Menstrual Hygiene ManagementNCT02243488
Does Menstrual Hygiene Matter? Investigating the Impact of a Menstrual Hygiene Program on Ugandan Girls' School Absenteeism
A study testing Irise Easy Pad & Menstrual Health Education in people with Menstrual Hygiene Management, run by Irise International at 1 site in Uganda.
Trial summary
This study builds on the pilot work of the Irise research group to investigate the impact of menstrual hygiene interventions on East African girls' school attendance, activities of daily living and self-esteem. The trial will be carried out in 40 schools to either intervention or control arms. Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Hygiene Management
- What is being tested?
- Irise Easy Pad & Menstrual Health Education
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUganda
- Study dates
- Sep 2014to Dec 2015
- Phase
- Interventional
- 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 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Girls from schools who have not previously been recipients of a menstrual hygiene programme between the ages of 14-18 who have started menstruating.
Who cannot join
- Girls who have not started their periods will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Menstrual Hygiene Matter? Randomised Control Step-Wedge Trial Investigating the Impact of a Menstrual Hygiene Program (Reusable Sanitary Pad and Menstrual Health Education) on Rural Ugandan Girls' School Absenteeism
This study builds on the pilot work of the Irise research group to investigate the impact of menstrual hygiene interventions on East African girls' school attendance, activities of daily living and self-esteem. The trial will be carried out in 40 schools to either intervention or control arms. Schools will receive a menstrual hygiene program, including the distribution of reusable sanitary pads and menstrual health education. The impact of the programme on girls' school attendance will be monitored using the validated Irise questionnaire and school registers. The impact of the programme on activities of daily living during menstruation and self-esteem during menstruation will also be measured using the Irise Questionnaire and explored using focus groups.
Read the detailed description
Research Aims and Objectives
Aims
- To assess the impact of a Menstrual Hygiene Management (MHM) Programme, based around the distribution of reusable pads and delivery of health education in schools, on East African schoolgirls.
Objectives
- To explore initial (baseline) MHM practices and knowledge
- To assess school absenteeism during the study period
- To assess the impact of menstruation on activities of daily living at baseline and at 6 and 12 months into the study
- To assess girls' self-esteem during menstruation at baseline and at 6 and 12 months into the study
Background
Irise International
Irise International is a small charitable organisation and research group founded in 2011 in response to Kenyan school girls' accounts of their difficulties attending school during menstruation. School enrolment in East Africa is the highest it has ever been. In Uganda primary school enrolment is 94% with almost equal numbers of girls and boys enrolled in the first grade. However primary school completion rates are only 25% for girls, compared to 56% for boys. This data highlights a need for interventions to help keep girls in school so they can make the most of the opportunities they are being offered. It is in this context that menstrual hygiene and sanitation interventions may become an important means of promoting girls' education and empowerment.
Pilot work
Irise undertook a pilot study in Kisumu Kenya. Groups of 30 girls from 10 schools were randomly allocated to control or intervention groups. The intervention group received training on how to make a reusable pad and enough equipment to make three. Data was collected at baseline and at one month using a questionnaire. The mean number of days girls reported missing specifically due to menstruation was 1.66 with responses ranged from 0-11. Overall 5 in 10 girls reported missing some school because of menstruation compared to just 1 in 10 in the UK.
After one month follow-up, absenteeism was reduced, on average, by 1.5 days in the schools that received the intervention. A covariate adjusted t-test of group mean number of days missed, control group vs intervention group, showed a result that was close to the 95% significance level (2.01 mean days (±2.14) vs 1.32 mean days (±1.89); P=0.077; 95% CI -3.17: 0.21).
For all schools in the intervention group the mean number of days of school missed decreased or stayed constant; schools in the control group either stayed constant or increased.
More research is needed to investigate the long term effect of menstrual hygiene programmes on school girls' attendance, activities of daily living and self-esteem. This study will therefore build on the investigators previous pilot work and is part of an on-going process to research this neglected issue.
Preliminary work
A preliminary round of data collection took place in June and July 2013 in 30 schools through the delivery of a questionnaire. A more detailed investigation using interviews was carried out in a select number of schools in order to understand local menstrual hygiene practices in more depth and collect context specific information relevant to the delivery of a menstrual hygiene program. It also enabled us to introduce the concept of research and how it should be conducted to the investigators local partner and helped to identify logistical issues which the investigators can take steps to avoid in the main study.
