Menstrual cups and cash transfer to reduce sexual and reproductive harm and school dropout in adolescent schoolgirls: Study protocol of a cluster-randomised controlled trial in western Kenya

Garazi Zulaika, Daniel Kwaro, Elizabeth Nyothach, Duolao Wang, Emily Zielinski-Gutierrez, Linda Mason, Alie Eleveld, Tao Chen, Emily Kerubo, Annemieke Van Eijk, Cheryl Pace, David Obor, Jane Juma, Boaz Oyaro, Louis Niessen, Godfrey Bigogo, Isaac Ngere, Carl Henry, Maxwell Majiwa, Clayton O. OnyangoFeiko O. Ter Kuile, Penelope A. Phillips-Howard

Research output: Contribution to journalArticle

Abstract

Background: Adolescent girls in sub-Saharan Africa are disproportionally vulnerable to sexual and reproductive health (SRH) harms. In western Kenya, where unprotected transactional sex is common, young females face higher rates of school dropout, often due to pregnancy, and sexually transmitted infections (STIs), including HIV. Staying in school has shown to protect girls against early marriage, teen pregnancy, and HIV infection. This study evaluates the impact of menstrual cups and cash transfer interventions on a composite of deleterious outcomes (HIV, HSV-2, and school dropout) when given to secondary schoolgirls in western Kenya, with the aim to inform evidence-based policy to improve girls' health, school equity, and life-chances. Methods: Single site, 4-arm, cluster randomised controlled superiority trial. Secondary schools are the unit of randomisation, with schoolgirls as the unit of measurement. Schools will be randomised into one of four intervention arms using a 1:1:1:1 ratio and block randomisation: (1) menstrual cup arm; (2) cash transfer arm, (3) cups and cash combined intervention arm, or (4) control arm. National and county agreement, and school level consent will be obtained prior to recruitment of schools, with parent consent and girls' assent obtained for participant enrolment. Participants will be trained on safe use of interventions, with all arms receiving puberty and hygiene education. Annually, the state of latrines, water availability, water treatment, handwashing units and soap in schools will be measured. The primary endpoint is a composite of incident HIV, HSV-2, and all-cause school dropout, after 3 years follow-up. School dropout will be monitored each term via school registers and confirmed through home visits. HIV and HSV-2 incident infections and risk factors will be measured at baseline, mid-line and end-line. Intention to treat analysis will be conducted among all enrolled participants. Focus group discussions will provide contextual information on uptake of interventions. Monitoring for safety will occur throughout. Discussion: If proved safe and effective, the interventions offer a potential contribution toward girls' schooling, health, and equity in low- and middle-income countries.

Original languageEnglish (US)
Article number1317
JournalBMC public health
Volume19
Issue number1
DOIs
StatePublished - Oct 21 2019

Fingerprint

Student Dropouts
Kenya
Randomized Controlled Trials
HIV-2
Human Herpesvirus 2
Reproductive Health
Random Allocation
Toilet Facilities
Unsafe Sex
Pregnancy in Adolescence
Hand Disinfection
Soaps
House Calls
Intention to Treat Analysis
Water Purification
Africa South of the Sahara
Puberty
Sexually Transmitted Diseases
Focus Groups
Marriage

Keywords

  • Adolescence
  • Clinical trial
  • Equity
  • HIV
  • HSV-2
  • Kenya
  • Menstruation
  • Pregnancy
  • School dropout
  • Sexual and reproductive health
  • Study protocol

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

Cite this

Menstrual cups and cash transfer to reduce sexual and reproductive harm and school dropout in adolescent schoolgirls : Study protocol of a cluster-randomised controlled trial in western Kenya. / Zulaika, Garazi; Kwaro, Daniel; Nyothach, Elizabeth; Wang, Duolao; Zielinski-Gutierrez, Emily; Mason, Linda; Eleveld, Alie; Chen, Tao; Kerubo, Emily; Van Eijk, Annemieke; Pace, Cheryl; Obor, David; Juma, Jane; Oyaro, Boaz; Niessen, Louis; Bigogo, Godfrey; Ngere, Isaac; Henry, Carl; Majiwa, Maxwell; Onyango, Clayton O.; Ter Kuile, Feiko O.; Phillips-Howard, Penelope A.

In: BMC public health, Vol. 19, No. 1, 1317, 21.10.2019.

