VaccinationNCT00966849
Manicaland Cash Transfer Trial for Children in Zimbabwe
A study testing Conditional Cash Transfer, Unconditional Cash Transfers and Standard Agricultural Package in people with Vaccination and Education, run by Imperial College London at 1 site in Zimbabwe.
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. Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccination, Education, Birth Registration
- What is being tested?
- Conditional Cash Transfer, Unconditional Cash Transfers and Standard Agricultural Package
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,043 participants
- Where
- 1 siteZimbabwe
- Study dates
- Aug 2009to Feb 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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.
Read the 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.
- Conditions
- Vaccination, Education, Birth Registration, Financial Support
- Being tested
- Conditional Cash Transfer, Unconditional Cash Transfers, Standard Agricultural Package, Parenting Skills Classes
- Keywords
- Randomized Controlled Trial, Financial Support, Poverty, Child, Orphaned, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conditional Cash TransferOther
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 TransfersOther
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 PackageOther
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 ClassesOther
2-3 parenting skills classes will be held annually in each study cluster.
| Study group | Role | What they receive |
|---|---|---|
| Conditional Cash Transfer | Experimental | 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. Receives: Other: Conditional Cash Transfer; Other: Standard Agricultural Package; Other: Parenting Skills Classes |
| Unconditional Cash Transfer | Experimental | 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. Receives: Other: Unconditional Cash Transfers; Other: Standard Agricultural Package; Other: Parenting Skills Classes |
| Control | Other | 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. Receives: Other: Standard Agricultural Package; Other: Parenting Skills Classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate
Measured: 1 year
Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations
Measured: 1 year
Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month
Measured: 1 year
Secondary outcomes (1)
Proportion of Children Aged 13-17 Years That Attended Secondary School 80% of Days in the Last Month
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for VaccinationStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,043 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Biomedical Research and Training Institute, Catholic Relief Services, UNICEF, Wellcome Trust, World Bank
- Responsible party
- Principal investigator, Simon Gregson, Imperial College London
- Investigators
- Laura Robertson, MSc, Principal investigator, Imperial College LondonSimon Gregson, DPhil, Principal investigator, Imperial College LondonConstance Nyamukapa, PhD, Principal investigator, Imperial College LondonShungu Munyati, MSc, Principal investigator, Biomedical Research and Training InstitutePhyllis Mushati, MSc, Principal investigator, Biomedical Research and Training Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966849
- Sponsor's protocol ID
- inh051
- Status last verified
- Jul 2019
- First submitted
- 26 Aug 2009
- Last updated
- 2 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24748713Robertson 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.
PubMed 23103074Robertson 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.
PubMed 23453283Crea 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.
PubMed 26017676Skovdal 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.
PubMed 24019380Skovdal 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.
PubMed 23587136Fenton 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.
PubMed 26899880Schaefer 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.
PubMed 33097016
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Scientific Evaluation of a Cash Transfer Pilot Project to Support Orphans and Vulnerable Children (OVC) in Manicaland, Zimbabwe
- ClinicalTrials.gov ID
- NCT00966849
- Acronym / sponsor ID
- inh051
- Conditions
- Vaccination, Education, Birth Registration, Financial Support
- Keywords
- Randomized Controlled Trial, Financial Support, Poverty, Child, Orphaned, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,043 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Biomedical Research and Training Institute, Catholic Relief Services, UNICEF, Wellcome Trust, World Bank
- Study start
- Aug 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Posted 22 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conditional Cash Transfer | Experimental | Other: Conditional Cash Transfer, Other: Standard Agricultural Package, Other: Parenting Skills ClassesVulnerable 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. |
| Unconditional Cash Transfer | Experimental | Other: Unconditional Cash Transfers, Other: Standard Agricultural Package, Other: Parenting Skills ClassesVulnerable 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. |
| Control | Other | Other: Standard Agricultural Package, Other: Parenting Skills ClassesVulnerable 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conditional Cash TransferHouseholds 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 | Conditional Cash Transfer |
| Unconditional Cash TransfersHouseholds 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 | Unconditional Cash Transfer |
| Standard Agricultural PackageA 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 | Conditional Cash Transfer, Control, Unconditional Cash Transfer |
| Parenting Skills Classes2-3 parenting skills classes will be held annually in each study cluster. | Other | Conditional Cash Transfer, Control, Unconditional Cash Transfer |
Primary outcome
Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate
Time frame: 1 year
Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations
Time frame: 1 year
Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month
Time frame: 1 year
1 secondary outcome
Proportion of Children Aged 13-17 Years That Attended Secondary School 80% of Days in the Last Month
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24748713Robertson 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.
- Background: PubMed 23103074Robertson 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.
- Results publication: PubMed 23453283Robertson 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.
- Results publication: PubMed 26017676Crea 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.
- Results publication: PubMed 24019380Skovdal 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.
- Results publication: PubMed 23587136Skovdal 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.
- Results publication: PubMed 26899880Fenton 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.
- Derived from this study: PubMed 33097016Schaefer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Robertson, MSc principal investigator
Imperial College London
Simon Gregson, DPhil principal investigator
Imperial College London
Constance Nyamukapa, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conditional Cash Transfer, Unconditional Cash Transfers and Standard Agricultural Package in people with Vaccination and Education, run by Imperial College London at 1 site in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00966849, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.