Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202003815291283 Date of Approval: 12/03/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Cups or Cash for Girls Trial to Reduce Sexual and Reproductive Harm and School Dropout ( CCg )
Official 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
Brief summary describing the background and objectives of the trial 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 school years followup. This was registered a priori at ClinicalTrials.gov ID: NCT03051789, 15th February 2017
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CCG
Disease(s) or condition(s) being studied Infections and Infestations,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied HIV/AIDS,pregnancy
Purpose of the trial Prevention
Anticipated trial start date 28/02/2017
Actual trial start date 28/02/2017
Anticipated date of last follow up 30/06/2020
Actual Last follow-up date 30/06/2021
Anticipated target sample size (number of participants) 3960
Actual target sample size (number of participants) 4138
Recruitment status Completed
Publication URL https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-019-7594-3
Secondary Ids Issuing authority/Trial register
NCT03051789 ClinicalTrials.gov
3215 Kenya Scientific and Ethics Review Unit
15005 Liverpool School of Tropical Medicine Research Ethics Committee
ECCT 160706 Kenya Pharmacy and Poisons Board
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Menstrual cup One menstrual cup (Mooncup®), with handwash soap termly. To completion of Form 4 (secondary school) estimated to be equivalent to up to 10 school terms Menstrual cups are reusable bell-shaped receptacles which collect ~30 ml of menstrual blood when inserted into the vaginal canal. Emptying is required every 4-8 hours depending on menstrual flow and once emptied can be immediately reinserted, with cleansing by boiling at the end of a cycle. Some companies provide cups for young adolescents that are smaller than the adult women’s size. Some 199 brands of menstrual cup area available worldwide, Mooncup® (manufactured by Mooncup Ltd, UK),was selected for regulatory reasons. It is made from high grade medical silicone, which is safe, durable, and pliable, and the material is hypoallergenic. The cup design has no open pores or edges to harbour bacteria. It is produced in the UK to ISO 13485:2003 standards, a regulated quality management system requiring the service provided by an organisation “consistently meet[s] customer and regulatory requirements applicable to medical devices and related services.” The brand is registered with the US Food and Drug Administration Registration Number 3009117944, and is registered for international use. 990
Experimental Group Cash Ksh 1500 (US$15, Dec15 exch) To completion of Form 4 (seconrady school) estimated to approximate 10 school terms The cash stipend 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. Participants will first receive child-friendly financial literacy training, on how to access, and keep their moneys secure, and themselves safe, ways to spend and save money. 990
Experimental Group Cups and Cash one menstrual cup (as per cup arm) PLUS Cash transfer (as per cash arm) To completion of Form 9 (seconary school) estimated to be up to 10 school terms Same as Cup and Cash arms 990
Control Group Control Soap for handwashing termly To completion of Form 4 (secondary school) estimated to be up to 10 school terms To completion of Form 4 (secondary school) estimated to be up to 10 school terms 990 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria for schools • Secondary school in study area • Girls or co-educational school • Day school • Approval by Head Teacher in consultation with teachers, parents, and students Inclusion criteria for participants • Attend secondary day schools in the study area at enrolment • Resident of the study area • Have a history of established menses (>=3 times) • Have no disability preventing participation i.e. school for the blind • Have received parent or guardian’s consent and assent to participation. Exclusion criteria for schools • Boys only school • Boarding schools • Special needs schools (i.e. for the blind) Exclusion criteria for participants • Attend boarding schools • Pregnant at time of enrolment (declared or confirmed) • Parental or own refusal Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 11 Year(s) 35 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/05/2016 Scientific and Ethics Review Unit SERU