Research output: Contribution to journalArticle

Zulaika, G, Kwaro, D, Nyothach, E, Wang, D, Zielinski-Gutierrez, E, Mason, L, Eleveld, A, Chen, T, Kerubo, E, Van Eijk, A, Pace, C, Obor, D, Juma, J, Oyaro, B, Niessen, L, Bigogo, G, Ngere, I, Henry, C, Majiwa, M, Onyango, CO, Ter Kuile, FO & Phillips-Howard, PA 2019, 'Menstrual cups and cash transfer to reduce sexual and reproductive harm and school dropout in adolescent schoolgirls: Study protocol of a cluster-randomised controlled trial in western Kenya', BMC public health, vol. 19, no. 1, 1317. https://doi.org/10.1186/s12889-019-7594-3
Zulaika, Garazi ; Kwaro, Daniel ; Nyothach, Elizabeth ; Wang, Duolao ; Zielinski-Gutierrez, Emily ; Mason, Linda ; Eleveld, Alie ; Chen, Tao ; Kerubo, Emily ; Van Eijk, Annemieke ; Pace, Cheryl ; Obor, David ; Juma, Jane ; Oyaro, Boaz ; Niessen, Louis ; Bigogo, Godfrey ; Ngere, Isaac ; Henry, Carl ; Majiwa, Maxwell ; Onyango, Clayton O. ; Ter Kuile, Feiko O. ; Phillips-Howard, Penelope A. / Menstrual cups and cash transfer to reduce sexual and reproductive harm and school dropout in adolescent schoolgirls : Study protocol of a cluster-randomised controlled trial in western Kenya. In: BMC public health. 2019 ; Vol. 19, No. 1.
@article{64bc069afe5642199e89cbc1f4885912,
title = "Menstrual cups and cash transfer to reduce sexual and reproductive harm and school dropout in adolescent schoolgirls: Study protocol of a cluster-randomised controlled trial in western Kenya",
abstract = "Background: Adolescent girls in sub-Saharan Africa are disproportionally vulnerable to sexual and reproductive health (SRH) harms. In western Kenya, where unprotected transactional sex is common, young females face higher rates of school dropout, often due to pregnancy, and sexually transmitted infections (STIs), including HIV. Staying in school has shown to protect girls against early marriage, teen pregnancy, and HIV infection. This study evaluates the impact of menstrual cups and cash transfer interventions on a composite of deleterious outcomes (HIV, HSV-2, and school dropout) when given to secondary schoolgirls in western Kenya, with the aim to inform evidence-based policy to improve girls' health, school equity, and life-chances. Methods: Single site, 4-arm, cluster randomised controlled superiority trial. Secondary schools are the unit of randomisation, with schoolgirls as the unit of measurement. Schools will be randomised into one of four intervention arms using a 1:1:1:1 ratio and block randomisation: (1) menstrual cup arm; (2) cash transfer arm, (3) cups and cash combined intervention arm, or (4) control arm. National and county agreement, and school level consent will be obtained prior to recruitment of schools, with parent consent and girls' assent obtained for participant enrolment. Participants will be trained on safe use of interventions, with all arms receiving puberty and hygiene education. Annually, the state of latrines, water availability, water treatment, handwashing units and soap in schools will be measured. The primary endpoint is a composite of incident HIV, HSV-2, and all-cause school dropout, after 3 years follow-up. School dropout will be monitored each term via school registers and confirmed through home visits. HIV and HSV-2 incident infections and risk factors will be measured at baseline, mid-line and end-line. Intention to treat analysis will be conducted among all enrolled participants. Focus group discussions will provide contextual information on uptake of interventions. Monitoring for safety will occur throughout. Discussion: If proved safe and effective, the interventions offer a potential contribution toward girls' schooling, health, and equity in low- and middle-income countries.",
keywords = "Adolescence, Clinical trial, Equity, HIV, HSV-2, Kenya, Menstruation, Pregnancy, School dropout, Sexual and reproductive health, Study protocol",
author = "Garazi Zulaika and Daniel Kwaro and Elizabeth Nyothach and Duolao Wang and Emily Zielinski-Gutierrez and Linda Mason and Alie Eleveld and Tao Chen and Emily Kerubo and {Van Eijk}, Annemieke and Cheryl Pace and David Obor and Jane Juma and Boaz Oyaro and Louis Niessen and Godfrey Bigogo and Isaac Ngere and Carl Henry and Maxwell Majiwa and Onyango, {Clayton O.} and {Ter Kuile}, {Feiko O.} and Phillips-Howard, {Penelope A.}",
year = "2019",
month = "10",
day = "21",
doi = "10.1186/s12889-019-7594-3",
language = "English (US)",
volume = "19",
journal = "BMC Public Health",
issn = "1471-2458",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Menstrual cups and cash transfer to reduce sexual and reproductive harm and school dropout in adolescent schoolgirls

T2 - Study protocol of a cluster-randomised controlled trial in western Kenya

AU - Zulaika, Garazi

AU - Kwaro, Daniel

AU - Nyothach, Elizabeth

AU - Wang, Duolao

AU - Zielinski-Gutierrez, Emily

AU - Mason, Linda

AU - Eleveld, Alie

AU - Chen, Tao

AU - Kerubo, Emily

AU - Van Eijk, Annemieke

AU - Pace, Cheryl

AU - Obor, David

AU - Juma, Jane

AU - Oyaro, Boaz

AU - Niessen, Louis

AU - Bigogo, Godfrey

AU - Ngere, Isaac

AU - Henry, Carl

AU - Majiwa, Maxwell

AU - Onyango, Clayton O.

