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.: PACTR202403586718783 Date of Approval: 20/03/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Multi-mOnth Refill of Anti-TB Drugs (MORAD) study in rural eastern Uganda
Official scientific title Effectiveness of multi-month dispensing of anti-TB drugs on treatment success among people with drug-susceptible TB aged ≥15 years on the standard 6-month anti-TB regimen in rural eastern Uganda
Brief summary describing the background and objectives of the trial Multi-MOnth Refill of Anti-TB Drugs (MORAD) study will focus on the practicability and effectiveness of multi-month refill of anti-TB drugs (MULTI-DAT) among people with drug-susceptible pulmonary TB (PTB) aged ≥15 years on the standard 6-month anti-TB treatment regimen in eastern Uganda. In this study, we propose a novel and innovative approach to reducing frequent health facility visits. We hypothesize that reducing frequent health facility visits will help to overcome physical and economic barriers that deter people with TB from picking up their medication. This will lead to better adherence to anti-TB medications and optimal treatment outcomes. In this approach, we will dispense anti-TB drugs to cover more than two months compared to the current standard of one month, a phenomenon called multi-month dispensing of anti-TB drugs (MULTI-DAT) in the context of this study. Multi-month dispensing is recommended by the Uganda Ministry of Health under the differentiated anti-retroviral therapy (ART) delivery models for people living with HIV (PLHIV) regardless of their TB status, provided one is stable on ART. The trial objectives are 1) To explore stakeholder perceptions regarding the relevance and appropriateness of MULTI-DAT including the delivery of MULTI-DAT among people with drug-susceptible PTB aged ≥15 years using a qualitative study design (Aim 1); 2) To evaluate the effectiveness of MULTI-DAT on the TB treatment success at month 6 compared to the standard of care (SOC) using a non-inferiority, open-label, individually randomized controlled trial or RCT (Aim 2).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 17/06/2024
Actual trial start date
Anticipated date of last follow up 09/05/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 260
Actual target sample size (number of participants)
Recruitment status Not yet 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
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Multimonth refill of antituberculosis drugs Monthly anti-TB refills of isoniazid, rifampicin, pyrazinamide, and ethambutol (2HRZE/4RH) for two months followed by a 2-month refill for twice, totaling 4 visits. 6 months All participants will receive a standard 6-month anti-TB regimen comprising rifampicin, isoniazid, pyrazinamide, and ethambutol for 2 months, followed by RH for 4 months (2RHZE/4RH), same key TB messages according to national guidelines, and Medication Event Reminder Monitor (MERM) to track adherence to TB medications. Intervention participants will receive monthly anti-TB refills for two months followed by a 2-month refill for twice, totaling 4 visits. 130
Control Group Standard of care Bi-weekly anti-TB refills consisting of isoniazid, rifampicin, pyrazinamide, and ethambutol (2RHZE/4RH) for 2 months and monthly refills for 6 months, totaling 8 visits. 6 months Control participants will receive a standard of care consisting of bi-weekly anti-TB refills for 2 months and monthly refills for 6 months, totaling 8 visits. 130 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Aim 1: 1) TB focal persons with ≥1 year of work experience; 2) Other stakeholders with ≥3 years of work experience in TB; 3) People with TB on treatment for ≥4 months including the respective treatment supporters. Aim 2: People with drug-susceptible PTB aged ≥15 years. Aim 1 1) Unreachable participants Aim 2: 1) People with TB who are very ill and require close clinical and laboratory monitoring or hospitalization; 2) People with PTB likely to migrate to another district/ or place during the study period; 3) Treated with anti-TB drugs for ≥2 months; 4) People with drug-resistant TB; 5) People with extrapulmonary TB since treatment duration exceeds 6 months. 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) 15 Year(s) 80 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 19/02/2024 Makerere University Infectious Disease Institute REC
Ethics Committee Address
Street address City Postal code Country
Mulago Hpspital Kampala 22418 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Treatment success measured at 6 months following TB treatment. 6 months following treatment/post-treatment.
Secondary Outcome Sputum smear conversion measured at 2 months following TB treatment initiation among people with bacteriologically confirmed pulmonary TB. 2 months following TB treatment initiation.
Secondary Outcome Sputum smear conversion measured at 6 months following TB treatment initiation among people with bacteriologically confirmed pulmonary TB. 6 months following TB treatment initiation.
Secondary Outcome Monthly anti-TB adherence rate calculated as the number of pills taken divided by the number expected to have been taken, expressed as a percentage. Adherence rates <85% will be considered poor, 85-94% as good, and ≥95% as excellent. Months 1, 2, 3, 4, 5, and 6
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Soroti Hospital Soroti Soroti Uganda
Princess Diana Health Center IV Soroti Soroti Uganda
Tiriiri Health Center Soroti Soroti Uganda
Kumi Hospital Kumi Kumi Uganda
Atutur Hospital Kumi Kumi Uganda
Ngora Health Center Ngora Ngora Uganda
Ngora Hospital Ngora Ngora Uganda
Kumi Health Center IV Kumi Kumi Uganda
Serere Hospital Serere Serere Uganda
Apapai HC IV Apapai Serere Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Center for Effective Global Action University of California Berkeley 207 Giannini Hall, Berkeley, CA 94720 Berkeley United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of California Berkeley 207 Giannini Hall, Berkeley, CA 94720 Berkeley United States of America University
COLLABORATORS
Name Street address City Postal code Country
Prof. Adithya Cattamanchi San Francisco, UCSF, CA San Francisco United States of America
Dr. Francis Bajunirwe Kabala road Mbarara 1410 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jonathan Izudi jonahzd@gmail.com +256782097744 Kabale road
City Postal code Country Position/Affiliation
Mbarara 1410 Uganda Mbarara University of Science and Technology
Role Name Email Phone Street address
Scientific Enquiries Stephen Okoboi sokoboi@idi.co.ug +256704817590 Mulago Hospital
City Postal code Country Position/Affiliation
Kampala 22418 Uganda Research Scientist Infectious Diseases Institute Makerere University
Role Name Email Phone Street address
Public Enquiries Damazo Kadengye dkadengye@aphrc.org +256773465282 Kitisuru, Kenya
City Postal code Country Position/Affiliation
Nairobi Kenya Research Scientist African Population and Health Research Center
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes For this MORAD study, 2 years after the publication of results, de-identified individual participant data (IPD) will be shared. The trial data will be available to researchers with a reasonable interest in conducting a secondary analysis after submitting a 1-page concept detailing the rationale and proposed analytic approach. For such purposes, all requests will be directed to Dr. Jonathan Izudi (MPH, MS, Ph.D) via email (jonahzd@gmail.com) and will be reviewed by the Makerere University Infectious Disease Institute Research Ethics Committee (IDI-REC) that will then grant such individuals data access. In addition, the individuals will sign data access agreements and confirm by written signature that the trial data will be used for the intended purpose. Analytic Code,Statistical Analysis Plan June 2025 Accessible upon reasonable request and REC approval
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