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

NCT05350735 | Completed

• 1 other identifier: KEMRI/SERU/CGHR/046/3268
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rabies

Keywords

Rabies; SMS; Post exposure prophylaxis; Ant-rabies vaccine; Dog bite patients; Regimen

Outcome Measures

Primary Outcomes (2)

• Number of participants that complete the five-dose Essen rabies vaccine regimen in the control versus intervention group

  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.

  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

Study Arms (2)

Intervention arm: SMS text reminders and medical card

EXPERIMENTAL

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

Control arm: Medical card

NO INTERVENTION

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.

Interventions

Intervention arm: SMS text reminders and medical card BEHAVIORAL

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.

Intervention arm: SMS text reminders and medical card

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington State University: lead

Study Sites (1)

Makueni County Referral Hospital

Makueni, Kenya

Location

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Thumbi Mwangi, PhD

  Washington State University, Paul G Allen School for Global Animal Health

  PRINCIPAL INVESTIGATOR

• Veronicah M Chuchu, PhD(c)

  Washington State University - Global Health Kenya

  STUDY DIRECTOR

• Mutono Nyamai, PhD(c)

  Washington State University - Global Health Kenya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know which arm they belong to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 28, 2022
• Study Start: October 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: April 28, 2022

Record last verified: 2022-04

Locations

KE (1)