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