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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Are there results?
None posted in the registry

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.

Kenya1 site

  • Gem and Asembo Area

    Gem and Asembo Area, Siaya County

Other trials in Kenya

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.

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 groups in NCT01878435
Study groupRoleWhat they receive
SMS reminderExperimentalNot described
Receives: Other: SMS reminder
SMS reminder and Travel subsidyExperimentalNot described
Receives: Other: SMS reminder; Other: Travel subsidy
ControlNo interventionNot described
SMS reminder and Travel subsidy 2ExperimentalNot 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.

  1. Percent of children immunized

    Measured: Up to 12 months of age

Secondary outcomes (9)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  1. First posted17 Jun 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

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)
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 23246258

  • Gibson 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 27189422

  • Gibson 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

Questions about this trial

What is this clinical trial studying?

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.

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 3 inclusion and 3 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 27 Oct 2022. 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 Kenya. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percent of children immunized (time frame: Up to 12 months of age). 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 NCT01878435, which also lists 3 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 27 Oct 2022.

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