Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201610001763265 Date of Approval: 03/09/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
Official scientific title GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
Brief summary describing the background and objectives of the trial Brief summary describing the background and objectives of trial: Clustered-randomized trial with nested mixed methods and economic/transmission modeling studies at 20 TB microscopy centers (control) in Uganda. Aim 1: To compare patient outcomes at health centers randomized to intervention vs. standard-of-care TB diagnostic evaluation strategies. Intervention arm: onsite molecular testing for TB + process redesign to facilitate same-day TB diagnosis + performance feedback. Standard-of-care arm: onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols. Aim 2: To identify processes and contextual factors that influence the effectiveness and fidelity of the intervention TB diagnostic evaluation strategy Aim 3: To compare the costs and epidemiological impact of intervention vs. standard-of-care TB diagnostic evaluation strategies.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) XPEL TB
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2018
Actual trial start date
Anticipated date of last follow up 29/02/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 5500
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
R01HL130192 National Heart, Lung, and Blood Institute (NHLBI)
172155 University of California San Francisco Institutional Review Board
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard of care Duration of the study Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols 2750 Active-Treatment of Control Group
Experimental Group Intervention Duration of trial Onsite molecular testing for TB + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback 2750
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. (Site-level) Use standard (multi-day) sputum smear microscopy as the primary method of TB diagnosis 2. (Site-level) Participate in NTP-sponsored external quality assurance (EQA) for sputum smear microscopy 3. (Site-level) Send samples to a district or regional hospital/health center for Xpert testing 4. (Patient-level) Initiate evaluation for active TB at a study health center 1. (Site-level) Do not agree to be randomized to standard-of-care vs. intervention arms 2. (Site-level) Perform sputum smear examination on <150 patients per year (based on 2015 data) 3. (Site-level) Diagnose <15 smear-positive TB cases per year (based on 2015 data) 4. (Patient-level) Have sputum collected for monitoring of response to anti-TB therapy 5. (Patient-level) Have sputum collected as part of active, community-based case finding (e.g., contact tracing, community outreach campaign) 6. (Patient-level) Referred to a study health center for TB treatment after a diagnosis is established elsewhere 7. (Patient-level) Started on TB treatment for extra-pulmonary TB only 1 Day(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/07/2018 University of California San Francisco Committee on Human Research Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Human Research Protection Program, Box 0962, 3333 California Street, Suite 315 San Francisco 9414 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/04/2016 Uganda National Council for Science and Technology (UNCST)
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road, Ntinda, P.O. Box 6884 Kampala Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/06/2018 Makerere University School of Public Health
Ethics Committee Address
Street address City Postal code Country
PO Box 7072 Kampala 00000 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number treated for microbiologically-confirmed TB within two weeks of referral for sputum-based TB testing 14 days after diagnosis
Secondary Outcome Proportion completing testing Number with one valid Xpert result OR one positive smear result (if HIV negative)
Secondary Outcome Proportion completing testing Number with one valid Xpert result or one positive smear result (if HIV negative)
Secondary Outcome Number diagnosed with microbiologically-confirmed TB Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Proportion diagnosed with microbiologically-confirmed TB Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Number diagnosed with RIF-resistant TB Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Proportion diagnosed with RIF-resistant TB Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Time to microbiologically-confirmed TB Days from initial sputum submission to being diagnosed
Secondary Outcome Number treated for TB Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Proportion treated for TB Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Number treated for microbiologically-confirmed TB Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Proportion treated for microbiologically-confirmed TB Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Proportion with microbiologically-confirmed TB treated Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Time to treatment of microbiologically-confirmed TB Days from initial health center visit to initiation of treatment if diagnosed
Secondary Outcome Number with microbiologically-confirmed TB completing treatment Six months after treatment initiation Nine months after treatment initiation One year after treatment initiation
Secondary Outcome Proportion with microbiologically-confirmed TB completing treatment Six months after treatment initiation Nine months after treatment initiation One year after treatment initiation
Secondary Outcome Number who died within 6 months Six months after treatment initiation
Secondary Outcome Proportion who died within 6 months Six months after treatment initiation
Secondary Outcome Patient costs (total costs, direct costs, indirect costs) At initial health center visit
Secondary Outcome Patient satisfaction with care survey (general satisfaction with care, convenience of services, health facility environment, provider interpersonal skills, provider technical competence) At initial health center visit
