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.: PACTR201906852160014 Date of Approval: 03/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluating the Impact of Cash Transfers on Tuberculosis (TB) Care: ExaCT TB Study
Official scientific title Evaluating the Impact of Cash Transfers on Tuberculosis (TB) Care: ExaCT TB Study
Brief summary describing the background and objectives of the trial Stepped wedge trial conducted among patients undergoing TB diagnostic evaluation in 10 community health centers (HC IV) in Uganda. The overall objective of this study is to test the feasibility and effectiveness of a cash transfer intervention on improving TB diagnostic evaluation outcomes. Objective 1: To test the feasibility and effectiveness of a cash transfer intervention on improving TB diagnostic evaluation outcomes. We will abstract information from patient records in order to compare the effectiveness of the intervention based on the numbers and proportions of patients treated for microbiologically-confirmed TB within two weeks of referral for sputum-based testing. Objective 2: To evaluate the economic impact of a cash transfer intervention on patients suspected of having tuberculosis in Uganda. Objective 3: To assess the utility of a cash transfer intervention on overcoming barriers to TB diagnostic evaluation among patients suspected of having TB in Uganda.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ExaCT TB
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/06/2019
Actual trial start date 01/06/2020
Anticipated date of last follow up 31/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 6500
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intervention period The intervention consists of one cash transfer occurring once at the time of sputum submission. The intervention period will last 7 months at each site and will be rolled out in a stepped wedge trial design. The intervention is a cash transfer at the time of sputum submission. 3500
Control Group Control Period The control period at each of the sites will be of different length depending on when they enter into the intervention period, but ranges anywhere from 4-8 months. Patients will receive standard-of-care treatment at participating sites. 3000 Active-Treatment of Control Group
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 and/or GeneXpert testing as the primary method of TB diagnosis 2. (Patient-level): Aged ≥18 years 3. (Patient-level): Initiate evaluation for active pulmonary TB at a community health center (HC IV) enrolled in the study 4. (Provider-level): All providers (e.g., physicians, nurse practitioners, midwives, laboratory staff) (a) aged ≥18 years; (b) employed by the community health center (HC IV); and (c) involved in the conduct or supervision of health center work related to diagnosis and management of TB 1. (Site-level) Do not agree to participation 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. (Site-level) Have on-going economic support program(s) for patients 5. (Patient-level) Have sputum collected for monitoring of response to anti-TB therapy 6. (Patient-level) Have sputum collected as part of active, community-based case finding (e.g., contact tracing, community outreach campaign) 7. (Patient-level) Referred to a study health center for TB treatment after a diagnosis is established elsewhere 8. (Patient-level) Started on TB treatment for extra-pulmonary TB only 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(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 11/09/2019 University of California San Francisco Human Research Protection Program
Ethics Committee Address
Street address City Postal code Country
Box 0962 3333 California Street, Suite 315 San Francisco 94143 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 30/05/2019 Makerere University College of Health Sciences School of Public Health
Ethics Committee Address
Street address City Postal code Country
New Mulago Hill Rd Kampala 00000 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion treated for microbiologically-confirmed TB within two weeks of initial submission of sample for sputum-based testing 14 days after diagnosis
Secondary Outcome Proportion completing testing After the intervention period is over
Secondary Outcome Number diagnosed with microbiologically-confirmed TB* Within 1 day of initial sputum submission and within 14 days of initial sputum submission
Secondary Outcome Proportion diagnosed with microbiologically-confirmed TB* Within 1 day of initial sputum submission and within 14 days of initial sputum submission
Secondary Outcome Number suspected/diagnosed with RIF-resistant TB* Within 1 day of initial sputum submission and within 14 days of initial sputum submission
Secondary Outcome Proportion suspected/diagnosed with RIF-resistant TB* Within 1 day of initial sputum submission and 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 and within 14 days of initial sputum submission
Secondary Outcome Proportion treated for TB Within 1 day of initial sputum submission and within 14 days of initial sputum submission
Secondary Outcome Number treated for microbiologically-confirmed TB Within 1 day of initial sputum submission and 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 and 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 Patient costs (total costs, direct costs, indirect costs) Post-intervention data collection
Secondary Outcome Intervention arm process metrics Post-intervention data collection
Secondary Outcome Patient satisfaction with care survey (general satisfaction with care, convenience of services, health facility environment, provider interpersonal skills, provider technical competence) Post-intervention data collection
Secondary Outcome Provider survey (intention, attitudes/beliefs, social norms/expectations, self-efficacy/ behavioral control) Last month of the intervention at each site
Primary Outcome Number initiating treatment for microbiologically-confirmed TB within two weeks of submission of sample for sputum-based testing 14 days after diagnosis
Secondary Outcome Number referred for TB testing After the intervention period is over
Secondary Outcome Proportion who receive cash transfer at time of sputum submission Within 14 days of diagnosis
Secondary Outcome Time to cash transfer Time from patient sputum submission to cash transfer deployment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bale HC IV NA Kayunga Uganda
Bukomero HC IV NA Kiboga Uganda
Kangulumira HC IV NA Kayunga Uganda
Kasangati HC IV NA Wakiso Uganda
Kyanamukaka HC IV NA Makasa Uganda
Ndejje HC IV NA Wakiso Uganda
Kalagala HC IV NA Luwero Uganda
Kanoni HC III NA Gomba Uganda
Kojja HC IV NA Mukono Uganda
Nakasongola HC IV NA Nakasongola Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Government of Sweden Karolinska Institutet SE-171 77 Stockholm Sweden
Parker B. Francis Fellowship Program 800 W. 47th Street, Suite 717 Kansas City 64112 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
Priya Shete 1001 Potrero Ave, Room 5K1 San Francisco 94110 United States of America
Adithya Cattamanchi 1001 Potrero Ave, Room 5K1 San Francisco 94110 United States of America
Achilles Katamba Upper Mulago Hill Road Kampala Uganda
Noah Kiwanuka Upper Mulago Hill Road Kampala Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Priya Shete priya.shete@ucsf.edu +14152064964 1001 Potrero Ave, Room 5K1
City Postal code Country Position/Affiliation
San Francisco 94110 United States of America Assistant Professor University of California San Francisco
Role Name Email Phone Street address
Principal Investigator Achilles Katamba axk95@case.edu 256414530692 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 Jillian Kadota jillian.kadota@ucsf.edu 4154761248 1001 Potrero Ave, Room 5K1
City Postal code Country Position/Affiliation
San Francisco 94110 United States of America Research Associate
Role Name Email Phone Street address
Scientific Enquiries Priya Shete priya.shete@ucsf.edu +14152064964 1001 Potrero Ave, Room 5K1
City Postal code Country Position/Affiliation
San Francisco 94110 United States of America Assistant Professor University of California San Francisco
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes At a minimum, summary results or a link to summary results within the trial registration record. Study Protocol Within 12 months of the study completion date. Requests for study data will be made to the principal investigator and decisions to share data will be made by the trial steering committee. Access for secondary analyses of study data be determined by the quality of the request and all analyses will be approved by the principal investigator. All manuscripts pertaining to this data will include recognition of principal investigator and the original study data source.
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