Diphtheriam-SIMUNCT01878435
Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya
A study testing SMS reminder, Travel subsidy and Travel subsidy 2 in people with Diphtheria and Tetanus, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Kenya.
Trial summary
The project goal is to conduct a randomized controlled trial (RCT) to test whether mobile phone short message system (SMS) reminders, either with or without mobile-phone based travel subsidies will improve timeliness, coverage, and drop-out rates of routine EPI vaccines in rural western Kenya. Read more about this study
- Who is it for?
- Ages 0 to 5 weeksHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- SMS reminder, Travel subsidy and Travel subsidy 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,018 participants
- Where
- 1 siteKenya
- Study dates
- Oct 2013to Feb 2016
- Phase
- Interventional
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 0 to 5 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mother of infant aged 0-4 weeks during the study period
- Current resident of one of the study villages
- Willing to sign informed consent for the study
Who cannot join
- Plans to move out of the study area in the next 6 months
- Resides in a village with active immunization intervention/program
- Has already received immunizations other than birth dose of BCG or polio
Trial locations and contacts
1 site in 1 country.
About this study
The project goal is to conduct a randomized controlled trial (RCT) to test whether mobile phone short message system (SMS) reminders, either with or without mobile-phone based travel subsidies will improve timeliness, coverage, and drop-out rates of routine EPI vaccines in rural western Kenya.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Measles
- Being tested
- SMS reminder, Travel subsidy, Travel subsidy 2
- Keywords
- Short Message System, SMS reminder, mobile phone, cell phone, vaccination, immunization, mHealth
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Haemophilus Infections, Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS reminderOther
Travel subsidyOther
Travel subsidy 2Other
| Study group | Role | What they receive |
|---|---|---|
| SMS reminder | Experimental | Not described Receives: Other: SMS reminder |
| SMS reminder and Travel subsidy | Experimental | Not described Receives: Other: SMS reminder; Other: Travel subsidy |
| Control | No intervention | Not described |
| SMS reminder and Travel subsidy 2 | Experimental | Not described Receives: Other: SMS reminder; Other: Travel subsidy 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of children immunized
Measured: Up to 12 months of age
Secondary outcomes (9)
Percent of fully immunized children (FIC) by study arm
FIC = One dose bacille Calmette-Guerin (BCG) vaccine, three doses pentavalent (diphtheria, pertussis, tetanus, hepatitis B, haemophilus influenzae type b) vaccine, three doses polio vaccine and one dose measles vaccine. The proportion of FIC infants by 10 months of age in each of the intervention arms (SMS only and SMS + subsidy) will be separately compared to the control arm using statistical analyses that adjust for the cluster design and any socio-demographic variables that may be unequally distributed across study arms
Measured: 10 months of age
Proportion of children vaccinated by study arm
The proportion of intervention arm infants that receive vaccination within 2 weeks of the scheduled date will be calculated for each dose of vaccine and compared to the control arm using statistical analyses that adjust for our cluster design and any socio-demographic variables that may be unequally distributed across study arms
Measured: Within 2 weeks of each scheduled vaccine date
Proportion of children dropping out between doses
Comparison of the differences in percentages of children vaccinated with pentavalent1 and pentavalent3 in the interventions arms compared to this difference in the control arm using statistical analyses that adjust for our cluster design and any socio-demographic variables that may be unequally distributed across study arms
Measured: Age 24 weeks
Proportion of children receiving measles and pentavalent vaccines by study arm
Comparison of vaccine coverage (pentavalent3 and measles, separately) between intervention and control arms
Measured: Age 24 weeks (pentavalent only), 10 months and age 12 months
Proportion in each arm vaccinated by mobile phone ownership and by residential distance from a health facility
Vaccine coverage analysis stratified by mobile phone ownership and residential distance
Measured: Age 12 months
Height-for-age,to evaluate if the interventions had impact on other health status indicators
Using regression, average height for age in each group will be compared across study groups
Measured: Age 12 months
Direct costs for each intervention arm
Costs include SMS messages, the amount of travel subsidy transferred, and the tariffs and fees that are associated with using mobile-money. For each arm, these costs will be divided by the number of children vaccinated and comparisons will be made across study arms
Measured: 25 months, approximate time period for deploying interventions
Bed-net usage, to evaluate if the interventions had impact on other indicators of health status
Proportion of children using bed-nets will be compared across study groups
Measured: Age 12 months
Vitamin A coverage, o evaluate if the interventions had impact on other indicators of health status
Proportion of children who have received vitamin A supplementation will be compared across study groups
Measured: Age 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiphtheriaStudies of the same condition, open and under way.
- 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
- 2,018 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Kenya Medical Research Institute, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878435
- Sponsor's protocol ID
- OPP1053900
- Acronym
- m-SIMU
- Status last verified
- Oct 2022
- First submitted
- 10 Jun 2013
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Wakadha H, Chandir S, Were EV, Rubin A, Obor D, Levine OS, Gibson DG, Odhiambo F, Laserson KF, Feikin DR. The feasibility of using mobile-phone based SMS reminders and conditional cash transfers to improve timely immunization in rural Kenya. Vaccine. 2013 Jan 30;31(6):987-93. doi: 10.1016/j.vaccine.2012.11.093. Epub 2012 Dec 13.
PubMed 23246258Gibson DG, Kagucia EW, Ochieng B, Hariharan N, Obor D, Moulton LH, Winch PJ, Levine OS, Odhiambo F, O'Brien KL, Feikin DR. The Mobile Solutions for Immunization (M-SIMU) Trial: A Protocol for a Cluster Randomized Controlled Trial That Assesses the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya. JMIR Res Protoc. 2016 May 17;5(2):e72. doi: 10.2196/resprot.5030.
PubMed 27189422Gibson DG, Ochieng B, Kagucia EW, Were J, Hayford K, Moulton LH, Levine OS, Odhiambo F, O'Brien KL, Feikin DR. Mobile phone-delivered reminders and incentives to improve childhood immunisation coverage and timeliness in Kenya (M-SIMU): a cluster randomised controlled trial. Lancet Glob Health. 2017 Apr;5(4):e428-e438. doi: 10.1016/S2214-109X(17)30072-4.
PubMed 28288747