Condition category
Not Applicable
Date applied
16/11/2020
Date assigned
18/11/2020
Last edited
18/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Due to prolonged school closures and extreme household economic stress due to the COVID-19 pandemic, adolescent girls who were attending school in March 2020 are at high risk of not re-enrolling in school and losing key literacy and numeracy skills. The combination of household inability to pay school fees, teenage pregnancy, and prioritization of boys education have created a harmful environment for girls education.

Who can participate?
A former cohort of adolescent girls in two informal settlements in Nairobi, Kenya, which was part of the Adolescent Girls Initiative-Kenya evaluation (ISRCTN77455458) will be leveraged to implement the cash transfer study.

What does the study involve?
This study will evaluate the effect of a one-time cash transfer of ~US$150 on school re-enrollment in Kenya. Households will receive the cash transfer the first week of January, when schools are scheduled to re-open after the COVID-19 closures. Households will be contacted in November and December 2020 to establish current details and payment avenues and then followed up in February 2021 to assess school enrollment approximately six weeks after the transfer is paid, and then again in July 2021.

What are the possible benefits and risks of participating?
There are minimal benefits or risks to the participants in this study.

Where is the study run from?
Population Council (Kenya)

When is the study starting and how long is it expected to run for?
October 2020 to June 2021

Who is funding the study?
Echidna Giving (USA)
Bill and Melinda Gates Foundation (USA)
Foreign Commonwealth and Development Office (UK)

Who is the main contact?
Dr. Karen Austrian, atkaustrian@popcouncil.org

Trial website

Contact information

Type

Scientific

Primary contact

Dr Karen Austrian

ORCID ID

http://orcid.org/0000-0001-5464-7908

Contact details

Avenue 5
3rd Floor
Rose Avenue
PO Box 17643
Nairobi
00500
Kenya
+254-5134751
kaustrian@popcouncil.org

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

p661

Study information

Scientific title

The effect of cash transfers on school re-enrollment during COVID-19 among vulnerable girls in informal settlements in Kenya: a randomised controlled trial

Acronym

Study hypothesis

A one time cash transfer paid to the household when schools re-open after the prolonged COVID-19 school closures will increase re-enrollment amongst adolescent girls

Ethics approval

Approved 28/10/2020, Population Council IRB (1230 York Avenue, New York, NY 10065, USA; +1 212 3277112; ngontarz@popcouncil.org), ref: p661

Study design

Individual randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

Increasing school enrollment among adolescent girls after the long-term COVID-19 school closures

Intervention

Intervention arm: Households will receive a one-time cash transfer in January 2021 (the week that schools re-open for all students). The amount of the one-time transfer will be KES 16,000 (~$150). The funds will be paid into a bank account designated by the student’s parent/guardian.

Control - no treatment

An existing cohort that has five arms will be used. Half of each arm will be randomized into each arm.
Participants in all study arms will be enrolled approximately six weeks before schools are currently set to open and will be followed up for an additional six weeks after schools open/the payment is made. Within the cohort there are five arms. Using a program in STATA, half of the eligible participants in each arm will be randomized to the treatment and half to the control

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

School enrollment 6 weeks after the start of the school term measured by self-reported enrollment at baseline and 6 weeks after school re-opening

Secondary outcome measures

1. School matriculation at any point in the 6 weeks since the start of the school term measured by self-reported enrollment 6 weeks after school re-opening
2. Sibling school enrollment measured by self-reported enrollment 6 weeks after the start of the school term

Overall trial start date

02/10/2020

Overall trial end date

30/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Interviewed in 2019 as part of AGI-K cohort
2. Had not reported completing secondary school in 2019
3. Not in the final year of secondary school in 2019
4. Attended school between 2017 and 2019

Participant type

Healthy volunteer

Age group

Child

Gender

Female

Target number of participants

1,700

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

21/11/2020

Recruitment end date

15/12/2020

Locations

Countries of recruitment

Kenya

Trial participating centre

Population Council Kenya
Avenue 5, 3rd Floor Rose Avenue PO Box 17643-00500
Nairobi
00500
Kenya

Sponsor information

Organisation

Population Council - Kenya

Sponsor details

Avenue 5
3rd Floor
Rose Avenue
PO Box 17643
Nairobi
00500
Kenya
+254-20-5134700
info.nairobi@popcouncil.org

Sponsor type

Research organisation

Website

http://www.popcouncil.org

Funders

Funder type

Charity

Funder name

Echidna Giving

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bill and Melinda Gates Foundation

Alternative name(s)

बिल एंड मिलिंडा गेट्स फाउंडेशन, Bill & Melinda Gates Foundation, Gates Foundation, 比尔及梅琳达·盖茨基金会, BMGF, B&MGF

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

United States of America

Funder name

UK Aid - Kenya

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

-Planned publication in a high-impact peer-reviewed journal.
-Policy brief that summarizes the lessons learned for non-research audiences

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository.
The de-identified data will be stored in the Adolescent Data Hub. http://popcouncil.org/girlcenter/adolescentdatahub/ The data set from the follow up survey six weeks after the transfer will be made available at the time of the publication of the main results manuscript. The underlying data from the AGI-K cohort is already posted in that repository. The data will be available indefinitely. The person interested in the data will need to submit a request and so long as what they are proposing to do with the data isn’t overlapping with the study investigators ongoing research objectives, the data will be made available for downloading from the site. The consent forms for the study include language on de-identified data from the study being made available open access.

Intention to publish date

30/06/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/11/2020: Trial’s existence confirmed by Population Council IRB.