Research methods
Design
A step wedge design was chosen to provide a control group for 6 months but allow all girls enrolled in the study to receive the intervention at 12 months. The investigators will also be able to see if the effect of the intervention in the intervention group is replicated in the control when they receive the intervention at six months. Class 6 in each school will be enrolled in the study and will receive pads and menstrual health education. Schools will be selected a predefined distance apart in order to avoid contamination. If schools do fall less than the predefined distance apart they will be classed as a cluster and be analysed together. At baseline half the schools will be randomly allocated to receive the intervention and while the other half will act as a control group. After six months the remaining schools will also be given the intervention and all schools will be followed up for the remainder of the study period.
Recruitment of schools
Forty schools in Western Uganda will be recruited through local Irise partner, LuYoDeFo and through contacts at Kampala International University and the Department of Health. These Irise partners and contacts will provide a list of schools in the areas selected to take part in the research. These schools will then be visited by an Irise researcher and be given information about the study. They will have the opportunity to opt in or out at this point. Written informed consent will be obtained from the head teachers of the schools and from the girls themselves.
Planned Intervention
During the first 6 months 20 schools will receive menstrual health education and free promotional reusable pads from a local social enterprise set-up as part of Irise's project work in Uganda. During the second 6 months the remaining 20 schools will receive menstrual health education and free promotional pads from the local social enterprise.
- Conditions
- Menstrual Hygiene Management
- Being tested
- Irise Easy Pad & Menstrual Health Education
- Keywords
- Menstruation, MHM, Menstrual Hygiene Management, Girls Education, Absenteeism, Access to Education, Menstrual Health Education, Reusable Sanitary Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irise Easy Pad & Menstrual Health EducationDevice
Reusable manufactured sanitary pad produced by Irise Uganda Limited and education sessions provided by qualified menstrual health educators
| Study group | Role | What they receive |
|---|---|---|
| 12 month menstrual hygiene programme | Experimental | This is the first group to receive the intervention. They will receive the intervention after baseline and be followed up for the following 12 months. Receives: Device: Irise Easy Pad & Menstrual Health Education |
| 6 month menstrual hygiene programme | Experimental | This is the second group to receive the intervention. They will act as a control group for the first 6 months then receive intervention at 6 months. Receives: Device: Irise Easy Pad & Menstrual Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of days of school missed per month
The number of days of school missed during a month for the female members of the class in the participating school. This will be measured through self-reported questionnaires and the results will be triangulated through the use of school registers.
Measured: Baseline
The number of days of school missed per month
The number of days of school missed during a month for the female members of the class in the participating school. This will be measured through self-reported questionnaires and the results will be triangulated through the use of school registers.
Measured: Baseline to 6 months
The number of days of school missed per month
The number of days of school missed during a month for the female members of the class in the participating school. This will be measured through self-reported questionnaires and the results will be triangulated through the use of school registers.
Measured: 6 months to 12 months
Secondary outcomes (6)
Impact of menstruation on activities of daily living
This will be measured through self-reported questionnaires. The questions are part of the validated questionnaire developed by Irise International on menstrual hygiene. The frequency that menstrual hygiene interferes with participants ADLs can be categorized. Proportions can then be displayed to give an idea of impact.
Measured: Baseline
Impact of menstruation on activities of daily living
This will be measured through self-reported questionnaires. The questions are part of the validated questionnaire developed by Irise International on menstrual hygiene. The frequency that menstrual hygiene interferes with participants ADLs can be categorized. Proportions can then be displayed to give an idea of impact.
Measured: 6 months
Impact of menstruation on activities of daily living
This will be measured through self-reported questionnaires. The questions are part of the validated questionnaire developed by Irise International on menstrual hygiene. The frequency that menstrual hygiene interferes with participants ADLs can be categorized. Proportions can then be displayed to give an idea of impact.
Measured: 12 months
Self-esteem during menstruation
The impact of menstruation on participants self-esteem will be investigated through qualitative techniques of focus groups and interviews.
