ARTGOALSNCT05378607
Goals for Adherence With Low-cost Incentives
A study testing Incentivization based on gradually increasing, externally chosen adherence goals, End of year 1 adherence prize drawing and SMS motivational messages + reminder of prize drawing in people with ART and HIV, run by RAND at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- What is being tested?
- Incentivization based on gradually increasing, externally chosen adherence goals, End of year 1 adherence prize drawing and SMS motivational messages + reminder of prize drawing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 560 participants
- Where
- 1 siteUganda
- Study dates
- 18 Apr 2022to 11 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Low ART adherence among youth living with HIV threatens positive treatment outcomes. Increasingly incentive interventions have targeted low adherence, yet little is known about how to best structure the incentives and associated eligibility criteria. A particular concern is that for those with low baseline performance, the often relatively high, fixed eligibility thresholds may be perceived as too difficult to reach and be demotivating for the most vulnerable. Our study tests a novel incentive design that permits even those with low initial adherence to qualify for incentives aimed at increasing ART adherence by allowing participants to win prizes for smaller subgoals that build towards a higher goal. This design is based on applications of behavioral economics' Prospect Theory to the psychological literature on goal setting and motivation, which suggests that distant goals can exert a demotivating effect on the individual compared to more proximal goals.
The study is separated into two parts. Study 1 will monitor ART adherence using Wisepill devices for three months among an expected 1,049 individuals aged 15-30 years who have been on ART for three or more months and have regular access to a mobile phone. Monitoring baseline adherence will ensure that individuals being randomized to the interventions in Study 2 are indeed those in need of adherence support, i.e. have low baseline mean adherence of less than 90%.
Study 2 will randomize an expected 560 participants with low adherence from Study 1 into one of four equal-sized intervention arms. In the three treatment arms, participants will be eligible for a prize drawing to win small amounts of mobile airtime of either 500, 5,000 or 10,000 Ugandan Shillings (approximately $0.15, $1.5 and $3) if they reach the adherence goal required in the respective treatment arm. The goals will be set as follows:
- Assigned sub-goals: the study coordinator will choose an ART adherence target for the participant based on their baseline adherence and gradually increase the target every three months, working towards 90% adherence at the end of year 1.
- Participatory sub-goals: the participant will choose their own adherence target every three months, working towards 90% adherence at the end of year 1.
- Fixed goal: the study participant must reach a target adherence level of 90% every three months.
- Control group: will receive the usual standard of care offered at Mildmay. All treatment groups will receive weekly motivational messages and a reminder of their upcoming prize drawing. Weekly SMS messages will help maintain contact with study participants and enable them to become accustomed to receiving messages from the study for potential remote prize drawings. In contrast, the control group will only receive the motivational portion of the text messages (without the reminders of the possibility of winning prizes) as an attention control due to the potential beneficial effects of the messages.
Year 1 of the three-year RCT will evaluate the relative effectiveness of the three incentive approaches for improving adherence. Participants in the three treatment arms will be eligible to enter an in-person or remote prize drawing for a mobile airtime reward every three months if they meet their target adherence. In-person prize drawings will be done if the date of the drawing coincides with the participants' regularly scheduled clinic visits; otherwise, they will be done remotely. Participants will also be eligible to enter a larger prize drawing at the end of year 1 if they reach 90% adherence. Year 2 will test the relative effectiveness of the interventions for maintaining at least 90% mean adherence. Participants will be eligible for a prize drawing every three months if they maintain 90% adherence and a larger prize drawing at the end of the year if viral suppression is attained. Participants that did not reach 90% adherence by the end of year 1 will be allocated to the treatment arm that showed the highest effectiveness in year 1. Follow-up surveys will be conducted every six months after enrolment into Study 2, and prize drawing surveys will be done at every prize drawing to understand cognitive and motivational factors that the intervention may influence. Year 3 will investigate the effectiveness of the three treatment arms on long-term adherence once incentives are removed. A cost-effectiveness analysis will also be performed to help determine the intervention design's potential for sustainability and scale-up.
- Being tested
- Incentivization based on gradually increasing, externally chosen adherence goals, End of year 1 adherence prize drawing, SMS motivational messages + reminder of prize drawing, Year 2 re-allocation based on year 1 performance, End of Year 2 viral suppression prize drawing
- Keywords
- HIV, Behavior change, Health behavior, Adherence, Goal setting, Behavioral economics, Incentives
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentivization based on gradually increasing, externally chosen adherence goalsBehavioural
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.
