- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05010291
Behavioural Text Messages to Improve Retention in Care in South Africa
Behavioural Text Messaging to Improve Retention in Care for Patients on Antiretroviral Therapy in Ekurhuleni District, South Africa
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Standard of Care (SOC) text message reminder to attend clinic appointment
- Behavioral: Loss aversion framed text message reminder to attend clinic appointment
- Behavioral: Social norms framed text message reminder to attend clinic appointment
- Behavioral: Altruism framed text message reminder to attend clinic appointment
Detailed Description
The objective of this study is to rapidly determine whether text messages framed according to behavioural economics principles increase the likelihood that recipients of care attend their clinic appointment and return to clinic within 28 days of a missed appointment. The study will be nested in a routine HIV program, in approximately 5 selected Aurum Institute clinics based in Ekurhuleni district, Gauteng province, South Africa.
Intervention arms will include voice call attempts and one-way text messages sent by clinic staff to recipients of care in two scenarios: 1) Approximately 3-7 days in advance of a clinic appointment for collecting antiretroviral medication supplies or collection of a specimen for viral load testing and 2) Approximately 24 hours after a missed clinic appointment.
This individually randomised trial will have four arms. Each time there is an upcoming or missed clinic visit clinic staff will randomly assign recipients of care to one of the following study arms: 1) Standard of Care 2) Loss aversion framed messaging 3) Social norms framed messaging or 4) Altruism framed messaging.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gauteng
-
Johannesburg, Gauteng, South Africa, 2194
- Aurum Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Registered to receive ART (this includes patients receiving ART through multi-month scripting) at selected study sites.
- Aged ≥18 years.
- Have a documented cell phone number in their clinic records
- Are eligible to receive appointment reminders as part of routine care OR eligible to receive follow-up text messages as part of routine care for missed clinic appointments.
Exclusion Criteria:
- Do not have contact details in their clinic records.
- Have contact details on record that are established to belong to someone else upon follow-up (i.e., wrong number).
- Have contact details that are deactivated/non-functional (i.e., voice notification that the number does not exist).
- Are documented to have self-transferred out of the clinic.
- Are known to have been deceased.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Standard of Care (SOC) messaging
Participants randomized into this arm will receive standard voice call reminders + the Standard of Care (SOC) text message reminders.
The study team will send these one-way text messages to recipients of care as a reminder 1) approximately 3-7 days in advance of a clinic appointment, or 2) to follow-up approximately 24 hours after a missed clinic appointment.
These text messages will include the SOC text
|
SOC one-way text message reminding recipient of care to either 1) attend a scheduled clinic appointment or 2) visit the clinic after a missed appointment.
|
Experimental: Loss aversion messaging
Participants randomized into this arm will receive standard voice call reminders + loss aversion text message reminders.
The study team will send these one-way text messages to recipients of care as a reminder 1) approximately 3-7 days in advance of a clinic appointment, or 2) to follow-up approximately 24 hours after a missed clinic appointment.
These text messages will include loss aversion framing.
|
Loss aversion framed one-way text message reminding recipient of care to either 1) attend a scheduled clinic appointment or 2) visit the clinic after a missed appointment.
|
Experimental: Social norms messaging
Participants randomized into this arm will receive standard voice call reminders + social norms text message reminders.
The study team will send these one-way text messages to recipients of care as a reminder 1) approximately 3-7 days in advance of a clinic appointment, or 2) to follow-up approximately 24 hours after a missed clinic appointment.
These text messages will include social norms framing.
|
Social norms framed one-way text message reminding recipient of care to either 1) attend a scheduled clinic appointment or 2) visit the clinic after a missed appointment.
|
Experimental: Altruism messaging
Participants randomized into this arm will receive standard voice call reminders + altruism text message reminders.
The study team will send these one-way text messages to recipients of care as a reminder 1) approximately 3-7 days in advance of a clinic appointment, or 2) to follow-up approximately 24 hours after a missed clinic appointment.
These text messages will include altruism framing.
|
Altruism framed one-way text message reminding recipient of care to either 1) attend a scheduled clinic appointment or 2) visit the clinic after a missed appointment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appointment reminders
Time Frame: Approximately 3-5 months
|
Proportion of clients with schedule clinic visit attendance, defined as the number of patients with a verified clinic on the scheduled appointment day/the total number of clients that were sent appointment reminders (stratified by study arm).
|
Approximately 3-5 months
|
Missed clinic appointments
Time Frame: Approximately 3-5 months
|
Proportion of patients with a verified clinic visit within 28 days of missing a scheduled clinic appointment defined as the number of patients with a verified clinic within 28 days of missing a scheduled clinic appointment/the total number of clients that Tracers sent text messages following a missed clinic appointment.
|
Approximately 3-5 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tonderai Mabuto, PhD, Aurum Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 210308
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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