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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05010291
Other study ID # 210308
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 5, 2021
Est. completion date December 7, 2021

Study information

Verified date July 2022
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1541
Est. completion date December 7, 2021
Est. primary completion date December 7, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Standard of Care (SOC) text message reminder to attend clinic appointment
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.
Loss aversion framed text message reminder to attend clinic appointment
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.
Social norms framed text message reminder to attend clinic appointment
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.
Altruism framed text message reminder to attend clinic appointment
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.

Locations

Country Name City State
South Africa Aurum Institute Johannesburg Gauteng

Sponsors (3)

Lead Sponsor Collaborator
University of Pennsylvania Aurum Institute, University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Approximately 3-5 months
Primary 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. Approximately 3-5 months
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