Puberty health intervention to improve menstrual health and school attendance among adolescent girls in The Gambia: study methodology of a cluster-randomised controlled trial in rural Gambia (MEGAMBO TRIAL)

Our previous study [26] showed that students gained relatively little knowledge about puberty and menstruation from their teachers and they felt more comfortable to talk with their peers. To address this lack of knowledge, Nova Scotia Gambia Association (NSGA) was subcontracted as a partner, to deliver an innovative two-session MH training per school. NSGA is a Canadian NGO working with adolescents and communities in The Gambia since 1985, it is known for using an interactive and direct engagement approach, dealing with different public health issues (Malaria, HIV, early marriage). The NSGA team went through a four-day training before the pilot intervention and again before the main trial intervention. The training covered aims of the intervention and familiarisation with intervention content.

In preparation for the first session, the school teachers were asked to select 15 boys and 15 girls that were outspoken and respected by other students. The first session was a full day session delivered to the 30 students, it included an introduction to the study, discussion about puberty education affecting both boys and girls, and discussions about menstruation. These 30 students served as menstrual ambassadors, to share information about puberty and MH practices with other students. The session had role-play activities, that showed the students how they can talk to others students about what they have learnt, they were also encouraged to talk to adolescents outside of the school setting. They were given different options of how they could spread the message such as through school assemblies, use of peer educator rooms in school etc. It was explained to the ambassadors that it was their responsibility to share what they learnt in the sessions with those that could not attend. This is the ethos of NSGA and the students are used to this approach. At the second session (the following day), all the school girls aged 13 years and above, were invited to attend a menstrual hygiene laboratory (if the school was large, this ran as multiple sessions, to ensure the group size was manageable). During this session, girls were split up into similar age groups, so as to ensure they were more comfortable discussing and asking questions. They were taught more in detail about menstruation, menstrual management practices, how to prepare for the period, tracking the menstrual cycle, information about absorbent materials and pain management (e.g., exercise, applying heat and or pressure, stretching, hydration, medical-herbal and pharmaceutical). The 15 ambassador girls that attended the first session also attended the menstrual hygiene laboratory session, and supported the NSGA staff in facilitation. One poster was given to each school after the training, with information about menstrual hygiene practices, physiological knowledge and tips for managing pain and how to prepare for your cycle. The same information was also included into a leaflet which was given to each girl that attended the training. The sessions with the students were full day sessions, with many icebreakers and activities throughout to keep the students engaged. Sessions were carried out on weekends, to reduce impact on school learning.

Our previous study showed that mothers were one of the first point of contact for advice about how to manage menstruation for girls [26], however, mothers have limited knowledge about menstruation and also have different perceptions about how menstruation should be managed. At the stakeholder meetings, it was suggested that parents should be involved in the intervention package to be able to support girls with good information and a more open approach. Therefore, we decided to organize mothers’ meetings in each school. The school admin/teachers were asked to identify 20 mothers that were active, confident, vocal and easy for others to approach. These mothers were invited for a two-day meeting. The meeting ran from 9 am to 12/1 pm, we opted to have half day meetings, as we found concentration levels were low in the afternoon, and mothers were rushing to get back to other chores. During the first session, issues about importance of girls finishing school, and information about puberty and reproductive issues were discussed. The second session discussed menstruation in greater detail, role-play approaches of talking with children about menstruation, and menstrual hygiene management (including strategies for using different type of absorbents, absorbent and body hygiene practices, managing pain). Mothers were shown all the types of absorbents and explained their advantages and disadvantages and how to use them. Mothers were encouraged to work with the school administration to help maintain the WASH facilities, examples of assisting with cleaning school facilities or making soap for the school were given. The mothers were also encouraged to share this information with other women and adolescents in the community to increase discussion and awareness about menstruation. During the sessions, the mothers practiced different interactive methods of sharing the information. The sessions were conducted by two female facilitators (one nurse and one traditional influencer) who have experience discussing sensitive topics and have an energetic and engaging approach. The facilitators had three days training to discuss content of training materials and how they could engage the mothers, after which they had a practice session with a group of mothers that were not part of the study, followed by another training session to go over feedback and address any challenges faced.

