Menstrual Health InterventionMENISCUs-2NCT04064736
Menstrual Health Interventions and School Attendance Among Ugandans
An observational study of Menstrual Health Intervention, run by London School of Hygiene and Tropical Medicine at 1 site in Uganda.
Trial summary
Management of menstruation can present substantial challenges to girls in low-income settings. The aim of this study is to pilot an intervention package to improve menstrual health (MH) management among school girls in 2 secondary schools in Entebbe sub-District, Uganda, and to prepare for a future cluster randomised… Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Menstrual Health Intervention
- How many people
- 450 participants
- Where
- 1 siteUganda
- Study dates
- 14 Aug 2017to 24 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- Child, Adult
Study population: This pilot study was conducted in Entebbe Municipality in Wakiso District, Uganda. Entebbe has 13 registered secondary schools. Two day schools (one government and one private), both with students of low socio-economic status, were purposively selected.
Who may be able to join
- Eligible participants were all male and female secondary students in the second school year in the 2 selecteed schools. Written informed consent was sought from students aged >18 years, and from the parents/caretakers of those aged <18 years, with student assent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Management of menstruation can present substantial challenges to girls in low-income settings. The aim of this study is to pilot an intervention package to improve menstrual health (MH) management among school girls in 2 secondary schools in Entebbe sub-District, Uganda, and to prepare for a future cluster randomised trial to evaluate the impact of the intervention on school attendance, school performance and bacterial vaginosis.
The recently completed study (MENstrual hygiene and Safe male Circumcision in Ugandan Schools (MENISCUS-1) showed that menstruation is a key reason for school absenteeism in this setting. The qualitative research showed substantial embarrassment and fear of teasing regarding menstruation, and suggested that this, together with pain and lack of effective materials for menstrual hygiene management, led to school absenteeism. In a small quantitative sub-study of daily diaries, 40 girls reported school absence on 28% of period-days, compared with 7% of non-period days (adjusted odds ratio=5.99, 95%CI 4.4-8.2, p<0.001). Evaluation of menstrual management interventions, which address both the psycho social aspects of menstruation (knowledge, self-confidence, attitudes), and the physical aspects (management of pain, use of appropriate materials to eliminate leakage of menstrual blood, improved WASH facilities) are needed.
Read more
In the current study (MENISCUs-2), the investigators will pilot the MH interventions developed in MENISCUS-1 as a package delivered to all girls in one school year in two schools in Wakiso District. The intervention consists of:
- Training teachers to improve current delivery of the Government guidelines for puberty education delivered by teachers (usually female).
- A drama skit to address issues around menstruation, engaging girls, boys, parents and teachers.
- Provision of a menstrual management kit, including re-usable pads and training teachers and peers to teach girls how to use these menstrual management methods
- Supplying analgesics (paracetamol) for menstrual cramps using a voucher scheme
- Basic improvements to school sanitation facilities, including ensuring girls' privacy
The primary outcome is to review whether criteria for progression to a future trial are met. The criteria are that i) the education session and drama skit are delivered, the majority of girls use the pads, and that soap is available for >50% of observation visits; and ii) the retention rate in school over 9 months is >60%. The investigators will compare the relative risk of absenteeism on period-days and non-period-days from diaries, within MENISCUS-2 (the new pilot study in which the intervention will take place) and within MENISCUS-1 (the previous feasibility study where no intervention had taken place when the diaries were collected) schools. They will estimate the number of girls who are retained at school in order to estimate the likely loss to follow-up within a future trial. They plan to submit a proposal for a full trial in 2019.
Read the detailed description
The study will take place in two secondary schools (one private and another government) in Entebbe sub-district. The study will take place among students in Class S2 aged. The study will consist of i) A stakeholder workshop to finalise the intervention including a Theory of Change workshop ii) Introduction of the intervention package to all S2 students and assess outcomes over 9 months (into the next school year), to assess retention (including those repeating year S2).
iii) Provision of daily diaries to a random sample of 50 students per school. A research assistant will make unannounced visits to the schools approximately every month to check the diaries and will collect them 2 weeks before the end of term (to avoid loss or damage).
iv) Cross-sectional surveys at baseline and endline in all girls in S2 to assess menstruation knowledge, attitudes, management practices and school absenteeism.
- Cross-sectional surveys at baseline and endline for all boys in S2 to access menstruation attitudes and school absenteeism. vi) Endline in-depth interviews (IDIs) will be conducted with 30 female students, 10 teachers (male and female) and 10 parents, sampled purposively (e.g. by attendance for girls) to assess perceptions of the interventions and impact on self-reported school absence vii) End line focus group discussions (FGDs) with two groups of girls in each school to assess their perceptions of the intervention and its impact on school attendance as well as one group of boys in each school to assess their perceptions of the intervention. viii) Analysis of vouchers assessing uptake of analgesics ix) School examination data to assess performance x) Strengths \& Difficulties questionnaire to assess psychosocial issues xi) Second stakeholder workshop will be held to discuss findings and plan for the future trial. This will include representatives from schools that are potential sites for the future trial.
Outcomes of the study: Primary outcome is school attendance using menstrual daily diaries for menstruating girls. School attendance will be compared using diaries, class registers, direct observation check visits and retrospective self-reported school attendance at the endline cross-sectional survey.
Secondary trial outcomes for the girls will be: 1) Knowledge and attitudes towards menstruation and MH evaluated using baseline and endline questionnaires with closed questions. Information will include menstruation knowledge and attitudes in boys and girls, and practices in girls; 2) Acceptability of re-usable pads (AFRIpads): In this trial development study, the study will provide girls with re-usable pads and collect further qualitative and quantitative data on the MH management methods practiced. To include girls' attitudes towards using the re-usable pads including privacy for changing and washing the re-usable pad. Ability to do usual activities and comfort or discomfort of use, ease of washing, drying and storing the re-usable pads, accessibility of water and soap, use of other MH methods alongside the re-usable pad, and feedback on the training given by WoMena the implementing partner.
- Psychosocial issues: In the main trial the investigators will assess whether the intervention affects psychosocial outcomes through multiple methods including the quantitative interviews, the 25-item Strengths and Difficulties Questionnaire (self-report version; (http://www.sdqinfo.com) for 11-17 year-olds, and through qualitative methods. The SDQ consists of 25, 3-point Likert scale items from 0 'not true' to 2 'true', with a midpoint of 1 'somewhat true'.
- Conditions
- Menstrual Health Intervention
- Keywords
- Menstrual Health, School attendance, Adolescent health
What is being measured
The primary outcome is the main question the study is designed to answer.
School attendance
Measured using menstrual daily diaries for menstruating girls. This will be compared using diaries, class registers, direct observation check visits and retrospective self-reported school attendance at the endline cross-sectional survey.
Measured: 9 months
Secondary outcomes (2)
Knowledge and attitudes towards menstruation
Measured using baseline and endline questionnaires. Information included menstruation knowledge and attitudes in boys and girls, and practices in girls; 2) Acceptability of re-usable pads: In this trial development study, the investigators will provide girls with re-usable pads and collect further qualitative and quantitative data on the MH management methods practiced. To include girls' attitudes towards using the re-usable pads including privacy for changing and washing the re-usable pad. Ability to do usual activities and comfort or discomfort of use, ease of washing, drying and storing the re-usable pads, accessibility of water and soap, use of other MH methods alongside the re-usable pad, and feedback on the training on menstrual management given by WoMena the implementing partner.
Measured: 9months
Psychosocial wellbeing
In the main trial the investigators propose to assess whether the intervention affects psychosocial outcomes through multiple methods including the quantitative interviews, the 25-item Strengths and Difficulties Questionnaire (self-report version; (http://www.sdqinfo.com) for 11-17 year-olds, and through qualitative methods. The SDQ consists of 25, 3-point Likert scale items from 0 'not true' to 2 'true', with a midpoint of 1 'somewhat true'.
Measured: 9months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start14 Aug 2017
- Primary completion20 Aug 2018
- Study completion24 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Menstrual Health InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Uganda, MRC/UVRI and LSHTM Uganda Research Unit, WoMena Uganda, Makerere University, World Health Organization
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064736
- Sponsor's protocol ID
- MENISCUs-2
- Acronym
- MENISCUs-2
- Status last verified
- Aug 2019
- First submitted
- 20 Aug 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: : Data will be made available in the LSHTM Data Compass repository on request from the corresponding author (Helen Weiss https://orcid.org/0000-0003-3547-7936) from the website https://datacompass.lshtm.ac.uk/
Publications
Nalugya R, Tanton C, Hytti L, Kansiime C, Nakuya K, Namirembe P, Nakalema S, Neema S, Alezuyo C, Namuli Musoke S, Torondel B, Francis SC, Ross DA, Bonell C, Seeley J, Weiss HA. Assessing the effectiveness of a comprehensive menstrual health intervention program in Ugandan schools (MENISCUS): process evaluation of a pilot intervention study. Pilot Feasibility Stud. 2020 Apr 24;6:51. doi: 10.1186/s40814-020-00585-2. eCollection 2020.
