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Behavioural Text Messages to Improve Retention in Care in South Africa

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Standard of Care (SOC) text message reminder to attend clinic appointment
Loss aversion framed text message reminder to attend clinic appointment
Social norms framed text message reminder to attend clinic appointment
Altruism framed text message reminder to attend clinic appointment
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for HIV/AIDS focused on measuring Behavioral sciences, Retention in care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Aurum Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Standard of Care (SOC) messaging

Loss aversion messaging

Social norms messaging

Altruism messaging

Arm Description

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

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.

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.

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.

Outcomes

Primary Outcome Measures

Appointment reminders
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).
Missed clinic appointments
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.

Secondary Outcome Measures

Full Information

First Posted
August 10, 2021
Last Updated
July 19, 2022
Sponsor
University of Pennsylvania
Collaborators
University of Witwatersrand, South Africa, Aurum Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05010291
Brief Title
Behavioural Text Messages to Improve Retention in Care in South Africa
Official Title
Behavioural Text Messaging to Improve Retention in Care for Patients on Antiretroviral Therapy in Ekurhuleni District, South Africa
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 5, 2021 (Actual)
Primary Completion Date
December 7, 2021 (Actual)
Study Completion Date
December 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
University of Witwatersrand, South Africa, Aurum Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The proportion of South Africans aware of their HIV status and on treatment remains lower than optimal. The goal of this study is to rapidly determine whether text messages framed according to behavioural economics principles increase clinic attendance among recipients of care on antiretroviral therapy in South Africa. We hypothesize that messages incorporating behavioural economics principles will increase the likelihood of recipients of care attending clinic appointments and returning within 28 days of a missed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
Behavioral sciences, Retention in care

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1541 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care (SOC) messaging
Arm Type
Experimental
Arm Description
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
Arm Title
Loss aversion messaging
Arm Type
Experimental
Arm Description
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.
Arm Title
Social norms messaging
Arm Type
Experimental
Arm Description
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.
Arm Title
Altruism messaging
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care (SOC) text message reminder to attend clinic appointment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Loss aversion framed text message reminder to attend clinic appointment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social norms framed text message reminder to attend clinic appointment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Altruism framed text message reminder to attend clinic appointment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Appointment reminders
Description
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).
Time Frame
Approximately 3-5 months
Title
Missed clinic appointments
Description
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.
Time Frame
Approximately 3-5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tonderai Mabuto, PhD
Organizational Affiliation
Aurum Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harsha Thirumurthy, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aurum Institute
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2194
Country
South Africa

12. IPD Sharing Statement

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Behavioural Text Messages to Improve Retention in Care in South Africa

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