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.: PACTR202205876377808 Date of Registration: 13/05/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title WISECAP Study
Official scientific title Comparing adherence to MDR-TB treatment among patients on self-administered therapy and those on Directly Observed Therapy: Non inferiority Randomized Controlled Trial.
Brief summary describing the background and objectives of the trial Multi-drug tuberculosis (MDR-TB) is of public health concern. The success in treatment is dependent on adherence to therapy. The standard of care is Directly Observed Therapy (DOTS), but it is costly to implement, burdensome to the healthcare system and limits patient autonomy. Differentiated service delivery may help address these limitations of DOTS and help improve adherence to treatment and hence outcomes. Primary Objectives 1. To determine if adherence to MDR-TB treatment among patients on self-administered therapy (measured by Medication Events Monitoring System (MEMS) technology) is non-inferior to that among patients on Directly Observed Therapy (DOT) Secondary objectives 1. To determine the correlation between serum MDR-TB drug concentrations and adherence as measured by MEMS technology 2. To compare treatment outcomes between MDR-TB patients on self-administered therapy and DOT
Type of trial RCT
Acronym (If the trial has an acronym then please provide) WISECAP
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Treatment: Devices
Anticipated trial start date 30/10/2021
Actual trial start date 17/11/2021
Anticipated date of last follow up 29/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 164
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
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group MEMSCAP and EDP medicine box Dependent on duration of MDR-T oral therapy 12-18 months Use of a adherence technology in form of a MEMSCAP and EDP medicine box to house oral MDR-TB drugs for patients self administering therapy and remotely monitor adherence by taking count of the number of times a medicine container is opened 82
Control Group Standard of Care Directly Observed Therapy For the duration of therapy on oral MDR-TB treatment which ranges from 12-18months Patients have to report back everyday to be observed by health worker as they ingest their MDR-TB medicines. A TB treatment card is used to track adherence to treatment. 82 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Newly diagnosed patient of pulmonary MDR-TB and or Rifampicin resistant TB aged 8 years and above. 2. Patients being initiated on the oral MDR-TB treatment 3. Evidence of a personally signed and dated informed consent document (or a legal representative). 1. Patients with any condition that inhibits the use of the MEMS device e.g. dexterity or debilitating arthritis. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 8 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 26/09/2021 Mulago Hospital Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Old Mulago Hill Road Kampala Central 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 20/10/2021 Uganda National Council of Science and Technology
Ethics Committee Address
Street address City Postal code Country
Kimera Road Kampala 6884 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 09/08/2021 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Lumumba Avenue Kampala 23096 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Overall adherence rates among MDR-TB patients on self-administered therapy and on DOT At study end
Secondary Outcome 1. Correlation between serum MDR_TB drug concentrations and adherence data for patients on self-administered therapy and DOT 2,8 and 11 months of therapy
Secondary Outcome Sputum conversion 2, 8 and 11 months in both arms
Secondary Outcome MDR-TB outcomes (cure, treatment completion, loss to follow-up or death) in each arm At study end
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
TB clinic Mulago National Referral Hospital Old Mulago Hill Road Kampala Uganda
Lira Regional Referral Hospital Ngetta Police road Lira Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Janssen Global Public Health Turnhoutseweg Antwerp B-2340 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Infectious Diseases Institute Makerere University Old Mulago Hill Road Kampala Uganda Non Profit Research Institute
COLLABORATORS
Name Street address City Postal code Country
Mulago Hospital Old Mulago Hill Road Kampala Uganda
Lira Regional Referral Hospital Ngeta Police Road Kampala Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Clara Wekesa cwekesa@idi.co.ug +256772342181 Old Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala Uganda Trial Manager
Role Name Email Phone Street address
Principal Investigator Susan Adakun adakunsusan@gmail.com +256772391455 Old Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala Uganda Principle Investigator
Role Name Email Phone Street address
Public Enquiries Rosalind Parkes Ratanshi rratanshi@idi.co.ug +256752323253 Old Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala Uganda Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All participant data collected during the trial after de-identification Informed Consent Form,Study Protocol Immediately following publication Researchers that provide a methodologically sound proposal
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