PubMed 32346485Kansiime C, Hytti L, Nalugya R, Nakuya K, Namirembe P, Nakalema S, Neema S, Tanton C, Alezuyo C, Namuli Musoke S, Torondel B, Francis SC, Ross DA, Bonell C, Seeley J, Weiss HA. Menstrual health intervention and school attendance in Uganda (MENISCUS-2): a pilot intervention study. BMJ Open. 2020 Feb 4;10(2):e031182. doi: 10.1136/bmjopen-2019-031182.
PubMed 32024786
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menstrual Health Interventions and School Attendance Among Ugandans
- ClinicalTrials.gov ID
- NCT04064736
- Acronym / sponsor ID
- MENISCUs-2 / MENISCUs-2
- Conditions
- Menstrual Health Intervention
- Keywords
- Menstrual Health, School attendance, Adolescent health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Ministry of Health, Uganda, MRC/UVRI and LSHTM Uganda Research Unit, WoMena Uganda, Makerere University, World Health Organization
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 24 Aug 2018 (actual)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Management of menstruation can present substantial challenges to girls in low-income settings. The aim of this study is to pilot an intervention package to improve menstrual health (MH) management among school girls in 2 secondary schools in Entebbe sub-District, Uganda, and to prepare for a future cluster randomised trial to evaluate the impact of the intervention on school attendance, school performance and bacterial vaginosis.
The recently completed study (MENstrual hygiene and Safe male Circumcision in Ugandan Schools (MENISCUS-1) showed that menstruation is a key reason for school absenteeism in this setting. The qualitative research showed substantial embarrassment and fear of teasing regarding menstruation, and suggested that this, together with pain and lack of effective materials for menstrual hygiene management, led to school absenteeism. In a small quantitative sub-study of daily diaries, 40 girls reported school absence on 28% of period-days, compared with 7% of non-period days (adjusted odds ratio=5.99, 95%CI 4.4-8.2, p<0.001). Evaluation of menstrual management interventions, which address both the psycho social aspects of menstruation (knowledge, self-confidence, attitudes), and the physical aspects (management of pain, use of appropriate materials to eliminate leakage of menstrual blood, improved WASH facilities) are needed.
In the current study (MENISCUs-2), the investigators will pilot the MH interventions developed in MENISCUS-1 as a package delivered to all girls in one school year in two schools in Wakiso District. The intervention consists of:
- Training teachers to improve current delivery of the Government guidelines for puberty education delivered by teachers (usually female).
- A drama skit to address issues around menstruation, engaging girls, boys, parents and teachers.
- Provision of a menstrual management kit, including re-usable pads and training teachers and peers to teach girls how to use these menstrual management methods
- Supplying analgesics (paracetamol) for menstrual cramps using a voucher scheme
- Basic improvements to school sanitation facilities, including ensuring girls' privacy
The primary outcome is to review whether criteria for progression to a future trial are met. The criteria are that i) the education session and drama skit are delivered, the majority of girls use the pads, and that soap is available for >50% of observation visits; and ii) the retention rate in school over 9 months is >60%. The investigators will compare the relative risk of absenteeism on period-days and non-period-days from diaries, within MENISCUS-2 (the new pilot study in which the intervention will take place) and within MENISCUS-1 (the previous feasibility study where no intervention had taken place when the diaries were collected) schools. They will estimate the number of girls who are retained at school in order to estimate the likely loss to follow-up within a future trial. They plan to submit a proposal for a full trial in 2019.
Detailed description
The study will take place in two secondary schools (one private and another government) in Entebbe sub-district. The study will take place among students in Class S2 aged. The study will consist of i) A stakeholder workshop to finalise the intervention including a Theory of Change workshop ii) Introduction of the intervention package to all S2 students and assess outcomes over 9 months (into the next school year), to assess retention (including those repeating year S2).
iii) Provision of daily diaries to a random sample of 50 students per school. A research assistant will make unannounced visits to the schools approximately every month to check the diaries and will collect them 2 weeks before the end of term (to avoid loss or damage).
iv) Cross-sectional surveys at baseline and endline in all girls in S2 to assess menstruation knowledge, attitudes, management practices and school absenteeism.
