Goals for Adherence with Low-cost Incentives

NCT05378607 | Active Not Recruiting

• 1 other identifier: HCPCC074
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

GOALS is a three-year randomized control trial (RCT) aimed at testing the effectiveness of three incentive designs to improve the ART adherence of those in need of adherence support. Participants in the first treatment group (T1, n=140) will be eligible for a prize drawing every three months if they reach the adherence target set for them by the study team, gradually increasing from their baseline adherence towards 90% by the end of the year. Participants in the second treatment group (T2, n=140) will be eligible if they reach the adherence target they set for themselves (subject to reaching 90% at the end of year 1 and each target being at least as high as the previous one). Participants in the third treatment group will have a fixed adherence target of 90% and will be eligible for a prize drawing every three months if this target is reached. All treatment groups will receive weekly motivational messages and a reminder of the upcoming prize drawing. The control group (T4, n=140) will receive the usual standard of care offered by the hospital and weekly motivational messages. Primary outcomes measured using Wisepill devices are mean ART adherence and the fraction of clients with adherence of 90% or more. Secondary outcomes are viral suppression, the fraction of clients with treatment interruptions of 48hrs or more, and retention in care.

Conditions

ART; HIV

Keywords

HIV; Behavior change; Health behavior; Adherence; Goal setting; Behavioral economics; Incentives

Outcome Measures

Primary Outcomes (4)

• Mean adherence to ART in previous 12 months

  Wisepill devices monitor the date and time of all device openings to retrieve ART medication, allowing ART adherence to be tracked continuously on the Wisepill server. This will be coded as the number of ART doses taken / number of doses prescribed.

  Measured at 12 months

• Mean adherence to ART in previous 12 months

  Wisepill devices monitor the date and time of all device openings to retrieve ART medication, allowing ART adherence to be tracked continuously on the Wisepill server. This will be coded as the number of ART doses taken / number of doses prescribed.

  Measured at 24 months

• The fraction of clients with adherence of 90% or more

  Wisepill devices monitor the date and time of all openings of the device to retrieve ART medication allowing adherence to be tracked continuously through the Wisepill server. The fraction of clients with 90% adherence or more from the total number of clients will be monitored.

  Measured at 12 months

• The fraction of clients with adherence of 90% or more

  Wisepill devices monitor the date and time of all openings of the device to retrieve ART medication allowing adherence to be tracked continuously through the Wisepill server. The fraction of clients with 90% adherence or more from the total number of clients will be monitored.

  Measured at 24 months

Secondary Outcomes (11)

• Fraction of clients with treatment interruptions of more than 48 hours

  Measured at 12 months

• Fraction of clients with treatment interruptions of more than 48 hours

  Measured at 24 months

• Fraction of clients with treatment interruptions of more than 48 hours

  Measured at 36 months

• Suppressed viral load (viral load <=200 copies/ML)

  Measured at 12 months

• Suppressed viral load (viral load <=200 copies/ML)

  Measured at 24 months

Study Arms (4)

Externally assigned sub-goals

EXPERIMENTAL

Participants will be eligible for prize drawings every three months based on meeting externally chosen subgoals in year 1 and maintaining 90% or more adherence in Year 2 as measured using a Wisepill device. In addition, there will be a larger prize drawing conditional on showing 90% adherence at the end of year 1 and viral suppression at the end of Year 2. This arm will receive the intervention 'Incentivization based on gradually increasing externally chosen adherence goals ', 'Annual adherence prize drawing', 'SMS motivational messages + reminder of prize drawing', 'Year 2 re-allocation based on year 1 performance' and the intervention 'End of Year 2 viral suppression prize drawing.'

Behavioral: Incentivization based on gradually increasing, externally chosen adherence goals; Behavioral: End of year 1 adherence prize drawing; Behavioral: SMS motivational messages + reminder of prize drawing; Behavioral: Year 2 re-allocation based on year 1 performance; Behavioral: End of Year 2 viral suppression prize drawing

Participatory sub-goals

EXPERIMENTAL

Participants will be eligible for prize drawings every three months based on meeting self-chosen subgoals in year 1 and maintaining 90% or more adherence in Year 2 as measured using a Wisepill device. In addition, there will be a larger prize drawing at the end of Years 1 and 2 that is conditional on showing 90% adherence and viral suppression, respectively. This arm will receive the intervention ' Incentivization based on gradually increasing self-chosen adherence goals ', 'Annual adherence prize drawing', 'SMS motivational messages + reminder of prize drawing', 'Year 2 re-allocation based on year 1 performance' and the intervention 'End of Year 2 viral suppression prize drawing.'

Behavioral: End of year 1 adherence prize drawing; Behavioral: SMS motivational messages + reminder of prize drawing; Behavioral: Year 2 re-allocation based on year 1 performance; Behavioral: End of Year 2 viral suppression prize drawing; Behavioral: Incentivization based on gradually increasing self-chosen adherence goals

Fixed goal

EXPERIMENTAL

Participants will be eligible for prize drawings every three months based on meeting a fixed adherence goal of 90% in year 1 and maintaining this adherence level in Year 2 as measured using a Wisepill device. In addition, there will be a larger prize drawing at the end of Years 1 and 2 that is conditional on showing 90% adherence and viral suppression, respectively. This arm will receive the intervention ' Incentivization based on a fixed adherence goal', 'Annual adherence prize drawing', 'SMS motivational messages + reminder of prize drawing', 'Year 2 re-allocation based on year 1 performance' and the intervention 'End of Year 2 viral suppression prize drawing.'

Behavioral: End of year 1 adherence prize drawing; Behavioral: SMS motivational messages + reminder of prize drawing; Behavioral: Year 2 re-allocation based on year 1 performance; Behavioral: End of Year 2 viral suppression prize drawing; Behavioral: Incentivization based on a fixed adherence goal

Control

PLACEBO COMPARATOR

This arm will be provided with Mildmay's usual standard of care. Participants will not receive a prize drawing incentive based on adherence, but they will also be asked to use the Wisepill device and receive weekly motivational messages. This arm will receive the intervention ' SMS motivational messages '

Behavioral: SMS motivational messages

Interventions

Incentivization based on gradually increasing, externally chosen adherence goals BEHAVIORAL

Wisepill data on adherence will be collected remotely. Every three months, participants have a chance to participate in a prize drawing for an airtime reward of 500, 5,000, or 10,000 Ugandan Shillings if adherence matches or exceeds the subgoal chosen by the study coordinator. Subgoals will gradually increase from the participant's baseline adherence up to 90%. Prize drawings can be done during regularly scheduled clinic visits if the participant has a visit corresponding to the 3-month mark or remotely via SMS text message.

Externally assigned sub-goals

End of year 1 adherence prize drawing BEHAVIORAL

Participants will have a chance to participate in a prize drawing at the end of year 1 with larger prize amounts of up to 20,000 Ugandan Shillings (approximately $6), where eligibility is based on reaching 90% in the three months preceding the end of year 1.

Externally assigned sub-goals; Fixed goal; Participatory sub-goals

SMS motivational messages + reminder of prize drawing BEHAVIORAL

Participants will receive weekly motivational messages with a reminder of their upcoming prize drawing throughout year 1 of the study.

Externally assigned sub-goals; Fixed goal; Participatory sub-goals

Year 2 re-allocation based on year 1 performance BEHAVIORAL

In Year 2 of the study, participants who have reached 90% by the end of year 1 will no longer be given sub-goals and instead will be eligible for prize drawings if they maintain the fixed level of 90% or higher. Those who have not reached 90% by the end of year 1 will be allocated to the intervention group that showed the highest effectiveness in year 1.

Externally assigned sub-goals; Fixed goal; Participatory sub-goals

End of Year 2 viral suppression prize drawing BEHAVIORAL

Participants will have a chance to participate in a prize drawing at the end of Year 2 with larger prize amounts of up to 20,000 Ugandan Shillings (approximately $6), where eligibility is based on achieving viral suppression by the end of Year 2.

Externally assigned sub-goals; Fixed goal; Participatory sub-goals

Incentivization based on gradually increasing self-chosen adherence goals BEHAVIORAL

Wisepill data on adherence will be collected remotely. Every three months, participants have a chance to participate in a prize drawing for an airtime reward of 500, 5,000, or 10,000 Ugandan Shillings if adherence matches or exceeds the self-chosen subgoal. While self-chosen, subgoals are subject to a minimum threshold determined by baseline adherence working towards 90% adherence. Prize drawings can be done during regularly scheduled clinic visits if the participant has a visit corresponding to the 3-month mark or remotely via SMS text message.

Participatory sub-goals

Incentivization based on a fixed adherence goal BEHAVIORAL

Wisepill data on adherence will be collected remotely. Every three months, participants have a chance to participate in a prize drawing for an airtime reward of 500, 5,000 or 10,000 Ugandan Shillings if adherence matches or exceeds the fixed adherence goal of 90%. Prize drawings can be done during regularly scheduled clinic visits if the participant has a visit corresponding to the 3-month mark or remotely via SMS text message.

Fixed goal

SMS motivational messages BEHAVIORAL

The control group will also receive weekly motivational messages but without the reminder of the upcoming prize drawing.

Control

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• If the participant is between 15 and 30 years of age (inclusive),
• has received ART from Mildmay for at least three months,
• exhibits Wisepill-measured adherence of under 90%,
• and has regular access to a mobile phone (at least five days per week)

You may not qualify if:

• If the participant is not within the age range specified above,
• has not received ART from Mildmay for at least three months,
• cannot use a Wisepill device when taking ART medication,
• cannot follow the consenting procedures
• does not have regular access to a mobile phone (at least five days per week)
• or shows Wisepill-measured adherence of over 90%

Sponsors & Collaborators

• RAND: lead
• IDinsight: collaborator
• Mildmay Uganda Limited: collaborator

Study Sites (1)

Mildmay Uganda

Kampala, Uganda

Location

Related Publications (1)

• Linnemayr S, Huang HC, Wagner Z, Onkundi FK, Mukasa B, Odiit M. Goals for Adherence with Low-cost Incentives (GOALS): a protocol for a randomized controlled trial evaluating the impact of small airtime incentives on ART adherence among young people living with HIV in Kampala, Uganda. Trials. 2023 Aug 9;24(1):511. doi: 10.1186/s13063-023-07449-z.

  PMID: 37559069 DERIVED

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Alison Connor, PhD

  IDinsights

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2022
• First Posted: May 18, 2022
• Study Start: April 18, 2022
• Primary Completion (Estimated): February 11, 2027
• Study Completion (Estimated): August 11, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Once the project is finished and the primary outcome data have been published, the data from the project will be made available for public use through the NICHD Data and Specimen Hub "DASH" (https://dash.nichd.nih.gov/).
• Access Criteria: The data from the project will be made available for public use through the NICHD Data and Specimen Hub "DASH" (https://dash.nichd.nih.gov/). Constraints imposed by human research subjects protection regulations (e.g., HIPAA Protected Health Information) and RAND's IRB will be recognized as allowed by NIH.

Locations

UG (1)