End of year 1 adherence prize drawingBehavioural
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.
SMS motivational messages + reminder of prize drawingBehavioural
Participants will receive weekly motivational messages with a reminder of their upcoming prize drawing throughout year 1 of the study.
Year 2 re-allocation based on year 1 performanceBehavioural
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.
End of Year 2 viral suppression prize drawingBehavioural
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.
Incentivization based on gradually increasing self-chosen adherence goalsBehavioural
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.
Incentivization based on a fixed adherence goalBehavioural
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.
SMS motivational messagesBehavioural
The control group will also receive weekly motivational messages but without the reminder of the upcoming prize drawing.
| Study group | Role | What they receive |
|---|---|---|
| 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.' Receives: 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.' Receives: 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.' Receives: 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 ' Receives: Behavioral: SMS motivational messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: Measured at 24 months
Secondary outcomes (11)
Fraction of clients with treatment interruptions of more than 48 hours
Wisepill devices monitor the date and time of all openings of the device to retrieve ART medication, allowing the fraction of clients with treatment interruptions of more than 48 hours to be tracked continuously over the Wisepill server.
Measured: Measured at 12 months
Fraction of clients with treatment interruptions of more than 48 hours
Wisepill devices monitor the date and time of all openings of the device to retrieve ART medication, allowing the fraction of clients with treatment interruptions of more than 48 hours to be tracked continuously over the Wisepill server.
Measured: Measured at 24 months
Fraction of clients with treatment interruptions of more than 48 hours
Wisepill devices monitor the date and time of all openings of the device to retrieve ART medication, allowing the fraction of clients with treatment interruptions of more than 48 hours to be tracked continuously over the Wisepill server.
Measured: Measured at 36 months
Suppressed viral load (viral load <=200 copies/ML)
Viral load will be chart abstracted from clinic data. They are typically done once a year.
Measured: Measured at 12 months
Suppressed viral load (viral load <=200 copies/ML)
Viral load will be chart abstracted from clinic data. They are typically done once a year.
Measured: Measured at 24 months
Suppressed viral load (viral load <=200 copies/ML)
Viral load will be chart abstracted from clinic data. They are typically done once a year.
Measured: Measured at 36 months
Retention in Care
Retention in care will be chart abstracted from clinic data. First, we will use the binary definition from the Health Resources and Services Administration HIV/AIDS Bureau, which defines retention as at least 2 clinic visits separated by 90 days in the previous 12 months. Second, we will use the more detailed measure outlined by Lee et al. (2018) to create a variable that categorizes clients as having different levels of retention in care over the previous 12 months. This goes beyond the binary definition and provides more granular information about retention. We will define a client as fully retained in care if they attended all scheduled appointments over the previous 12 months (usually 4 or 5 total appointments). We will then create three different levels of care disengagement: missed one appointment but not more than 6 months without a visit, missed 2 appointments or 6-9 months without a visit, and missed 3 or more appointments or 9-12 months without a visit.
Measured: Measured at 12 months
Retention in Care
Retention in care will be chart abstracted from clinic data. First, we will use the binary definition from the Health Resources and Services Administration HIV/AIDS Bureau, which defines retention as at least 2 clinic visits separated by 90 days in the previous 12 months. Second, we will use the more detailed measure outlined by Lee et al. (2018) to create a variable that categorizes clients as having different levels of retention in care over the previous 12 months. This goes beyond the binary definition and provides more granular information about retention. We will define a client as fully retained in care if they attended all scheduled appointments over the previous 12 months (usually 4 or 5 total appointments). We will then create three different levels of care disengagement: missed one appointment but not more than 6 months without a visit, missed 2 appointments or 6-9 months without a visit, and missed 3 or more appointments or 9-12 months without a visit.
Measured: Measured at 24 months
Retention in Care
Retention in care will be chart abstracted from clinic data. First, we will use the binary definition from the Health Resources and Services Administration HIV/AIDS Bureau, which defines retention as at least 2 clinic visits separated by 90 days in the previous 12 months. Second, we will use the more detailed measure outlined by Lee et al. (2018) to create a variable that categorizes clients as having different levels of retention in care over the previous 12 months. This goes beyond the binary definition and provides more granular information about retention. We will define a client as fully retained in care if they attended all scheduled appointments over the previous 12 months (usually 4 or 5 total appointments). We will then create three different levels of care disengagement: missed one appointment but not more than 6 months without a visit, missed 2 appointments or 6-9 months without a visit, and missed 3 or more appointments or 9-12 months without a visit.
