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.: PACTR201808609844917 Date of Approval: 31/08/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title From Directly-Observed Therapy (DOT) to Digital Adherence Technology (DAT) for TB Treatment
Official scientific title From Directly-Observed Therapy (DOT) to Digital Adherence Technology (DAT) for TB Treatment
Brief summary describing the background and objectives of the trial Stepped-wedge randomized trial at 18 TB treatment units in Uganda (3 health centers, 15 hospitals). Aim 1: Determine whether a 99DOTS-based intervention improves TB treatment outcomes. Eighteen TB treatment units will be included in a stepped-wedge randomized trial (SWT) of the 99DOTS-based intervention strategy. The primary outcome will be the proportion of patients completing treatment successfully. Key secondary outcomes will include persistence (proportion of patients remaining on treatment at 2 months), and proportion lost to follow-up. Aim 2: Evaluate reach, adoption and implementation of the 99DOTS-based intervention. During the intervention period at each site, we will assess the proportion of eligible patients registered on 99DOTS. We will also use quantitative metrics to assess adoption and implementation of each component of the 99DOTS-based intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DOT to DAT
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 01/12/2018
Anticipated date of last follow up 30/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 3060
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003628
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 a randomization 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 Control Until randomized into intervention arm Routine community- or facility-based DOTS treatment 1530 Active-Treatment of Control Group
Experimental Group Intervention Once randomized into intervention arm 1) Confirmation of dosing via toll-free phone calls using 99DOTS; 2) SMS dosing reminders to patients delivered via 99DOTS; 3) Weekly two-way check-in via SMS or interactive voice response using 99DOTS; 4) Differential management based on dosing history and response to weekly check-in. 1530
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Site-level Inclusion Criteria: 1. Diagnosed >10 PTB patients/month in 2017; 2. Not located within Kampala District; 3. Located within 225km of Kampala city; 4. PTB treatment success rate in 2016 of <80% Patient-level Inclusion Criteria: 1. Initiating Category I treatment for active pulmonary TB at a study facility during the study period Site-level Exclusion Criteria: 1. Do not agree to participate in the trial Patient-level Exclusion Criteria: 1. Diagnosed with extra-pulmonary TB; 2. Diagnosed with or referred for evaluation of drug-resistant TB; 3. Does not own a mobile phone with SMS capabilities 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 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 15/06/2018 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 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 19/06/2018 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road, Ntinda Kampala 00000 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion treated successfully Trial duration
Secondary Outcome Proportion with persistence Trial duration
Secondary Outcome Proportion lost to follow-up Trial duration
Secondary Outcome Proportion enrolled on 99DOTS Trial duration
Secondary Outcome Proportion of scheduled doses confirmed by phone call Trial duration
Secondary Outcome Proportion of daily SMS sent by 99DOTS platform Trial duration
Secondary Outcome Proportion of daily SMS received on patient handset Trial duration
Secondary Outcome Proportion of weekly SMS sent by 99DOTS platform Trial duration
Secondary Outcome Proportion of weekly SMS received on patient handset Trial duration
Secondary Outcome Proportion of weekly SMS to which patients send a response Trial duration
Secondary Outcome Proportion of patients followed-up via phone call or home visit if responding No or not responding to weekly check-in Trial duration
Secondary Outcome Proportion of patients called or visited by DTU staff/CHW when missing >2 consecutive doses Trial duration
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bugiri Hospital Bugiri Town Council Bugiri Uganda
Kawolo Hospital Lugazi Town Council Buikwe Uganda
Gombe Hospital Gombe Town Council Butambala Uganda
Hoima Regional Referral Hospital Kahoora Division Hoima Uganda
Iganga Hospital Iganga Central Division Iganga Uganda
Jinja Regional Referral Hospital JMC West HSD Jinja Uganda
Kamuli Hospital Kamuli Town Council Kamuli Uganda
Kayunga Hospital Kayunga Town Council Kayunga Uganda
