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.: PACTR202407662708627 Date of Approval: 26/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title "Effectiveness of Reusable Menstrual Pads as a Sustainable Alternative to Disposable Pads among Secondary School Students in Kano, Nigeria"
Official scientific title Exploring the Effectiveness and Sustainability of Reusable Menstrual Pads as an Intervention for Improved Menstrual Hygiene Management among Secondary School Students in Kano, Nigeria: A randomized controlled trial
Brief summary describing the background and objectives of the trial Background: Menstrual hygiene management is a critical aspect of adolescent health, particularly in resource-constrained settings like Kano, Nigeria. Poor menstrual hygiene can lead to various health issues and negatively impact educational attainment and psychosocial well-being among adolescent girls. Despite the importance of menstrual hygiene, there is a lack of comprehensive interventions tailored to the needs of secondary school students in Kano. Objectives: This randomized controlled trial aims to evaluate the effectiveness of a menstrual hygiene intervention among secondary school students in Kano, Nigeria. The intervention includes education on menstrual hygiene practices, provision of menstrual hygiene products, and creating a supportive environment for menstrual health in schools. The objectives of the trial are: 1. To assess the effect of menstrual hygiene educational intervention on knowledge and practices related to menstrual hygiene among secondary school students. 2. To evaluate the effect of the reusable menstrual pad distribution intervention on knowledge and practices related to menstrual hygiene among secondary school students. 3. To evaluate the effect of the educational and reusable menstrual pad distribution interventions on the prevalence of menstrual-related health issues, such as infections and discomfort, among participants. 4. To examine the influence of the interventions on school attendance among adolescent girls. 5. To examine the influence of the interventions on academic performance among adolescent girls. 6. To Investigate the effectiveness of reusable menstrual pads as a sustainable alternative to disposable menstrual pads
Type of trial RCT
Acronym (If the trial has an acronym then please provide) INFINITY REUSABLE PAD TRIAL
Disease(s) or condition(s) being studied MENSTRUATION
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 22/04/2024
Actual trial start date
Anticipated date of last follow up 12/07/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 84
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 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 EDUCATIONAL INTERVENTION Once a week health education program will be given 5-week health education program An educational intervention will be implemented in schools for 5 weeks. 21
Experimental Group REUSABLE PAD DISTRIBUTION ONLY 6 reusable pads+ 1 wet bag For 5 weeks In the experimental group receiving the intervention, each participant will be provided with a set of six reusable menstrual pads along with one wet bag. The reusable pads are designed to be washable and can be reused multiple times, offering a sustainable and cost-effective alternative to disposable menstrual products. The wet bag is included for convenient storage and transport of used pads until they can be washed. Participants will be instructed on the proper use and care of the reusable pads, including how to clean them and maintain hygiene during menstruation. 21
Experimental Group EDUCATIONAL INTERVENTION AND REUSABLE PAD DISTRIBUTION 6 REUSABLE PADS + 1 WET BAG AND EDUCATIONAL INTERVENTION 5 WEEKS In the experimental group, participants will receive a comprehensive intervention package consisting of six reusable menstrual pads, one wet bag for storage, and educational sessions focused on menstrual hygiene management. 21
Control Group BUSINESS AS USUAL NONE 5 WEEKS NO INTERVENTION 21 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Secondary schools located within Kano City, Nigeria. Girls-only schools. Secondary school students aged between 15 to 18 years. Students who have started menstruating. Willingness to participate in the study and provide informed consent (or assent if under 18 years old) from both students and their parents or guardians. Schools willing to participate in the educational intervention and distribution of reusable pads. Ability to understand and communicate in Hausa or English, the languages used for data collection and intervention delivery. Co-educational schools. Primary schools or tertiary institutions. Students outside the age range of 15 to 18 years. Lack of willingness to participate in the study or provide informed consent (or assent if under 18 years old) from both students and their parents or guardians. Schools unwilling to participate in the educational intervention and distribution of reusable pads. Inability to understand or communicate in Hausa or English, the languages used for data collection and intervention delivery. Adolescent: 13 Year-18 Year 15 Year(s) 18 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 25/06/2024 BAYERO UNIVERSITY KANO HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
NO. 2 ZARIA ROAD, AMINU KANO TEACHING HOSPITAL, KANO KANO 700233 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of this study is the change in knowledge and practices related to menstrual hygiene among secondary school students in Kano, Nigeria, as measured by pre- and post-intervention assessments. This includes understanding of menstrual hygiene practices, proper usage of menstrual hygiene products, and adoption of healthy menstrual hygiene behaviors. Pre and Post Intervention
Secondary Outcome The prevalence of menstrual-related health issues, such as infections and discomfort, among participants. School attendance among adolescent girls. Academic performance among adolescent girls. Pre and Post Intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
BAYERO UNIVERSITY KANO AMINU KANO TEACHING HOSPITAL, KANO KANO 700233 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
The Burdett Trust for Nursing OX1 2JD, University of Oxford, Wellington Square, Oxford, KANO Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor OXFORD UNIVERSITY OX1 2JD, University of Oxford, Wellington Square, Oxford, KANO Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AMINA SULEIMAN RAJAH asrajah.nur@buk.edu.ng +2347037550409 BAYERO UNIVERSITY, KANO
City Postal code Country Position/Affiliation
KANO Nigeria LECTURER BAYERO UNIVERSITY KANO
Role Name Email Phone Street address
Public Enquiries ABDULAZIZ SULAIMAN TUKUNTAWA abdulazeezslmn@yahoo.com +2348073793703 NATIONAL ORTHOPEDIC HOSPITAL, DALA-KANO
City Postal code Country Position/Affiliation
KANO Nigeria LECTURER
Role Name Email Phone Street address
Scientific Enquiries FAIZA TIJJANI TASHI faeexahtashi@gmail.com +2347038179989 KANO STATE COLLEGE OF NURSING AND MIDWIFERY
City Postal code Country Position/Affiliation
KANO Nigeria LECTURER
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. Study Protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report, Analytic Code will be shared Immediately following publication with no end date. All information will be shared to anyone who wishes to access the data. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Study Protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report, Analytic Code will be shared Immediately following publication with no end date. All information will be shared to anyone who wishes to access the data.
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