Following suggestions from the stakeholder workshop to involve men in discussions about puberty, menstruation and the importance of girls schooling, a community meeting in the evening after prayers was considered to be the best opportunity to discuss these topics. One community meeting was conducted in each community, where both men and women attended. The sessions discussed the above mentioned topics and provided an opportunity for community members to ask questions. The sessions were arranged through the village elders, village development community chairman, and a religious elder, to increase acceptance of the program and promote attendance. The meeting lasted an hour or two depending on the level of engagement from the attendees. The sessions were conducted by two facilitators (one female and one male), who have an energetic approach and are used to discussing sensitive topics within communities and are respected by the communities. The facilitators had a day training to go over context of the session, after which they had a practice session in a community that was not part of the study, followed by another training session to go over feedback and address and challenges faced.

During the stakeholder meeting, representatives from all the schools showed willingness to help with the suggested interventions, and WASH improvements were seen as a major intervention priority. In the intervention schools, the school management team, mother’s outreach group and peer education camps were engaged to implement inexpensive measures including ensuring water storage containers were close to the toilets, and hand-washing stations were present with kettles (water pouring device commonly used in The Gambia), water and soap. After an initial WASH spot check (Additional file 3: Appendix S3), the team discussed with the school management team, simple changes that could be made to the current system where required, e.g., separating toilet facilities for boys and girls where possible, creating simple doors to increase privacy etc. A tailored TOR was created with each school at the beginning of the study with the agreed maintenance tasks. The agreement also included that the study team would provide materials to improve WASH facilities in a step wise manner. First the schools were provided with 100 L water tanks to be placed near the toilets and ensure they were always filled together with two handwashing stations and four kettles. After which at the next visit, they were provided with soap and materials to make tippy taps, which should also be placed near the toilets.

Initially part of the WASH intervention included an aspect of absorbent disposal facility in the schools, as most students dispose their used disposable pads into the pit latrine and the study team recognised that this would cause the pit latrines to filling up quickly. However, after further discussions with the girls and mothers, it was realised there were many differing views on used material disposal, some felt the material should be burnt, while others felt burning would lead to infertility and therefore was not an option. Because an intervention provided by the researchers could not thus be standardised across schools, this aspect was removed. This was replaced by including discussion on disposal options in the outreach sessions, where participants were encouraged to use the method they were most comfortable with, instead of throwing the material into the latrine. During the formative research no girl reported methods of disposal as a barrier to attending school.

All intervention components were simultaneously run in all intervention schools over the intervention period.

The primary outcome for this study was the proportion of girls with at least one-day absence during their last period. We aimed to collect school register data as a gold standard method to measure school attendance and to be able to compare and validate the survey data used to measure the primary outcome. However, we found lots of inaccuracies in register data, and data could not be collected from all the schools. Previous studies have also found registers to be inaccurate, irregularly completed, and difficult to use due to teachers not completing daily, and girls using different names for school enrolment and study enrolment [17, 41, 42]. Thus, we will perform a comparison exercise only with the data from the available schools which have the most complete data to be able to estimate validity of the survey data.

The MENISCUS study in Uganda [15] had success in using self-completed diaries to collect information about school attendance, however formative research in The Gambia found this to be an unsuitable tool for the primary outcome as the diaries are often left empty. This difference could have been due to differences in literacy level, or not being able to have the diaries in the local language, since the local languages are not written, or students in The Gambia had never done such activities. Therefore, for this context, we decided to use self-reported school absence during the last period as the measure to estimate the primary outcome. The question that we used in our questionnaire to measure this outcome was: In the last 30 days how many days of school did you miss because of menstruation? Girls had the option to say they did not menstruate in the last 30 days, in this case, a further question was asked: During your last period, how many days of school did you miss because of menstruation? For the primary outcome the responses from both these questions will be combined to calculate the proportion of girls with at least one-day absence during last period. For the secondary outcome responses from the question “In the last 30 days how many days of school did you miss because of menstruation?” will be used to ascertain the number of days missed in the last 30 days due to period.

This secondary outcome was defined as proportion of girls reporting at least one urinary tract infection symptom over the 7 days preceding the survey. The questions used are listed in Table 2.