Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03402646
Other study ID # MOPING/V2/07/17
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 19, 2017
Last updated January 10, 2018
Start date May 2018
Est. completion date December 2019

Study information

Verified date January 2018
Source Universiti Putra Malaysia
Contact Surajudeen A Abdulrahman, MBBS, PhD
Phone +60167067760
Email abdulsuraj@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1813
Est. completion date December 2019
Est. primary completion date June 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Mothers/caregivers of healthy infants (age 0 - 12 months) who:

1. Have a mobile phone access

2. Received antenatal care and/or delivered their babies in a hospital

3. 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

Exclusion Criteria:

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

2. Foreigners

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Reminder module (SMS and Phone call)
Same as described under arm/group descriptions
Photovoice
Same as described under arm/group descriptions

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Universiti Putra Malaysia Penang Medical College

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Timeliness of receipt of scheduled immunization Proportion of infants receiving scheduled immunization within 1 week of schedule 12 months
Secondary Incidence of any childhood vaccine-preventable disease Risk ratio of vaccine-preventable disease between intervention and control groups 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Completed NCT04042246 - Effect of Knowledge on Vaccine Take-up in Adamawa State, Northeastern Nigeria N/A
Enrolling by invitation NCT05570630 - VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination N/A
Completed NCT03145324 - Immunisation History Survey - a Study to Measure Levels of Immunity to Routine Immunisations
Recruiting NCT06185647 - Evaluation in Practice of the Impact of NIrsevimab on EmeRgency Use for BRONCHIOlitis
Recruiting NCT05215327 - High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients Phase 2
Completed NCT03355989 - Evaluation of Conditional Cash Transfers (CCTs) for Immunization N/A
Completed NCT02992925 - Phase 3 Study of BK1310 in Healthy Infants Phase 3
Completed NCT03121638 - Safety Study of NBP608 in Healthy Adult Volunteers Phase 1
Not yet recruiting NCT05171946 - Phase-I Study to Evaluate the Safety and Immunogenicity of a Prophylactic pDNA Vaccine Candidate Against COVID-19 in Healthy Adults Phase 1
Completed NCT05661890 - Seasonal Influenza and Pneumococcal Vaccination in the Elderly
Active, not recruiting NCT04444518 - Increasing Influenza and Tdap Vaccination of Pregnant Women N/A
Active, not recruiting NCT03908164 - Optimising the Timing of Whooping Cough Immunisation in MUMs Phase 4
Completed NCT03379467 - Use of SMS and Interactive Reminders to Improve Timely Immunization Coverage N/A
Completed NCT04824638 - BNT162b2 Vaccination With 2 Doses in COVID-19 Negative Volunteers and With a Single Dose in COVID-19 Positive Volunteers Phase 2
Recruiting NCT05774093 - Evaluation of COVID-19 Immune Barrier and Reinfection Risk
Completed NCT03083158 - Immunity to Hepatitis B Vaccine Phase 4
Recruiting NCT04816760 - Immune Cells Phenotypes During COVID-19
Completed NCT04870021 - Hepatitis B Birth Dose for Newborns Phase 4
Completed NCT03519373 - Pertussis Immunization During Pregnancy & HIV Infection