Ethics Committee Address
Street address City Postal code Country
PO Box 54840 Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Composite outcome variable comprised of incident HIV, HSV-2, and all-cause school dropout by the end of the study HIV and HSV-2 - baseline, midline, endline. Dropout continuous to endline
Secondary Outcome disaggregate of composite primary outcomes HIV, HSV-2, dropout. Reported sexual behaviour indicators - age of debut, number of lifetime sexual partners, partner age discordance, pregnancy, use of modern contraceptives, coercive sex. Schooling indicators – performance, grade repetition, re-enrolment, transfers, absence. Quality of life. Baseline, midline, endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Apuoyo Mixed Secondary School Apuoyo, Gem Siaya Kenya
Argwings Kodhek Secondary SChool Argwings Kodhek, Gem Siaya Kenya
Dienya Mixed secondary school Dienya, Gem Siaya Kenya
Gongo Warom Secondary School Gongo Warom, Gem Siaya Kenya
Kaudha Mixed Secondary School Kaudha, Gem Siaya Kenya
Lundha Mixed Secondary School Lundha, Gem Siaya Kenya
Luri Secondary School Luri, Gem Siaya Kenya
Malele mixed Secondary School Malele, Gem Siaya Kenya
Mutumbu Girls Secondary School Mutumbu, Gem Siaya Kenya
Ndegwe Mixed Secondary School Ndegwe, Gem Siaya Kenya
Ndori Mixed Secondary School Ndori, Gem Siaya Kenya
Nyagondo Mixed Secondary School Nyagondo, Gem Siaya Kenya
Nyalunya Mixed Secondary School Nyalunya, Gem Siaya Kenya
Nyamninia Secondary School Nyamninia, Gem Siaya Kenya
Nyangulu Secondary School Nyangulu, Gem Siaya Kenya
Ramula Mixed Secondary Ramula, Gem Siaya Kenya
Sagam Mixed Secondary School Sagam, Gem Siaya Kenya
Lihanda Mixed Secondary School Lihanda, Gem Siaya Kenya
St Marks Kagilo Secondary Kagilo, Gem Siaya Kenya
St Paul Siriwo Seconary School Siriwo, Gem Siaya Kenya
St Peters Wagai Mixed Secondary School Wagai, Gem Siaya Kenya
St. Barnabas Anyiko Secondary School Anyiko, Gem Siaya Kenya
St. Stephens Aluor Mixed Secondary School Aluor, Gem Siaya Kenya
Ulumbi Secondary School Ulumbi, Gem Siaya Kenya
Agoro Oyombe Secondary School Agoro Oyombe, Siaya Siaya Kenya
Ambrose Adeya Adongo Secondary School Adenya, Siaya Siaya Kenya
Bar Olengo Secondary School Bar Olengo, Siaya Siaya Kenya
Christian Mixed Secondary School Karapul, Siaya Siaya Kenya
Holy Cross Secondary School Haga, Siaya Siaya Kenya
Hono Secondary School Hono, Siaya Siaya Kenya
Kalkada Secondary School Kalkada, Siaya Siaya Kenya
Uranga Secondary School Uranga, Gem Siaya Kenya
Kowet Mixed Secondary School Kowet, Siaya Siaya Kenya
Mahero Mixed Secondary School Mahero, Siaya Siaya Kenya
Mahola Mixed Secondary School Mahola, Siaya Siaya Kenya
Mbaga Mixed Secondary Schoolo Mbaga, Siaya Siaya Kenya
Mulaha Mixed Secondary School Mulaha, Siaya Siaya Kenya
Ngiya Mixed Secondary School Ngiya, Siaya Siaya Kenya
Nyambare Secondary School Nyambare, Siaya Siaya Kenya
Nyasita Mixed Secondary school Nyasita, Siaya Siaya Kenya
Obambo Mixed Secondary School Obambo, Siaya Siaya Kenya
Senator Obama Kogelo Secondary School Kogelo, Siaya Siaya Kenya
Siaya Township Secondary School Siaya Township, Siaya Siaya Kenya
Sidok Mixed Secondary School Sidok, Siaya Siaya Kenya
St Joseph Nyalula Secondary School Nyalula, Siaya Siaya Kenya
St. Patricks Segere Secondary School Segere, Siaya Siaya Kenya
Ulafu Secondary School Ulafu, Siaya Siaya Kenya
Yala Township Mixed Secondary School Yala Township, Siaya Siaya Kenya
Anyiko Mixed Secondary School Anyiko, Ugenya Siaya Kenya
Got Nanga Secondary School Got Nanga, Ugenya Siaya Kenya
Got Odima Secondary School Got Odima, Ugenya Siaya Kenya
Inungo Secondary School Inungo, Ugenya Siaya Kenya
Jera Mixed Secondary School Jera, Ugenya Siaya Kenya
Kagonya Secondary School Kagonya, Ugenya Siaya Kenya
Lifunga Girls Secondary School Lifunga, Ugenya Siaya Kenya
Luanda Kathieno Mixed Secondary School Luanda, Ugenya Siaya Kenya
Ndenga Secondary School Ndenga , Ugenya Siaya Kenya
Ralak Girls Secondary School Ralak, Ugenya Siaya Kiribati
