Menstrual Health Interventions and School Attendance Among Ugandans

NCT04064736 | Completed DMC

• 1 other identifier: MENISCUs-2
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Management of menstruation can present substantial challenges to girls in low-income settings. The aim of this study is to pilot an intervention package to improve menstrual health (MH) management among school girls in 2 secondary schools in Entebbe sub-District, Uganda, and to prepare for a future cluster randomised trial to evaluate the impact of the intervention on school attendance, school performance and bacterial vaginosis. The recently completed study (MENstrual hygiene and Safe male Circumcision in Ugandan Schools (MENISCUS-1) showed that menstruation is a key reason for school absenteeism in this setting. The qualitative research showed substantial embarrassment and fear of teasing regarding menstruation, and suggested that this, together with pain and lack of effective materials for menstrual hygiene management, led to school absenteeism. In a small quantitative sub-study of daily diaries, 40 girls reported school absence on 28% of period-days, compared with 7% of non-period days (adjusted odds ratio=5.99, 95%CI 4.4-8.2, p\<0.001). Evaluation of menstrual management interventions, which address both the psycho social aspects of menstruation (knowledge, self-confidence, attitudes), and the physical aspects (management of pain, use of appropriate materials to eliminate leakage of menstrual blood, improved WASH facilities) are needed. In the current study (MENISCUs-2), the investigators will pilot the MH interventions developed in MENISCUS-1 as a package delivered to all girls in one school year in two schools in Wakiso District. The intervention consists of:

• Training teachers to improve current delivery of the Government guidelines for puberty education delivered by teachers (usually female).
• A drama skit to address issues around menstruation, engaging girls, boys, parents and teachers.
• Provision of a menstrual management kit, including re-usable pads and training teachers and peers to teach girls how to use these menstrual management methods
• Supplying analgesics (paracetamol) for menstrual cramps using a voucher scheme
• Basic improvements to school sanitation facilities, including ensuring girls' privacy The primary outcome is to review whether criteria for progression to a future trial are met. The criteria are that i) the education session and drama skit are delivered, the majority of girls use the pads, and that soap is available for \>50% of observation visits; and ii) the retention rate in school over 9 months is \>60%. The investigators will compare the relative risk of absenteeism on period-days and non-period-days from diaries, within MENISCUS-2 (the new pilot study in which the intervention will take place) and within MENISCUS-1 (the previous feasibility study where no intervention had taken place when the diaries were collected) schools. They will estimate the number of girls who are retained at school in order to estimate the likely loss to follow-up within a future trial. They plan to submit a proposal for a full trial in 2019.

Conditions

Menstrual Health Intervention

Keywords

Menstrual Health; School attendance; Adolescent health

Outcome Measures

Primary Outcomes (1)

• School attendance

  Measured using menstrual daily diaries for menstruating girls. This will be compared using diaries, class registers, direct observation check visits and retrospective self-reported school attendance at the endline cross-sectional survey.

  9 months

Secondary Outcomes (2)

• Knowledge and attitudes towards menstruation

  9months

• Psychosocial wellbeing

  9months

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This pilot study was conducted in Entebbe Municipality in Wakiso District, Uganda. Entebbe has 13 registered secondary schools. Two day schools (one government and one private), both with students of low socio-economic status, were purposively selected.

You may qualify if:

• Eligible participants were all male and female secondary students in the second school year in the 2 selecteed schools. Written informed consent was sought from students aged \>18 years, and from the parents/caretakers of those aged \<18 years, with student assent

You may not qualify if:

• None

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Ministry of Health, Uganda: collaborator
• MRC/UVRI and LSHTM Uganda Research Unit: collaborator
• WoMena Uganda: collaborator
• Makerere University: collaborator
• World Health Organization: collaborator

Study Sites (1)

MRC/UVRI and LSHTM Uganda Unit

Entebbe, Uganda

Location

Related Publications (2)

• Nalugya R, Tanton C, Hytti L, Kansiime C, Nakuya K, Namirembe P, Nakalema S, Neema S, Alezuyo C, Namuli Musoke S, Torondel B, Francis SC, Ross DA, Bonell C, Seeley J, Weiss HA. Assessing the effectiveness of a comprehensive menstrual health intervention program in Ugandan schools (MENISCUS): process evaluation of a pilot intervention study. Pilot Feasibility Stud. 2020 Apr 24;6:51. doi: 10.1186/s40814-020-00585-2. eCollection 2020.

  PMID: 32346485 DERIVED

• Kansiime C, Hytti L, Nalugya R, Nakuya K, Namirembe P, Nakalema S, Neema S, Tanton C, Alezuyo C, Namuli Musoke S, Torondel B, Francis SC, Ross DA, Bonell C, Seeley J, Weiss HA. Menstrual health intervention and school attendance in Uganda (MENISCUS-2): a pilot intervention study. BMJ Open. 2020 Feb 4;10(2):e031182. doi: 10.1136/bmjopen-2019-031182.

  PMID: 32024786 DERIVED

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 22, 2019
• Study Start: August 14, 2017
• Primary Completion: August 20, 2018
• Study Completion: August 24, 2018
• Last Updated: December 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: From January 2020 with unlimited duration

Locations

UG (1)