Cups or Cash for Girls Trial to Reduce Sexual and Reproductive Harm and School Dropout (CCg)
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|ClinicalTrials.gov Identifier: NCT03051789|
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : March 13, 2018
|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|
|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.|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- Reported sexual behaviour: age of debut [ Time Frame: Form 4 (3 years) ]Age of sexual debut, reported by participant at survey.
- Reported sexual behaviour: number of sexual partners [ Time Frame: Form 4 (3 years) ]Number of lifetime sexual partners, reported by participant at survey.
- Reported sexual behaviour: partner age concordance [ Time Frame: Form 4 (3 years) ]Age of partners, reported by participant at survey.
- 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.
- Reported sexual behaviour: contraceptive use [ Time Frame: Form 4 (3 years) ]Use of modern contraceptives, reported by participants at survey.
- Reported sexual behaviour: coercive sex [ Time Frame: Form 4 (3 years) ]Frequency of coercive sex, reported by participants at survey.
- School indicators: performance [ Time Frame: Form 4 (3 years) ]Participant grades from the Kenyan Certificate of Secondary Education Examinations (Form 4).
- School indicators: grade repitition [ Time Frame: Form 4 (3 years) ]Documented school year of participants by endline.
- School indicators: re-enrolment [ Time Frame: Form 4 (3 years) ]Frequency of participants re-enrolled after dropout by endline.
- School indicators: absence [ Time Frame: Form 4 (3 years) ]Frequency of absence, as documented in school registers.
- 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.
- 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.
- 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.
- 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).
- 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
- 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
- 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
- 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
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
|Contact: Elizabeth Nyothach, MA||+254726308873||ENyothach@kemricdc.org|
|Contact: Garazi Zulaika, MSC||+254792746393||Garazi.Zulaika@lstmed.ac.uk|
|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 firstname.lastname@example.org|
|Principal Investigator:||Penelope A Phillip-Howard, PhD||Liverpool School of Tropical Medicine|
|Principal Investigator:||Daniel Kwaro, MD||Kenya Medical Research Institute|