Cups or Cash for Girls Trial to Reduce Sexual and Reproductive Harm and School Dropout
Cups or Cash for Girls Trial to Reduce Sexual and Reproductive Harm and School Dropout
A 4-armed cluster randomised controlled trial conducted among secondary schoolgirls in Siaya,
 western Kenya, where clusters are the unit of allocation and schoolgirls the unit of
 measurement. The overall aim of the trial is to inform evidence-based policy to develop
 intervention programmes which improve adolescent girls' health, school equity and
 life-chances. The primary objective is to determine the impact of menstrual cups or cash
 transfer alone, or in combination, compared against controls, on a composite of deleterious
 outcomes (HIV, HSV-2 infection, and school dropout) over 3 schoolyears follow-up.
Title: Menstrual cups and cash transfer to reduce sexual and reproductive harm and school
 dropout in adolescent schoolgirls in western Kenya: a cluster randomised controlled trial.

 Short Title: Cups or cash for girls (CCg) trial

 Background and rationale: Adolescence is a critical time of psychological and biological
 change, and advocacy has increased to identify interventions that protect against sexual and
 reproductive health (SRH) harms, which are disproportionately high among adolescent girls in
 sub-Saharan Africa. In much of eastern and southern Africa including western Kenya, where
 unprotected transactional sex is common, young females are highly vulnerable to sexually
 transmitted infections (STIs), including HIV, and pregnancy resulting in school dropout.
 While the burden of young female SRH harms is high for individuals, communities and health
 services, sustainable preventive interventions are lacking. Evidence of a positive
 association between girls' education, health and economic potential has strengthened
 international resolve to improve educational opportunities for adolescent girls. While SRH
 education has minimal impact on SRH harms, staying in school has shown to protect girls
 against early marriage, teen pregnancy, and HIV infection, with schoolgirls reporting less
 frequent sex, and fewer partners with less age disparity. While MDGs focused on primary
 school attendance, the post-2015 Sustainability Development Goals continue to encourage
 investment in secondary, tertiary and vocational education to build human capital, innovation
 and economic growth, but require the support of cost-effective interventions. Interventions
 using cash transfer (CT) have demonstrated a protective effect on girls SRH (HIV, HSV-2,
 sexual behaviours, and school indicators). Menstrual hygiene management (MHM) is a pervasive
 problem across low middle income countries (LMICs) and a lack of MHM materials and facilities
 negatively impact girls' school-life. This increases girls' vulnerability to coercive sex,
 which often creates a pathway to obtain necessities such as soap, sanitary products, and
 underwear; 10% of 15 year old girls report that they obtain money through sex to purchase
 sanitary products in western Kenya. To tackle these challenges, our team ran a pilot
 menstrual study in western Kenya. It provided MHM tools to adolescent girls in the form of
 reusable menstrual cups and disposable sanitary pads. The results demonstrated a lower
 prevalence of STI and bacterial vaginosis among girls who were provided with a single
 menstrual cup (one cup can last up to 10 years), and a lower prevalence of school dropout
 after 12 months follow-up compared to controls. This pilot requires replication in a larger
 trial population with longer follow-up. Comparison against CT offers an opportunity to
 examine the efficacy and cost-effectiveness of these different approaches to improve girls'
 life-chances in rural western Kenya. The study is designed to inform evidence-based policy to
 improve girls' health, school equity and their life-chances.

 Primary objective: To determine the impact of menstrual cups alone, cash transfer alone, or
 the two in combination, in secondary schoolgirls on a composite of deleterious outcomes (HIV,
 HSV-2 infection, or school dropout).

 Hypothesis: The investigators postulate the interventions tested will break the cycle of
 sexual and reproductive ill-health, under-achievement, and poverty which impede girls'
 successful completion of school.

 Overview Study Design: Single site open-label 4-arm, school-cluster randomised controlled
 superiority trial. Schools are the unit of randomisation (clusters), with girls the unit of
 measurement. Schools will be randomly allocated into 4 arms using a 1:1:1:1 ratio and
 permuted block randomisation to minimise bias. Enrollment will be staggered over >=2 school
 terms if logistically required. Girls will be followed-up through graduation and into
 employment or up to 10 academic terms to determine if they complete secondary school (Form
 4). Sealed, opaque envelopes will be prepared with the study allocation. Counsellors
 conducting HIV and HSV-2 testing, and laboratory technicians will be blinded to the study
 arm. Field staff who conduct home visits to confirm dropout will also be masked where
 feasible.

