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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202009826515511 Date of Registration: 16/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Good Schools Toolkit – Secondary Schools (GST-S) pilot trial
Official scientific title Good Schools Toolkit – Secondary Schools (GST-S) pilot trial
Brief summary describing the background and objectives of the trial The Good School Toolkit - Secondary Schools is a whole-school intervention to prevent physical, sexual and emotional violence against students, from school staff, peers, and within student intimate partnerships. The aims of the trial are: 1. To refine and finalise the GST-S intervention, ensuring acceptability and understanding 2. To understand feasibility of delivery of the intervention 3. To explore design parameters for a subsequent phase 3 trial
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 25/11/2019
Actual trial start date
Anticipated date of last follow up 15/09/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 8
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group GSTS Over 3 school terms Educational and behavioural intervention 4
Control Group Control arm Over 3 school terms Treatment as usual 4 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Schools with >=500 students >50% day students mixed sex For data collection: willingness to participate ability to provide informed consent Schools with <500 students <50% day students Single sex Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 11 Year(s) 65 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 30/08/2019 Mildmay Uganda Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Plot 27, Lweza Kampala 24985 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 04/09/2019 London School of Hygiene and Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Keppel Street London 1000 United Kingdom
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 07/10/2019 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Kampala 6884 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Whether criteria for progression to a phase 3 trial are met. This will defined based on acceptability and understanding of key intervention content with staff and students, implementation with fidelity in intervention schools, school agreement to participate, be randomised and participate in endline data collection, and student participation in endline survey. At all points in recruitment and data collection process and at endline data collection
Secondary Outcome Prevalence of sexual, emotional and physical violence experienced from different perpetrators in different time frames to inform planning for a phase 3 trial. Baseline and endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AfriChild Centre Makerere University, Mary Stuart Rd Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
UK Medical Research Council 14Th Floor One Kemble Street, London, WC2B 4AN London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor LSHTM Keppel Street London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
AfriChild Centre Makerere University, Mary Stuart Road, Kampala Uganda
Raising Voices Plot 16, P.O Box 6770 Tufnell Dr Kampala Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Karen Devries karen.devries@lshtm.ac.uk +442079588164 15-17 Tavistock Place, London, WC1H 9SH
City Postal code Country Position/Affiliation
London United Kingdom Professor of Social Epidemiology
Role Name Email Phone Street address
Public Enquiries Clare Tanton clare.tanton@lshtm.ac.uk +442079588393 15-17 Tavistock Place, London, WC1H 9SH
City Postal code Country Position/Affiliation
London United Kingdom Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Clare Tanton clare.tanton@lshtm.ac.uk +442079588393 15-17 Tavistock Place, London, WC1H 9SH
City Postal code Country Position/Affiliation
London United Kingdom Assistant Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonymised datasets from baseline and endline surveys from teachers and students. Statistical Analysis Plan Data will be archived 10 years after the end of the study. Supporting documents will be open access. Anonymised data will be controlled access with access decided by the research team based on the quality of the request.
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