Phone Text Message Reminders on Compliance With Human Rabies Post Exposure Prophylaxis Project

April 21, 2022 updated by: Washington State University

Effect of Phone Text Message Reminders on Compliance With Rabies Post-Exposure Prophylaxis Following Dog-Bites in Rural Kenya

Every year, rabies, a disease transmitted to humans by rabid dogs, is estimated to kill 59,000 people globally, mostly children 15 years and below in Africa and Asia. This is despite the availability of effective vaccines against rabies in humans, and in dogs. Following a dog bite, there are two critical steps required to prevent clinical disease and death: thorough wound washing with clean running water for at least 15 minutes; and immediate injection with anti-rabies vaccine on the day of being bitten followed by other four injections over the course of one month. Delay in seeking first dose of anti-rabies or failure to complete the recommended dosage may result in clinical rabies and death. The investigators proposed to assess the effect of short message system (SMS) phone text reminders sent to bite patients ahead of their scheduled visits on the adherence to scheduled anti-rabies doses among bite patients in rural eastern Kenya. The investigators enrolled bite patients presenting at Makueni County Referral Hospital between October 2018 and March 2019. Bite patients presenting to the facility between January and March 2019 received SMS reminder written in both English and local dialect a day before each dose of anti-rabies vaccine. These data were compared to those presenting to the health facility in the period prior (October to December 2018) before the introduction of the SMS reminder. This group received routine hospital cards as reminder of their next dose of anti-rabies vaccine injection. Each study participant was contacted after one month from the time of the bite and a phone interview completed to assess compliance and factors associated with completion of the five doses of anti-rabies vaccine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: Rabies is a fatal viral disease transmitted to humans mainly by domestic dogs. It is a neglected zoonosis that primarily affects underserved populations that have limited access to health care. Every year, rabies is estimated to kill 59,000 people globally, mostly children 15 years and below in Africa and Asia. This is despite the development of effective vaccines against rabies in humans, and in dogs. Although rabies is always fatal once clinical signs manifest, the disease is preventable with timely treatment after exposure to the rabies virus. The World Health Organization (WHO) recommend that bite patients should receive thorough wound cleaning with soap and water for approximately 15 minutes, followed by administration of anti-rabies vaccine on the day of the bite, as well as additional injections over the course of one month. Bite patients with multiple severe bites particularly to the head and upper trunk, infiltration of rabies immunoglobulin into and around the wound is added. Poor availability of rabies vaccines, lack of access to anti-rabies vaccine or deviations from WHO recommendations such as delays in seeking anti-rabies vaccine and incomplete courses of the vaccine increases the risk of clinical rabies and death. Access to mobile phones has increased globally including in rural settings presenting an opportunity to use them to enhance access to health interventions. Text message reminders has been shown to improve patient compliance including for childhood immunization attendance and appointment reminders across different geographical settings and health care services.

Objective: To assess the effect of SMS reminders on compliance with the five-dose Essen rabies vaccine regimen and determine the factors associated with compliance among dog-bite patients.

Methods: The investigators employed a single arm before-after field trial among patients presenting with dog bites in Makueni County Referral Hospital between October 2018 to March 2019. The study participants were allocated to one of two groups: group 1: bite patients enrolled between January - March 2019 who received a medical card at the first day of visiting the health facility indicating return date for the subsequent dose, and SMS reminders a day before the next dose of anti-rabies vaccine. The SMS messages were written in both English and the local dialect, Kamba; group 2: bite patients recruited into the study between October and December 2018 before the SMS reminder was introduced, this group was designated as the control group. Every bite patient routinely receives a medical card indicating return date for the subsequent dose. To collect data on other factors affecting completion and adherence to the five doses of anti-rabies vaccine, a phone interview was completed to all study participants after at least a month from the bite time.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Makueni, Kenya
        • Makueni County Referral Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants will be patients of any age reporting to the health facility with dog bites.
  • Participants (dog-bite patients or next of kin) in possession of mobile phones.
  • Participants (dog-bite patients) consenting to and participating in a phone interview after the last date of the scheduled anti-rabies vaccine dose.
  • In the intervention arm - participants acknowledging receipt of SMS text reminders.

Exclusion Criteria:

  • Participants (dog-bite patient) that do not consent to participate in the study.
  • Participants that do not own mobile phones.
  • Participants in the intervention arm that did not receive SMS reminders despite owning mobile phones.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention arm: SMS text reminders and medical card
Participants in this intervention arm will receive the routine medical card indicating return date for the subsequent doses of anti-rabies vaccine and SMS reminders sent a day before each dose until the scheduled date of the last dose of anti-rabies vaccine.
Behavioral: Intervention arm: SMS text reminders and medical card
This study arm will assess compliance with anti-rabies vaccine regimen by participants in the presence of SMS text reminders as compared to without the SMS reminder.
No Intervention: Control arm: Medical card
Participants in the control arm will receive the routine medical card indicating return date for the subsequent doses of anti-rabies vaccine. No SMS text reminders will be sent to this group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants that complete the five-dose Essen rabies vaccine regimen in the control versus intervention group
Time Frame: 7 months
The number anti-rabies vaccine doses received by each participant will be reviewed from ant-rabies vaccine register placed at the health facility where participants are recorded after receiving an injection. The investigators will also conduct a phone interview with the participants to determine the number of doses received (using a questionnaire). The investigators will then determine if SMS reminders are associated with completion of the five doses of anti-rabies vaccine.
7 months
Number of participants adhering to the scheduled date of the five-dose Essen rabies vaccine regimen.
Time Frame: 7 months
The number of participants adhering to the scheduled date of anti-rabies vaccine doses will be reviewed from ant-rabies vaccine register placed at the health facility where participants are recorded after receiving an injection. The investigators will also conduct a phone interview with the participants to investigate the exact dates participants received the anti-rabies vaccine injections. The investigators will then determine if SMS reminders are associated with adherence to the five doses of anti-rabies vaccine.
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thumbi Mwangi, PhD, Washington State University, Paul G Allen School for Global Animal Health
  • Study Director: Veronicah M Chuchu, PhD(c), Washington State University - Global Health Kenya
  • Study Director: Mutono Nyamai, PhD(c), Washington State University - Global Health Kenya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KEMRI/SERU/CGHR/046/3268

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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