Evaluating a Caregiver SMS Reminder Intervention to Reduce Immunization

Status Completed

Clinical Trial Summary

Faced with high rates of immunization drop-out, Uganda's immunization program requires innovative approaches to address this weakness. Building upon Uganda's growing mHealth infrastructure to pilot a scalable short message service (SMS) system to remind caregivers of their children's upcoming vaccination visits, it was hypothesized that the SMS intervention will increase immunization coverage in a cost-effective and affordable manner that would make it scalable. The study design was an investigator-blinded, multi-center, parallel groups randomized controlled trial with randomization occurring at the caregiver level in select health facilities of Arua District in Uganda. Enrollment took place at the time of Pentavalent 1 vaccination, and both arms included standard of care provided by the health worker. However, in the intervention arm, caregivers also received SMS text messages reminding them to return for their children's second and third doses of Pentavalent vaccine (four and eight weeks after the first dose of Pentavalent vaccine) and measles-containing vaccine (9 months of age). The primary outcome of interest is vaccination coverage at 12 months of age among children enrolled in the study and will be measured by comparing Penta3 and MCV coverage between arms. The study will also examine the SMS impact on timeliness of vaccine receipt, as it is hypothesized that those children receiving the SMS intervention will be more likely to have timely vaccination than those in the control group. The study will also assess caregiver acceptability and cost-effectiveness of the SMS intervention. In addition to assessing its impact on strengthening the immunization program, this intervention has implications for strengthening other programs of the health system through similar health messaging directed toward caregivers.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Diphtheria
Haemophilus Infections
Haemophilus Influenzae Type b Infection
Hepatitis B
Measles
Pertussis
Polio
Tetanus

Clinical Trial Details

NCT number	NCT04177485
Study type	Interventional
Source	Centers for Disease Control and Prevention
Contact
Status	Completed
Phase	N/A
Start date	February 1, 2016
Completion date	December 4, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01182311` - Duration of Long-term Immunity After Hepatitis B Virus Immunization
Completed	`NCT04971928` - Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment	Phase 1
Completed	`NCT03285620` - A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants	Phase 1
Completed	`NCT01884415` - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis	Phase 3
Recruiting	`NCT05404919` - Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates	Phase 2
Completed	`NCT02153320` - Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers	Phase 1
Completed	`NCT00352963` - Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).	Phase 3
Completed	`NCT03567382` - Arresting Vertical Transmission of Hepatitis B Virus	Phase 4
Not yet recruiting	`NCT04056728` - A Phase IV Study to Assess the Safety of EupentaTM Inj	Phase 4
Not yet recruiting	`NCT03604016` - Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver	Phase 4
Completed	`NCT00753649` - Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants	Phase 4
Recruiting	`NCT03027258` - Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome	N/A
Terminated	`NCT02604199` - A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection	Phase 2
Completed	`NCT02540538` - Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders	Phase 1
Completed	`NCT02169674` - Hepatitis B Booster Study in Adolescence	Phase 4
Completed	`NCT02421666` - A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV	N/A
Completed	`NCT01917357` - A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject	Phase 3
Completed	`NCT01368497` - Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection	Phase 3
Completed	`NCT01732354` - Study for Consolidation Period of Chronic Hepatitis B
Recruiting	`NCT01462981` - Cohort of Hepatitis B Research of Amsterdam	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluating a Caregiver SMS Reminder Intervention to Reduce Immunization Drop-out in Arua, Uganda

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms