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.: PACTR201702002028911 Date registered: 09/02/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Safe School Project
Official scientific title Reducing Incidences of Sexual Assault And Pregnancy Related School Drop-Out Among Teenage Girls In Lilongwe, Salima And Dedza
Brief summary describing the background and objectives of the trial This study will investigate pregnancy related school dropout in schools where adolescent girls 13-20 years old will be part of a study on the efficacy of a sexual assault prevention intervention ┬┐IMpower┬┐ in January of 2015 to January of 2017.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied violence against women and girls
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/01/2015
Actual trial start date 16/02/2015
Anticipated date of last follow up 31/01/2017
Actual Last follow-up date 31/05/2016
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 7832
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
nil known NATIONAL COMMISSION ON SCIENCE AND TECHNOLOGY, MALAWI
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
Randomised Stratified randomization was done at the district and school levels. Using a probabilistic algorithm, we assigned schools into either the control or treatment arms based on school size. Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IMpower 12 Hours 6 weeks Empowerment self defense for girls to prevent sexual assault 3812 Active-Treatment of Control Group
Control Group Malawi Government Standard Life Skills 2 hours 1 week Standard 2-hour Malawian school Life skills program covering adolescent health 4020
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Primary school girls class 5-7 Secondary schools girls form 1-3 Primary schools girls class 8 Secondary school girls Form 4 8 Year(s) 26 Year(s) Female
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 11/02/2015 NATIONAL COMMISSION ON SCIENCE AND TECHNOLOGY
Ethics Committee Address
Street address City Postal code Country
CITY CENTER Lilongwe Private bag B303 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Prevalence and incidence of sexual assault Baseline 10.5 month follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lilongwe PO BOX 1318 Lilongwe NA Malawi
Salima PO BOX 1318 Lilongwe NA Malawi
Dedza PO BOX 1318 Lilongwe NA Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
unicef Area 40/31 Lilongwe 30375 Malawi
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ujamaa Pamodzi PO Box 1318, Area 47 Sector 3, Ngombe Kwawa Drive Lilongwe Malawi Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
unicef Area 40/31 Lilongwe 30375 Malawi
Johns Hopkins Bloomberg School of Public Health 615 N Wolfe St. Baltimore, MD 21205 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jacob Sinclair jsinclair@ujamaa-africa.org +1 415 518 7319 1011 Shotwell St.
City Postal code Country Position/Affiliation
San Francisco, CA 94110 United States of America Co-Founder, Ujamaa
Role Name Email Phone Street address
Public Enquiries Martin Ndirangu ndirangumartin38@gmail.com +265 993 130 111 P.O. Box 1318
City Postal code Country Position/Affiliation
Lilongwe Malawi Director, Ujamaa-Pamodzi
Role Name Email Phone Street address
Scientific Enquiries Martin Ndirangu ndirangumartin38@gmail.com +265 993 130 111 P.O. Box 1318
City Postal code Country Position/Affiliation
Lilongwe Malawi Director, Ujamaa-Pamodzi
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 URL Hyperlinks Baseline Characters Participant Flow Adverse Events Outcome Measures Description
Link To Protocol
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 13/02/2017 On review we realized further clarification was needed Primary school girls class 6-7 Secondary schools girls form 1-4 Primary school girls class 5-7 Secondary schools girls form 1-3
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 13/02/2017 On review we realized further clarification was needed Primary schools girls class 8 Randomised out by beads method Primary schools girls class 8 Secondary school girls Form 4
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 13/02/2017 Upon further review, realized that it needed further clarification 26 26
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 13/02/2017 Upon further review, realized that it needed further clarification 8 8
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation sequence 13/02/2017 On review we realized further clarification was needed Beads in opaque plastic containers Allocation was determined by the holder of the sequence who is situated off site
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation sequence 13/02/2017 On review we realized further clarification was needed Randomization was done at the school level using a probabilistic algorithm that assigned schools into either the control or treatment arms based on school sizes. At participant level students were randomly chosen using colored beads selection method. These randomisation were done separately for all districts covered (3) Stratified randomization was done at the district and school level. Using a probabilistic algorithm, we assigned schools into either the control or treatment arms based on school size.
Section Name Field Name Date Reason Old Value Updated Value
Intervention InterventionTypeID 23/02/2017 previously combined sample size Experimental group Experimental group
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 13/02/2017 Upon further review, realized that it needed further clarification Primary school girls class 6-7 Secondary schools girls form 1-4 Primary school girls class 5-7 Secondary schools girls form 1-3
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 13/02/2017 Upon review, realized that it needed further clarification Primary schools girls class 8 Randomised out by beads method Primary schools girls class 8 Secondary schools Form 4
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 23/02/2017 correction 6644 7832
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 13/02/2017 Upon further review, realized that it needed further clarification Primary schools girls class 8 Randomised out by beads method Primary schools girls class 8 Secondary school girls form 4
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 13/02/2017 Upon review, realized that it needed further clarification Primary school girls class 6-7 Secondary schools girls form 1-4 Primary school girls class 5-7 Secondary schools girls Form 1-3
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 26/02/2019 edit Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Other disease 26/02/2019 edit violence against women and girls (VAWG) violence against women and girls