Measured: Baseline
Self-esteem during menstruation
The impact of menstruation on participants self-esteem will be investigated through qualitative techniques of focus groups and interviews.
Measured: 6 months
Self-esteem during menstruation
The impact of menstruation on participants self-esteem will be investigated through qualitative techniques of focus groups and interviews.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menstrual Hygiene ManagementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irise International
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Wilson-Smith, BA, MBChB, Principal investigator, Irise International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243488
- Sponsor's protocol ID
- 0677/KW
- Other IDs
- SAS-2014-010\7
- Status last verified
- Mar 2016
- First submitted
- 5 Sep 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Emily Wilson, Josephine Reeve & Alice Pitt Education. Period. Developing an acceptable and replicable menstrual hygiene intervention Development in Practice 24(1): 63-80, 2014
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Menstrual Hygiene Matter? Randomised Control Step-Wedge Trial Investigating the Impact of a Menstrual Hygiene Program (Reusable Sanitary Pad and Menstrual Health Education) on Rural Ugandan Girls' School Absenteeism
- ClinicalTrials.gov ID
- NCT02243488
- Acronym / sponsor ID
- 0677/KW
- Conditions
- Menstrual Hygiene Management
- Keywords
- Menstruation, MHM, Menstrual Hygiene Management, Girls Education, Absenteeism, Access to Education, Menstrual Health Education, Reusable Sanitary Product
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Irise InternationalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Sep 2014 (estimated)
- 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.
This study builds on the pilot work of the Irise research group to investigate the impact of menstrual hygiene interventions on East African girls' school attendance, activities of daily living and self-esteem. The trial will be carried out in 40 schools to either intervention or control arms. Schools will receive a menstrual hygiene program, including the distribution of reusable sanitary pads and menstrual health education. The impact of the programme on girls' school attendance will be monitored using the validated Irise questionnaire and school registers. The impact of the programme on activities of daily living during menstruation and self-esteem during menstruation will also be measured using the Irise Questionnaire and explored using focus groups.
Detailed description
Research Aims and Objectives
Aims
- To assess the impact of a Menstrual Hygiene Management (MHM) Programme, based around the distribution of reusable pads and delivery of health education in schools, on East African schoolgirls.
Objectives
- To explore initial (baseline) MHM practices and knowledge
- To assess school absenteeism during the study period
- To assess the impact of menstruation on activities of daily living at baseline and at 6 and 12 months into the study
- To assess girls' self-esteem during menstruation at baseline and at 6 and 12 months into the study
Background
Irise International
Irise International is a small charitable organisation and research group founded in 2011 in response to Kenyan school girls' accounts of their difficulties attending school during menstruation. School enrolment in East Africa is the highest it has ever been. In Uganda primary school enrolment is 94% with almost equal numbers of girls and boys enrolled in the first grade. However primary school completion rates are only 25% for girls, compared to 56% for boys. This data highlights a need for interventions to help keep girls in school so they can make the most of the opportunities they are being offered. It is in this context that menstrual hygiene and sanitation interventions may become an important means of promoting girls' education and empowerment.
Pilot work
Irise undertook a pilot study in Kisumu Kenya. Groups of 30 girls from 10 schools were randomly allocated to control or intervention groups. The intervention group received training on how to make a reusable pad and enough equipment to make three. Data was collected at baseline and at one month using a questionnaire. The mean number of days girls reported missing specifically due to menstruation was 1.66 with responses ranged from 0-11. Overall 5 in 10 girls reported missing some school because of menstruation compared to just 1 in 10 in the UK.
After one month follow-up, absenteeism was reduced, on average, by 1.5 days in the schools that received the intervention. A covariate adjusted t-test of group mean number of days missed, control group vs intervention group, showed a result that was close to the 95% significance level (2.01 mean days (±2.14) vs 1.32 mean days (±1.89); P=0.077; 95% CI -3.17: 0.21).
For all schools in the intervention group the mean number of days of school missed decreased or stayed constant; schools in the control group either stayed constant or increased.
More research is needed to investigate the long term effect of menstrual hygiene programmes on school girls' attendance, activities of daily living and self-esteem. This study will therefore build on the investigators previous pilot work and is part of an on-going process to research this neglected issue.