Measured: Measured at 36 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: Measured at 36 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: Measured at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start18 Apr 2022
- Primary completion11 Feb 2027 (estimated)
- Study completion11 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARTStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- IDinsight, Mildmay Uganda Limited
- Responsible party
- Principal investigator, Sebastian Linnemayr, RAND
- Investigators
- Alison Connor, PhD, Study director, IDinsights
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378607
- Sponsor's protocol ID
- HCPCC074
- Acronym
- GOALS
- Status last verified
- Apr 2026
- First submitted
- 8 May 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data resulting from the proposed research will be shared with external researchers. 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/). 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.
Publications
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.
PubMed 37559069
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goals for Adherence With Low-cost Incentives
- ClinicalTrials.gov ID
- NCT05378607
- Acronym / sponsor ID
- GOALS / HCPCC074
- Keywords
- HIV, Behavior change, Health behavior, Adherence, Goal setting, Behavioral economics, Incentives
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- IDinsight, Mildmay Uganda Limited
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 11 Feb 2027 (estimated)
- Study completion
- 11 Aug 2027 (estimated)
- First posted
- 18 May 2022 (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.
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.
Detailed description
Low ART adherence among youth living with HIV threatens positive treatment outcomes. Increasingly incentive interventions have targeted low adherence, yet little is known about how to best structure the incentives and associated eligibility criteria. A particular concern is that for those with low baseline performance, the often relatively high, fixed eligibility thresholds may be perceived as too difficult to reach and be demotivating for the most vulnerable. Our study tests a novel incentive design that permits even those with low initial adherence to qualify for incentives aimed at increasing ART adherence by allowing participants to win prizes for smaller subgoals that build towards a higher goal. This design is based on applications of behavioral economics' Prospect Theory to the psychological literature on goal setting and motivation, which suggests that distant goals can exert a demotivating effect on the individual compared to more proximal goals.
The study is separated into two parts. Study 1 will monitor ART adherence using Wisepill devices for three months among an expected 1,049 individuals aged 15-30 years who have been on ART for three or more months and have regular access to a mobile phone. Monitoring baseline adherence will ensure that individuals being randomized to the interventions in Study 2 are indeed those in need of adherence support, i.e. have low baseline mean adherence of less than 90%.
Study 2 will randomize an expected 560 participants with low adherence from Study 1 into one of four equal-sized intervention arms. In the three treatment arms, participants will be eligible for a prize drawing to win small amounts of mobile airtime of either 500, 5,000 or 10,000 Ugandan Shillings (approximately $0.15, $1.5 and $3) if they reach the adherence goal required in the respective treatment arm. The goals will be set as follows:
- Assigned sub-goals: the study coordinator will choose an ART adherence target for the participant based on their baseline adherence and gradually increase the target every three months, working towards 90% adherence at the end of year 1.
- Participatory sub-goals: the participant will choose their own adherence target every three months, working towards 90% adherence at the end of year 1.
- Fixed goal: the study participant must reach a target adherence level of 90% every three months.
- Control group: will receive the usual standard of care offered at Mildmay. All treatment groups will receive weekly motivational messages and a reminder of their upcoming prize drawing. Weekly SMS messages will help maintain contact with study participants and enable them to become accustomed to receiving messages from the study for potential remote prize drawings. In contrast, the control group will only receive the motivational portion of the text messages (without the reminders of the possibility of winning prizes) as an attention control due to the potential beneficial effects of the messages.