 Sites: The study will be conducted in Siaya County, western Kenya. Depending on the
 recruitment rate enrolment will be expanded to other neighbouring counties.

 Study Population: Secondary schoolgirls who attend eligible schools in the western Kenya
 study site. Girls will be residents of the area, with a history of established menses (>=3
 times), no disability preventing participation, with parent or guardian's consent and girl's
 assent. Girls attending boarding schools or with visible/declared pregnancy will be excluded
 at baseline.

 Study Interventions: 1. One menstrual cup (Mooncup®) with handwash soap termly; 2. Cash
 transfer (CT; girls' pocket money) via local community/mobile banking with financial
 literacy; 3. A combination of cup and CT interventions; 4. 'Usual practice' (control) with
 handwash soap termly.

 Outcome Measures: Primary efficacy outcome: Composite endpoint comprised of incident HIV,
 HSV-2, and all-cause school dropout, by end of follow-up. Key secondary outcomes include
 incident HIV, HSV-2, school dropout, BV and reported sexual behaviours including pregnancy,
 quality of life measures, school indicators (performance, grade repitition, re-enrolment,
 absence, transfers), and cost-effectiveness. Primary safety outcome measure: toxic shock
 syndrome (TSS), and severe violence associated with intervention. Key secondary safety
 outcome include contamination on menstrual cups and other emergent harms associated with the
 interventions.

 Follow-up procedures: HIV and HSV-2 serostatus will be assessed at baseline and around the
 time of final school term (Form 4), with interim testing or annual testing if funding allows,
 including for bacterial vaginosis and other STI. School dropout will be assessed every term
 until the end of Form (class) 4. Other endpoints will be evaluated at baseline, midline, and
 end of study. Safety monitoring of TSS and physical violence will be conducted throughout by
 study nurses, supplemented by health facilities and evaluation of HDSS census mortality data.

 Sample size: Main trial: 84 schools (clusters) (21 per arm) with an approximate average of 46
 girls per school (~3864 participants, 966 per arm). Protocol amendment v7: 96 schools with
 approximately 41.5 girls per school (3980 participants, 995 per arm).

 Data Analysis: Primary trial analyses will be based on the intention to treat principle and a
 secondary analyses will also be done on the per protocol population. Generalised estimating
 equation (GEE) log binomial models will be used to analyse the primary endpoint and its
 components. The GEE model will include the arm as a fixed effect and school as a cluster
 effect. The RR values for the 5 pre-specified primary comparisons together with their 95%
 confidence intervals will be derived from the GEE model. The secondary endpoints will be
 analysed similarly using GEE models. For GEE analysis of a continuous endpoint such as
 quality of life, normal distribution and identity link functions will be used. For GEE
 analysis of a binary outcome (such as having an event of STI, HIV, pregnancy, or school
 dropout), binomial distribution and log link functions will be used; for GEE analysis of
 recurrence of events (such as number of sexual partners during a specific time), Poisson
 distribution and log link functions will be used. Covariate adjusted analysis of primary
 endpoint will be performed within the GEE framework with treatment as the study variable, and
 other predictors as covariates, and school as cluster effect. For qualitative analysis, FGD
 recordings will be transcribed verbatim with back translation. Transcripts will analysed
 using thematic analysis by study group, 2 researchers will separately assign codes for
 emergent themes, subthemes patterns, and associations using NVIVO with intercoder reliability
 checked and consensus reached following discussion. As themes emerge, differences and
 similarities will be compared across trial arms, and between study groups. Qualitative data
 from in depth interviews will be similarly evaluated.
Inclusion Criteria:

 -  Attend secondary day schools in the study area

 -  Resident of the study area

 -  Have a history of established menses (>=3 times)

 -  Have no disability preventing participation

 -  Have received parent or guardian's consent and themselves assent

 Exclusion Criteria:

 -  Attend boarding schools

 -  Visibly pregnant or declare pregnancy at baseline (non-declared girls who are pregnant
 will be excluded from analysis after normal (or otherwise) delivery dates confirm
 pregnancy started prior to intervention)