Manicaland Cash Transfer Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Imperial College London.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Biomedical Research and Training Institute
Catholic Relief Services Zimbabwe
Diocese of Mutare Community Care Programme
UNICEF
Wellcome Trust
World Bank
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00966849
First received: August 26, 2009
Last updated: March 5, 2010
Last verified: March 2010

August 26, 2009
March 5, 2010
August 2009
October 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00966849 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Manicaland Cash Transfer Trial
The Scientific Evaluation of a Cash Transfer Pilot Project to Support Orphans and Vulnerable Children (OVC) in Manicaland, Zimbabwe

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:

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Vaccination
  • Education
  • Birth Registration
  • Financial Support
  • 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: 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.
  • 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.
    Interventions:
    • Other: Conditional Cash Transfer
    • Other: Standard Agricultural Package
    • Other: Parenting Skills Classes
  • 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.
    Interventions:
    • Other: Unconditional Cash Transfers
    • Other: Standard Agricultural Package
    • Other: Parenting Skills Classes
  • 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.
    Interventions:
    • Other: Standard Agricultural Package
    • Other: Parenting Skills Classes
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
9150
July 2013
October 2011   (final data collection date for primary outcome measure)

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.

Both
up to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Zimbabwe
 
NCT00966849
inh051
No
Imperial College London
Imperial College London
  • Biomedical Research and Training Institute
  • Catholic Relief Services Zimbabwe
  • Diocese of Mutare Community Care Programme
  • UNICEF
  • Wellcome Trust
  • World Bank
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
Imperial College London
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP