Immunization; InfectionMOPINGNCT03402646
Mobile Phone Reminders (and Photovoice) for Routine Immunization in Nigeria - The MOPING Study
A study testing Reminder module (SMS and Phone call) and Photovoice in people with Immunization; Infection, run by Universiti Putra Malaysia.
Trial summary
This study aims to implement and test the efficacy of photovoice, Short Messaging Service (SMS) and phone call reminders in improving childhood immunization coverage (uptake, timeliness and completion rates) and reducing incidence of vaccine-preventable diseases (VPDs) among infants in Nigeria Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Immunization; Infection
- What is being tested?
- Reminder module (SMS and Phone call) and Photovoice
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,813 participants
- Where
- No sites listed yet
- Study dates
- May 2018to Dec 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mothers/caregivers of healthy infants (age 0 - 12 months) who:
- Have a mobile phone access
- Received antenatal care and/or delivered their babies in a hospital
- Plans to receive immunizations at the selected PHCs
- Purposively-selected community sample of pregnant women in their third trimester, parents/caregivers of infants, providers, community gatekeepers and policy makers
Who cannot join
- Parents of infants requiring hospital admission due to significant illness, congenital deformity/malformation and prematurity
- Foreigners
Trial locations and contacts
No sites are listed yet.
About this study
Official title: EFFICACY OF MOBILE PHONE REMINDERS (AND PHOTOVOICE) IN IMPROVING CHILDHOOD IMMUNIZATION UPTAKE AND REDUCING INCIDENCE OF VACCINE-PREVENTABLE DISEASES - A RANDOMIZED CONTROLLED TRIAL AMONG POSTPARTUM MOTHERS AND CAREGIVERS IN NIGERIA
This study aims to implement and test the efficacy of photovoice, Short Messaging Service (SMS) and phone call reminders in improving childhood immunization coverage (uptake, timeliness and completion rates) and reducing incidence of vaccine-preventable diseases (VPDs) among infants in Nigeria
Read the detailed description
This will be a single-blind three-arm cluster randomized controlled trial involving post-partum mothers and/or caregivers of infants (age 0-12months) attending immunization clinics in 12 randomly selected Primary Health Care Centres (clusters) across Sokoto, Jigawa, Kano, Ogun, Oyo and Lagos States of Nigeria. Additionally, a photovoice methodology will be implemented in 6 community clusters (one in each State) involving group discussions between community members (pregnant women in their third trimester, parents/caregivers of infants age 0-12 months), community leaders, service providers and policy makers on benefits of timely immunization and consequences of non-vaccination. Parent-infant pairs will be followed up for 12 months during which SMS and phone call immunization clinic appointment reminders will be provided to mothers and/or caregivers in intervention arm 1, and photovoice intervention provided at study commencement to participants in intervention arm 2. Respondents in the control group would receive standard care (routine paper-based appointment scheduling alone). The investigators will document and compare immunization uptake (all doses and vaccines), timeliness of receipt and completion rates of scheduled immunization between the three groups, as well as incidence of VPDs between the groups using multivariate statistical analyses.
