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 14 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 14 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)	14 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
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Final no of participants	24/09/2018	The total number of participants where the primary and secondary outcomes of the trial will be collected is 9100. We got confused, as we stated the number of participants that will be receiving the intervention (half of the participants). The other half, will be in the control group that won't be receiving any intervention.		9100
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Final no of participants	24/09/2018	Sorry, it has been a mistake. The total number of participants where the outcomes will be measured is 3640 (half of them will receive the intervention (1820) and half of them will be the control group (1820))	9100	3640
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	24/09/2018	We have grouped the different sub-interventions into one unique group called intervention group.	Experimental Group, Peer health training, Frequency of sessions will be determined during the pilot stage. , 2 days per session, 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 students will serve as point of contact to the other students as a way of share information about puberty and MHM practices. 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. , 1820,	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, 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 students will serve as point of contact to the other students as a way of share information about puberty and MHM practices. 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. , 1820,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	24/09/2018	We have included the information of all the different sub-interventions into 1 unique intervention group.		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,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Recruitment status	10/03/2020	We have started recruiting for the trial.	Not yet recruiting	Recruiting
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Completion date	19/05/2021	Due to COVID outbreak, the endline data collection of the last 5 schools had to be postponed.		23 Dec 2020
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Final no of participants	19/05/2021	One school refused to participate in the study due to COVID situation, then we lost some participants	3640	3554
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Recruitment status	19/05/2021	The trial has been completed.	Recruiting	Completed
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	19/05/2021	The ethical letter approval and the data when it was received has been attached.	FALSE, SCC and the Gambia Government MRC Ethics Committee, MRC Unit The Gambia at LSHTM Atlantic Boulevard, Fajara P. O. Box 273, Banjul, Banjul, 00273, Gambia, 20 Aug 2018, , +2204495442, njobe@mrc.gm,	TRUE, SCC and the Gambia Government MRC Ethics Committee, MRC Unit The Gambia at LSHTM Atlantic Boulevard, Fajara P. O. Box 273, Banjul, Banjul, 00273, Gambia, 20 Aug 2018, 17 Oct 2018, +2204495442, njobe@mrc.gm, 3539_2832_4737.pdf

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