<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/NCT03044158</url>
  </required_header>
  <id_info>
    <org_study_id>R01HL130192</org_study_id>
    <secondary_id>PACTR201610001763265</secondary_id>
    <secondary_id>R01HL130192</secondary_id>
    <nct_id>NCT03044158</nct_id>
  </id_info>
  <brief_title>GeneXpert Performance Evaluation for Linkage to Tuberculosis Care</brief_title>
  <acronym>XPEL-TB</acronym>
  <official_title>GeneXpert Performance Evaluation for Linkage to Tuberculosis Care: The XPEL-TB Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Makerere University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The investigators' overall objective is to assess the effectiveness, implementation and costs&#xD;
      of a streamlined TB diagnostic evaluation strategy based around rapid, onsite molecular&#xD;
      testing. The intervention strategy was developed based on theory-informed assessment of&#xD;
      barriers to TB diagnostic evaluation at community health centers in Uganda and a process of&#xD;
      engagement with local stakeholders. It includes: 1) Point-of-care molecular testing using&#xD;
      GeneXpert as a replacement for sputum smear microscopy; 2) Re-structuring of clinic-level&#xD;
      procedures to facilitate same-day TB diagnosis and treatment; and 3) Quarterly feedback of TB&#xD;
      evaluation metrics to health center staff. The investigators' central hypothesis is that the&#xD;
      intervention strategy will have high uptake and increase the number of patients diagnosed&#xD;
      with and treated for active pulmonary TB. To test this hypothesis, the investigators will&#xD;
      conduct a pragmatic cluster-randomized trial at community health centers that provide TB&#xD;
      microscopy services in Uganda in partnership with the National TB Program (NTP). The&#xD;
      investigators utilize an effectiveness-implementation hybrid design in which, concurrent with&#xD;
      the clinical trial, the investigators will conduct nested mixed methods, health economic and&#xD;
      modeling studies to assess 1) whether the intervention strategy modifies targeted barriers to&#xD;
      TB diagnostic evaluation; 2) fidelity of implementation of the intervention components (i.e,&#xD;
      the degree to which intervention components were implemented as intended vs. adapted across&#xD;
      sites); and 3) cost-effectiveness and public health impact.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim 1: To compare patient outcomes at health centers randomized to intervention vs.&#xD;
      standard-of-care TB diagnostic evaluation strategies. The investigators will randomize 20&#xD;
      community health centers to continue standard TB evaluation (routine microscopy plus referral&#xD;
      of patients for Xpert testing per existing processes of care) or to implement the&#xD;
      intervention strategy (1. Onsite molecular testing; 2. Re-structuring clinic-level procedures&#xD;
      to facilitate same-day TB diagnosis and treatment; and 3. Performance feedback). The&#xD;
      investigators will compare reach and effectiveness based on the numbers and proportions of&#xD;
      patients (N=5500) who complete TB testing, are found to have TB, and have treatment initiated&#xD;
      within one week of specimen provision.&#xD;
&#xD;
      Aim 2: To identify processes and contextual factors that influence the effectiveness and&#xD;
      fidelity of the intervention TB diagnostic evaluation strategy. The investigators will use&#xD;
      quantitative process metrics to assess the adoption and maintenance over time of the core&#xD;
      components of the intervention strategy. The investigators will also collect quantitative and&#xD;
      qualitative data to describe the fidelity of implementation of each component and&#xD;
      faithfulness to the conceptual model.&#xD;
&#xD;
      Aim 3: To compare the costs and epidemiological impact of intervention vs. standard-of-care&#xD;
      TB diagnostic evaluation strategies. The investigators will model the incremental costs and&#xD;
      cost-effectiveness of intervention relative to standard-of-care TB diagnostic evaluation from&#xD;
      the health system and patient perspective. The investigators will then construct an epidemic&#xD;
      model of the population-level impact of the intervention strategy on TB incidence and&#xD;
      mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 22, 2018</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">March 31, 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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number treated for microbiologically-confirmed TB within two weeks of referral for sputum-based testing</measure>
    <time_frame>Within 2 weeks of initial sputum submission</time_frame>
    <description>Effectiveness outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number referred for TB testing</measure>
    <time_frame>Within 2 weeks of initial sputum submission</time_frame>
    <description>Effectiveness outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number diagnosed with microbiologically-confirmed TB</measure>
    <time_frame>Within 2 weeks of initial sputum submission</time_frame>