Year 1 of the three-year RCT will evaluate the relative effectiveness of the three incentive approaches for improving adherence. Participants in the three treatment arms will be eligible to enter an in-person or remote prize drawing for a mobile airtime reward every three months if they meet their target adherence. In-person prize drawings will be done if the date of the drawing coincides with the participants' regularly scheduled clinic visits; otherwise, they will be done remotely. Participants will also be eligible to enter a larger prize drawing at the end of year 1 if they reach 90% adherence. Year 2 will test the relative effectiveness of the interventions for maintaining at least 90% mean adherence. Participants will be eligible for a prize drawing every three months if they maintain 90% adherence and a larger prize drawing at the end of the year if viral suppression is attained. Participants that did not reach 90% adherence by the end of year 1 will be allocated to the treatment arm that showed the highest effectiveness in year 1. Follow-up surveys will be conducted every six months after enrolment into Study 2, and prize drawing surveys will be done at every prize drawing to understand cognitive and motivational factors that the intervention may influence. Year 3 will investigate the effectiveness of the three treatment arms on long-term adherence once incentives are removed. A cost-effectiveness analysis will also be performed to help determine the intervention design's potential for sustainability and scale-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Externally assigned sub-goals | Experimental | 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 drawingParticipants 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.' |
| Participatory sub-goals | Experimental | 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 goalsParticipants 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.' |
| Fixed goal | Experimental | 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 goalParticipants 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.' |
| Control | Placebo comparator | Behavioral: SMS motivational messagesThis 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 ' |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| Incentivization based on gradually increasing, externally chosen adherence goalsWisepill 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. | Behavioural | Externally assigned sub-goals |
| End of year 1 adherence prize drawingParticipants 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. | Behavioural | Externally assigned sub-goals, Fixed goal, Participatory sub-goals |
| SMS motivational messages + reminder of prize drawingParticipants will receive weekly motivational messages with a reminder of their upcoming prize drawing throughout year 1 of the study. | Behavioural | Externally assigned sub-goals, Fixed goal, Participatory sub-goals |
| Year 2 re-allocation based on year 1 performanceIn 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. | Behavioural | Externally assigned sub-goals, Fixed goal, Participatory sub-goals |
| End of Year 2 viral suppression prize drawingParticipants 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. | Behavioural | Externally assigned sub-goals, Fixed goal, Participatory sub-goals |
| Incentivization based on gradually increasing self-chosen adherence goalsWisepill 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. | Behavioural | Participatory sub-goals |
| Incentivization based on a fixed adherence goalWisepill 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. | Behavioural | Fixed goal |
| SMS motivational messagesThe control group will also receive weekly motivational messages but without the reminder of the upcoming prize drawing. | Behavioural | Control |
Primary outcome
Mean adherence to ART in previous 12 months
Time frame: Measured at 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.
Mean adherence to ART in previous 12 months
Time frame: Measured at 24 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.
The fraction of clients with adherence of 90% or more
Time frame: Measured at 12 months
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.
The fraction of clients with adherence of 90% or more
Time frame: Measured at 24 months
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.
11 secondary outcomes
Fraction of clients with treatment interruptions of more than 48 hours
Time frame: Measured at 12 months
Fraction of clients with treatment interruptions of more than 48 hours
Time frame: Measured at 24 months
Fraction of clients with treatment interruptions of more than 48 hours
Time frame: Measured at 36 months
Suppressed viral load (viral load <=200 copies/ML)
Time frame: Measured at 12 months
Suppressed viral load (viral load <=200 copies/ML)
Time frame: Measured at 24 months
Suppressed viral load (viral load <=200 copies/ML)
Time frame: Measured at 36 months
Retention in Care
Time frame: Measured at 12 months
Retention in Care
Time frame: Measured at 24 months
Retention in Care
Time frame: Measured at 36 months
Mean adherence to ART in previous 12 months
Time frame: Measured at 36 months
The fraction of clients with adherence of 90% or more
Time frame: Measured at 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 37559069Linnemayr 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.
- Individual participant dataSharing planned: Yes. Data resulting from the proposed research will be shared with external researchers. 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/). 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.
Related trials for ART
Not yet recruiting
Effects of Art-Based Group Reminiscence Therapy on Resilience and Joy of Living in Older Adults
Resilience, Psychological, Joy of Living
RecruitingPhase 3
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
Infertility
Enrolling by invitationObservational study
Analysis of HIV-1 Replication During Antiretroviral Therapy
HIV
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
Not yet recruitingPhase 1
A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute/Early HIV-1 Infection
HIV-1-infection
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.
Alison Connor, PhD study director
IDinsights
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentivization based on gradually increasing, externally chosen adherence goals, End of year 1 adherence prize drawing and SMS motivational messages + reminder of prize drawing in people with ART and HIV, run by RAND at 1 site in Uganda.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. 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 Uganda. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mean adherence to ART in previous 12 months (time frame: Measured at 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05378607, which also lists 1 linked publication.
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 8 May 2026.