- Conditions
- Immunization; Infection
- Being tested
- Reminder module (SMS and Phone call), Photovoice
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminder module (SMS and Phone call)Behavioural
Same as described under arm/group descriptions
PhotovoiceBehavioural
Same as described under arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Reminder module (SMS and Phone call) | Experimental | Intervention will consist of a "Reminder module" delivered via SMS and telephone calls by an automated, customized software application. This will include standardized SMS reminder 3 days prior to scheduled immunization clinic appointments, telephone call reminders a day prior to scheduled clinic appointment (4 to 6pm) (in addition to standard care - routine paper-based appointment scheduling and counselling by care providers) for routine immunization. Reminders will be provided consistently for all immunization clinic appointments until the child turns 12 months of age. Receives: Behavioral: Reminder module (SMS and Phone call) |
| Photovoice | Experimental | In two small groups of 15 participants each per state, purposively selected pregnant women in their third trimester and parents of infants aged 0-12 months in the community, as well as community leaders, service providers and policy makers will be exposed to photographs (taken from other sources) of debilitating consequences of non-immunization, which will form the basis of the group discussions, knowledge sharing and consensus-building sessions, each lasting about 45 minutes to 1 hour. Each community cluster will be linked to a PHC. Receives: Behavioral: Photovoice |
| Control | No intervention | Respondents in control clusters will receive standard care only - comprising routine paper-based appointment scheduling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunization coverage
Proportion of randomized infants who received birth doses of BCG and OPV (overall), and complete doses of each vaccine as scheduled
Measured: 12 months
Timeliness of receipt of scheduled immunization
Proportion of infants receiving scheduled immunization within 1 week of schedule
Measured: 12 months
Secondary outcomes (1)
Incidence of any childhood vaccine-preventable disease
Risk ratio of vaccine-preventable disease between intervention and control groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study startMay 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immunization; InfectionStudies 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
- Model description
- This will be a single-blind three-arm cluster randomized controlled trial involving post-partum mothers and/or caregivers of infants (age 0-12months) attending immunization clinics in 12 randomly selected Primary Health Care Centres (clusters) across Sokoto, Jigawa, Kano, Ogun, Oyo and Lagos States of Nigeria. Additionally, the investigators will be implementing a photovoice methodology in 6 community clusters (one in each State) involving group discussions between community members (pregnant women in their third trimester, parents/caregivers of infants age 0-12 months), community leaders, service providers and policy makers on benefits of timely immunization and consequences of non-vaccination.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,813 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- RCSI & UCD Malaysia Campus
- Responsible party
- Principal investigator, Dr. Surajudeen Abiola Abdulrahman, Universiti Putra Malaysia
- Investigators
- Surajudeen A Abdulrahman, MBBS, PhD, Principal investigator, RCSI & UCD Malaysia CampusNiyi Osamiluyi, Study director, Premier Medical Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402646
- Sponsor's protocol ID
- MOPING/V2/07/17
- Acronym
- MOPING
- Status last verified
- Jan 2018
- First submitted
- 19 Dec 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 32813276
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY OF MOBILE PHONE REMINDERS (AND PHOTOVOICE) IN IMPROVING CHILDHOOD IMMUNIZATION UPTAKE AND REDUCING INCIDENCE OF VACCINE-PREVENTABLE DISEASES - A RANDOMIZED CONTROLLED TRIAL AMONG POSTPARTUM MOTHERS AND CAREGIVERS IN NIGERIA
- ClinicalTrials.gov ID
- NCT03402646
- Acronym / sponsor ID
- MOPING / MOPING/V2/07/17
- Conditions
- Immunization; Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,813 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- RCSI & UCD Malaysia Campus
- Study start
- May 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 Jan 2018 (actual)
- 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.
This study aims to implement and test the efficacy of photovoice, Short Messaging Service (SMS) and phone call reminders in improving childhood immunization coverage (uptake, timeliness and completion rates) and reducing incidence of vaccine-preventable diseases (VPDs) among infants in Nigeria
Detailed description
This will be a single-blind three-arm cluster randomized controlled trial involving post-partum mothers and/or caregivers of infants (age 0-12months) attending immunization clinics in 12 randomly selected Primary Health Care Centres (clusters) across Sokoto, Jigawa, Kano, Ogun, Oyo and Lagos States of Nigeria. Additionally, a photovoice methodology will be implemented in 6 community clusters (one in each State) involving group discussions between community members (pregnant women in their third trimester, parents/caregivers of infants age 0-12 months), community leaders, service providers and policy makers on benefits of timely immunization and consequences of non-vaccination. Parent-infant pairs will be followed up for 12 months during which SMS and phone call immunization clinic appointment reminders will be provided to mothers and/or caregivers in intervention arm 1, and photovoice intervention provided at study commencement to participants in intervention arm 2. Respondents in the control group would receive standard care (routine paper-based appointment scheduling alone). The investigators will document and compare immunization uptake (all doses and vaccines), timeliness of receipt and completion rates of scheduled immunization between the three groups, as well as incidence of VPDs between the groups using multivariate statistical analyses.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This will be a single-blind three-arm cluster randomized controlled trial involving post-partum mothers and/or caregivers of infants (age 0-12months) attending immunization clinics in 12 randomly selected Primary Health Care Centres (clusters) across Sokoto, Jigawa, Kano, Ogun, Oyo and Lagos States of Nigeria. Additionally, the investigators will be implementing a photovoice methodology in 6 community clusters (one in each State) involving group discussions between community members (pregnant women in their third trimester, parents/caregivers of infants age 0-12 months), community leaders, service providers and policy makers on benefits of timely immunization and consequences of non-vaccination.
