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.
N1 - Funding Information:
This study is funded by the Joint Global Health Trials Initiative (UK-Medical Research Council/Department for International Development/Wellcome Trust /Department of Health and Social Care, grant MR/N006046/1). The funders have or will have no role in the design of the study, the collection, analysis, and interpretation of data, or in writing the manuscript.
Publisher Copyright:
© 2019 The Author(s).
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
SN - 1471-2458
VL - 19
JO - BMC public health
JF - BMC public health
IS - 1
M1 - 1317
ER -