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

NCT03051789 | Completed DMC

• 1 other identifier: 15-005
• Study Type: interventional
• Target: 4,138
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Reproductive Health; Herpesvirus Infection; HIV Infections; Woman Abuse; Quality of Life; Adolescent Behavior

Keywords

Menstrual hygiene management; Sexual and Reproductive Health; Adolescent schoolgirls; School dropoout; sub-Saharan Africa; Kenya

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• School dropout

  Form 4 (3 years)

• HSV-2

  Form 4 (3 years)

• HIV

  Form 4 (3 years)

Other Outcomes (20)

• Reported sexual behaviour: age of debut

  Form 4 (3 years)

• Reported sexual behaviour: number of sexual partners

  Form 4 (3 years)

• Reported sexual behaviour: partner age concordance

  Form 4 (3 years)

Study Arms (4)

Menstrual Cup

EXPERIMENTAL

One menstrual cup (Mooncup®), an insertable menstrual hygiene product, together with handwash soap termly; puberty and hygiene education and cup training given at intervention.

Device: Menstrual Cup

Cash Transfer

EXPERIMENTAL

Cash transfer (CT; girls' pocket money; of Ksh 1500 per term) via local community/mobile banking with financial literacy, puberty and hygiene education and cash pocket money financial literacy training given at intervention.

Other: Cash transfer

Cups and Cash

EXPERIMENTAL

A combination of cup and cash transfer interventions; puberty and hygiene education, cup training, and cash pocket money financial literacy training given at intervention.

Other: Cups and Cash

Control

NO INTERVENTION

'Usual practice' (control) with handwash soap termly; puberty and hygiene education given at intervention.

Interventions

Menstrual Cup DEVICE

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

Also known as: Mooncup

Menstrual Cup

Cash transfer OTHER

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.

Also known as: Pocket-money

Cash Transfer

Cups and Cash OTHER

Combination of both interventions, using the same interventions and implementation methods.

Also known as: Combination of cups and cash

Cups and Cash

Eligibility Criteria

• Gender Eligibility Details: Target population for intervention is menstruating schoolgirls.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Liverpool School of Tropical Medicine: lead
• Kenya Medical Research Institute: collaborator
• Centers for Disease Control and Prevention: collaborator
• Safe Water and AIDS Project: collaborator

Study Sites (1)

84 rural secondary schools in Siaya County (expanded to total 96 schools; Protocol v7)

Siaya, Siaya County, 40600, Kenya

Location

Related Publications (8)

• 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 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. BMC Public Health. 2019 Oct 21;19(1):1317. doi: 10.1186/s12889-019-7594-3.

  PMID: 31638946 RESULT

• Czapar AE, Paul S, Zulaika G, Otieno F, Agingu W, Chaudhary A, Bhaumik R, van Eijk AM, Green SJ, Nyothach E, Phillips-Howard PA, Mehta SD. Water source, latrine type, and rainfall are associated with detection of non-optimal and enteric bacteria in the vaginal microbiome: a prospective observational cohort study nested within a cluster randomized controlled trial. BMC Infect Dis. 2024 Dec 18;24(1):1419. doi: 10.1186/s12879-024-10313-3.

  PMID: 39695422 DERIVED

• Zulaika G, Nyothach E, van Eijk AM, Wang D, Opollo V, Obor D, Mason L, Chen T, Kerubo E, Oyaro B, Mwaki A, Eleveld A, Ngere I, Fwaya E, Ter Kuile FO, Kwaro D, Phillips-Howard PA. 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. EClinicalMedicine. 2023 Oct 10;65:102261. doi: 10.1016/j.eclinm.2023.102261. eCollection 2023 Nov.