AU - Ter Kuile, Feiko O.

AU - Phillips-Howard, Penelope A.

PY - 2019/10/21

Y1 - 2019/10/21

N2 - Background: Adolescent girls in sub-Saharan Africa are disproportionally vulnerable to sexual and reproductive health (SRH) harms. In western Kenya, where unprotected transactional sex is common, young females face higher rates of school dropout, often due to pregnancy, and sexually transmitted infections (STIs), including HIV. Staying in school has shown to protect girls against early marriage, teen pregnancy, and HIV infection. This study evaluates the impact of menstrual cups and cash transfer interventions on a composite of deleterious outcomes (HIV, HSV-2, and school dropout) when given to secondary schoolgirls in western Kenya, with the aim to inform evidence-based policy to improve girls' health, school equity, and life-chances. Methods: Single site, 4-arm, cluster randomised controlled superiority trial. Secondary schools are the unit of randomisation, with schoolgirls as the unit of measurement. Schools will be randomised into one of four intervention arms using a 1:1:1:1 ratio and block randomisation: (1) menstrual cup arm; (2) cash transfer arm, (3) cups and cash combined intervention arm, or (4) control arm. National and county agreement, and school level consent will be obtained prior to recruitment of schools, with parent consent and girls' assent obtained for participant enrolment. Participants will be trained on safe use of interventions, with all arms receiving puberty and hygiene education. Annually, the state of latrines, water availability, water treatment, handwashing units and soap in schools will be measured. The primary endpoint is a composite of incident HIV, HSV-2, and all-cause school dropout, after 3 years follow-up. School dropout will be monitored each term via school registers and confirmed through home visits. HIV and HSV-2 incident infections and risk factors will be measured at baseline, mid-line and end-line. Intention to treat analysis will be conducted among all enrolled participants. Focus group discussions will provide contextual information on uptake of interventions. Monitoring for safety will occur throughout. Discussion: If proved safe and effective, the interventions offer a potential contribution toward girls' schooling, health, and equity in low- and middle-income countries.

AB - Background: Adolescent girls in sub-Saharan Africa are disproportionally vulnerable to sexual and reproductive health (SRH) harms. In western Kenya, where unprotected transactional sex is common, young females face higher rates of school dropout, often due to pregnancy, and sexually transmitted infections (STIs), including HIV. Staying in school has shown to protect girls against early marriage, teen pregnancy, and HIV infection. This study evaluates the impact of menstrual cups and cash transfer interventions on a composite of deleterious outcomes (HIV, HSV-2, and school dropout) when given to secondary schoolgirls in western Kenya, with the aim to inform evidence-based policy to improve girls' health, school equity, and life-chances. Methods: Single site, 4-arm, cluster randomised controlled superiority trial. Secondary schools are the unit of randomisation, with schoolgirls as the unit of measurement. Schools will be randomised into one of four intervention arms using a 1:1:1:1 ratio and block randomisation: (1) menstrual cup arm; (2) cash transfer arm, (3) cups and cash combined intervention arm, or (4) control arm. National and county agreement, and school level consent will be obtained prior to recruitment of schools, with parent consent and girls' assent obtained for participant enrolment. Participants will be trained on safe use of interventions, with all arms receiving puberty and hygiene education. Annually, the state of latrines, water availability, water treatment, handwashing units and soap in schools will be measured. The primary endpoint is a composite of incident HIV, HSV-2, and all-cause school dropout, after 3 years follow-up. School dropout will be monitored each term via school registers and confirmed through home visits. HIV and HSV-2 incident infections and risk factors will be measured at baseline, mid-line and end-line. Intention to treat analysis will be conducted among all enrolled participants. Focus group discussions will provide contextual information on uptake of interventions. Monitoring for safety will occur throughout. Discussion: If proved safe and effective, the interventions offer a potential contribution toward girls' schooling, health, and equity in low- and middle-income countries.

KW - Adolescence

KW - Clinical trial

KW - Equity

KW - HIV

KW - HSV-2

KW - Kenya

KW - Menstruation

KW - Pregnancy

KW - School dropout

KW - Sexual and reproductive health

KW - Study protocol

UR - http://www.scopus.com/inward/record.url?scp=85073718526&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85073718526&partnerID=8YFLogxK

U2 - 10.1186/s12889-019-7594-3

DO - 10.1186/s12889-019-7594-3

M3 - Article

C2 - 31638946

AN - SCOPUS:85073718526

VL - 19

JO - BMC Public Health

JF - BMC Public Health

SN - 1471-2458

IS - 1

M1 - 1317

ER -