Manicaland Cash Transfer Trial - Full Text View

Purpose

The purpose of this study is to determine whether cash transfers (conditional and unconditional) can improve health and social outcomes amongst children living in vulnerable households in Manicaland, eastern Zimbabwe. The study hypotheses are:

Cash transfers will increase the percentage of vulnerable children aged 0-4 years with a birth certificate.
Cash transfers will increase the percentage of vulnerable children aged 0-4 years with up-to-date vaccinations.
Cash transfers will increase the percentage of vulnerable children aged 6-12 years attending primary school at least 80% of days per month.

Condition	Intervention
Vaccination Education Birth Registration Financial Support	Other: Conditional Cash Transfer Other: Unconditional Cash Transfers Other: Standard Agricultural Package Other: Parenting Skills Classes

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	The Scientific Evaluation of a Cash Transfer Pilot Project to Support Orphans and Vulnerable Children (OVC) in Manicaland, Zimbabwe

Resource links provided by NLM:

MedlinePlus related topics: Parenting

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:

Proportion of children under 5 years in vulnerable households that have a birth certificate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Proportion of children under 5 years in vulnerable households that have up-to-date vaccinations [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Proportion of children aged 6-12 years that attended primary school 80% of days in the last month [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	9150
Study Start Date:	August 2009
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Conditional Cash Transfer Vulnerable households in this arm will receive conditional cash transfers. A standard agricultural package (e.g. seeds, fertiliser etc) will be made available. Parenting skills classes will also be made available. Standard social services will continue in the area.	Other: Conditional Cash Transfer Households will receive bimonthly payments of US$18 plus US$4 per child under 18 years living in the house up to a maximum of 3 children i.e. transfers will vary from $22 to $30. Households will only be given the cash if they comply with the following conditions: An application for a birth certificate must be made for all children under 18 years in the household who do not already have a birth certificate, including all newborn children within 3 months of birth. All children under 5 years in the household must be up-to-date with vaccinations. All children under 5 years must attend a growth monitoring clinic twice per year. All children 6-17 years in the household attended school at least 90% of days in the last month. At least one adult from each household attended at least 2 of the 3 most recent parenting skills classes. Other: Standard Agricultural Package A standard agricultural package (e.g. seeds, fertiliser etc.) will be distributed in all study arms including the control arm as a gesture of goodwill to all those participating in the study. Other: Parenting Skills Classes 2-3 parenting skills classes will be held annually in each study cluster.
Experimental: Unconditional Cash Transfer Vulnerable households in this arm will receive unconditional cash transfers. A standard agricultural package (e.g. seeds, fertiliser etc) will be made available. Parenting skills classes will also be made available. Standard social services will continue in the area.	Other: Unconditional Cash Transfers Households will receive bimonthly payments of US$18 plus US$4 per child under 18 years living in the house up to a maximum of 3 children i.e. transfers will vary from $22 to $30. Households will not be required to comply with conditions in order to receive the cash. Other: Standard Agricultural Package A standard agricultural package (e.g. seeds, fertiliser etc.) will be distributed in all study arms including the control arm as a gesture of goodwill to all those participating in the study. Other: Parenting Skills Classes 2-3 parenting skills classes will be held annually in each study cluster.
Control Vulnerable households in this arm will not receive cash transfers. A standard agricultural package (e.g. seeds, fertiliser etc) will be made available. Parenting skills classes will also be made available. Standard social services will continue in the area.	Other: Standard Agricultural Package A standard agricultural package (e.g. seeds, fertiliser etc.) will be distributed in all study arms including the control arm as a gesture of goodwill to all those participating in the study. Other: Parenting Skills Classes 2-3 parenting skills classes will be held annually in each study cluster.

Detailed Description:

Cash transfer programmes provide cash to families caring for orphans and vulnerable children (OVC). Conditional cash transfer programmes require families to comply with conditions relating to child health, education and general social welfare in order to receive the cash.

We plan to evaluate conditional and unconditional cash transfer programmes in Manicaland, eastern Zimbabwe - a predominantly rural area with high HIV prevalence. We will employ a cluster randomised controlled trial design. Ten existing study sites that represent four socio-economic strata - subsistence farming areas, roadside trading settlements, large-scale agricultural estates (tea estates and forestry estates) and small towns - have been identified as part of a separate, ongoing cohort study. Each site has been divided into 3 smaller, socio-economically homogenous clusters providing a total of 30 clusters that will form ten matched triplets. One site from each matched triplet will then be randomly assigned to one of three study arms - conditional cash transfer arm, unconditional cash transfer arm, and standard social services arm.

Data on the primary endpoints will be collected using a rapid, baseline census of all households in the study clusters. This will take approximately 3 months to complete. The cash transfer programmes will commence, in the appropriate intervention arms, shortly after completion of baseline data collection. A similar follow-up census will take place two years after initiation of the intervention.

The cash transfer interventions will be delivered by a local NGO called Diocese of Mutare Community Care Programme (DOMCCP), who work in partnership with Catholic Relief Services Zimbabwe. The baseline and follow-up censuses will be managed and conducted by the Biomedical Research and Training Institute Zimbabwe (BRTI) and Imperial College London. Data will also be collected from children in a sample of households from each of the study clusters as part of the ongoing Manicaland Cohort Study, which is a parallel study conducted by BRTI and Imperial College London. This data will also be used to evaluate the cash transfer programmes.

Eligibility

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A household will be defined as vulnerable and thereby eligible for inclusion in the programme if there are children <18 years resident in the household at baseline AND

household is in the poorest quintile of households (20%) at baseline OR
household contains one or more orphans at baseline OR
the household head is under 18 years of age at baseline OR
household contains a chronically ill member OR
household contains a disabled member

A household will be defined as individuals that live within the same homestead and eat from the same pot.

Exclusion Criteria:

Households already receiving cash transfers for orphans or vulnerable children (OVC) will not be eligible to enroll in the pilot programme.

During the trial, households that do not qualify at baseline but whose conditions later change such that they become eligible to participate in the pilot will not be able to enroll.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966849

Locations

Zimbabwe
Biomedical Research and Training Institute
Harare, Zimbabwe

Sponsors and Collaborators

Imperial College London

Biomedical Research and Training Institute

Catholic Relief Services Zimbabwe

Diocese of Mutare Community Care Programme

UNICEF

Wellcome Trust

World Bank

Investigators

Principal Investigator:	Laura Robertson, MSc	Imperial College London
Principal Investigator:	Simon Gregson, DPhil	Imperial College London
Principal Investigator:	Constance Nyamukapa, PhD	Imperial College London
Principal Investigator:	Shungu Munyati, MSc	Biomedical Research and Training Institute
Principal Investigator:	Phyllis Mushati, MSc	Biomedical Research and Training Institute

More Information

No publications provided by Imperial College London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Robertson L, Mushati P, Eaton JW, Dumba L, Mavise G, Makoni J, Schumacher C, Crea T, Monasch R, Sherr L, Garnett GP, Nyamukapa C, Gregson S. Effects of unconditional and conditional cash transfers on child health and development in Zimbabwe: a cluster-randomised trial. Lancet. 2013 Apr 13;381(9874):1283-92. doi: 10.1016/S0140-6736(12)62168-0. Epub 2013 Feb 27.

Responsible Party:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00966849 History of Changes
Other Study ID Numbers:	inh051
Study First Received:	August 26, 2009
Last Updated:	March 5, 2010
Health Authority:	Zimbabwe: Medical Research Council United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:

Randomized Controlled Trial
Financial Support
Poverty
Child, Orphaned
HIV

ClinicalTrials.gov processed this record on May 16, 2013