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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2021
• Main ID: NCT03051789
• Date of registration: 09/02/2017
• Prospective Registration: Yes
• Primary sponsor: Liverpool School of Tropical Medicine
• Public title: Cups or Cash for Girls Trial to Reduce Sexual and Reproductive Harm and School Dropout CCg
• Scientific 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
• Date of first enrolment: February 28, 2017
• Target sample size: 4138
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03051789
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Kenya

Contacts

• Name: Penelope A Phillip-Howard, PhD
• Affiliation: Liverpool School of Tropical Medicine

• Name: Daniel Kwaro, MD
• Affiliation: Kenya Medical Research Institute

Key inclusion & exclusion criteria

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)



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Herpesvirus Infection

Reproductive Health

Woman Abuse

Quality of Life

HIV Infections

Adolescent Behavior

Intervention(s)

Other: Cash transfer

Other: Cups and Cash

Device: Menstrual Cup

Primary Outcome(s)

Composite HIV, HSV-2, and school dropout [Time Frame: Form 4 (3 years)]

Secondary Outcome(s)

HSV-2 [Time Frame: Form 4 (3 years)]

School dropout [Time Frame: Form 4 (3 years)]

HIV [Time Frame: Form 4 (3 years)]

Secondary ID(s)

15-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Kenya Medical Research Institute

Safe Water and AIDS Project (SWAP), Kenya

Centers for Disease Control and Prevention