ImmunizationISAPNCT03705455
Immunization Schedule Alert Platform
A study testing ISAP SMS in people with Immunization, run by Lifespan Healthcare Resource Limited at 1 site in Nigeria.
Trial summary
The ISAP study is investigating the efficacy of SMS messages in improving routine childhood Immunization timeliness and completeness in Nigeria. Read more about this study
- Who is it for?
- Ages 6 weeks to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Immunization
- What is being tested?
- ISAP SMS
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Nov 2018to 31 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 6 weeks to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Caregiver with child due for birth dose vaccination or at 6weeks-OPV1,Penta1,PCV1,Rota1.
- Exclusion Criteria: Caregiver with child who have already had OPV1,Penta1,PCV1and Rota1.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
Nkanu East Health centre Immunization clinic
Enugu
Ani
2348101313587, ckprime2000@yahoo.co.uk
About this study
Official title: Immunization Schedule Alert Platform: Determining ISAP SMS Efficacy in Improving Childhood Immunization Timeliness and Completeness in Nigeria
The ISAP study is investigating the efficacy of SMS messages in improving routine childhood Immunization timeliness and completeness in Nigeria.
Read the detailed description
The ISAP - Immunization Schedule Alert Platform study is investigating the efficacy of ISAP SMS exposure to Caregivers with children( who have fulfilled our inclusion criteria) due for routine childhood Immunisation in influencing decision for timely and complete Immunization uptake. ISAP SMS messages contains information on the Immunization appointment schedule, time ,vaccine to be administered and the address of the Immunization centre.
- Conditions
- Immunization
- Being tested
- ISAP SMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISAP SMSBehavioural
ISAP SMS is a text message for caregivers use that provides immunization schedule and vaccine availability at the nearest immunization clinic.
| Study group | Role | What they receive |
|---|---|---|
| ISAP SMS | Active comparator | ISAP SMS will be sent to enrolled caregivers Receives: Behavioral: ISAP SMS |
| No ISAP SMS | No intervention | No ISAP SMS will be sent to enrolled caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of timely and complete vaccine uptake after ISAP SMS Intervention
Proportion of timely and complete vaccine uptake after ISAP SMS Intervention
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 posted15 Oct 2018
- Study start1 Nov 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 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 ImmunizationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifespan Healthcare Resource Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Ihedioha Emmanuel Chukwunwike, Lifespan Healthcare Resource Limited
- Investigators
- Emmanuel Ihedioha, MBBS, Principal investigator, Lifespan Healthcare Resource
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705455
- Sponsor's protocol ID
- OPP1182651
- Acronym
- ISAP
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 32813276
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunization Schedule Alert Platform: Determining ISAP SMS Efficacy in Improving Childhood Immunization Timeliness and Completeness in Nigeria
- ClinicalTrials.gov ID
- NCT03705455
- Acronym / sponsor ID
- ISAP / OPP1182651
- Conditions
- Immunization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Lifespan Healthcare Resource LimitedUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 15 Oct 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.
The ISAP study is investigating the efficacy of SMS messages in improving routine childhood Immunization timeliness and completeness in Nigeria.
Detailed description
The ISAP - Immunization Schedule Alert Platform study is investigating the efficacy of ISAP SMS exposure to Caregivers with children( who have fulfilled our inclusion criteria) due for routine childhood Immunisation in influencing decision for timely and complete Immunization uptake. ISAP SMS messages contains information on the Immunization appointment schedule, time ,vaccine to be administered and the address of the Immunization centre.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISAP SMS | Active comparator | Behavioral: ISAP SMSISAP SMS will be sent to enrolled caregivers |
| No ISAP SMS | No intervention | –No ISAP SMS will be sent to enrolled caregivers |
Who may qualify
- Ages
- 6 weeks to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Caregiver with child due for birth dose vaccination or at 6weeks-OPV1,Penta1,PCV1,Rota1.
- Exclusion Criteria: Caregiver with child who have already had OPV1,Penta1,PCV1and Rota1.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ISAP SMSISAP SMS is a text message for caregivers use that provides immunization schedule and vaccine availability at the nearest immunization clinic. | Behavioural | ISAP SMS |
Primary outcome
Proportion of timely and complete vaccine uptake after ISAP SMS Intervention
Time frame: 12 months
Proportion of timely and complete vaccine uptake after ISAP SMS Intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 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.
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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.
Emmanuel Ihedioha, MBBS principal investigator
Lifespan Healthcare Resource
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISAP SMS in people with Immunization, run by Lifespan Healthcare Resource Limited at 1 site in Nigeria.
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 0 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 15 Oct 2018. 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 Nigeria. 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 Emmanuel Ihedioha, MBBS (23407038861841 ext. 23407038861841, emmanuel.ihedioha@lifespanhcr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of timely and complete vaccine uptake after ISAP SMS Intervention (time frame: 12 months). 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 NCT03705455, 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 15 Oct 2018.