    <description>Effectiveness outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number suspected/diagnosed with RIF-resistant TB</measure>
    <time_frame>Within 2 weeks of initial sputum submission</time_frame>
    <description>Effectiveness outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to microbiologically-confirmed TB</measure>
    <time_frame>Days from initial sputum submission to being diagnosed, up to 60 days.</time_frame>
    <description>Effectiveness outcome. Time-to-diagnosis if microbiologically-confirmed TB.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number treated for TB</measure>
    <time_frame>Within 2 weeks of initial sputum submission</time_frame>
    <description>Effectiveness outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients enrolled</measure>
    <time_frame>Within 2 weeks of initial sputum submission</time_frame>
    <description>Effectiveness outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number diagnosed and treated for microbiologically-confirmed TB</measure>
    <time_frame>Within 2 weeks of initial sputum submission</time_frame>
    <description>Effectiveness outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-to-treatment of microbiologically-confirmed TB</measure>
    <time_frame>Days from initial health center visit to initiation of treatment if diagnosed, up to 1 year.</time_frame>
    <description>Effectiveness outcome. Time-to-treatment if microbiologically-confirmed TB and treated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number diagnosed AND completing treatment</measure>
    <time_frame>Days from initial health center visit to treatment outcome, up to 2 years.</time_frame>
    <description>Effectiveness outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number who died within 6 months</measure>
    <time_frame>Days from initial health center visit to treatment outcome, up to 6 months.</time_frame>
    <description>Effectiveness outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10644</enrollment>
  <condition>Tuberculosis, Pulmonary</condition>
  <condition>Rifampicin Resistant Tuberculosis</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Onsite molecular testing for TB with GeneXpert I + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GeneXpert I</intervention_name>
    <description>Onsite molecular testing with GeneXpert I as a replacement for microscopy</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>GeneXpert</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Process re-design</intervention_name>
    <description>Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Performance Feedback</intervention_name>
    <description>Feedback of TB diagnostic evaluation quality indicators to health center staff</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Site-level: Use standard (multi-day) sputum smear microscopy as the primary method of&#xD;
             TB diagnosis&#xD;
&#xD;
          -  Site-level: Participate in NTP-sponsored external quality assurance (EQA) for sputum&#xD;
             smear microscopy&#xD;
&#xD;
          -  Site-level: Send samples to a district or regional hospital/health center for Xpert&#xD;
             testing&#xD;
&#xD;
          -  Patient-level: Initiate evaluation for active TB at a study health center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Site-level: Do not agree to be randomized to standard-of-care vs. intervention arms&#xD;
&#xD;
          -  Site-level: Perform sputum smear examination on &lt;150 patients per year (based on 2015&#xD;
             data)&#xD;
&#xD;
          -  Site-level: Diagnose &lt;15 smear-positive TB cases per year (based on 2015 data)&#xD;
&#xD;
          -  Patient-level: Have sputum collected for monitoring of response to anti-TB therapy&#xD;
&#xD;
          -  Patient-level: Have sputum collected as part of active, community-based case finding&#xD;
             (e.g., contact tracing, community outreach campaign)&#xD;
&#xD;
          -  Patient-level: Referred to a study health center for TB treatment after a diagnosis is&#xD;
             established elsewhere&#xD;
&#xD;
          -  Patient-level: Started on TB treatment for extra-pulmonary TB only&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adithya Cattamanchi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Francis Njeru Health Center III</name>
      <address>
        <city>Buikwe</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Busana Health Center III</name>
      <address>
        <city>Busana</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Busesa Health Center IV</name>
      <address>
        <city>Busesa</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Buwama Health Center III</name>
      <address>
        <city>Buwama</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iganga TC</name>
      <address>
        <city>Iganga</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bukulula Health Center IV</name>
      <address>
        <city>Kalungu</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nazigo Health Center III</name>
      <address>
        <city>Kayunga</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kiganda Health Center IV</name>
