NCT02243488

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 18, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

1.2 years

First QC Date

September 5, 2014

Last Update Submit

March 15, 2016

Conditions

Menstrual Hygiene Management

Keywords

MenstruationMHMMenstrual Hygiene ManagementGirls EducationAbsenteeismAccess to EducationMenstrual Health EducationReusable Sanitary Product

Outcome Measures

Primary Outcomes (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.

    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.

    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.

    6 months to 12 months

Secondary Outcomes (6)

  • Impact of menstruation on activities of daily living

    Baseline

  • Impact of menstruation on activities of daily living

    6 months

  • Impact of menstruation on activities of daily living

    12 months

  • Self-esteem during menstruation

    Baseline

  • Self-esteem during menstruation

    6 months

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Device: Irise Easy Pad & Menstrual Health Education

Interventions

Irise Easy Pad & Menstrual Health EducationDEVICE

Reusable manufactured sanitary pad produced by Irise Uganda Limited and education sessions provided by qualified menstrual health educators

12 month menstrual hygiene programme6 month menstrual hygiene programme

Eligibility Criteria

Age14 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Girls from schools who have not previously been recipients of a menstrual hygiene programme between the ages of 14-18 who have started menstruating.

You may not qualify if:

  • Girls who have not started their periods will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kampala International University

Kasese, Kasese, Uganda

Location

Related Publications (1)

  • Emily Wilson, Josephine Reeve & Alice Pitt Education. Period. Developing an acceptable and replicable menstrual hygiene intervention Development in Practice 24(1): 63-80, 2014

    BACKGROUND

Related Links

Study Officials

  • Emily Wilson-Smith, BA, MBChB

    Irise International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 18, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

UG(1)