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: www.pactr.org
Trial no.: PACTR201711002758216 Date of Approval: 13/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of stickers on road traffic crashes
Official scientific title Impact of new RTSA stickers in Public Service Vehicles (PSVs) on road traffic crashes involving buses: an impact evaluation
Brief summary describing the background and objectives of the trial Given the alarmingly high rate of road traffic accidents involving minibuses and big buses within Zambia, there is a need to mitigate this through multiple measures. One of the most promising interventions is a sticker campaign that was proven effective in Kenya; based on this study, RTSA has developed new stickers that potentially have a two-pronged effect by reminding both passengers and drivers of the dangers of reckless driving of buses. Thus the stickers either encourage passengers to speak up to their bus drivers alerting them to reduce speed or drive carefully, or having the driver drive more responsibly. This study will provide evidence on the impact of the new RTSA sticker program on road traffic crashes as implemented through minibuses and big buses, that can help inform the scale up of a national ┬┐Zambia sticker campaign┬┐.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Road Traffic Crashes
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/11/2017
Actual trial start date 20/10/2017
Anticipated date of last follow up 30/04/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 2320
Actual target sample size (number of participants) 2247
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
2017-Aug-024 ERES Converge
Pro00022769 Chesapeake IRB
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised To randomize the sticker placement, RTSA will place the new sticker only in buses with licenses plates ending with an even number (intervention arm) while buses with a license plate ending with an odd number will be considered for the control arm. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Speak Out Sticker 1 7 months This study aims to evaluate the new sticker campaign, which highlights the dangers of reckless driving and proposes the passengers speak out to their bus drivers alerting them to reduce speed or drive carefully, or having the driver drive more responsibly. These stickers will be placed in buses ensuring that at least one sticker is within eye view of each passenger in the vehicle. 1160
Control Group Standard Practice 1 7 months Standard practice and no new stickers will be placed in these buses. 1160 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be included the PSV must be a licensed operator i.e. with a registration number plate and; Must be insured with one of the companies listed in this study PSVs will not be included in the study if they are not insured with any of the companies listed in this study; and Do not have a license to operate as a PSV. 0 Year(s) 0 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 20/10/2017 ERES Converge
Ethics Committee Address
Street address City Postal code Country
33 Joseph Mwilwa Road Lusaka 0 Zambia
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 24/08/2017 Chesapeake IRB
Ethics Committee Address
Street address City Postal code Country
6940 Columbia Gateway Drive Suite 110 Columbia 21046 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in accident rate per 1000 buses over a 14-month period during 7-month period of study or 7-months prior to study
Secondary Outcome Change in the accident rate per 1000 buses overtime for a 14-month period (monthly analysis) each month for the 7-month period of study or 7-months prior to study
Secondary Outcome Change in accidents resulting in fatalities per 1000 buses over a 14-month period the period of the study as compared to the 7 months prior to the study
Secondary Outcome Mean number of road traffic crashes period of the study as compared to the 7 months prior to the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kitwe bus terminals Kitwe 0 Zambia
Kabwe Bus Terminals Kabwe 0 Zambia
Livingstone Bus Terminals Livingstone 0 Zambia
Lusaka bus terminals Lusaka 0 Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Department for International Development (DFID) Abercrombie House Eaglesham Road East Kilbride G75 8EA United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Road Transport and Safety Agency Lusaka 0 Zambia Commercial Sector/Industry
Primary Sponsor Clinton Health Access Initiative - Zambia 175 Kudu Road, Kabulonga Lusaka 0 Zambia Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Sandra Mudhune 175 Kudu Road, Kabulonga Lusaka 0 Zambia
Chuncky Kanchele Road Transport and Safety Agency Lusaka 0 Zambia
Sydney Phiri 175 Kudu Road, Kabulonga Lusaka 0 Zambia
Prudence Haimbe 175 Kudu Road, Kabulonga Lusaka 0 Zambia
Hilda Shakwelele 175 Kudu Road, Kabulonga Lusaka 0 Zambia
Marta Prescott 383 Dorchester Ave Boston 02127 United States of America
Margaret Prust 383 Dorchester Ave Boston 02127 United States of America
Elizabeth McCarthy 383 Dorchester Ave Boston 02127 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sandra Mudhune smudhune@clintonhealthaccess.org 260960349758 175 Kudu Road, Kabulonga
City Postal code Country Position/Affiliation
Lusaka 0 Zambia Senior Evaluation Manager
Role Name Email Phone Street address
Public Enquiries Phiri Sydney sphiri@clintonhealthaccess.org +26 0211 267 985 175 Kudu Road, Kabulonga
City Postal code Country Position/Affiliation
Lusaka 0 Zambia Senior Evaluation Coordinator
Role Name Email Phone Street address
Scientific Enquiries Mudhune Sandra smudhune@clintonhealthaccess.org 260960349758 175 Kudu Road, Kabulonga
City Postal code Country Position/Affiliation
Lusaka 0 Zambia Senior Evaluation Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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
Ethics IsApprovedByEC 16/11/2017 edit true true
Section Name Field Name Date Reason Old Value Updated Value
Ethics IsApprovedByEC 16/11/2017 yes true true
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 09/07/2018 pactr update Not Applicable