TB patients.
arm group label: Index
arm group type: Other
description: Index subjects are confirmed TB and drug-resistant TB patients who distribute referral cards to their household contacts.
intervention type: Behavioral
intervention name: Contacts
description: Household contacts who come to the study clinic, present a referral card, and complete TB symptom screening will receive a shopping voucher of $5-10 value.
arm group label: Contacts
intervention type: Behavioral
intervention name: Index
description: Index subjects will be entered in a prize lottery if any of their contacts complete TB symptom screening at the study clinic.
arm group label: Index
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Sydney Rosen
role: Principal Investigator
affiliation: Boston University
facility: 
facility: 
country: South Africa
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Tuberculosis, Multidrug-Resistant
sharing ipd: Undecided