ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03051789
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : March 13, 2018
Sponsor:
Collaborators:
Kenya Medical Research Institute
Centers for Disease Control and Prevention
Safe Water and AIDS Project (SWAP), Kenya
Information provided by (Responsible Party):
Liverpool School of Tropical Medicine

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.

Condition or disease Intervention/treatment Phase
Reproductive Health Herpesvirus Infection HIV Infections Woman Abuse Quality of Life Adolescent Behavior Device: Menstrual Cup Other: Cash transfer Other: Cups and Cash Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3864 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official 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
Actual Study Start Date : February 28, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Menstrual Cup
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
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 Name: Mooncup

Experimental: Cash Transfer
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
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 Name: Pocket-money

Experimental: Cups and Cash
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
Combination of both interventions, using the same interventions and implementation methods.
Other Name: Combination of cups and cash

No Intervention: Control
'Usual practice' (control) with handwash soap termly; puberty and hygiene education given at intervention.



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


Secondary Outcome Measures :
  1. School dropout [ Time Frame: Form 4 (3 years) ]
    Disaggregate of composite. Participant does not attend school consecutively for at least one full term or longer. Girls who attended part of Form (class) 4, but do not sit the final national Kenya Secondary Certificate of Education (KSCE) exams that year will be considered dropouts in that final term. Investigators will evaluate reasons for dropout.

  2. HSV-2 [ Time Frame: Form 4 (3 years) ]
    Disaggregate of composite. HSV-2 incidence measured at end survey among girls sero-negative for HSV-2 on enrollment and in girls where sero-status could not be determined on enrollment.

  3. HIV [ Time Frame: Form 4 (3 years) ]
    Disaggregate of composite. HIV incidence measured at end survey among girls sero-negative for HIV on enrollment and in girls where sero-status could not be determined on enrollment.


Other Outcome Measures:
  1. Reported sexual behaviour: age of debut [ Time Frame: Form 4 (3 years) ]
    Age of sexual debut, reported by participant at survey.

  2. Reported sexual behaviour: number of sexual partners [ Time Frame: Form 4 (3 years) ]
    Number of lifetime sexual partners, reported by participant at survey.

  3. Reported sexual behaviour: partner age concordance [ Time Frame: Form 4 (3 years) ]
    Age of partners, reported by participant at survey.

  4. Reported sexual behaviour: pregnancy [ Time Frame: Form 4 (3 years) ]
    Frequency of pregnancy, reported by participants at survey and validation among dropouts by study staff home visit.

  5. Reported sexual behaviour: contraceptive use [ Time Frame: Form 4 (3 years) ]
    Use of modern contraceptives, reported by participants at survey.

  6. Reported sexual behaviour: coercive sex [ Time Frame: Form 4 (3 years) ]
    Frequency of coercive sex, reported by participants at survey.

  7. School indicators: performance [ Time Frame: Form 4 (3 years) ]
    Participant grades from the Kenyan Certificate of Secondary Education Examinations (Form 4).

  8. School indicators: grade repitition [ Time Frame: Form 4 (3 years) ]
    Documented school year of participants by endline.

  9. School indicators: re-enrolment [ Time Frame: Form 4 (3 years) ]
    Frequency of participants re-enrolled after dropout by endline.

  10. School indicators: absence [ Time Frame: Form 4 (3 years) ]
    Frequency of absence, as documented in school registers.

  11. Pediatric quality of Life (PEDSQL) [ Time Frame: Form 4 (3 years) ]
    PEDSQL-23 measures 23 individual items to group participants' wellbeing into four categories: physical, emotional, social, and school wellbeing.

  12. EuroQual Quality of Life (Eq-5D) [ Time Frame: Form 4 (3 years) ]
    Eq-5D Evaluates participants health state in 5 dimensions, of mobility, self care, usual activities, pain/discomfort, anxiety/depression.

  13. Cost-effectiveness [ Time Frame: Form 4 (3 years) ]
    Estimate the societal cost consequences and the societal cost-effectiveness of the intervention packages, including the health services perspective, as compared to the controls.

  14. Other sexually transmitted infections [ Time Frame: Form 4 (3 years) ]
    Prevalence of other sexually transmitted infections including bacterial vaginosis, by end study (if funding permits).

  15. Primary safety outcome: toxic shock syndrome associated with interventions [ Time Frame: Form 4 (3 years) ]
    Toxic shock syndrome verified through safety monitoring by study nurses, associated with interventions

  16. Primary safety outcome: severe violence associated with interventions [ Time Frame: Form 4 (3 years) ]
    Severe violence verified through safety monitoring by study nurses, associated with interventions

  17. Secondary safety outcome: cup contamination [ Time Frame: Form 4 (3 years) ]
    Frequency of contamination of cups with e. coli among a random sample of used menstrual cups at intervals (~6 monthly) over the intervention trial

  18. Secondary safety outcome: other emergent harms associated with interventions [ Time Frame: Form 4 (3 years) ]
    Other unexpected emergent harms associated with interventions identified during safety monitoring



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Target population for intervention is menstruating schoolgirls.
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051789


Contacts
Contact: Elizabeth Nyothach, MA +254726308873 ENyothach@kemricdc.org
Contact: Garazi Zulaika, MSC +254792746393 Garazi.Zulaika@lstmed.ac.uk

Locations
Kenya
84 rural secondary schools in Siaya County (expanded to total 96 schools; Protocol v7) Recruiting
Siaya, Siaya County, Kenya, 40600
Contact: Isaac Ngere, MD    +254724963660    ngereisaac@gmail.com   
Sponsors and Collaborators
Liverpool School of Tropical Medicine
Kenya Medical Research Institute
Centers for Disease Control and Prevention
Safe Water and AIDS Project (SWAP), Kenya
Investigators
Principal Investigator: Penelope A Phillip-Howard, PhD Liverpool School of Tropical Medicine
Principal Investigator: Daniel Kwaro, MD Kenya Medical Research Institute

Responsible Party: Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier: NCT03051789     History of Changes
Other Study ID Numbers: 15-005
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A link will be provided from LSTM and study-specific website to study resources including the protocol, participant information sheets, SOPs, publications and the database. A data repository is being established at LSTM and will be entrusted with storing data when ready. The investigators policy to data sharing will be published on the study website. A final database containing all research data will be made fully publicly available in an unrestricted format once the findings have been published. The only limits to data sharing will be to safeguard participants' confidentiality. The proposed procedures for data sharing will be set out and explained to the research participants as part of the informed consent process. External users will be bound by data sharing agreements in line with The MRC Data Sharing Policy. External users will be required to accept terms and conditions of use using a declaration tick box.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Liverpool School of Tropical Medicine:
Menstrual hygiene management
Sexual and Reproductive Health
Adolescent schoolgirls
School dropoout
sub-Saharan Africa
Kenya

Additional relevant MeSH terms:
HIV Infections
Infection
Communicable Diseases
Herpesviridae Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
DNA Virus Infections