- Cross-sectional surveys at baseline and endline for all boys in S2 to access menstruation attitudes and school absenteeism. vi) Endline in-depth interviews (IDIs) will be conducted with 30 female students, 10 teachers (male and female) and 10 parents, sampled purposively (e.g. by attendance for girls) to assess perceptions of the interventions and impact on self-reported school absence vii) End line focus group discussions (FGDs) with two groups of girls in each school to assess their perceptions of the intervention and its impact on school attendance as well as one group of boys in each school to assess their perceptions of the intervention. viii) Analysis of vouchers assessing uptake of analgesics ix) School examination data to assess performance x) Strengths \& Difficulties questionnaire to assess psychosocial issues xi) Second stakeholder workshop will be held to discuss findings and plan for the future trial. This will include representatives from schools that are potential sites for the future trial.
Outcomes of the study: Primary outcome is school attendance using menstrual daily diaries for menstruating girls. School attendance will be compared using diaries, class registers, direct observation check visits and retrospective self-reported school attendance at the endline cross-sectional survey.
Secondary trial outcomes for the girls will be: 1) Knowledge and attitudes towards menstruation and MH evaluated using baseline and endline questionnaires with closed questions. Information will include menstruation knowledge and attitudes in boys and girls, and practices in girls; 2) Acceptability of re-usable pads (AFRIpads): In this trial development study, the study will provide girls with re-usable pads and collect further qualitative and quantitative data on the MH management methods practiced. To include girls' attitudes towards using the re-usable pads including privacy for changing and washing the re-usable pad. Ability to do usual activities and comfort or discomfort of use, ease of washing, drying and storing the re-usable pads, accessibility of water and soap, use of other MH methods alongside the re-usable pad, and feedback on the training given by WoMena the implementing partner.
- Psychosocial issues: In the main trial the investigators will assess whether the intervention affects psychosocial outcomes through multiple methods including the quantitative interviews, the 25-item Strengths and Difficulties Questionnaire (self-report version; (http://www.sdqinfo.com) for 11-17 year-olds, and through qualitative methods. The SDQ consists of 25, 3-point Likert scale items from 0 'not true' to 2 'true', with a midpoint of 1 'somewhat true'.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- This pilot study was conducted in Entebbe Municipality in Wakiso District, Uganda. Entebbe has 13 registered secondary schools. Two day schools (one government and one private), both with students of low socio-economic status, were purposively selected.
Key inclusion criteria (1 listed)
- Eligible participants were all male and female secondary students in the second school year in the 2 selecteed schools. Written informed consent was sought from students aged >18 years, and from the parents/caretakers of those aged <18 years, with student assent
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
School attendance
Time frame: 9 months
Measured using menstrual daily diaries for menstruating girls. This will be compared using diaries, class registers, direct observation check visits and retrospective self-reported school attendance at the endline cross-sectional survey.
2 secondary outcomes
Knowledge and attitudes towards menstruation
Time frame: 9months
Psychosocial wellbeing
Time frame: 9months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Derived from this study: PubMed 32346485Nalugya R, Tanton C, Hytti L, Kansiime C, Nakuya K, Namirembe P, Nakalema S, Neema S, Alezuyo C, Namuli Musoke S, Torondel B, Francis SC, Ross DA, Bonell C, Seeley J, Weiss HA. Assessing the effectiveness of a comprehensive menstrual health intervention program in Ugandan schools (MENISCUS): process evaluation of a pilot intervention study. Pilot Feasibility Stud. 2020 Apr 24;6:51. doi: 10.1186/s40814-020-00585-2. eCollection 2020.
- Derived from this study: PubMed 32024786Kansiime C, Hytti L, Nalugya R, Nakuya K, Namirembe P, Nakalema S, Neema S, Tanton C, Alezuyo C, Namuli Musoke S, Torondel B, Francis SC, Ross DA, Bonell C, Seeley J, Weiss HA. Menstrual health intervention and school attendance in Uganda (MENISCUS-2): a pilot intervention study. BMJ Open. 2020 Feb 4;10(2):e031182. doi: 10.1136/bmjopen-2019-031182.
- Individual participant dataSharing planned: Yes. : Data will be made available in the LSHTM Data Compass repository on request from the corresponding author (Helen Weiss https://orcid.org/0000-0003-3547-7936) from the website https://datacompass.lshtm.ac.uk/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Health Intervention, run by London School of Hygiene and Tropical Medicine at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
School attendance (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04064736, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.