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

NCT03051789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4138

Last updated 2021-08-05

No results posted yet for this study

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

Interventions

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.

OTHER

Cups and Cash

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

Sponsors & Collaborators

Principal Investigators

  • Penelope A Phillip-Howard, PhD · Liverpool School of Tropical Medicine

  • Daniel Kwaro, MD · Kenya Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-28
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Kenya

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03051789 on ClinicalTrials.gov