NCT03051789: CCg

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

Completed NA Last updated 5 August 2021

What this trial tests

NA trial testing Menstrual Cup in Reproductive Health in 4,138 participants. Completed in 30 June 2021.

Timeline

28 February 2017

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Liverpool School of Tropical Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	4,138
Start date	28 February 2017
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across Kenya

Drugs / interventions tested

• Menstrual Cup
• Cash transfer
• Cups and Cash

Conditions studied

• Reproductive Health — all drugs for Reproductive Health →
• Herpesvirus Infection — all drugs for Herpesvirus Infection →
• HIV Infections — all drugs for HIV Infections →
• Woman Abuse — all drugs for Woman Abuse →

Sponsor

Liverpool School of Tropical Medicine

Who can join

Eligibility, female only, with Reproductive Health or Herpesvirus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of COVID-19 lockdowns on adolescent pregnancy and school dropout among secondary schoolgirls in Kenya.
   Zulaika G, Bulbarelli M, Nyothach E, van Eijk A, et al · · 2022 · cited 73× · PMID 35027438 · DOI 10.1136/bmjgh-2021-007666
2. 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.
   Zulaika G, Kwaro D, Nyothach E, Wang D, et al · · 2019 · cited 31× · PMID 31638946 · DOI 10.1186/s12889-019-7594-3
3. 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.
   Mehta SD, Zulaika G, Agingu W, Nyothach E, et al · · 2023 · cited 26× · PMID 37490459 · DOI 10.1371/journal.pmed.1004258
4. High Prevalence of <i>Lactobacillus crispatus</i> Dominated Vaginal Microbiome Among Kenyan Secondary School Girls: Negative Effects of Poor Quality Menstrual Hygiene Management and Sexual Activity.
   Mehta SD, Zulaika G, Otieno FO, Nyothach E, et al · · 2021 · cited 24× · PMID 34621690 · DOI 10.3389/fcimb.2021.716537
5. 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.
   Zulaika G, Nyothach E, van Eijk AM, Obor D, et al · · 2021 · cited 20× · PMID 34582445 · DOI 10.1371/journal.pmed.1003756
6. 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.
   Zulaika G, Nyothach E, van Eijk AM, Wang D, et al · · 2023 · cited 17× · PMID 37860578 · DOI 10.1016/j.eclinm.2023.102261
7. '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.
   Mason L, Zulaika G, van Eijk AM, Fwaya E, et al · · 2022 · cited 4× · PMID 36962656 · DOI 10.1371/journal.pgph.0000987
8. 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.
   Czapar AE, Paul S, Zulaika G, Otieno F, et al · · 2024 · cited 3× · PMID 39695422 · DOI 10.1186/s12879-024-10313-3