<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02243488</url>
  </required_header>
  <id_info>
    <org_study_id>0677/KW</org_study_id>
    <secondary_id>SAS-2014-010\7</secondary_id>
    <nct_id>NCT02243488</nct_id>
  </id_info>
  <brief_title>Does Menstrual Hygiene Matter? Investigating the Impact of a Menstrual Hygiene Program on Ugandan Girls' School Absenteeism</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Irise International</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Irise International</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study builds on the pilot work of the Irise research group to investigate the impact of&#xD;
      menstrual hygiene interventions on East African girls' school attendance, activities of daily&#xD;
      living and self-esteem. The trial will be carried out in 40 schools to either intervention or&#xD;
      control arms. Schools will receive a menstrual hygiene program, including the distribution of&#xD;
      reusable sanitary pads and menstrual health education. The impact of the programme on girls'&#xD;
      school attendance will be monitored using the validated Irise questionnaire and school&#xD;
      registers. The impact of the programme on activities of daily living during menstruation and&#xD;
      self-esteem during menstruation will also be measured using the Irise Questionnaire and&#xD;
      explored using focus groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research Aims and Objectives&#xD;
&#xD;
      Aims&#xD;
&#xD;
      - To assess the impact of a Menstrual Hygiene Management (MHM) Programme, based around the&#xD;
      distribution of reusable pads and delivery of health education in schools, on East African&#xD;
      schoolgirls.&#xD;
&#xD;
      Objectives&#xD;
&#xD;
        -  To explore initial (baseline) MHM practices and knowledge&#xD;
&#xD;
        -  To assess school absenteeism during the study period&#xD;
&#xD;
        -  To assess the impact of menstruation on activities of daily living at baseline and at 6&#xD;
           and 12 months into the study&#xD;
&#xD;
        -  To assess girls' self-esteem during menstruation at baseline and at 6 and 12 months into&#xD;
           the study&#xD;
&#xD;
      Background&#xD;
&#xD;
      Irise International&#xD;
&#xD;
      Irise International is a small charitable organisation and research group founded in 2011 in&#xD;
      response to Kenyan school girls' accounts of their difficulties attending school during&#xD;
      menstruation. School enrolment in East Africa is the highest it has ever been. In Uganda&#xD;
      primary school enrolment is 94% with almost equal numbers of girls and boys enrolled in the&#xD;
      first grade. However primary school completion rates are only 25% for girls, compared to 56%&#xD;
      for boys. This data highlights a need for interventions to help keep girls in school so they&#xD;
      can make the most of the opportunities they are being offered. It is in this context that&#xD;
      menstrual hygiene and sanitation interventions may become an important means of promoting&#xD;
      girls' education and empowerment.&#xD;
&#xD;
      Pilot work&#xD;
&#xD;
      Irise undertook a pilot study in Kisumu Kenya. Groups of 30 girls from 10 schools were&#xD;
      randomly allocated to control or intervention groups. The intervention group received&#xD;
      training on how to make a reusable pad and enough equipment to make three. Data was collected&#xD;
      at baseline and at one month using a questionnaire. The mean number of days girls reported&#xD;
      missing specifically due to menstruation was 1.66 with responses ranged from 0-11. Overall 5&#xD;
      in 10 girls reported missing some school because of menstruation compared to just 1 in 10 in&#xD;
      the UK.&#xD;
&#xD;
      After one month follow-up, absenteeism was reduced, on average, by 1.5 days in the schools&#xD;
      that received the intervention. A covariate adjusted t-test of group mean number of days&#xD;
      missed, control group vs intervention group, showed a result that was close to the 95%&#xD;
      significance level (2.01 mean days (±2.14) vs 1.32 mean days (±1.89); P=0.077; 95% CI -3.17:&#xD;
      0.21).&#xD;
&#xD;
      For all schools in the intervention group the mean number of days of school missed decreased&#xD;
      or stayed constant; schools in the control group either stayed constant or increased.&#xD;
&#xD;
      More research is needed to investigate the long term effect of menstrual hygiene programmes&#xD;
      on school girls' attendance, activities of daily living and self-esteem. This study will&#xD;
      therefore build on the investigators previous pilot work and is part of an on-going process&#xD;
      to research this neglected issue.&#xD;
&#xD;
      Preliminary work&#xD;
&#xD;
      A preliminary round of data collection took place in June and July 2013 in 30 schools through&#xD;
      the delivery of a questionnaire. A more detailed investigation using interviews was carried&#xD;
      out in a select number of schools in order to understand local menstrual hygiene practices in&#xD;
      more depth and collect context specific information relevant to the delivery of a menstrual&#xD;
      hygiene program. It also enabled us to introduce the concept of research and how it should be&#xD;
      conducted to the investigators local partner and helped to identify logistical issues which&#xD;
      the investigators can take steps to avoid in the main study.&#xD;
&#xD;
      Research methods&#xD;
&#xD;
      Design&#xD;
&#xD;
      A step wedge design was chosen to provide a control group for 6 months but allow all girls&#xD;
      enrolled in the study to receive the intervention at 12 months. The investigators will also&#xD;
      be able to see if the effect of the intervention in the intervention group is replicated in&#xD;
      the control when they receive the intervention at six months. Class 6 in each school will be&#xD;
      enrolled in the study and will receive pads and menstrual health education. Schools will be&#xD;
      selected a predefined distance apart in order to avoid contamination. If schools do fall less&#xD;
      than the predefined distance apart they will be classed as a cluster and be analysed&#xD;
      together. At baseline half the schools will be randomly allocated to receive the intervention&#xD;
      and while the other half will act as a control group. After six months the remaining schools&#xD;
      will also be given the intervention and all schools will be followed up for the remainder of&#xD;
      the study period.&#xD;
&#xD;
      Recruitment of schools&#xD;
&#xD;
      Forty schools in Western Uganda will be recruited through local Irise partner, LuYoDeFo and&#xD;
      through contacts at Kampala International University and the Department of Health. These&#xD;
      Irise partners and contacts will provide a list of schools in the areas selected to take part&#xD;
      in the research. These schools will then be visited by an Irise researcher and be given&#xD;