  PMID: 37860578 DERIVED

• Mehta SD, Zulaika G, Agingu W, Nyothach E, Bhaumik R, Green SJ, van Eijk AM, Kwaro D, Otieno F, Phillips-Howard P. Analysis of bacterial vaginosis, the vaginal microbiome, and sexually transmitted infections following the provision of menstrual cups in Kenyan schools: Results of a nested study within a cluster randomized controlled trial. PLoS Med. 2023 Jul 25;20(7):e1004258. doi: 10.1371/journal.pmed.1004258. eCollection 2023 Jul.

  PMID: 37490459 DERIVED

• Spinhoven P, Zulaika G, Nyothach E, van Eijk AM, Obor D, Fwaya E, Mason L, Wang D, Kwaro D, Phillips-Howard PA. Quality of life and well-being problems in secondary schoolgirls in Kenya: Prevalence, associated characteristics, and course predictors. PLOS Glob Public Health. 2022 Dec 19;2(12):e0001338. doi: 10.1371/journal.pgph.0001338. eCollection 2022.

  PMID: 36962912 DERIVED

• Mason L, Zulaika G, van Eijk AM, Fwaya E, Obor D, Phillips-Howard P, Nyothach E. 'You don't have to sleep with a man to get how to survive': Girl's perceptions of an intervention study aimed at improving sexual and reproductive health and schooling outcomes. PLOS Glob Public Health. 2022 Oct 13;2(10):e0000987. doi: 10.1371/journal.pgph.0000987. eCollection 2022.

  PMID: 36962656 DERIVED

• Zulaika G, Bulbarelli M, Nyothach E, van Eijk A, Mason L, Fwaya E, Obor D, Kwaro D, Wang D, Mehta SD, Phillips-Howard PA. Impact of COVID-19 lockdowns on adolescent pregnancy and school dropout among secondary schoolgirls in Kenya. BMJ Glob Health. 2022 Jan;7(1):e007666. doi: 10.1136/bmjgh-2021-007666.

  PMID: 35027438 DERIVED

• Zulaika G, Nyothach E, van Eijk AM, Obor D, Mason L, Wang D, Chen T, Kerubo E, Opollo V, Ngere I, Omondi Owino S, Oyaro B, Ter Kuile FO, Kwaro D, Phillips-Howard P. Factors associated with the prevalence of HIV, HSV-2, pregnancy, and reported sexual activity among adolescent girls in rural western Kenya: A cross-sectional analysis of baseline data in a cluster randomized controlled trial. PLoS Med. 2021 Sep 28;18(9):e1003756. doi: 10.1371/journal.pmed.1003756. eCollection 2021 Sep.

  PMID: 34582445 DERIVED

MeSH Terms

Conditions

Herpesviridae Infections; HIV Infections; Adolescent Behavior; Coitus

Interventions

Menstrual Hygiene Products; CASP8 and FADD-Like Apoptosis Regulating Protein

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior; Sexual Behavior

Intervention Hierarchy (Ancestors)

Feminine Hygiene Products; Equipment and Supplies; Death Domain Receptor Signaling Adaptor Proteins; Adaptor Proteins, Signal Transducing; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Tumor Necrosis Factor Receptor-Associated Peptides and Proteins; Apoptosis Regulatory Proteins; Carrier Proteins; Proteins

Study Officials

• Penelope A Phillip-Howard, PhD

  Liverpool School of Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Daniel Kwaro, MD

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators cannot mask participants to their treatment (intervention) status due to the nature of interventions provided. However, counsellors conducting the HIV and HSV-2 testing and laboratory technicians will be blinded to the study arm. Investigators and trial statisticians will be masked. Field staff who conduct home visits to confirm dropout will also be masked when feasible. Bias will also be minimised by use of block randomisation stratified by school size and WASH facilities at baseline. An independent person will prepare the sealed envelopes with the study allocation. Study arm allocation will not be recorded in the central database to ensure the trial statistician and data managers remain blinded throughout the study. This information will be recorded separately and only be merged with the main database following approval of the statistical analytics plan (SAP), closure of the databases and submission of a copy to the independent statistician of the DMEC.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 14, 2017
• Study Start: February 28, 2017
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: August 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

KE (1)