      <address>
        <city>Kiganda</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kira Health Center III</name>
      <address>
        <city>Kira</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lugasa Health Center III</name>
      <address>
        <city>Lugala</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bishop Asili Health Center</name>
      <address>
        <city>Luwero</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kinoni Health Center III</name>
      <address>
        <city>Lwengo</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kityerera Health Center IV</name>
      <address>
        <city>Mayuge</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Malongo Health Center III</name>
      <address>
        <city>Mayuge</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayuge Health Center III</name>
      <address>
        <city>Mayuge</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wabulungu Health Center III</name>
      <address>
        <city>Mayuge</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Malangala Health Center III</name>
      <address>
        <city>Mityana</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lwampanga Health Center III</name>
      <address>
        <city>Nakasongola</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Namungalwe Health Center III</name>
      <address>
        <city>Namungalwe</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nankandulo Health Center IV</name>
      <address>
        <city>Nankandulo</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
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    <PMID>18677415</PMID>
  </reference>
  <reference>
    <citation>Salje H, Andrews JR, Deo S, Satyanarayana S, Sun AY, Pai M, Dowdy DW. The importance of implementation strategy in scaling up Xpert MTB/RIF for diagnosis of tuberculosis in the Indian health-care system: a transmission model. PLoS Med. 2014 Jul 15;11(7):e1001674. doi: 10.1371/journal.pmed.1001674. eCollection 2014 Jul.</citation>
    <PMID>25025235</PMID>
  </reference>
  <reference>
    <citation>Dowdy DW, Basu S, Andrews JR. Is passive diagnosis enough? The impact of subclinical disease on diagnostic strategies for tuberculosis. Am J Respir Crit Care Med. 2013 Mar 1;187(5):543-51. doi: 10.1164/rccm.201207-1217OC. Epub 2012 Dec 21.</citation>
    <PMID>23262515</PMID>
  </reference>
  <reference>
    <citation>Sun AY, Denkinger CM, Dowdy DW. The impact of novel tests for tuberculosis depends on the diagnostic cascade. Eur Respir J. 2014 Nov;44(5):1366-9. doi: 10.1183/09031936.00111014. Epub 2014 Sep 3.</citation>
    <PMID>25186263</PMID>
  </reference>
  <reference>
    <citation>Chandrasekaran V, Ramachandran R, Cunningham J, Balasubramaniun R, Thomas A, Sudha G, et al. Factors leading to tuberculosis diagnostic drop-out and delayed treatment initiation in Chennai, India. Int J Tuberc Lung Dis. 2005;9:172.</citation>
  </reference>
  <reference>
    <citation>Den Boon S, Semitala F, Cattamanchi A, Walter N, Worodria W, Joloba M, Huang L, Davis JL. Impact of patient drop-out on the effective sensitivity of smear microscopy strategies. Am J Respir Crit Care Med 2010;181:A2258.</citation>
  </reference>
  <reference>
    <citation>Miller C, Haguma P, Ochom E, Ross J, Davis JL, Cattamanchi A, Katamba A. Costs associated with tuberculosis evaluation in rural Uganda. 43rd Union World Conference on Lung Health; Kuala Lumpur, Malaysia 2012.</citation>
  </reference>
  <reference>
    <citation>WHO. Global strategy and targets for tuberculosis prevention, care and control after 2015. Geneva, Switzerland: World Health Organization, 2013 EB134/12.</citation>
  </reference>
  <reference>
    <citation>WHO. WHO monitoring of Xpert MTB/RIF roll-out. Available at: http://www.who.int/tb/areas-of-work/laboratory/mtb-rif-rollout/en/ [cited 2015 January 15].</citation>
  </reference>
  <reference>
    <citation>Churchyard GJ, on behalf of the Xtend study team. Xpert MTB/RIF vs microscopy as the first line TB test in South Africa: mortality, yield, initial loss to follow up and proportion treated. The Xtend Study. Conference on Retroviruses and Opportunistic Infections; Boston, USA: Available at: http://www.stoptb.org/wg/gli/assets/documents/M6/Churchyard%20-%20XTEND%20study.pdf; 2014.</citation>
  </reference>
  <reference>
    <citation>Cepheid. GeneXpert Omni: The True Point of Care Molecular Diagnostic System: Cepheid Inc; 2015. Available from: http://www.cepheid.com/us/genexpert-omni.</citation>
  </reference>
  <reference>
    <citation>Ajzen I. The theory of planned behavior. Organizational Behavior and Human Decision Processes. 1991;50:179-211.</citation>
  </reference>
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    <citation>Green LW, Krueter M. Health Program Planning - An Educational and Ecological Approach. 4th ed. Philadelphia, USA: McGraw-Hill; 2005.</citation>
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  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>April 18, 2023</last_update_submitted>
  <last_update_submitted_qc>April 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tuberculosis</keyword>
  <keyword>implementation science</keyword>
