Vaccination, Education, Birth Registration, Financial Support
Conditions
Keywords
Randomized Controlled Trial, Financial Support, Poverty, Child, Orphaned, HIV
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.
Interventions
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.
OTHERUnconditional 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.
OTHERStandard 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.
OTHERParenting Skills Classes
2-3 parenting skills classes will be held annually in each study cluster.
Sponsors
Biomedical Research and Training Institute
Catholic Relief Services
UNICEF
Wellcome Trust
World Bank
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate | 1 year |
| Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations | 1 year |
| Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Children Aged 13-17 Years That Attended Secondary School 80% of Days in the Last Month | 1 year |
Countries
Zimbabwe
Participant flow
Pre-assignment details
The enrolment number (4043) represents the total number of Households enrolled in the study
Participants by arm
| Arm | Count |
|---|---|
| Conditional Cash Transfer 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 \<18 years in the household who do not already have a birth certificate, including all newborn children within 3 months of birth.
* All children \<5 yrs in the household must be up-to-date with vaccinations
* All children \<5 yrs must attend a growth monitoring clinic twice per yr
* All children 6-17 yrs in the household attended school at least 90% of days in the last month
* At least one adult from each household attended at least 2/3 most recent parenting skills classes
Other procedures will be the same as in the unconditional cash transfer arm. | 3,660 |
| 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.
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. | 3,976 |
| 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.
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. | 3,169 |
| Total | 10,805 |
Baseline characteristics
| Characteristic | Conditional Cash Transfer | Unconditional Cash Transfer | Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 3660 Participants | 3976 Participants | 3169 Participants | 10805 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 1179 Participants | 1332 Participants | 1064 Participants | 3575 Participants |
| Sex: Female, Male Male | 1218 Participants | 1329 Participants | 1071 Participants | 3618 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 3,660 | 0 / 3,976 | 0 / 3,169 |
| serious Total, serious adverse events | 0 / 3,660 | 0 / 3,976 | 0 / 3,169 |
Outcome results
Primary
Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conditional Cash Transfer | Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month | 772 Participants |
| Unconditional Cash Transfer | Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month | 895 Participants |
| Control | Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month | 608 Participants |
Primary
Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conditional Cash Transfer | Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate | 252 Participants |
| Unconditional Cash Transfer | Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate | 255 Participants |
| Control | Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate | 163 Participants |
Primary
Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conditional Cash Transfer | Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations | 317 Participants |
| Unconditional Cash Transfer | Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations | 393 Participants |
| Control | Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations | 253 Participants |
Secondary
Proportion of Children Aged 13-17 Years That Attended Secondary School 80% of Days in the Last Month
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conditional Cash Transfer | Proportion of Children Aged 13-17 Years That Attended Secondary School 80% of Days in the Last Month | 735 Participants |
| Unconditional Cash Transfer | Proportion of Children Aged 13-17 Years That Attended Secondary School 80% of Days in the Last Month | 812 Participants |
| Control | Proportion of Children Aged 13-17 Years That Attended Secondary School 80% of Days in the Last Month | 570 Participants |