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.: PACTR202311500681715 Date of Approval: 06/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of the Menstrual Hygiene Management intervention in priority regions of Cameroon
Official scientific title Menstrual Hygiene Management in Schools in Cameroon: A Cluster Randomized Control Trial
Brief summary describing the background and objectives of the trial Menstrual hygiene management (MHM) poses a significant barrier to access, retention, and quality of learning in schools in LMICs. It also poses a significant health risk to young girls in school. The UN organizations have developed a guidance for MHM in schools to include education, MHM supportive facilities, and MHM materials. An assessment of MHM research body of evidence suggests significant research gap and a need for more research to inform policies. There is also a need for a teacher professional development component. The objective of this efficacy trial is to evaluate the impact of the a modified MHM in schools approach on access, retention, quality of learning, and health outcomes in 40 intervention versus 40 control schools in Cameroon.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Menstrual hygiene management
Purpose of the trial Education /Training
Anticipated trial start date 01/10/2023
Actual trial start date
Anticipated date of last follow up 25/12/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 1600
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
04Sep2023Exp eBASE Ethic Committee
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Menstrual Hygiene Management in Schools in Cameroon Construction of safe spaces in school will be done once. Dignity kits will be provided to girls monthly. From 1st of October 2023 to 30th June 2024. The MHM intervention under study for this trial consists of a range of complementary activities designed to support improved MHM practices in schools and local communities. This includes the construction or renovation of improved toilet facilities for girls, providing access to period products and MHM educational materials, establishing MHM clubs within schools, training teachers as MHM leaders and community engagement activities. The different components are summarised below: Teacher training and MHM focal points • Each school will nominate 2 staff members to receive training and ongoing support in delivering MHM in the schools. These staff members will act as teacher leaders and MHM focal points in their respective schools. • Each focal point will be required to organise trainings for at least 15 staff members on menstrual hygiene management. • The training component will be delivered using MHM training manuals, which will also be provided to trained teachers to continue to use in schools during the year. These manuals include UN Women Cameroon’s ‘training of trainers’ manual, and UNICEF’s WinS (Wash in Schools) and MHM guide. These documents have been designed in line with the three pillars of the MHM: 1. Breaking the silence on menstruation: this is to raise awareness among participants that menstruation is a normal phenomenon among girls and women that they should not feel ashamed of. 2. Ensure safe and hygienic management of menstruation: this is to build users' capacity about good menstrual hygiene practices. 3. Dispose of menstrual waste safely: this is to ensure the safe disposal of menstrual protection and menstrual waste while protecting the environment. Construction or renovation of menstrual hygiene safe spaces for girls • Toilets will be built or renovated (depending on the level of existing provision) in 40 schools, adhering to safety regulations and maintaining a suitable distance from facilities designated for boys. The renovated facilities 800
Control Group Menstrual Hygiene Management in Schools in Cameroon The schools will not receive any arm of the intervention, rather, a survey questionnaire will be administered to the girls and boys in the school. Diaries will also be given out to girls to fill on a monthly basis. Attendance data will equally be collected from the control schools on a weekly basis. 1st October 2023 to June 30th 2023. The control schools will be doing business as usual. 800 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adolescent girls age 10-20 years who have experienced menarche. Girls who have not attain 10 or above 20 years. Adolescent: 13 Year-18 Year 10 Year(s) 20 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 25/09/2023 eBASE IRB
Ethics Committee Address
Street address City Postal code Country
Evidence Building, City Chemist, Bamenda, Cameroon Bamenda 5175 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome School attendance amongst adolescent girls. Weekly
Secondary Outcome School attainment, retention and knowledge and attitudes relating to MHM At the end of the school term
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Diamare Division Delegation Regional de MINEDUB Maroua Maroua EN00237 Cameroon
Mayo Sava Division Delegation d Arrondissement de MINEDUB Mora Mora EN00237 Cameroon
Mayo Tsanaga Division Delegation d Arrondissement de Mayo Tsanaga, Mokolo Mokolo EN00237 Cameroon
Mezam Division Divisional Delegation of MINEDUB Bamenda NW00237 Cameroon
Ndonga Mantung Division Divisional delegation of MINEDUB Ndonga Mantung Nkambe NW00237 Cameroon
Haut Nyong Division Delegation d Arrondissement de Haut Nyong Abong Mbang EN00237 Cameroon
Lom et Djerem Division Delegation d Arrondissement de Bertoua Bertoua ES00237 Cameroon
Kadey Division Delegation d Arrondissement de Kadey Batouri ES00237 Cameroon
Fako Division Divisional Delegation of Fako Buea SW00237 Cameroon
Meme Division Divisional Delegation of Mamfe Mamfe SW00237 Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Effective Basic Services Africa City Chemist Round about, Bamenda Bamenda 5175 Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Effective Basic Services eBASE Africa Evidence Building BAMENDA 5175 Cameroon Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
National Centre for Social Research 35 Northampton Square London EC1V 0AX 020 7250 1866 Wales British Indian Ocean Territory
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Valery CHE NJI njival@yahoo.com +237677325809 Mile 7 Mankon Bamenda
City Postal code Country Position/Affiliation
Bamenda Cameroon Principal Investigor
Role Name Email Phone Street address
Public Enquiries MBIHBIH NIYING ROGERS niyingrogers200@gmail.com +237676238479 Mile 17 Chief Street Mbomaka
City Postal code Country Position/Affiliation
Buea Cameroon ASOWWIP and University of Buea Cameroon
Role Name Email Phone Street address
Scientific Enquiries Ramatu Abdu ramatuabdu68@gmail.com +237677574822 Mile 2 Nkwen Bamenda
City Postal code Country Position/Affiliation
Bamenda Cameroon ASOWWIP
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in sickle cell anemia. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact njival@yahoo.com
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