  <keyword>point-of-care</keyword>
  <keyword>diagnostics</keyword>
  <keyword>GeneXpert</keyword>
  <keyword>Uganda</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Tuberculosis, Pulmonary</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/NCT03044158
org study id: R01HL130192
secondary id: PACTR201610001763265
secondary id: R01HL130192
nct id: NCT03044158
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators' overall objective is to assess the effectiveness, implementation and costs
      of a streamlined TB diagnostic evaluation strategy based around rapid, onsite molecular
      testing. The intervention strategy was developed based on theory-informed assessment of
      barriers to TB diagnostic evaluation at community health centers in Uganda and a process of
      engagement with local stakeholders. It includes: 1) Point-of-care molecular testing using
      GeneXpert as a replacement for sputum smear microscopy; 2) Re-structuring of clinic-level
      procedures to facilitate same-day TB diagnosis and treatment; and 3) Quarterly feedback of TB
      evaluation metrics to health center staff. The investigators' central hypothesis is that the
      intervention strategy will have high uptake and increase the number of patients diagnosed
      with and treated for active pulmonary TB. To test this hypothesis, the investigators will
      conduct a pragmatic cluster-randomized trial at community health centers that provide TB
      microscopy services in Uganda in partnership with the National TB Program (NTP). The
      investigators utilize an effectiveness-implementation hybrid design in which, concurrent with
      the clinical trial, the investigators will conduct nested mixed methods, health economic and
      modeling studies to assess 1) whether the intervention strategy modifies targeted barriers to
      TB diagnostic evaluation; 2) fidelity of implementation of the intervention components (i.e,
      the degree to which intervention components were implemented as intended vs. adapted across
      sites); and 3) cost-effectiveness and public health impact.
Aim 1: To compare patient outcomes at health centers randomized to intervention vs.
      standard-of-care TB diagnostic evaluation strategies. The investigators will randomize 20
      community health centers to continue standard TB evaluation (routine microscopy plus referral
      of patients for Xpert testing per existing processes of care) or to implement the
      intervention strategy (1. Onsite molecular testing; 2. Re-structuring clinic-level procedures
      to facilitate same-day TB diagnosis and treatment; and 3. Performance feedback). The
      investigators will compare reach and effectiveness based on the numbers and proportions of
      patients (N=5500) who complete TB testing, are found to have TB, and have treatment initiated
      within one week of specimen provision.

      Aim 2: To identify processes and contextual factors that influence the effectiveness and
      fidelity of the intervention TB diagnostic evaluation strategy. The investigators will use
      quantitative process metrics to assess the adoption and maintenance over time of the core
      components of the intervention strategy. The investigators will also collect quantitative and
      qualitative data to describe the fidelity of implementation of each component and
      faithfulness to the conceptual model.

      Aim 3: To compare the costs and epidemiological impact of intervention vs. standard-of-care
      TB diagnostic evaluation strategies. The investigators will model the incremental costs and
      cost-effectiveness of intervention relative to standard-of-care TB diagnostic evaluation from
      the health system and patient perspective. The investigators will then construct an epidemic
      model of the population-level impact of the intervention strategy on TB incidence and
      mortality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number treated for microbiologically-confirmed TB within two weeks of referral for sputum-based testing
time frame: Within 2 weeks of initial sputum submission
description: Effectiveness outcome.
measure: Number referred for TB testing
time frame: Within 2 weeks of initial sputum submission
description: Effectiveness outcome.
measure: Number diagnosed with microbiologically-confirmed TB
time frame: Within 2 weeks of initial sputum submission
description: Effectiveness outcome.
measure: Number suspected/diagnosed with RIF-resistant TB
time frame: Within 2 weeks of initial sputum submission
description: Effectiveness outcome.
measure: Time to microbiologically-confirmed TB
time frame: Days from initial sputum submission to being diagnosed, up to 60 days.
description: Effectiveness outcome. Time-to-diagnosis if microbiologically-confirmed TB.
measure: Number treated for TB
time frame: Within 2 weeks of initial sputum submission
description: Effectiveness outcome.
measure: Number of patients enrolled
time frame: Within 2 weeks of initial sputum submission
description: Effectiveness outcome.
measure: Number diagnosed and treated for microbiologically-confirmed TB
time frame: Within 2 weeks of initial sputum submission
description: Effectiveness outcome.
