Clinical trial NCT00966849: Manicaland Cash Transfer Trial for Children in Zimbabwe
Official title: The Scientific Evaluation of a Cash Transfer Pilot Project to Support Orphans and Vulnerable Children (OVC) in Manicaland, Zimbabwe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination
Education
Birth Registration
Financial Support
Keywords: Randomized Controlled Trial
Financial Support
Poverty
Child, Orphaned
HIV
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Biomedical Research and Training Institute
name: Catholic Relief Services
name: UNICEF
name: Wellcome Trust
name: World Bank
First posted: 2009-08-27
Enrollment: 4043
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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 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.

Primary outcomes:
measure: Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate
timeFrame: 1 year
measure: Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations
timeFrame: 1 year
measure: Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of Children Aged 13-17 Years That Attended Secondary School 80% of Days in the Last Month
timeFrame: 1 year
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: Biomedical Research and Training Institute
Study officials:
affiliation: Imperial College London
name: Laura Robertson, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Simon Gregson, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Constance Nyamukapa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Biomedical Research and Training Institute
name: Shungu Munyati, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Biomedical Research and Training Institute
name: Phyllis Mushati, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.worlddev.2013.09.002.
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.
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-randomised trial. Lancet. 2013 Apr 13;381(9874):1283-92. doi: 10.1016/S0140-6736(12)62168-0. Epub 2013 Feb 27.
citation: 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 based on orphan status and household assets. BMC Public Health. 2015 May 28;15:511. doi: 10.1186/s12889-015-1857-4.
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/heapol/czt060. Epub 2013 Sep 9.
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.
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 Health Med. 2016 Dec;21(8):909-17. doi: 10.1080/13548506.2016.1140903. Epub 2016 Feb 22.
citation: Schaefer R, Thomas R, Robertson L, Eaton JW, Mushati P, Nyamukapa C, Hauck K, Gregson S. Spillover HIV prevention effects of a cash transfer trial in East Zimbabwe: evidence from a cluster-randomised trial and general-population survey. BMC Public Health. 2020 Oct 23;20(1):1599. doi: 10.1186/s12889-020-09667-5.