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.: PACTR202009822379650 Date of Approval: 15/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Two-way risk communication mobile application versus traditional methods of adverse drug reaction reporting in Uganda: a randomized controlled trial
Official scientific title Two-way risk communication mobile application use versus traditional methods of adverse drug reaction reporting in Uganda: a cluster-randomized controlled trial
Brief summary describing the background and objectives of the trial We hypothesize that the use of a two-way risk communication mobile application for adverse drug reaction (ADR) reporting by healthcare professionals attending to people living with HIV (HIV) on dolutegravir-based (DTG) antiretroviral therapy (ART) and/or isoniazid preventive therapy (IPT) at selected ART-sites will increase the ADR-reporting-rate to Uganda's National Pharmacovigilance Centre by 25% when compared with the use of existing methods of ADR-reporting (paper-form and web-form) during 2.5 years of follow-up; from 2.6 to 3.3 DTG-linked ADR-reports per completed-month of follow-up per 100,000 person-months of treated-PLHIV; and from 1.0 to 1.25 IPT-linked ADR-reports per completed-month of follow-up per 100,000 person-months of treated-PLHIV.
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 HIV/AIDS,Tuberculosis
Purpose of the trial Mobile phone application for adverse drug reaction reporting
Anticipated trial start date 01/07/2020
Actual trial start date 01/07/2020
Anticipated date of last follow up 31/12/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 3820
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 Simple randomization using a randomization table created by a computer software program 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 Intervention arm Not applicable Follow-up for 30 months. Healthcare professionals (HCPs) at the intervention antiretroviral therapy sites (ART-sites) will be introduced to the mobile app and taught how to use it to report suspected adverse drug reactions (ADRs). Awareness campaigns for the mobile app will involve a multi-faceted approach including initial onsite face-to-face training, posters/brochures and monthly reminders via mobile-phone short messages (SMS) and WhatsApp, for 6-months. The HCPs will also be trained and encouraged to use traditional methods of ADR-reporting (paper-form and web-form). 191
Control Group Control arm Not applicable 30 months Healthcare professionals (HCPs) at the control sites will not be introduced to the mobile application. However, the HCPs will be trained and encouraged to use traditional methods of adverse drug reaction (ADR) reporting (paper-form and web-form). Paper-forms will be handed out and website details provided. HCPs will also be encouraged to report ADRs described to them by the people living with HIV under their care who receive ART. Also, monthly reminders via the short messaging system (SMS) and WhatsApp will be sent out periodically to the control group of HCPs, for 6-months. 191 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All health facilities where antiretroviral therapy is prescribed and dispensed to people living with HIV and at least one healthcare professional owns a smartphone. Health facilities where none of the healthcare professionals owns a smartphone. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 70 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 21/11/2019 School of Biomedical Sciences Research and Ethics Committee Makerere University College of Health Sciences
Ethics Committee Address
Street address City Postal code Country
Mulago Hill Road Kampala 256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of healthcare professional-reported adverse drug reactions per 100,000 person-months of treated-PLHIV per study arm End of follow-up
Secondary Outcome Number of app-ADR-reports per 1,000 app-downloads per completed-month of follow-up End of follow-up
Secondary Outcome Completeness score of ADR-report End of follow-up
Secondary Outcome Causality of ADR End of follow-up
Secondary Outcome Seriousness of ADR End of follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The 382 Randomized Antiretroviral Therapy Sites in Uganda Uganda Entire country Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Makerere University Research and Innovations Fund Makerere Hill Kampala Uganda
Medical Research Council London London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Makerere University Mulago Kampala Uganda University
Primary Sponsor Medical Research Council London London United Kingdom Funding Agency
COLLABORATORS
Name Street address City Postal code Country
National Drug Authority Uganda Lumumba Avenue Kampala Uganda
Medicines and Healthcare products Regulatory Agency Buckingham Palace Road London United Kingdom
World Health Organization Geneva Geneva Switzerland
University of Liverpool Liverpool Liverpool United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ronald Kiguba kiguba@gmail.com 00256700840683 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 Victoria Nambasa vnambasa@nda.or.ug 00256772834126 Lumumba Avenue
City Postal code Country Position/Affiliation
Kampala Uganda Pharmacovigilance Manager National Drug Authority
Role Name Email Phone Street address
Scientific Enquiries Ronald Kiguba kiguba@gmail.com 00256700840683 Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala Uganda Senior Lecturer Makerere University College of Health Sciences
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collected during the study will be available after de-identification immediately after publication and without an end date to anyone who accesses the data. The data will be available indefinitely on a link that will be provided. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately after publication and with no end date. Anyone who wishes to access the data.
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