Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
560 participants
INTERVENTIONAL
2022-04-18
2027-08-11
Brief Summary
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Detailed Description
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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:
1. 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.
2. Participatory sub-goals: the participant will choose their own adherence target every three months, working towards 90% adherence at the end of year 1.
3. Fixed goal: the study participant must reach a target adherence level of 90% every three months.
4. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Externally assigned sub-goals
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.'
Incentivization based on gradually increasing, externally chosen adherence goals
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 drawing
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 drawing
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 performance
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 drawing
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.
Participatory sub-goals
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.'
End of year 1 adherence prize drawing
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 drawing
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 performance
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 drawing
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 goals
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.
Fixed goal
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.'
End of year 1 adherence prize drawing
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 drawing
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 performance
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 drawing
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 a fixed adherence goal
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.
Control
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 '
SMS motivational messages
The control group will also receive weekly motivational messages but without the reminder of the upcoming prize drawing.
Interventions
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Incentivization based on gradually increasing, externally chosen adherence goals
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 drawing
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 drawing
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 performance
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 drawing
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 goals
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 goal
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 messages
The control group will also receive weekly motivational messages but without the reminder of the upcoming prize drawing.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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%
15 Years
30 Years
ALL
No
Sponsors
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IDinsight
OTHER
Mildmay Uganda Limited
OTHER
RAND
OTHER
Responsible Party
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Sebastian Linnemayr
Principal Investigator
Principal Investigators
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Alison Connor, PhD
Role: STUDY_DIRECTOR
IDinsights
Locations
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Mildmay Uganda
Kampala, , Uganda
Countries
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References
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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.
Other Identifiers
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HCPCC074
Identifier Type: -
Identifier Source: org_study_id
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