Preliminary work
A preliminary round of data collection took place in June and July 2013 in 30 schools through the delivery of a questionnaire. A more detailed investigation using interviews was carried out in a select number of schools in order to understand local menstrual hygiene practices in more depth and collect context specific information relevant to the delivery of a menstrual hygiene program. It also enabled us to introduce the concept of research and how it should be conducted to the investigators local partner and helped to identify logistical issues which the investigators can take steps to avoid in the main study.
Research methods
Design
A step wedge design was chosen to provide a control group for 6 months but allow all girls enrolled in the study to receive the intervention at 12 months. The investigators will also be able to see if the effect of the intervention in the intervention group is replicated in the control when they receive the intervention at six months. Class 6 in each school will be enrolled in the study and will receive pads and menstrual health education. Schools will be selected a predefined distance apart in order to avoid contamination. If schools do fall less than the predefined distance apart they will be classed as a cluster and be analysed together. At baseline half the schools will be randomly allocated to receive the intervention and while the other half will act as a control group. After six months the remaining schools will also be given the intervention and all schools will be followed up for the remainder of the study period.
Recruitment of schools
Forty schools in Western Uganda will be recruited through local Irise partner, LuYoDeFo and through contacts at Kampala International University and the Department of Health. These Irise partners and contacts will provide a list of schools in the areas selected to take part in the research. These schools will then be visited by an Irise researcher and be given information about the study. They will have the opportunity to opt in or out at this point. Written informed consent will be obtained from the head teachers of the schools and from the girls themselves.
Planned Intervention
During the first 6 months 20 schools will receive menstrual health education and free promotional reusable pads from a local social enterprise set-up as part of Irise's project work in Uganda. During the second 6 months the remaining 20 schools will receive menstrual health education and free promotional pads from the local social enterprise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12 month menstrual hygiene programme | Experimental | Device: Irise Easy Pad & Menstrual Health EducationThis is the first group to receive the intervention. They will receive the intervention after baseline and be followed up for the following 12 months. |
| 6 month menstrual hygiene programme | Experimental | Device: Irise Easy Pad & Menstrual Health EducationThis is the second group to receive the intervention. They will act as a control group for the first 6 months then receive intervention at 6 months. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Girls from schools who have not previously been recipients of a menstrual hygiene programme between the ages of 14-18 who have started menstruating.
Key exclusion criteria (1 listed)
- Girls who have not started their periods will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irise Easy Pad & Menstrual Health EducationReusable manufactured sanitary pad produced by Irise Uganda Limited and education sessions provided by qualified menstrual health educators | Device | 12 month menstrual hygiene programme, 6 month menstrual hygiene programme |
Primary outcome
The number of days of school missed per month
Time frame: Baseline
The number of days of school missed during a month for the female members of the class in the participating school. This will be measured through self-reported questionnaires and the results will be triangulated through the use of school registers.
The number of days of school missed per month
Time frame: Baseline to 6 months
The number of days of school missed during a month for the female members of the class in the participating school. This will be measured through self-reported questionnaires and the results will be triangulated through the use of school registers.
The number of days of school missed per month
Time frame: 6 months to 12 months
The number of days of school missed during a month for the female members of the class in the participating school. This will be measured through self-reported questionnaires and the results will be triangulated through the use of school registers.
6 secondary outcomes
Impact of menstruation on activities of daily living
Time frame: Baseline
Impact of menstruation on activities of daily living
Time frame: 6 months
Impact of menstruation on activities of daily living
Time frame: 12 months
Self-esteem during menstruation
Time frame: Baseline
Self-esteem during menstruation
Time frame: 6 months
Self-esteem during menstruation
Time frame: 12 months
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 16 Mar 2016.
- BackgroundEmily Wilson, Josephine Reeve & Alice Pitt Education. Period. Developing an acceptable and replicable menstrual hygiene intervention Development in Practice 24(1): 63-80, 2014
- Related InfoLink provided by the sponsor.
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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.
Emily Wilson-Smith, BA, MBChB principal investigator
Irise International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irise Easy Pad & Menstrual Health Education in people with Menstrual Hygiene Management, run by Irise International 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 16 Mar 2016. 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?
The number of days of school missed per month (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT02243488, which also lists 1 linked publication.
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 16 Mar 2016.