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.: PACTR202407741275896 Date of Approval: 18/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Prevention of violence against women and girls and transformation of masculine gender roles: Delivery of Empowerment Transformation Training (ETT) through integration with Ministry of Education (MoE) teachers
Official scientific title Prevention of violence against women and girls and transformation of masculine gender roles: Delivery of empowerment transformation training (ETT) through integration with ministry of education (MOE) teachers
Brief summary describing the background and objectives of the trial Violence against women and girls (VAWG) is a major issue globally and in East and Southern Africa. Eliminating VAWG and other forms of gender inequity are targets of the Sustainable Development Goals. Non-fatal consequences of violence include poor mental, physical, and sexual health. Further, over one-third of female homicides globally are perpetrated by an intimate partner. At the institutional level, there are policies in place to prosecute sexual assault perpetrators, yet the crime remains under-reported and under-prosecuted, largely because of the blame and stigma assigned to victims. Broader efforts to address sexual violence in schools have focused on increasing awareness and providing basic information about sexual and reproductive health rights. Beyond reporting on the number of beneficiaries “reached,” these efforts have not shown a demonstrable impact on the incidence of sexual assault. Ujamaa’s approach was first developed to address endemic VAWG in Nairobi’s informal settlements and has expanded to address the high rates of VAWG in conflict areas including Somalia and South Sudan. ETT is a multi-country curriculum designed to fit the African context and addresses thematic issues such as sexual assault and social stereotypes as contributing factors to VAWG. ETT is primarily school-based and uses a dual-pronged approach comprised of separate girls and boys’ curricula, Girls Empowerment Self Defense (GESD) and the Hero in Me (HIM). Ujamaa teaches classes in 6-week cycles, five times per school year, with the number of students ranging from 10-15,000 per cycle at an average instructor-student ratio of 1:30. In general, this study aims to: 1. Understand and estimate the prevalence of sexual assault among schoolgirls in rural and urban communities in Migori, Kajiado, Nakuru, Nairobi, Machakos, and Kiambu counties. 2. Evaluate the efficacy of the girls’ empowerment self-defense training and boys’ transformation training programs in reducing the incidence
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Sexual Gender Based Violence
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 19/02/2024
Actual trial start date 19/02/2024
Anticipated date of last follow up 30/03/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 1400
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 ETT Empowerment transformation Training two 12 hours and 4 hours refresher training Empowerment Transformation Training (ETT) engages youth to prevent violence through challenging harmful gender norms, and identifying and responding effectively to situations of violence and harassment. The curriculum consists of six, two-hour parallel classroom-based trainings sessions with the girls and boys. Boys and girls are trained separately in parallel sessions for the six weeks, followed by 2-hour refresher trainings after 6 months of initial delivery. The girls’ empowerment self-defense training and the boy’s empowerment transformation curriculum is administered by well-trained, experienced Ujamaa instructors, 700
Control Group standard of care life skill training 2 4 hours standard of care life skill training approved by Kenya’s Ministry of Education 700 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Upper primary and secondary school pupils at selected study schools aged 10 years and above. 2. Pupils should be of stable mental health. 3. Participant consent as indicated that they would like to participate in both the survey and the program. The participants who meet the following characteristics will not be allowed to participate in the study. 1. Pupils under the age of 10. 2. Pupils from schools not selected into the study. 3. Pupils who will not be of stable mental health. 4. Pupils who do not give consent to participate in either the survey or the program. Adolescent: 13 Year-18 Year 10 Year(s) 26 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 19/02/2024 Daystar University Institutional Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Nairobi-Kenya Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduction of Annual incidences of sexual violence 12 months post intervention
Primary Outcome Annual reduction in negative gender stereotypes 12 months after the intervention
Secondary Outcome increase in bystander intervention, step up 12 months after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
School based Kajiado county Kajiado Kenya
school based migori county migori Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
The Elma Philanthropies 1345 Avenue of the Americas New York, NY 10105 New York United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Wellspring Philanthropic Fund Inc 10 Times sq 1441 broadway, New York, NY 10018 New York United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Benjamin Omondi Mboya bomondi@ujamaa-africa.org +254725878455 kitengela
City Postal code Country Position/Affiliation
Nairobi Kenya Executive Director
Role Name Email Phone Street address
Scientific Enquiries Jake Sinclair jakesinclairmd@gmail.com +4155187319 1298 La Playa St. San Francisco, CA 94110
City Postal code Country Position/Affiliation
San Francisco United States of America Research Monitoring and Evaluation Director
Role Name Email Phone Street address
Public Enquiries Nickson Langat nycksonlangat4@gmail.com +254714936118 Umoja, Nasra
City Postal code Country Position/Affiliation
Nairobi Kenya Research Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available. We intend to share all of the de-identified individual participant data collected during the trial. In addition to the data, the following additional documents will be shared: study protocol, statistical analysis plan, informed consent/assent form, study report, and analytic code. The data will be shared immediately following publication with researchers who provide a methodologically sound proposal to achieve the aims of the approved proposal. The proposal should be directed to KaekeBeth@gmail.com. In order for the person(s) to gain access, they will be required to sign a data access agreement form. The data will be available for 6 years at a restricted link on the organization's website. Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be made available for six years after the results are published, and it will be shared right away. The individual making the request for data must sign a data access agreement in order to obtain access. Data are available for 6 years in the organization's database, and a link will be created and provided for ease of access.
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