Ramunde Secondary School Ramunde, Ugenya Siaya Kenya
Sega Township Secondary School Sega Township, Ugenya Siaya Kenya
Sihay Secondary School Sihay, Ugenya Siaya Kenya
Siranga Mixed Secondary School Siranga, Ugenya Siaya Kenya
St Jacobs Usinda Secondary School Usinda, Ugenya Siaya Kenya
St Benedicts Konya Secondary School Konya, Ugenya Siaya Kenya
St. Charles Humwend Secondary School Humwend, Ugenya Siaya Kenya
St. Nicholas Hafumbre Secondary School Hafumbre, Ugenya Siaya Kenya
St Stephens Siginga Secondary School Siginga, Ugenya Siaya Kenya
Udira Secondary School Udira, Ugenya Siaya Kenya
Konjra Mixed Secondary School Konjra, Ugunja Siaya Kenya
Madungu Mixed Secondary School Madungu, Ugunja Siaya Kenya
Moi Uloma Secondary School Uloma, Ugunja Siaya Kenya
Mudhiero Secondary School Mudhiero, Ugunja Siaya Kenya
Ngunya Mixed Secondary School Ngunya, Ugunja Siaya Kenya
Nyasanda Community Secondary SChool Nyasanda, Ugunja Siaya Kenya
Sidindi Secondary School Sidindi, Ugunja Siaya Kenya
Simenya Secondary School Simenya, Ugunja Siaya Kenya
Simerro Secondary School Simerro, Ugunja Siaya Kenya
St Alloice Mbosie Secondary SChool Mbosie, Ugunja Siaya Kenya
St. Antony Uluthe Secondary School Uluthe, Ugunja Siaya Kenya
St Pauls Sigomre Secondary School Sigomre, Ugunja Siaya Kenya
St Peters Rambula Secondary School Rambula, Ugunja Siaya Kenya
Tingare Mixed Secondary School Tingare, Ugunja Siaya Kenya
Ulwani Mixed Secondary School Ulwani, Ugunja Siaya Kenya
Umina Mixed Secondary School Umina, Ugunja Siaya Kenya
Gagra Secondary School Gagra, Rardieda Siaya Kenya
Kitambo Secondary School Kitambo, Rarieda Siaya Kenya
Lieta Secondary School Lieta, Rarieda Siaya Kenya
Majango Secondary School Majango, Rarieda Siaya Kenya
Memba Secondary School Memba, Rarieda Siaya Kenya
Ndigwa Secondary School Ndigwa, Rarieda Siaya Kenya
Nyagoko Secondary School Nyagoko, Rarieda Siaya Kenya
Okela Secondary School Okela, Rarieda Siaya Kenya
Raliew Secondary School Raliew, Rarieda Siaya Kenya
Rarieda Secondary School Rarieda town, Rarieda Siaya Kenya
Siger Secondary School Siger, Rarieda Siaya Kenya
Kandaria Secondary School Kandaria, Rarieda Siaya Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
UK Joint Global Health Trials Medical Research Council Polaris House, N Star Ave Swindon United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Liverpool School of Tropical Medicine Pembroke Place Liverpool United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Centre for Global Health Research Kenya Medical Research Institute Kisian Campus, Kisian Kisumu Kenya
Safe Water and AIDS Project Agha Khan Road, Milimani Kisumu Kisumu Kenya
CDC Kenya Kisian Campus, Kisian Kisumu Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Penelope Phillips Howard Penelope.Phillips-Howard@lstmed.ac.uk +447985431005 Pembroke Place
City Postal code Country Position/Affiliation
Liverpool United Kingdom Liverpool School of Tropical Medicine
Role Name Email Phone Street address
Principal Investigator Daniel Kwaro DKwaro@kemricdc.org +254700858288 Centre for Global Health Research, Kisian Campus, Kisian
City Postal code Country Position/Affiliation
Kisumu Kenya Kenya Medical Research Institute
Role Name Email Phone Street address
Public Enquiries Elizabeth Nyothach ENyothach@kemricdc.org +254726308873 Centre for Global Health Research, Kisian Campus, Kisian
City Postal code Country Position/Affiliation
Kisumu Kenya Kenya Medical Research Institute
Role Name Email Phone Street address
Scientific Enquiries Penelope Phillips Howard Penelope.Phillips-Howard@lstmed.ac.uk +447985431005 Pembroke Place
City Postal code Country Position/Affiliation
Liverpool United Kingdom Liverpool School of Tropical Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We intend to share the individual participant data after the main trial outcomes are published Statistical Analysis Plan,Study Protocol IPD after main trial outcomes published. Protocol is already published. SAP will be shared at time of main trial publications. Controlled access, secondary data analysis after main trial data published, or on request as a collaborative study, requests through email of the PI, with support of co-investigators
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information