Tuberculosis Clinical Trial
Official title:
Randomized Evaluation of a Conditional Cash Transfer Program for Routine Immunizations of Infants in Nigeria
NCT number | NCT03870061 |
Other study ID # | 001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2018 |
Est. completion date | February 20, 2020 |
Verified date | March 2020 |
Source | GiveWell |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Previous studies have shown that a small incentive can have a large impact on health behaviors like vaccinating children. New Incentives, an international non-governmental organization (NGO), aims to boost demand for immunization by offering cash incentives to caregivers who have their child vaccinated at a program clinic. In collaboration with New Incentives, IDinsight is conducting a study to see whether this approach will increase immunization in North West Nigeria. This study aims to investigate whether giving cash to caregivers in North West Nigeria who bring their infants to receive vaccination against common infections (tuberculosis, diphtheria, tetanus, pertussis, hepatitis B virus (HBV) infection, Haemophilus influenzae Type B (Hib), pneumococcal bacteria, measles, rotavirus, polio, yellow fever) increases the proportion of children who are immunized. The study's main hypothesis is that New Incentives' program will increase the percentage of children immunized with BCG, any PENTA, or Measles 1 by an average increase of at least 7-percentage points across all program clinics that share a similar profile to the clinics New Incentives will operate in at scale. The study is taking place in Jigawa, Katsina, and Zamfara States between August 2017 and January 2020.
Status | Completed |
Enrollment | 5187 |
Est. completion date | February 20, 2020 |
Est. primary completion date | February 20, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Months to 16 Months |
Eligibility |
Inclusion Criteria: - Children aged 0 to 16 months can be enrolled in the program and incentives paid to their caregivers - Children aged 12 to 16 months will have their data measured at endline - All participants must reside in study clinic catchment areas. - Vaccination status will be measured by caregiver survey. Caregivers must consent to the survey Exclusion Criteria: - Residence outside the study area (self-reported) - Outside the age range (self-reported) |
Country | Name | City | State |
---|---|---|---|
Nigeria | Primary Health Care facilities across Jigawa State | Various Cities | Jigawa |
Nigeria | Primary Health Care facilities across Katsina State | Various Cities | Katsina |
Nigeria | Primary Health Care facilities across the Zamfara State | Various Cities | Zamfara |
Lead Sponsor | Collaborator |
---|---|
GiveWell | All Babies are Equal Initiative, New Incentives |
Nigeria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The probability that a 12- to 16-month-old in a community served by a study clinic received BCG (based on caregivers' report of their child's vaccination history) | 12 to 16 months after birth | ||
Primary | The probability that a 12- to 16-month-old in a community served by a study clinic received at least one dose of PENTA (based on caregivers' report of their child's vaccination history) | 12 to 16 months after birth | ||
Primary | The probability that a 12- to 16-month-old in a community served by a study clinic received Measles 1 (based on caregivers' report of their child's vaccination history) | 12 to 16 months after birth | ||
Secondary | The probability that a 12- to 16-month-old in a community served by a study clinic is fully immunized (loose and strict) (based on caregivers' report of their child's vaccination history) | 12 to 16 months after birth | ||
Secondary | The timeliness of vaccination, particularly for Measles 1, among 12- to 16-month-olds in communities served by a study clinic (based on caregivers' report of their child's vaccination history) | 12 to 16 months after birth | ||
Secondary | The average number of vaccines received per 12- to 16-month-old child in communities served by a study clinic (based on caregivers' report of their child's vaccination history) | 12 to 16 months after birth | ||
Secondary | The percentage of 12- to 16-month-olds in communities served by a study clinic who received at least one injectable vaccine (based on caregivers' report of their child's vaccination history) | 12 to 16 months after birth | ||
Secondary | The probability that a 12 to 16-month old in a community served by a study clinic received at least one dose of PCV? | 12 to 16 months after birth | ||
Secondary | The change over time in the volume of BCG, Penta 1, Penta 2, Penta 3, and Measles vaccinations recorded in clinic administrative records between treatment and control | 12 to 16 months after birth |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05738681 -
Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial
|
Phase 2/Phase 3 | |
Recruiting |
NCT05526885 -
Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa
|
N/A | |
Completed |
NCT04369326 -
Community Initiated Preventive Therapy for TB
|
N/A | |
Recruiting |
NCT04568967 -
TB-CAPT EXULTANT - HIV
|
N/A | |
Completed |
NCT02337270 -
Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol
|
Phase 1 | |
Not yet recruiting |
NCT06253715 -
Shortened Regimen for Drug-susceptible TB in Children
|
Phase 3 | |
Recruiting |
NCT04271397 -
Immunological Biomarkers in Tuberculosis Management
|
N/A | |
Withdrawn |
NCT03639038 -
Tuberculosis Diagnosis by Flow Cytometry
|
||
Completed |
NCT03199313 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
|
Phase 1 | |
Recruiting |
NCT04975178 -
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
|
Phase 3 | |
Completed |
NCT04463680 -
Rifampin and the Contraceptive Implant
|
Phase 4 | |
Completed |
NCT03973970 -
Assessing the Ability of the T-SPOT®.TB Test (IQ)
|
||
Recruiting |
NCT04230395 -
Alcohol Reduction Among People With TB and HIV in India
|
N/A | |
Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
Active, not recruiting |
NCT02906007 -
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05917210 -
Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
|
N/A | |
Not yet recruiting |
NCT06017843 -
Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding
|
N/A | |
Not yet recruiting |
NCT05845112 -
Start Taking Action For TB Diagnosis
|
||
Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
Completed |
NCT02781909 -
Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis
|
Phase 2 |