MeaslesmimiNCT02662595
mHealth to Increase Measles Immunization - a Randomized Controlled Trial in Guinea-Bissau
A study testing SMS reminder message and Voice call + SMS message in people with Measles, run by Bandim Health Project at 3 sites in Guinea-Bissau.
Trial summary
The question that this project seeks to answer, is whether mobile phones can be used to increase the measles vaccination coverage and timeliness in Guinea-Bissau. The intervention will be evaluated in terms of direct health outcomes and cost/benefit analysis, generating evidence that could help policy makers making… Read more about this study
- Who is it for?
- Ages Up to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Measles
- What is being tested?
- SMS reminder message and Voice call + SMS message
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 3 sitesGuinea-Bissau
- Study dates
- Mar 2016to Jan 2018
- 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 Up to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- the mother has access to a cell phone (either her own phone or the phone of a household member)
- the mother lives in the uptake area of the health center.
Who cannot join
- the mother does not have access to a mobile phone.
Trial locations and contacts
3 sites in 1 country.
Amabélia Rodrigues, Dr. contact
Guinea-Bissau3 sites
Catio Health Center
Catío, Tombali
Paunca Health Center
Paunca, Gabú
Varela Health Center
Varela, Cacheu Region
About this study
Official title: Mimi - mHealth to Increase Measles Immunization. A Randomized Controlled Trial.
The question that this project seeks to answer, is whether mobile phones can be used to increase the measles vaccination coverage and timeliness in Guinea-Bissau. The intervention will be evaluated in terms of direct health outcomes and cost/benefit analysis, generating evidence that could help policy makers making informed decisions about implementing mHealth interventions at a national level.
The intervention takes the form of a randomized controlled trial in which text messages (SMS) as well as voice calls are scheduled and delivered to mo thers to remind and encourage them to have their children timely vaccinated against measles. In addition, the messages will include relevant information about opening hours and availability of the measles vaccine at the mothers' local health facilities thus improving coordination. The trial will include three different randomization groups with approx. 350 participants in each group. The first group will receive SMS messages, the second group will receive a voice call in addition to the SMS messages, and the third group is a control group that does not receive any intervention.
Read more
Study participants will be enrolled following birth at one of three health centers in different rural regions of Guinea-Bissau. Before the measles vaccine is scheduled to be given, at 9 months of age, mothers will receive the intervention message depending on their assigned randomization group. When the measles vaccine is administered, the child will be registered as having received the measles vaccination.
A follow-up phone interview will be conducted at 12 months of age for all children participating regardless of randomization group and whether or not they received the measles vaccine. All participating children, who at that time still have not received the measles vaccine, will be offered the vaccine at the expense of the project.
- Conditions
- Measles
- Being tested
- SMS reminder message, Voice call + SMS message
- Keywords
- mHealth, mobile phones, measles vaccination
- Medical subject headings
- Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS reminder messageOther
Voice call + SMS messageOther
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Text message | Active comparator | Subjects in this arm will receive a text message reminder in due time for measles vaccination. Receives: Other: SMS reminder message |
| Text message and voice call | Active comparator | Subjects in this arm will receive a voice call in addition to a text message reminder in due time for measles vaccination. Receives: Other: Voice call + SMS message |
What is being measured
The primary outcome is the main question the study is designed to answer.
MV Coverage at 12 months of age
Difference in measles vaccination coverage at 12 months of age between the intervention and the control groups.
Measured: 12 months of age
Secondary outcomes (2)
Timeliness
Difference in timeliness of measles vaccines administered, measured as median age of measles vaccinated children.
Measured: At 12 months
Average number of visits
Average number of visits to the health center with the purpose of receiving MV needed before MV is successfully administered.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MeaslesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662595
- Sponsor's protocol ID
- MIMI-01
- Acronym
- mimi
- Status last verified
- Jan 2016
- First submitted
- 20 Jan 2016
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
PubMed 32813276Rossing E, Ravn H, Batista CS, Rodrigues A. MHealth to Improve Measles Immunization in Guinea-Bissau: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2016 Jul 27;5(3):e158. doi: 10.2196/resprot.5968.
PubMed 27466046
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mimi - mHealth to Increase Measles Immunization. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02662595
- Acronym / sponsor ID
- mimi / MIMI-01
- Conditions
- Measles
- Keywords
- mHealth, mobile phones, measles vaccination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The question that this project seeks to answer, is whether mobile phones can be used to increase the measles vaccination coverage and timeliness in Guinea-Bissau. The intervention will be evaluated in terms of direct health outcomes and cost/benefit analysis, generating evidence that could help policy makers making informed decisions about implementing mHealth interventions at a national level.
The intervention takes the form of a randomized controlled trial in which text messages (SMS) as well as voice calls are scheduled and delivered to mo thers to remind and encourage them to have their children timely vaccinated against measles. In addition, the messages will include relevant information about opening hours and availability of the measles vaccine at the mothers' local health facilities thus improving coordination. The trial will include three different randomization groups with approx. 350 participants in each group. The first group will receive SMS messages, the second group will receive a voice call in addition to the SMS messages, and the third group is a control group that does not receive any intervention.
Study participants will be enrolled following birth at one of three health centers in different rural regions of Guinea-Bissau. Before the measles vaccine is scheduled to be given, at 9 months of age, mothers will receive the intervention message depending on their assigned randomization group. When the measles vaccine is administered, the child will be registered as having received the measles vaccination.
A follow-up phone interview will be conducted at 12 months of age for all children participating regardless of randomization group and whether or not they received the measles vaccine. All participating children, who at that time still have not received the measles vaccine, will be offered the vaccine at the expense of the project.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Text message | Active comparator | Other: SMS reminder messageSubjects in this arm will receive a text message reminder in due time for measles vaccination. |
| Text message and voice call | Active comparator | Other: Voice call + SMS messageSubjects in this arm will receive a voice call in addition to a text message reminder in due time for measles vaccination. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- the mother has access to a cell phone (either her own phone or the phone of a household member)
- the mother lives in the uptake area of the health center.
Key exclusion criteria (1 listed)
- the mother does not have access to a mobile phone.
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 |
|---|---|---|
| SMS reminder message | Other | Text message |
| Voice call + SMS message | Other | Text message and voice call |
Primary outcome
MV Coverage at 12 months of age
Time frame: 12 months of age
Difference in measles vaccination coverage at 12 months of age between the intervention and the control groups.
2 secondary outcomes
Timeliness
Time frame: At 12 months
Average number of visits
Time frame: At 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- Derived from this study: PubMed 32813276Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
- Derived from this study: PubMed 27466046Rossing E, Ravn H, Batista CS, Rodrigues A. MHealth to Improve Measles Immunization in Guinea-Bissau: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2016 Jul 27;5(3):e158. doi: 10.2196/resprot.5968.
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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.
Amabélia Rodrigues, Dr. contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS reminder message and Voice call + SMS message in people with Measles, run by Bandim Health Project at 3 sites in Guinea-Bissau.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Guinea-Bissau. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emil Rossing, MA (+2455772149, emro@ssi.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MV Coverage at 12 months of age (time frame: 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 NCT02662595, which also lists 2 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 25 Jan 2016.