Protocol No: ECCT/16/07/06 Date of Protocol: 14-04-2016

Study 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

Study Objectives:
AIM AND OBJECTIVES
  • The overall aim is to inform evidence-based policy to develop intervention programmes which improve adolescent girls’ health, school equity and life-chances.
PRIMARY OBJECTIVE
  • To determine the impact of menstrual cups or cash transfer alone, or in combination, provided to secondary schoolgirls, on a composite of deleterious outcomes (HIV, HSV-2 infection, and school dropout).
SECONDARY OBJECTIVES
  1. To measure the age-specific differences in the acquisition of HIV and HSV-2 infections in secondary schoolgirls and risk factors for incident HIV and HSV-2 infections.
  2. To determine the risk, risk factors and reasons for dropout and other school indicators among secondary schoolgirls examining the influence of social, epidemiological, and/or health characteristics.
  3. To determine the cost benefit of menstrual cup and CT programmes for schoolgirls by assessing the cost savings of outcomes averted, for individual and combined interventions, and resulting societal impact.
  4. To determine the safety of menstrual cups use, including risk of cup contamination over time, serious adverse events, and identify factors that increase or modify this risk.
  5. To determine factors affecting how adolescent girls spend CT money, and what training is required to support their financial literacy and decision-making.
  6. To determine any adverse outcomes associated with CT and evaluate ways to mitigate risk.
  7. To determine the impact of the interventions on girls' sexual behaviours, including age of sexual début, coerced sex, number of partners, age of partners, pregnancy, condom use and use of contraception.
  8. To examine programme implementation for interventions in schools, working with beneficiaries and stakeholders to develop programme implementation packages.
  9. If funding is available, examine the effect of interventions on other sexually transmitted infections and bacterial vaginosis.
Laymans Summary:

Adolescent girls in impoverished settings suffer from inadequate menstrual hygiene to manage their periods. Lack of materials result in girls’ poor engagement with schooling, or miss schooling due to stigma and shame, and can lead to an increase in reproductive tract infections due to poor hygiene. As a consequence, girls may seek to acquire menstrual products from boys and men, placing them at increased risk of sexual infections such as HIV or HSV-2, or pregnancy, which in turn will lead to girls dropping out of school.

 

We conducted a study among 4137 adolescent girls attending 96 secondary schools in Siaya County, rural western Kenya. We provided a menstrual product (a menstrual cup), or pocket money, or both to girls (allocated by school), and compared their ‘outcomes’ with girls not provided an intervention until the end of the project (these girls then received a menstrual cup). Our results indicate that the menstrual cup was effective in supporting girls’ menstrual hygiene at school without any serious adverse outcomes. We found girls who used cups had lower rates of HSV-2 infection, and school dropout, and a reduction in the rate of pregnancy while in school. Girls receiving the cup and pocket money also had a reduction in dropout but pocket money alone did not improve girls’ health or schooling outcomes. No serious adverse effects occurred with provision of the cup or pocket money to girls. These findings suggest a menstrual product like a menstrual cup can greatly improve schoolgirls sexual and reproductive health and help them complete their secondary school education.

Abstract of Study:

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)1-3. 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.4To 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.5This 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: We 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 in Siaya County, western Kenya. Dependent on the recruitment rate, enrolment will be expanded to other neighboring counties.

Study Population: Secondary schoolgirls who attend 84 eligible schools in the western Kenya study site. Girls wil 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 bording 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 study. 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), 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 and following completion of behavioural surveys each intervention year. Safety monitoring of TSS and physical violence will be conducted throughout by study nurses, supplemented by health facility registry reviews and evaluation of HDSS census mortality data.

Sample size: Main trial: 3864 participants (in 4 arms; 966 per arm), in 84 clusters (21 schools 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.

Partner institutions: KEMRI and CDC Collaboration, Kisumu, western Kenya; Kenya Ministries of Education and Health, Liverpool School of Tropical Medicine; US Centers for Disease Control and Prevention; Safe Water and AIDS Project.

Funding: Joint Global Health Trials (Department for International Development, Medical Research Council, Wellcome Trust), UK.