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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202110669615387 Date of Registration: 27/10/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ghana LEAP 1000 Impact Evaluation
Official scientific title Quasi-experimental impact evaluation of the LEAP 1000 unconditional cash transfer programme in rural Ghana
Brief summary describing the background and objectives of the trial This study is an impact evaluation of a social cash transfer programme implemented by the Government of Ghana. The study is conducted by the UNICEF Office of Research in collaboration with the University of North Carolina and ISSER, University of Ghana. The programme, LEAP 1000, targets pregnant women and mothers of children under 1 year and is an extension of the Livelihoods Empowerment Against Poverty (LEAP) programme, Ghana’s flagship poverty alleviation programme. The impact evaluation aims to understand the extent to which LEAP 1000 can reduce household poverty and vulnerability, with a focus on children’s health and nutrition status, and will utilize a regression-discontinuity study design. Approximately 2,500 households will be followed over two years in a mixed-methods study. Quantitative surveys will be conducted at baseline and after 24 months, and 16 treatment households will be selected for in-depth interviews at baseline, 12 months, and 24 months. Health facility and community price questionnaires will also be administered at baseline. Results will help the Government of Ghana in the design and targeting of future social protection programmes.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Nutritional, Metabolic, Endocrine,Obstetrics and Gynecology,Paediatrics,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Fertility-female,Malaria
Purpose of the trial Prevention
Anticipated trial start date 05/10/2015
Actual trial start date
Anticipated date of last follow up 09/01/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 2500
Actual target sample size (number of participants) 2497
Recruitment status Completed
Publication URL https://transfer.cpc.unc.edu/wp-content/uploads/2021/04/LEAP1000_Report_Final-2019-for-dissemination.pdf
Secondary Ids Issuing authority/Trial register
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ghana LEAP 1000 participants 64-106 Ghana cedi bi-monthly (variable based on number of eligible household members) and a premium fee waiver for enrolment into the National Health Insurance Scheme at least 2 years The intervention studied is the Livelihoods Empowerment Against Poverty (LEAP) programme, implemented by the Department of Social Welfare (DSW) at the Ministry of Gender, Children and Social Protection (MoGCSP) in Ghana. This intervention is targeted to extremely poor households with a pregnant woman or infant under the age of 14 months. Extreme poverty was assessed with a proxy means test (PMT), assessing assets, dwelling characteristics, and household composition. The intervention consists of bi-monthly cash transfers delivered to eligible households and a premium fee waiver to enroll in the national health insurance scheme (al household members are eligible but must individually enroll). The intervention was expected to be delivered for a minimum of two years. The evaluation assesses treatment and comparison households in five districts in Northern Ghana and runs from 2015 to 2017. 1262
Control Group Comparison Group Received no direct benefits At least two years The intervention studied is the Livelihoods Empowerment Against Poverty (LEAP) programme, implemented by the Department of Social Welfare (DSW) at the Ministry of Gender, Children and Social Protection (MoGCSP) in Ghana. This intervention is targeted to extremely poor households with a pregnant woman or infant under the age of 14 months. Extreme poverty was assessed with a proxy means test (PMT), assessing assets, dwelling characteristics, and household composition. The intervention consists of bi-monthly cash transfers delivered to eligible households and a premium fee waiver to enroll in the national health insurance scheme (al household members are eligible but must individually enroll). The intervention was expected to be delivered for a minimum of two years. The evaluation assesses treatment and comparison households in five districts in Northern Ghana and runs from 2015 to 2017. 1235 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria for the LEAP 1000 were household containing the following: 1) women of reproductive age (15-49 years old) who was currently pregnant or had recently given birht and could provide either a) a birth card (if infant is less than 15 months old) or b) a health card for antenatal care visits (if pregnant) and 2) were administered a proxy means test to determine eligibility based on poverty status 3) lived in 5 districts targeted for the pilot (Karaga, Yendi, Garu Tempane, Bongo, and East Mamprusi) Households containing: women who were not pregnant or lactating Women above or outside of a given range of PMT score used to determine the sample Women who could not provide either birth or health cards Women who lived outside of the 5 pilot districts Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Child: 6 Year-12 Year,Infant: 1 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Year(s) 49 Year(s) Both
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 13/07/2015 Ethics Committee for the Humanities of the University of Ghana
Ethics Committee Address
Street address City Postal code Country
P.O. Box LG 74 Accra N/A Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Anthropometry and nutrition Baseline 2015 and Endline 2017
Secondary Outcome Intermediate or pathway variables including consumption, food security, feeding, investment, time use, womens empowerment, health insurance enrollment, intimate partner violence, stress and mental health, and other moderators of programme impact Baseline 2015 and Endline 2017
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ministry of Gender Children and Social Protection P.O. BOX MBO 186 Accra N/A Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
United States Agency for International Development Ronald Reagan Building Washington D.C. 20523-100 United States of America
Canadian International Development Agency 125 Sussex Drive Ottawa K1A 0G2 Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UNICEF Ghana P.O. Box 5051 Acrra North N/A Ghana UN agency
COLLABORATORS
Name Street address City Postal code Country
UNICEF Ghana P.O. Box 5051 Accra North N/A Ghana
UNICEF Office of Research Innocenti Via degli Alfani 58 Florence 50121 Italy
University of North Carolina at Chapel Hill 101 Manning Dr Chapel Hill 27514 United States of America
Institute of Statistical Social and Economic Research P.O BOX LG 74 Accra N/A Ghana
Navrongo Health Research Center Post Office Box 114 Navrongo N/a Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sudhanshu Handa shanda@email.unc.edu 19198430350 CB 3435, Abernethy Hall
City Postal code Country Position/Affiliation
Chapel Hill 27599 United States of America Lawrence I. Gilbert Distinguished Professor
Role Name Email Phone Street address
Principal Investigator Clare Barrington cbarring@email.unc.edu 19199669009 Rosenau Hall 319B CB7440
City Postal code Country Position/Affiliation
Chapel Hill 27599 United States of America Associate Professor
Role Name Email Phone Street address
Principal Investigator Isaac Osei Akoto ioseiak@ug.edu.gh 2330577699902 P.O BOX LG 74
City Postal code Country Position/Affiliation
Legon Accra N/A Ghana Senior Research Fellow
Role Name Email Phone Street address
Public Enquiries Tia Palermo tiapaler@buffalo.edu 7168295368 270 Farber Hall
City Postal code Country Position/Affiliation
Buffalo 14214 United States of America Associate Professor
Role Name Email Phone Street address
Principal Investigator Akalpa Akaligaung director@navrongo-hrc.org 2330382122380 P.O.Box 114
City Postal code Country Position/Affiliation
Navrongo N/A Ghana Independent Consultant
Role Name Email Phone Street address
Scientific Enquiries Tia Palermo tiapaler@buffalo.edu 7168295368 270 Farber Hall
City Postal code Country Position/Affiliation
Buffalo 14214 United States of America Associate Professor
Role Name Email Phone Street address
Principal Investigator Tia Palermo tiapaler@buffalo.edu 7168295368 270 Farber Hall
City Postal code Country Position/Affiliation
Buffalo 14228 United States of America Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available after the trial and de-identification. Researchers who apply for the data via the Carolina Population Center will be able to access the data for any research purpose. Study Protocol After trial completion and de-identification (2021). Researchers who apply for the data via the Carolina Population Center will be able to access the data for any research purpose.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://data.cpc.unc.edu/projects/13/view#res_226 Yes 13/09/2021 04/11/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 13/09/2021 Result - 13/09/2021 Result - 13/09/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information