Menstrual health interventions, schooling, and mental health problems among Ugandan students (MENISCUS): study protocol for a school-based cluster-randomised trial.


Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
07 Sep 2022
Historique:
received: 25 05 2022
accepted: 18 08 2022
entrez: 7 9 2022
pubmed: 8 9 2022
medline: 11 9 2022
Statut: epublish

Résumé

Menstrual health is an increasingly recognised public health issue, defined as complete physical, mental, and social well-being in relation to the menstrual cycle. The MENISCUS trial aims to assess whether a multi-component intervention addressing physical and emotional aspects of menstrual health improves educational attainment, mental health problems, menstrual management, self-efficacy, and quality of life among girls in secondary school in Uganda. The study is a parallel-arm cluster-randomised controlled trial with 60 schools (clusters) in Wakiso and Kalungu districts, with a mixed-methods process evaluation to assess intervention fidelity and acceptability and economic and policy analyses. The schools will be randomised 1:1 to immediate intervention or to optimised usual care with delayed intervention delivery. The intervention includes creation of a Menstrual Health Action Group at schools and NGO-led training of trainers on puberty education, development of a drama skit, delivery of a menstrual health kit including reusable pads and menstrual cups, access to pain management strategies including analgesics, and basic improvements to school water, sanitation, and hygiene facilities. Baseline data will be collected from secondary 2 students in 2022 (median age ~15.5 years), with endline after 1 year of intervention delivery (~3600 females and a random sample of ~900 males). The primary outcomes assessed in girls are (i) examination performance based on the Mathematics, English, and Biology curriculum taught during the intervention delivery (independently assessed by the Uganda National Examinations Board) and (ii) mental health problems using the Total Difficulties Scale of the Strengths and Difficulties 25-item questionnaire. Secondary outcomes are menstrual knowledge and attitudes in girls and boys and, in girls only, menstrual practices, self-efficacy in managing menstruation, quality of life and happiness, prevalence of urogenital infections, school and class attendance using a self-completed menstrual daily diary, and confidence in maths and science. The trial is innovative in evaluating a multi-component school-based menstrual health intervention addressing both physical and emotional aspects of menstrual health and using a "training of trainers" model designed to be sustainable within schools. If found to be cost-effective and acceptable, the intervention will have the potential for national and regional scale-up. ISRCTN 45461276 . Registered on 16 September 2021.

Sections du résumé

BACKGROUND BACKGROUND
Menstrual health is an increasingly recognised public health issue, defined as complete physical, mental, and social well-being in relation to the menstrual cycle. The MENISCUS trial aims to assess whether a multi-component intervention addressing physical and emotional aspects of menstrual health improves educational attainment, mental health problems, menstrual management, self-efficacy, and quality of life among girls in secondary school in Uganda.
METHODS METHODS
The study is a parallel-arm cluster-randomised controlled trial with 60 schools (clusters) in Wakiso and Kalungu districts, with a mixed-methods process evaluation to assess intervention fidelity and acceptability and economic and policy analyses. The schools will be randomised 1:1 to immediate intervention or to optimised usual care with delayed intervention delivery. The intervention includes creation of a Menstrual Health Action Group at schools and NGO-led training of trainers on puberty education, development of a drama skit, delivery of a menstrual health kit including reusable pads and menstrual cups, access to pain management strategies including analgesics, and basic improvements to school water, sanitation, and hygiene facilities. Baseline data will be collected from secondary 2 students in 2022 (median age ~15.5 years), with endline after 1 year of intervention delivery (~3600 females and a random sample of ~900 males). The primary outcomes assessed in girls are (i) examination performance based on the Mathematics, English, and Biology curriculum taught during the intervention delivery (independently assessed by the Uganda National Examinations Board) and (ii) mental health problems using the Total Difficulties Scale of the Strengths and Difficulties 25-item questionnaire. Secondary outcomes are menstrual knowledge and attitudes in girls and boys and, in girls only, menstrual practices, self-efficacy in managing menstruation, quality of life and happiness, prevalence of urogenital infections, school and class attendance using a self-completed menstrual daily diary, and confidence in maths and science.
DISCUSSION CONCLUSIONS
The trial is innovative in evaluating a multi-component school-based menstrual health intervention addressing both physical and emotional aspects of menstrual health and using a "training of trainers" model designed to be sustainable within schools. If found to be cost-effective and acceptable, the intervention will have the potential for national and regional scale-up.
TRIAL REGISTRATION BACKGROUND
ISRCTN 45461276 . Registered on 16 September 2021.

Identifiants

pubmed: 36071530
doi: 10.1186/s13063-022-06672-4
pii: 10.1186/s13063-022-06672-4
pmc: PMC9449307
doi:

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

759

Subventions

Organisme : Medical Research Council
ID : MC_UU_00027/4
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/R010161/1
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/V005634/1
Pays : United Kingdom
Organisme : Joint Global Health Scheme with funding from the UK Foreign, Commonwealth and Development Office, the UK Medical Research Council, the UK Department of Health and Social Care through the National Institute of Health Research (NIHR) and Wellcome
ID : MR/V005634/1

Investigateurs

Aggrey Tumuhimbise (A)
Christopher Baleke (C)
Denis Ndekezi (D)
Denis Ssenyondwa (D)
Kevin Nakuya (K)
Levicatus Mugenyi (L)
Prossy Namirembe (P)
Ratifah Batuusa (R)
Robert Bakanoma (R)
Stephen Lagony (S)
Titus Kisa Ssesanga (TK)

Informations de copyright

© 2022. The Author(s).

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Auteurs

Catherine Kansiime (C)

MRC/UVRI and LSHTM Uganda Research Unit, P.O. Box 49, Plot 51-59 Nakiwogo Road, Entebbe, Uganda. Catherine.Kansiime@mrcuganda.org.

Laura Hytti (L)

LSHTM, London, UK.

Kate Andrews Nelson (KA)

LSHTM, London, UK.

Belen Torondel (B)

Faculty of Infectious and Tropical Diseases, LSHTM, London, UK.

Suzanna C Francis (SC)

LSHTM, London, UK.

Clare Tanton (C)

LSHTM, London, UK.

Giulia Greco (G)

LSHTM, London, UK.

Sophie Belfield (S)

WoMena Uganda, Kampala, Uganda.

Shamirah Nakalema (S)

WoMena Uganda, Kampala, Uganda.

Fred Matovu (F)

PADRI, Makerere University, Kampala, Uganda.

Andrew Sentoogo Ssemata (AS)

MRC/UVRI and LSHTM Uganda Research Unit, P.O. Box 49, Plot 51-59 Nakiwogo Road, Entebbe, Uganda.

Connie Alezuyo (C)

Education Response Plan Secretariat, Ministry of Education and Sports, Kampala, Uganda.

Stella Neema (S)

Makerere University, Kampala, Uganda.

John Jerrim (J)

UCL Institute of Education, University College London, London, UK.

Chris Bonell (C)

LSHTM, London, UK.

Janet Seeley (J)

LSHTM, London, UK.
Social Science Programme, MRC/UVRI and LSHTM, Entebbe, Uganda.

Helen A Weiss (HA)

LSHTM, London, UK.

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Classifications MeSH