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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Uganda1 site
  • Kampala International University

    Kasese, Kasese

Other trials in Uganda

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.

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 groups in NCT02243488
Study groupRoleWhat they receive
12 month menstrual hygiene programmeExperimentalThis 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 programmeExperimentalThis 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.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted18 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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)
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

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.

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