Masaka Regional Referral Hospital Kimanya-Kyabakuza Division Masaka Uganda
Buluba Hospital Baitambogwe Subcounty Mayuge Uganda
Kigandalo Health Center IV Kigandalo Subcounty Mayuge Uganda
Mbale Regional Referral Hospital Mbale Northern Division Mbale Uganda
Mityana Hospital Mityana Town Council Mityana Uganda
Mubende Regional Referral Hospital Mubende Town Council Mubende Uganda
Mukono Town Council Health Center IV Mukono Central Division Mukono Uganda
Kasangati Health Center IV Nangabo Subcounty Wakiso Uganda
Mildmay Uganda Hospital Ssabagabo-Makindye Subcounty Wakiso Uganda
Entebbe Hospital Entebbe Division A Wakiso Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
United Nations Office for Project Services Marmorvej 51, PO Box 2695 Copenhagen 2100 Denmark
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 Kampala 00000 Uganda University
COLLABORATORS
Name Street address City Postal code Country
Adithya Cattamanchi 001 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
Scientific Enquiries Adithya Cattamanchi adithya.cattamanchi@ucsf.edu +14152065489 1001 Potrero Ave, Room 5K1
City Postal code Country Position/Affiliation
San Francisco 94110 United States of America Associate Professor of Medicine
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 Rebecca Crowder rebecca.crowder@ucsf.edu +16282219063 1001 Potrero Ave, Room 5K1
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
Undecided
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 07/11/2019 Removing the secondary outcome conversion. We are using routine data, and two month smears have not been done in most patients, so the data is not available. Stepped-wedge randomized trial at 18 TB treatment units in Uganda (3 health centers, 15 hospitals). Aim 1: Determine whether a 99DOTS-based intervention improves TB treatment outcomes. Eighteen TB treatment units will be included in a stepped-wedge randomized trial (SWT) of the 99DOTS-based intervention strategy. The primary outcome will be the proportion of patients completing treatment successfully. Key secondary outcomes will include persistence (proportion of patients remaining on treatment at 2 months), conversion (proportion of bacteriologically-positive patients who are smear-negative at 2 months) and proportion lost to follow-up. Aim 2: Evaluate reach, adoption and implementation of the 99DOTS-based intervention. During the intervention period at each site, we will assess the proportion of eligible patients registered on 99DOTS. We will also use quantitative metrics to assess adoption and implementation of each component of the 99DOTS-based intervention. Stepped-wedge randomized trial at 18 TB treatment units in Uganda (3 health centers, 15 hospitals). Aim 1: Determine whether a 99DOTS-based intervention improves TB treatment outcomes. Eighteen TB treatment units will be included in a stepped-wedge randomized trial (SWT) of the 99DOTS-based intervention strategy. The primary outcome will be the proportion of patients completing treatment successfully. Key secondary outcomes will include persistence (proportion of patients remaining on treatment at 2 months), and proportion lost to follow-up. Aim 2: Evaluate reach, adoption and implementation of the 99DOTS-based intervention. During the intervention period at each site, we will assess the proportion of eligible patients registered on 99DOTS. We will also use quantitative metrics to assess adoption and implementation of each component of the 99DOTS-based intervention.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 30/09/2020 Dec 2018 was the first month of the trial when all sites were in the baseline period. October and November 2018 were included as pre-trial baseline months in the analysis. 01 Dec 2018
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 14/05/2020 Some patients did not finish treatment within 6 months. We anticipate all trial patients will be assigned an outcome by June 30, 2020. 01 Jun 2019 30 Jun 2020
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Publication URL 11/02/2022 Results published https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003628
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 07/11/2019 We are using routine data, and two month smears have not been done in most patients, so the data is not available. Secondary Outcome, Proportion converted, Trial duration
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 11/02/2022 Replaced previous staff Public Enquiries, Katherine, Farr, Ms., katherine.farr@ucsf.edu, , +16282219063, 1001 Potrero Ave, Room 5K1, San Francisco, 94110, United States of America, Research Associate Public Enquiries, Rebecca, Crowder, Ms., rebecca.crowder@ucsf.edu, , +16282219063, 1001 Potrero Ave, Room 5K1, San Francisco, 94110, United States of America, Research Associate