      information about the study. They will have the opportunity to opt in or out at this point.&#xD;
      Written informed consent will be obtained from the head teachers of the schools and from the&#xD;
      girls themselves.&#xD;
&#xD;
      Planned Intervention&#xD;
&#xD;
      During the first 6 months 20 schools will receive menstrual health education and free&#xD;
      promotional reusable pads from a local social enterprise set-up as part of Irise's project&#xD;
      work in Uganda. During the second 6 months the remaining 20 schools will receive menstrual&#xD;
      health education and free promotional pads from the local social enterprise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of days of school missed per month</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of days of school missed per month</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of days of school missed per month</measure>
    <time_frame>6 months to 12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of menstruation on activities of daily living</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of menstruation on activities of daily living</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of menstruation on activities of daily living</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-esteem during menstruation</measure>
    <time_frame>Baseline</time_frame>
    <description>The impact of menstruation on participants self-esteem will be investigated through qualitative techniques of focus groups and interviews.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-esteem during menstruation</measure>
    <time_frame>6 months</time_frame>
    <description>The impact of menstruation on participants self-esteem will be investigated through qualitative techniques of focus groups and interviews.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-esteem during menstruation</measure>
    <time_frame>12 months</time_frame>
    <description>The impact of menstruation on participants self-esteem will be investigated through qualitative techniques of focus groups and interviews.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Menstrual Hygiene Management</condition>
  <arm_group>
    <arm_group_label>12 month menstrual hygiene programme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6 month menstrual hygiene programme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Irise Easy Pad &amp; Menstrual Health Education</intervention_name>
    <description>Reusable manufactured sanitary pad produced by Irise Uganda Limited and education sessions provided by qualified menstrual health educators</description>
    <arm_group_label>12 month menstrual hygiene programme</arm_group_label>
    <arm_group_label>6 month menstrual hygiene programme</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Girls from schools who have not previously been recipients of a menstrual hygiene&#xD;
             programme between the ages of 14-18 who have started menstruating.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Girls who have not started their periods will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emily Wilson-Smith, BA, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Irise International</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kampala International University</name>
      <address>
        <city>Kasese</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <link>
    <url>http://www.irise.org.uk</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Emily Wilson, Josephine Reeve &amp; Alice Pitt Education. Period. Developing an acceptable and replicable menstrual hygiene intervention Development in Practice 24(1): 63-80, 2014</citation>
  </reference>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>March 15, 2016</last_update_submitted>
  <last_update_submitted_qc>March 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Menstruation</keyword>
  <keyword>MHM</keyword>
  <keyword>Menstrual Hygiene Management</keyword>
  <keyword>Girls Education</keyword>
  <keyword>Absenteeism</keyword>
  <keyword>Access to Education</keyword>
  <keyword>Menstrual Health Education</keyword>
  <keyword>Reusable Sanitary Product</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02243488
org study id: 0677/KW
secondary id: SAS-2014-010\7
nct id: NCT02243488
lead sponsor: 
has dmc: Yes
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
primary purpose: Prevention
masking: None (Open Label)
measure: The number of days of school missed per month
time frame: Baseline
description: 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.
measure: The number of days of school missed per month
time frame: Baseline to 6 months
description: 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.
measure: The number of days of school missed per month
time frame: 6 months to 12 months
description: 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.
measure: Impact of menstruation on activities of daily living
time frame: Baseline
description: 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.
measure: Impact of menstruation on activities of daily living
time frame: 6 months
description: 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.
measure: Impact of menstruation on activities of daily living
time frame: 12 months
description: 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.
measure: Self-esteem during menstruation
time frame: Baseline
description: The impact of menstruation on participants self-esteem will be investigated through qualitative techniques of focus groups and interviews.
measure: Self-esteem during menstruation
time frame: 6 months
description: The impact of menstruation on participants self-esteem will be investigated through qualitative techniques of focus groups and interviews.
measure: Self-esteem during menstruation
time frame: 12 months
description: The impact of menstruation on participants self-esteem will be investigated through qualitative techniques of focus groups and interviews.
arm group label: 12 month menstrual hygiene programme
arm group type: Experimental
description: 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.
arm group label: 6 month menstrual hygiene programme
arm group type: Experimental
description: 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.
intervention type: Device
intervention name: Irise Easy Pad & Menstrual Health Education
description: Reusable manufactured sanitary pad produced by Irise Uganda Limited and education sessions provided by qualified menstrual health educators
arm group label: 12 month menstrual hygiene programme
arm group label: 6 month menstrual hygiene programme
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Emily Wilson-Smith, BA, MBChB
role: Principal Investigator
affiliation: Irise International
facility: 
country: Uganda
url: http://www.irise.org.uk
description: Related Info
citation: Emily Wilson, Josephine Reeve & Alice Pitt Education. Period. Developing an acceptable and replicable menstrual hygiene intervention Development in Practice 24(1): 63-80, 2014
responsible party type: Sponsor