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 Onyango, Feiko O Ter Kuile, Penelope A Phillips-Howard, 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 Onyango, Feiko O Ter Kuile, Penelope A Phillips-Howard

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.

Trial registration: ClinicalTrials.gov NCT03051789 , 15th February 2017.

Keywords: Adolescence; Clinical trial; Equity; HIV; HSV-2; Kenya; Menstruation; Pregnancy; School dropout; Sexual and reproductive health; Study protocol.

Conflict of interest statement

The authors declare no conflict of interests.

Figures

Fig. 1
Fig. 1
Map of Siaya County Public Health Facilities and 96 CCG Study Schools
Fig. 2
Fig. 2
Flowchart of Randomization and Study Design

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