| Arm | Type | Receives |
|---|---|---|
| Reminder module (SMS and Phone call) | Experimental | Behavioral: Reminder module (SMS and Phone call)Intervention will consist of a "Reminder module" delivered via SMS and telephone calls by an automated, customized software application. This will include standardized SMS reminder 3 days prior to scheduled immunization clinic appointments, telephone call reminders a day prior to scheduled clinic appointment (4 to 6pm) (in addition to standard care - routine paper-based appointment scheduling and counselling by care providers) for routine immunization. Reminders will be provided consistently for all immunization clinic appointments until the child turns 12 months of age. |
| Photovoice | Experimental | Behavioral: PhotovoiceIn two small groups of 15 participants each per state, purposively selected pregnant women in their third trimester and parents of infants aged 0-12 months in the community, as well as community leaders, service providers and policy makers will be exposed to photographs (taken from other sources) of debilitating consequences of non-immunization, which will form the basis of the group discussions, knowledge sharing and consensus-building sessions, each lasting about 45 minutes to 1 hour. Each community cluster will be linked to a PHC. |
| Control | No intervention | –Respondents in control clusters will receive standard care only - comprising routine paper-based appointment scheduling |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Mothers/caregivers of healthy infants (age 0 - 12 months) who:
- Purposively-selected community sample of pregnant women in their third trimester, parents/caregivers of infants, providers, community gatekeepers and policy makers
Key exclusion criteria (2 listed)
- Parents of infants requiring hospital admission due to significant illness, congenital deformity/malformation and prematurity
- Foreigners
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 |
|---|---|---|
| Reminder module (SMS and Phone call)Same as described under arm/group descriptions | Behavioural | Reminder module (SMS and Phone call) |
| PhotovoiceSame as described under arm/group descriptions | Behavioural | Photovoice |
Primary outcome
Immunization coverage
Time frame: 12 months
Proportion of randomized infants who received birth doses of BCG and OPV (overall), and complete doses of each vaccine as scheduled
Timeliness of receipt of scheduled immunization
Time frame: 12 months
Proportion of infants receiving scheduled immunization within 1 week of schedule
1 secondary outcome
Incidence of any childhood vaccine-preventable disease
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- 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.
- Individual participant dataSharing planned: Undecided
Related trials for Immunization; Infection
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Active, not recruiting
Working Towards Empowered Community-driven Approaches to Increase Vaccination and Preventive Care Engagement
COVID-19
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Active, not recruitingPhase 4
An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen
HPV Infection
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.
Surajudeen A Abdulrahman, MBBS, PhD principal investigator
RCSI & UCD Malaysia Campus
Niyi Osamiluyi study director
Premier Medical Systems
Questions about this trial
What is this clinical trial studying?
A study testing Reminder module (SMS and Phone call) and Photovoice in people with Immunization; Infection, run by Universiti Putra Malaysia.
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 5 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: status not confirmed, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Surajudeen A Abdulrahman, MBBS, PhD (+60167067760, abdulsuraj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunization coverage (time frame: 12 months). The study lists 2 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 NCT03402646, which also lists 1 linked publication.
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 18 Jan 2018.