NCT03705455

Brief Summary

The ISAP study is investigating the efficacy of SMS messages in improving routine childhood Immunization timeliness and completeness in Nigeria.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

1.2 years

First QC Date

October 9, 2018

Last Update Submit

October 11, 2018

Conditions

Immunization

Outcome Measures

Primary Outcomes (1)

  • Proportion of timely and complete vaccine uptake after ISAP SMS Intervention

    Proportion of timely and complete vaccine uptake after ISAP SMS Intervention

    12 months

Study Arms (2)

ISAP SMS

ACTIVE COMPARATOR

ISAP SMS will be sent to enrolled caregivers

Behavioral: ISAP SMS

No ISAP SMS

NO INTERVENTION

No ISAP SMS will be sent to enrolled caregivers

Interventions

ISAP SMSBEHAVIORAL

ISAP SMS is a text message for caregivers use that provides immunization schedule and vaccine availability at the nearest immunization clinic.

ISAP SMS

Eligibility Criteria

Age6 Weeks - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Caregiver with child due for birth dose vaccination or at 6weeks-OPV1,Penta1,PCV1,Rota1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nkanu East Health centre Immunization clinic

Enugu, Nigeria

Location

Related Publications (1)

  • 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.

    PMID: 32813276DERIVED

Study Officials

  • Emmanuel Ihedioha, MBBS

    Lifespan Healthcare Resource

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel Ihedioha, MBBS

CONTACT

23407038861841emmanuel.ihedioha@lifespanhcr.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 15, 2018

Study Start

November 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

October 15, 2018

Record last verified: 2018-10

Locations

NG(1)