RabiesNCT05350735
Phone Text Message Reminders on Compliance With Human Rabies Post Exposure Prophylaxis Project
A study testing Intervention arm: SMS text reminders and medical card in people with Rabies, run by Washington State University at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rabies
- What is being tested?
- Intervention arm: SMS text reminders and medical card
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteKenya
- Study dates
- 1 Oct 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Rabies
- Being tested
- Intervention arm: SMS text reminders and medical card
- Keywords
- Rabies, SMS, Post exposure prophylaxis, Ant-rabies vaccine, Dog bite patients, Regimen
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention arm: SMS text reminders and medical cardBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Oct 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thumbi Mwangi, PhD, Principal investigator, Washington State University, Paul G Allen School for Global Animal HealthVeronicah M Chuchu, PhD(c), Study director, Washington State University - Global Health KenyaMutono Nyamai, PhD(c), Study director, Washington State University - Global Health Kenya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350735
- Sponsor's protocol ID
- KEMRI/SERU/CGHR/046/3268
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Phone Text Message Reminders on Compliance With Rabies Post-Exposure Prophylaxis Following Dog-Bites in Rural Kenya
- ClinicalTrials.gov ID
- NCT05350735
- Acronym / sponsor ID
- KEMRI/SERU/CGHR/046/3268
- Conditions
- Rabies
- Keywords
- Rabies, SMS, Post exposure prophylaxis, Ant-rabies vaccine, Dog bite patients, Regimen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm: SMS text reminders and medical card | Experimental | Behavioral: Intervention arm: SMS text reminders and medical cardParticipants 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention arm: SMS text reminders and medical cardThis 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. | Behavioural | Intervention arm: SMS text reminders and medical card |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thumbi Mwangi, PhD principal investigator
Washington State University, Paul G Allen School for Global Animal Health
Veronicah M Chuchu, PhD(c) study director
Washington State University - Global Health Kenya
Mutono Nyamai, PhD(c) study director
Washington State University - Global Health Kenya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention arm: SMS text reminders and medical card in people with Rabies, run by Washington State University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that complete the five-dose Essen rabies vaccine regimen in the control versus intervention group (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.