Cups or Cash for Girls Trial to Reduce Sexual and Reproductive Harm and School Dropout

HIV Infections Clinical Trial

— CCg  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03051789
• Other study ID #: 15-005
• Status: Completed
• Phase: N/A
• Start date: February 28, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Liverpool School of Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. Protocol amendment v10:Secondary analysis on primary and secondary outcomes using 'at the margins' factorial analysis will also be conducted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4138
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Adolescent Behavior
• Communicable Diseases
• Herpesviridae Infections
• Herpesvirus Infection
• HIV Infections
• Infection
• Quality of Life
• Reproductive Health
• Woman Abuse

Intervention

Device:
• Menstrual Cup
Menstrual cups are reusable bell-shaped receptacles made of high grade medical silicone which collect ~30 ml of menstrual blood when inserted into the vaginal canal

Other:
• Cash transfer
A small stipend of Ksh 1500 (US$15, Dec15 exch) per term will be provided to girls, through a safe and secure mobile money transfer system provider, like M-Pesa, Equity, or Postbank. Monies will be transferred at the beginning of a term, based on school registry statistics confirming participants attended for at least 80% of the previous term.
• Cups and Cash
Combination of both interventions, using the same interventions and implementation methods.

Locations

Country	Name	City	State
Kenya	84 rural secondary schools in Siaya County (expanded to total 96 schools; Protocol v7)	Siaya	Siaya County

Sponsors (4)

Lead Sponsor	Collaborator
Liverpool School of Tropical Medicine	Centers for Disease Control and Prevention, Kenya Medical Research Institute, Safe Water and AIDS Project (SWAP), Kenya

Country where clinical trial is conducted

Kenya, 

References & Publications (1)

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. Menstrual cups — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reported sexual behaviour: age of debut	Age of sexual debut, reported by participant at survey.	Form 4 (3 years)
Other	Reported sexual behaviour: number of sexual partners	Number of lifetime sexual partners, reported by participant at survey.	Form 4 (3 years)
Other	Reported sexual behaviour: partner age concordance	Age of partners, reported by participant at survey.	Form 4 (3 years)
Other	Reported sexual behaviour: pregnancy	Frequency of pregnancy, reported by participants at survey and validation among dropouts by study staff home visit.	Form 4 (3 years)
Other	Reported sexual behaviour: contraceptive use	Use of modern contraceptives, reported by participants at survey.	Form 4 (3 years)
Other	Reported sexual behaviour: coercive sex	Frequency of coercive sex, reported by participants at survey.	Form 4 (3 years)
Other	School indicators: performance	Participant grades from the Kenyan Certificate of Secondary Education Examinations (Form 4).	Form 4 (3 years)
Other	School indicators: grade repitition	Documented school year of participants by endline.	Form 4 (3 years)
Other	School indicators: re-enrolment	Frequency of participants re-enrolled after dropout by endline.	Form 4 (3 years)
Other	School indicators: absence	Frequency of absence, as documented in school registers.	Form 4 (3 years)
Other	Pediatric quality of Life (PEDSQL)	PEDSQL-23 measures 23 individual items to group participants' wellbeing into four categories: physical, emotional, social, and school wellbeing.	Form 4 (3 years)
Other	EuroQual Quality of Life (Eq-5D)	Eq-5D Evaluates participants health state in 5 dimensions, of mobility, self care, usual activities, pain/discomfort, anxiety/depression.	Form 4 (3 years)
Other	Cost-effectiveness	Estimate the societal cost consequences and the societal cost-effectiveness of the intervention packages, including the health services perspective, as compared to the controls.	Form 4 (3 years)
Other	Other sexually transmitted infections	Prevalence of other sexually transmitted infections including bacterial vaginosis, by end study (if funding permits).	Form 4 (3 years)
Other	Primary safety outcome: toxic shock syndrome associated with interventions	Toxic shock syndrome verified through safety monitoring by study nurses, associated with interventions	Form 4 (3 years)
Other	Primary safety outcome: severe violence associated with interventions	Severe violence verified through safety monitoring by study nurses, associated with interventions	Form 4 (3 years)
Other	Secondary safety outcome: cup contamination	Frequency of contamination of cups with e. coli among a random sample of used menstrual cups at intervals (~6 monthly) over the intervention trial	Form 4 (3 years)
Other	Secondary safety outcome: other emergent harms associated with interventions	Other unexpected emergent harms associated with interventions identified during safety monitoring	Form 4 (3 years)
Other	School indicators: transfers	Frequency of transfer to another school, as documented at follow-up	Form 4 (3 years)
Other	Wellbeing-mental health:PHQ-9	Anxiety-depression score using PHQ-9	Form 4 (3 years)
Primary	Composite HIV, HSV-2, and school dropout	The primary composite endpoint will include all three components (HIV+, HSV-2, school dropout) in girls sero-negative for both HIV and HSV-2 on enrolment and in girls where sero-status could not be determined on enrolment; i.e.among HIV-negative girls who were HSV-2 positive on enrolment only incident HIV infection and school dropout contribute to the primary endpoint.	Form 4 (3 years)
Secondary	School dropout	Disaggregate of composite. Participant does not attend school consecutively for at least one full term or longer. Girls who attended part of Form (class) 4, but do not sit the final national Kenya Secondary Certificate of Education (KSCE) exams that year will be considered dropouts in that final term. Investigators will evaluate reasons for dropout.	Form 4 (3 years)
Secondary	HSV-2	Disaggregate of composite. HSV-2 incidence measured at end survey among girls sero-negative for HSV-2 on enrollment and in girls where sero-status could not be determined on enrollment.	Form 4 (3 years)
Secondary	HIV	Disaggregate of composite. HIV incidence measured at end survey among girls sero-negative for HIV on enrollment and in girls where sero-status could not be determined on enrollment.	Form 4 (3 years)