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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00966849
Other study ID # inh051
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2009
Est. completion date February 2011

Study information

Verified date July 2019
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4043
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 17 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.
Parenting Skills Classes
2-3 parenting skills classes will be held annually in each study cluster.

Locations

Country Name City State
Zimbabwe Biomedical Research and Training Institute Harare

Sponsors (6)

Lead Sponsor Collaborator
Imperial College London Biomedical Research and Training Institute, Catholic Relief Services, UNICEF, Wellcome Trust, World Bank

Country where clinical trial is conducted

Zimbabwe, 

References & Publications (7)

Crea TM, Reynolds AD, Sinha A, Eaton JW, Robertson LA, Mushati P, Dumba L, Mavise G, Makoni JC, Schumacher CM, Nyamukapa CA, Gregson S. Effects of cash transfers on Children's health and social protection in Sub-Saharan Africa: differences in outcomes bas — View Citation

Fenton R, Nyamukapa C, Gregson S, Robertson L, Mushati P, Thomas R, Eaton JW. Wealth differentials in the impact of conditional and unconditional cash transfers on education: findings from a community-randomised controlled trial in Zimbabwe. Psychol Healt — View Citation

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-ran — View Citation

Robertson L, Mushati P, Eaton JW, Sherr L, Makoni JC, Skovdal M, Crea T, Mavise G, Dumba L, Schumacher C, Munyati S, Nyamukapa C, Gregson S. Household-based cash transfer targeting strategies in Zimbabwe: are we reaching the most vulnerable children? Soc Sci Med. 2012 Dec;75(12):2503-8. doi: 10.1016/j.socscimed.2012.09.031. Epub 2012 Oct 5. — View Citation

Robertson L, Mushati P, Skovdal M, Eaton JW, Makoni JC, Crea T, Mavise G, Dumba L, Schumacher C, Sherr L, Nyamukapa C, Gregson S. Involving Communities in the Targeting of Cash Transfer Programs for Vulnerable Children: Opportunities and Challenges. World Dev. 2014 Feb;54(100):325-337. — View Citation

Skovdal M, Mushati P, Robertson L, Munyati S, Sherr L, Nyamukapa C, Gregson S. Social acceptability and perceived impact of a community-led cash transfer programme in Zimbabwe. BMC Public Health. 2013 Apr 15;13:342. doi: 10.1186/1471-2458-13-342. — View Citation

Skovdal M, Robertson L, Mushati P, Dumba L, Sherr L, Nyamukapa C, Gregson S. Acceptability of conditions in a community-led cash transfer programme for orphaned and vulnerable children in Zimbabwe. Health Policy Plan. 2014 Oct;29(7):809-17. doi: 10.1093/h — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate 1 year
Primary Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations 1 year
Primary Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month 1 year
Secondary Proportion of Children Aged 13-17 Years That Attended Secondary School 80% of Days in the Last Month 1 year
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