NCT05010291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,541

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2021

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

August 10, 2021

Last Update Submit

July 19, 2022

Conditions

Keywords

Behavioral sciencesRetention in care

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (4)

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

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.

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.

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.

Behavioral: Altruism framed text message reminder to attend clinic appointment

Interventions

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.

Standard of Care (SOC) messaging

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.

Loss aversion messaging

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.

Social norms messaging

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.

Altruism messaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aurum Institute

Johannesburg, Gauteng, 2194, South Africa

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Tonderai Mabuto, PhD

    Aurum Institute

    PRINCIPAL INVESTIGATOR
  • Harsha Thirumurthy, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2021

First Posted

August 18, 2021

Study Start

August 5, 2021

Primary Completion

December 7, 2021

Study Completion

December 7, 2021

Last Updated

July 20, 2022

Record last verified: 2022-07

Locations