HIV/AIDSNCT05010291
Behavioural Text Messages to Improve Retention in Care in South Africa
A study testing Loss aversion framed text message reminder to attend clinic appointment, Social norms framed text message reminder to attend clinic appointment and Altruism framed text message reminder to attend clinic appointment in people with HIV/AIDS, run by University of Pennsylvania at 1 site in South Africa.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Loss aversion framed text message reminder to attend clinic appointment, Social norms framed text message reminder to attend clinic appointment and Altruism framed text message reminder to attend clinic appointment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,541 participants
- Where
- 1 siteSouth Africa
- Study dates
- 5 Aug 2021to 7 Dec 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioural Text Messaging to Improve Retention in Care for Patients on Antiretroviral Therapy in Ekurhuleni District, South Africa
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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- 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
- Keywords
- Behavioral sciences, Retention in care
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SOC) text message reminder to attend clinic appointmentBehavioural
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 appointmentBehavioural
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 appointmentBehavioural
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 appointmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) messaging | Experimental | 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 Receives: Behavioral: Standard of Care (SOC) text message reminder to attend clinic appointment |
| Loss aversion messaging | Experimental | 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. Receives: Behavioral: Loss aversion framed text message reminder to attend clinic appointment |
| Social norms messaging | Experimental | 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. Receives: Behavioral: Social norms framed text message reminder to attend clinic appointment |
| Altruism messaging | Experimental | 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. Receives: Behavioral: Altruism framed text message reminder to attend clinic appointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Approximately 3-5 months
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.
Measured: Approximately 3-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start5 Aug 2021
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,541 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, Aurum Institute
- Responsible party
- Sponsor
- Investigators
- Tonderai Mabuto, PhD, Principal investigator, Aurum InstituteHarsha Thirumurthy, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010291
- Sponsor's protocol ID
- 210308
- Status last verified
- Jul 2022
- First submitted
- 10 Aug 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural Text Messaging to Improve Retention in Care for Patients on Antiretroviral Therapy in Ekurhuleni District, South Africa
- ClinicalTrials.gov ID
- NCT05010291
- Acronym / sponsor ID
- 210308
- Conditions
- HIV/AIDS
- Keywords
- Behavioral sciences, Retention in care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,541 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, Aurum Institute
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 18 Aug 2021 (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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) messaging | Experimental | Behavioral: Standard of Care (SOC) text message reminder to attend clinic appointmentParticipants 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 |
| Loss aversion messaging | Experimental | Behavioral: Loss aversion framed text message reminder to attend clinic appointmentParticipants 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. |
| Social norms messaging | Experimental | Behavioral: Social norms framed text message reminder to attend clinic appointmentParticipants 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. |
| Altruism messaging | Experimental | Behavioral: Altruism framed text message reminder to attend clinic appointmentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Standard of Care (SOC) text message reminder to attend clinic appointmentSOC 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. | Behavioural | Standard of Care (SOC) messaging |
| Loss aversion framed text message reminder to attend clinic appointmentLoss 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. | Behavioural | Loss aversion messaging |
| Social norms framed text message reminder to attend clinic appointmentSocial 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. | Behavioural | Social norms messaging |
| Altruism framed text message reminder to attend clinic appointmentAltruism 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. | Behavioural | Altruism messaging |
Primary outcome
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).
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.
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 20 Jul 2022.
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Tonderai Mabuto, PhD principal investigator
Aurum Institute
Harsha Thirumurthy, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loss aversion framed text message reminder to attend clinic appointment, Social norms framed text message reminder to attend clinic appointment and Altruism framed text message reminder to attend clinic appointment in people with HIV/AIDS, run by University of Pennsylvania at 1 site in South Africa.
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 5 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 20 Jul 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 South Africa. 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?
Appointment reminders (time frame: Approximately 3-5 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 20 Jul 2022.