NCT03402646

Brief 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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,813

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

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

December 19, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

December 19, 2017

Last Update Submit

January 10, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Immunization coverage

    Proportion of randomized infants who received birth doses of BCG and OPV (overall), and complete doses of each vaccine as scheduled

    12 months

  • Timeliness of receipt of scheduled immunization

    Proportion of infants receiving scheduled immunization within 1 week of schedule

    12 months

Secondary Outcomes (1)

  • Incidence of any childhood vaccine-preventable disease

    12 months

Study Arms (3)

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.

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.

Behavioral: Photovoice

Control

NO INTERVENTION

Respondents in control clusters will receive standard care only - comprising routine paper-based appointment scheduling

Interventions

Same as described under arm/group descriptions

Reminder module (SMS and Phone call)
PhotovoiceBEHAVIORAL

Same as described under arm/group descriptions

Photovoice

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Parents of infants requiring hospital admission due to significant illness, congenital deformity/malformation and prematurity
  • Foreigners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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.

MeSH Terms

Conditions

Infections

Interventions

Spermine Synthase

Intervention Hierarchy (Ancestors)

Alkyl and Aryl TransferasesTransferasesEnzymesEnzymes and Coenzymes

Study Officials

  • Surajudeen A Abdulrahman, MBBS, PhD

    RCSI & UCD Malaysia Campus

    PRINCIPAL INVESTIGATOR
  • Niyi Osamiluyi

    Premier Medical Systems

    STUDY DIRECTOR

Central Study Contacts

Surajudeen A Abdulrahman, MBBS, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2017

First Posted

January 18, 2018

Study Start

May 1, 2018

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

January 18, 2018

Record last verified: 2018-01