Changes to trial information |
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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. |
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9100 |
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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 |
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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, |
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Intervention |
Intervention List |
24/09/2018 |
We have included the information of all the different sub-interventions into 1 unique intervention group. |
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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
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Field Name
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Old Value
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Updated Value
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Trial Information |
Recruitment status |
10/03/2020 |
We have started recruiting for the trial. |
Not yet recruiting |
Recruiting |
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Completion date |
19/05/2021 |
Due to COVID outbreak, the endline data collection of the last 5 schools had to be postponed. |
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23 Dec 2020 |
Section Name
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Date
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Reason
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Old Value
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Updated Value
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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
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Recruitment status |
19/05/2021 |
The trial has been completed. |
Recruiting |
Completed |
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Old Value
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Updated Value
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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 |