Secondary Outcome Provider survey (intention, attitudes/beliefs, social norms/expectations, self-efficacy/behavioral control) During initial baseline site visits During post-randomization site visits
Secondary Outcome Intervention arm process metrics Post-randomization data collection
Secondary Outcome Variation in and barriers to intervention strategy uptake Focus group discussions Semi-structured interviews
Secondary Outcome Incremental cost per DALY averted Ongoing
Secondary Outcome Incremental health system cost per DALY averted Ongoing
Secondary Outcome Incremental patient cost per DALY averted Ongoing
Secondary Outcome Projected reduction in TB incidence over 10 years Ongoing
Secondary Outcome Projected reduction in TB mortality over 10 years Ongoing
Primary Outcome Proportion treated for microbiologically-confirmed TB within two weeks of initial sputum submission 14 days after diagnosis
Secondary Outcome Proportion completing testing Number with one valid Xpert result OR one positive smear result (if HIV negative)
Secondary Outcome Proportion completing testing Number with one valid Xpert result or one positive smear result (if HIV negative)
Secondary Outcome Number diagnosed with microbiologically-confirmed TB Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Proportion diagnosed with microbiologically-confirmed TB Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Number diagnosed with RIF-resistant TB Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Proportion diagnosed with RIF-resistant TB Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Time to microbiologically-confirmed TB Days from initial sputum submission to being diagnosed
Secondary Outcome Number treated for TB Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Proportion treated for TB Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Number treated for microbiologically-confirmed TB Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Proportion treated for microbiologically-confirmed TB Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Proportion with microbiologically-confirmed TB treated Within 1 day of initial sputum submission Within 14 days of initial sputum submission
Secondary Outcome Time to treatment of microbiologically-confirmed TB Days from initial health center visit to initiation of treatment if diagnosed
Secondary Outcome Number with microbiologically-confirmed TB completing treatment Six months after treatment initiation Nine months after treatment initiation One year after treatment initiation
Secondary Outcome Proportion with microbiologically-confirmed TB completing treatment Six months after treatment initiation Nine months after treatment initiation One year after treatment initiation
Secondary Outcome Number who died within 6 months Six months after treatment initiation
Secondary Outcome Proportion who died within 6 months Six months after treatment initiation
Secondary Outcome Patient costs (total costs, direct costs, indirect costs) At initial health center visit
Secondary Outcome Patient satisfaction with care survey (general satisfaction with care, convenience of services, health facility environment, provider interpersonal skills, provider technical competence) At initial health center visit
Secondary Outcome Provider survey (intention, attitudes/beliefs, social norms/expectations, self-efficacy/behavioral control) During initial baseline site visits During post-randomization site visits
Secondary Outcome Intervention arm process metrics Post-randomization data collection
Secondary Outcome Variation in and barriers to intervention strategy uptake Focus group discussions Semi-structured interviews
Secondary Outcome Incremental cost per DALY averted Ongoing
Secondary Outcome Incremental health system cost per DALY averted Ongoing
Secondary Outcome Incremental patient cost per DALY averted Ongoing
Secondary Outcome Projected reduction in TB incidence over 10 years Ongoing
Secondary Outcome Projected reduction in TB mortality over 10 years Ongoing
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bishop Asili unknown Luwero Uganda
Bukulula HC IV unknown Kalungu Uganda
Busana HC III Kayunga Kayunga Uganda
BusesaHC IV Iganga Iganga Uganda
Buwama HC III Mpigi Mpigi Uganda
Iganga TC HC Iganga Iganga Uganda
Kiganda HC IV Mubende Mubende Uganda
Kiira HC III Wakiso Wakiso Uganda
Kinoni HC III Lwengo Lwengo Uganda
Kiyerera HC IV Mayuge Mayuge Uganda
Lugasa HC III Kayunga Kayunga Uganda
Lwampanga HC III Nakasongola Nakasongola Uganda
Malangala HC III Mityana Mityanha Uganda
Malongo HC III Myuge Mayuge Uganda
Mayuge HC III Mayuge Mayuge Uganda
Naungalwe HC III Iganga Iganga Uganda
Nankandulo HC IV Kamuli Kamuli Uganda
Nazigo HC III Kayunga Kayunga Uganda
St Francis Njeru HC III Buikwe Buikwe Uganda
Wabulungu HC III Mayuge Mayuge Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
National Heart, Lung, and Blood Institute (NHLBI) NHLBI Health Information Center, P.O. Box 30105 Bethesda 20824-0105 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of California San Francisco 505 Parnassus Ave San Francisco 94143 United States of America University
Secondary Sponsor Makerere University College of Health Sciences Upper Mulago Hill Road Kampala Uganda University
COLLABORATORS
Name Street address City Postal code Country
Adithya Cattamanchi 1001 Potrero Ave, Room 5K1 San Francisco 94110 United States of America
Achilles Katamba Upper Mulago Hill Road Kampala Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adithya Cattamanchi adithya.cattamanchi@ucsf.edu 1-415-206-5489 1001 Potrero Ave, Room 5K1
City Postal code Country Position/Affiliation
San Francisco 94110 United States of America Associate Professor of Medicine, University of California San Francisco
Role Name Email Phone Street address
Principal Investigator Achilles Katamba axk95@case.edu 256-414-530-692 Upper Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala Uganda Senior Lecturer, Makerere University College of Health Sciences
Role Name Email Phone Street address
Public Enquiries Katherine Farr katherine.farr@ucsf.edu 17574340806
City Postal code Country Position/Affiliation
San Francisco 94110 United States of America Research Associate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information