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.: PACTR201809769868245 Date of Approval: 25/09/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title MEGAMBO TRIAL
Official scientific title Puberty health intervention to improve menstrual health and School attendance among adolescent girls in Gambia (MEGAMBO TRIAL)
Brief summary describing the background and objectives of the trial School absenteeism is a big problem in developing countries including The Gambia and has a large impact on the country’s economy and prospects of growth. A study that we conducted in Gambia (MRC-PHIND) among school girls in Kiang region showed that challenges related to menstruation management (MHM) at home and at school could be associated with negative health outcomes and school absenteeism. One workshop with different stakeholders (parents, teachers, students, clinicians, education regional officer and NGOs) was held in Keneba in May 2017 to present the initial findings of the study and to discuss challenges associated with MHM and school attendance and find possible solutions. The workshop led to the development of a 3 pack interventions that could be included in programmes already existing in these communities: Mother’s club, Peers Education Programme, and Community meetings around puberty films. The aim of our study is to test, refine and adapt the intervention packages suggested in the first study and to conduct a school-randomised controlled trial to evaluate the effect of this intervention to improve MH and to reduce school absenteeism among girls. The intervention will be a comprehensive school and community-based package to improve menstrual hygiene management (MHM) among girls: it will provide puberty education for boys and girls, engage the support of mothers and the wider community. With the RCT we will evaluate the impact of the intervention on school attendance (primary outcome) and to knowledge of menstruation, menstrual management practices, psycho-social stress, urogenital symptoms and community support (as secondary outcomes).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MEGAMBO
Disease(s) or condition(s) being studied School attendance as primary outcome and urogenital symptoms as secondary outcome
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 04/11/2018
Actual trial start date
Anticipated date of last follow up 28/08/2020
Actual Last follow-up date 23/12/2020
Anticipated target sample size (number of participants) 3640
Actual target sample size (number of participants) 3554
Recruitment status Completed
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
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 Peer health training plus Mothers club plus Community meetings plus improving school WASH Frequency of sessions will be determined during the pilot stage. Peer health training: 2 days per session Mother's club: 2 days per session Community meetings: 1 evening per session Improvements of WASH: Several meetings and follow ups. Peer health training: We will deliver an innovative two-session training for 30 selected students (boys and girls) from each school. The session will be lead by NovaScotia (NS). The first session will be delivered to the 30 peers, and it will include an introduction to the study, discussion about puberty education using different interactive techniques, and discussions about menstruation. At the second session all the school girls will be invited to attend to a Menstrual hygiene laboratory, where the girls will be taught more in detail about menstrual management practices and information about absorbent materials. The boys will be invited to a puberty camp that will be led by the trained peers boys with support of NS staff. The peers leaders will then go on to organise other menstrual hygiene laboratories or boys puberty camps (with the help of NS) at different times of the school year. Mother clubs: Mother’s clubs will be organized in each village. FAWEGAM will be the NGO organizing these clubs. At each school, mothers will be invited for a 2 day meeting. The first day, issues about importance of having girls in school, and knowledge about puberty and reproductive issues will be discussed. On the second day there will be discussions about menstruation, about talking with children about it, and menstrual hygiene management (including strategies for using different type of absorbents, absorbent and body hygiene practices, managing pain).This will be followed 3-4 weeks later by a follow up visit for further feedback and discussions. Community meetings: We will show a film or drama about issues related to puberty and menstruation and deliver it to communities at night. Improvements of WASH: In the intervention schools, we will work with the school management, mother’s club and peers education camps to implement inexpensive measures including installing locks on the toilets doors, repairing broken/incomplete doors, providing bins for pads, and hand-washing stations. 1820
Control Group Control group 1 school year There will be no intervention given to this group. 1820 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
o Girls involved in the study should be older than 13 years. o Boys involved in the study should be older than 16 years. o Girls and boys should be enrolled in the selected schools o Mothers should have a daughter enrolled in the selected schools o Girls should not have been away from school for greater than two months continuously during term-time. o Endline outcome data collection will be only done in selected girls older than 13 years and that are menstruating. o Only enroll participants able to understand the nature of the study, therefore participants with mental disabilities will be excluded. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 13 Year(s) 80 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 02/08/2018 London School of Hygiene and Tropical Medicine ethics board
Ethics Committee Address
Street address City Postal code Country
Keppel St, Bloomsbury, London WC1E 7HT London 000000 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 17/10/2018 SCC and the Gambia Government MRC Ethics Committee
Ethics Committee Address
Street address City Postal code Country
MRC Unit The Gambia at LSHTM Atlantic Boulevard, Fajara P. O. Box 273, Banjul Banjul 00273 Gambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome School attendance Endline
Secondary Outcome Urogenital symptoms Endline
Secondary Outcome Urinary tract infections UTI biochemistry Endline
Secondary Outcome Reproductive tract infection symptoms Endline
Secondary Outcome Psychosocial stress Endline
Secondary Outcome Social support Endline
Secondary Outcome Knowledge of menstruation and its management Endline
Secondary Outcome Attitudes towards menstruation Endline
Secondary Outcome Menstrual hygiene management practices Endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medical Research Council MRC Gambia Atlantic Blvd, Serrekunda, The Gambia Keneba Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
MRC DFID NIHR Adolescent Health Call 2017 Medical Research Council 2nd Floor David Phillips Building, Polaris House, North Star Avenue, Swindon, United Kingdom SN2 1ET Swindon 000000 United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene and Tropical Medicine Keppel St, Bloomsbury, London WC1E 7HT London United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Medical Research Council MRC Gambia Atlantic Blvd, Serrekunda, The Gambia Serrekunda Gambia
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Vishna Shah vishna.shah@lshtm.ac.uk +254739836897 MRC Keneba
City Postal code Country Position/Affiliation
Keneba Gambia Trial manager
Role Name Email Phone Street address
Principal Investigator Belen Torondel belen.torondel@lshtm.ac.uk +442076368636 Keppel St, Bloomsbury, London WC1E 7HT
City Postal code Country Position/Affiliation
London United Kingdom Assistant Professor
Role Name Email Phone Street address
Public Enquiries Amulai Touray atouray@mrc.gm +2207296009 MRC Unit The Gambia at LSHTM Atlantic Boulevard, Fajara P. O. Box 273, Banjul The Gambia
City Postal code Country Position/Affiliation
Banjul Gambia Theme project manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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