measure: Time-to-treatment of microbiologically-confirmed TB
time frame: Days from initial health center visit to initiation of treatment if diagnosed, up to 1 year.
description: Effectiveness outcome. Time-to-treatment if microbiologically-confirmed TB and treated.
measure: Number diagnosed AND completing treatment
time frame: Days from initial health center visit to treatment outcome, up to 2 years.
description: Effectiveness outcome.
measure: Number who died within 6 months
time frame: Days from initial health center visit to treatment outcome, up to 6 months.
description: Effectiveness outcome.
arm group label: Control group
arm group type: No Intervention
description: Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols
arm group label: Intervention
arm group type: Experimental
description: Onsite molecular testing for TB with GeneXpert I + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback
intervention type: Device
intervention name: GeneXpert I
description: Onsite molecular testing with GeneXpert I as a replacement for microscopy
arm group label: Intervention
other name: GeneXpert
intervention type: Behavioral
intervention name: Process re-design
description: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.
arm group label: Intervention
intervention type: Other
intervention name: Performance Feedback
description: Feedback of TB diagnostic evaluation quality indicators to health center staff
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Adithya Cattamanchi, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
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country: Uganda
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citation: Salje H, Andrews JR, Deo S, Satyanarayana S, Sun AY, Pai M, Dowdy DW. The importance of implementation strategy in scaling up Xpert MTB/RIF for diagnosis of tuberculosis in the Indian health-care system: a transmission model. PLoS Med. 2014 Jul 15;11(7):e1001674. doi: 10.1371/journal.pmed.1001674. eCollection 2014 Jul.
PMID: 25025235
citation: Dowdy DW, Basu S, Andrews JR. Is passive diagnosis enough? The impact of subclinical disease on diagnostic strategies for tuberculosis. Am J Respir Crit Care Med. 2013 Mar 1;187(5):543-51. doi: 10.1164/rccm.201207-1217OC. Epub 2012 Dec 21.
PMID: 23262515
citation: Sun AY, Denkinger CM, Dowdy DW. The impact of novel tests for tuberculosis depends on the diagnostic cascade. Eur Respir J. 2014 Nov;44(5):1366-9. doi: 10.1183/09031936.00111014. Epub 2014 Sep 3.
PMID: 25186263
citation: Chandrasekaran V, Ramachandran R, Cunningham J, Balasubramaniun R, Thomas A, Sudha G, et al. Factors leading to tuberculosis diagnostic drop-out and delayed treatment initiation in Chennai, India. Int J Tuberc Lung Dis. 2005;9:172.
citation: Den Boon S, Semitala F, Cattamanchi A, Walter N, Worodria W, Joloba M, Huang L, Davis JL. Impact of patient drop-out on the effective sensitivity of smear microscopy strategies. Am J Respir Crit Care Med 2010;181:A2258.
citation: Miller C, Haguma P, Ochom E, Ross J, Davis JL, Cattamanchi A, Katamba A. Costs associated with tuberculosis evaluation in rural Uganda. 43rd Union World Conference on Lung Health; Kuala Lumpur, Malaysia 2012.
citation: WHO. Global strategy and targets for tuberculosis prevention, care and control after 2015. Geneva, Switzerland: World Health Organization, 2013 EB134/12.
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citation: Churchyard GJ, on behalf of the Xtend study team. Xpert MTB/RIF vs microscopy as the first line TB test in South Africa: mortality, yield, initial loss to follow up and proportion treated. The Xtend Study. Conference on Retroviruses and Opportunistic Infections; Boston, USA: Available at: http://www.stoptb.org/wg/gli/assets/documents/M6/Churchyard%20-%20XTEND%20study.pdf; 2014.
citation: Cepheid. GeneXpert Omni: The True Point of Care Molecular Diagnostic System: Cepheid Inc; 2015. Available from: http://www.cepheid.com/us/genexpert-omni.
citation: Ajzen I. The theory of planned behavior. Organizational Behavior and Human Decision Processes. 1991;50:179-211.
citation: Green LW, Krueter M. Health Program Planning - An Educational and Ecological Approach. 4th ed. Philadelphia, USA: McGraw-Hill; 2005.
citation: Hayes RJ, Moulton LH. Cluster Randomized Trials. Boca Raton, Florida, USA: CRC Press; 2009.
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Tuberculosis, Pulmonary
sharing ipd: No