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.: PACTR202311533798407 Date of Approval: 01/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Increasing disclosure of violence in surveys: a randomised trial of face-to-face interviewing versus audio-computer assisted self-interviewing
Official scientific title Increasing disclosure of violence in surveys: a randomised trial of face-to-face interviewing versus audio-computer assisted self-interviewing
Brief summary describing the background and objectives of the trial Evidence suggests that using audio-computer assisted self-interviewing (ACASI) may increase disclosure of both violence and other sensitive behaviours, compared to other data collection methods such as face-to-face-interviewing (FTFI). Limited research in school settings has also suggested this to be true. The objectives of the study are to: 1) determine whether disclosure of violence and other sensitive questions among students and teachers differs depending on whether data is collected by ACASI or FTFI; 2) to determine the ease of survey completion using ACASI compared to FTFI; and 3) determine how disclosure and ease of completion using ACASI compared to FTFI varies by characteristics of participants.
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 26/06/2023
Actual trial start date 26/06/2023
Anticipated date of last follow up 14/07/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 1080
Actual target sample size (number of participants) 935
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
16212 LSHTM
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 Audio computer assisted self interviewing Method of data collection used for a section of 1 hour survey Method of data collection where participants read questions and listen to pre-recorded questions through headphones and use a tablet to respond to questions themselves. 541
Control Group Face to face interviewing Method of data collection used for a section of 1 hour survey Participants respond verbally to researcher asking survey questions and interviewer completes the response on a handheld tablet. 394 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Students: Enrolled at participating schools Parents do not opt them out of the study Voluntary written informed consent/assent for participation from the child Staff: Employed as a teacher at participating school Provides voluntary written informed consent to participate in the study Students: Inability to speak or read either English or Luganda An inability to provide informed consent Having a significant cognitive impairment that would prevent them from completing the questionnaire. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,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
Makerere University, Mary Stuart Rd 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 LSHTM
Ethics Committee Address
Street address City Postal code Country
Keppel St, London London WC1E 7HT 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 30/07/2019 Uganda National Council of Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Rd, Kampala Kampala P.O. 6884 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Levels of disclosure of sexual violence, economic violence and gender norms among students, and use of physical discipline among teachers, using ACASI compared to FTFI At data collection - endline of wider trial
Secondary Outcome Ease of completion of questions using ACASI compared to FTFI At data collection - endline of wider trial
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 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 Jodie Pearlman jodie.pearlman@lshtm.ac.uk 02076368636 15-17 Tavistock Place
City Postal code Country Position/Affiliation
London WC1H 9SH United Kingdom Research Fellow
Role Name Email Phone Street address
Scientific Enquiries Jodie Pearlman jodie.pearlman@lshtm.ac.uk 02076368636 15-17 Tavistock Place
City Postal code Country Position/Affiliation
London WC1H 9SH United Kingdom Research Fellow
Role Name Email Phone Street address
Scientific Enquiries Mathew Amollo mamollo@africhild.or.ug +256414532482 Kigobe Rd
City Postal code Country Position/Affiliation
Kampala Uganda In country research manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonymised datasets from 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