Menstrual Hygiene Management Clinical Trial
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.
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.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05455073 -
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|
N/A |