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RCT·clinical trial, public health, infectious disease, pediatrics, epidemiology·PMC10410910

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 · 6 authors, 3 centres

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TL;DR

This protocol paper describes a three-year randomized controlled trial to be conducted in Kampala, Uganda.

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This protocol paper describes a three-year randomized controlled trial to be conducted in Kampala, Uganda. Arm 1 uses externally assigned subgoals adapted to baseline adherence; Arm 2 allows participants to set their own interim goals; and Arm 3 requires a uniformly fixed 90% adherence target. All groups receive weekly motivational messages. Adherence will be tracked continuously via Wisepill electronic devices over a 12-month intervention period and for 12 months post-intervention. Viral loads will be measured annually, and surveys conducted every six months. Secondary outcomes include treatment interruptions exceeding 48 hours, viral suppression at ≤200 copies/mL, and retention in care. This is a protocol paper; no trial results are reported.

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RCT

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clinical trial

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ORIGINAL PAPER

PMC10410910

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

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ABSTRACT

Background Treatment outcomes of HIV-positive individuals are threatened by low antiretroviral therapy (ART) adherence, a problem that is particularly acute among youth. Incentives are a promising tool to support ART adherence, but traditional incentive designs rewarding uniformly high levels of the desired health behavior may demotivate those with low levels of the behavior. In this study, we investigate the effectiveness of alternative approaches to target-setting for incentive eligibility using subgoals (i.e., individual-specific, interim targets leading up to the optimal target). Methods / design We will enroll 628 HIV-positive youth between ages 15 and 30 into a 3-year randomized controlled trial. Participants will be randomized 1:1:1:1 to a control arm or one of three intervention arms ( n = 157 each) that allow them to enter a prize drawing for small incentives if their ART adherence meets the given goal. In the first arm (T1, assigned subgoal), goals will be externally assigned and adapted to their initial adherence level. In the second arm (T2, participatory subgoal), participants can set their own interim goals. In the third arm (T3, fixed goal), all participants must reach the same target goal of 90% adherence. T1 and T2 participants are required to reach 90% adherence by month 12 to participate in a larger prize drawing. The control group receives the usual standard of care. All four groups will receive weekly motivational messages; the three treatment groups will additionally receive reminders of their upcoming prize drawing. Adherence will be measured continuously throughout the intervention period using electronic devices and for 12 months post-intervention. Surveys will be conducted at baseline and every 6 months. Viral loads will be measured annually. The primary outcome is Wisepill-measured adherence and a binary measure for whether the person took at least 90% of their pills. The secondary outcome is the log-transformed viral load as a continuous measure. Discussion Our study is one of the first to apply insights about the psychology and behavioral economics of goal-setting to the design of incentives, by testing whether conditioning the eligibility threshold for incentives on subgoals (interim goals leading up to the ultimate, high goal) improves motivation and adherence more than setting a uniformly highly goal, and a comparison group. Trial registration ClinicalTrials.gov NCT05378607 . Date of registration: May 18, 2022. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-023-07449-z.

CITATION EXPORT

Sebastian Linnemayr, Haijing Crystal Huang, Zachary Wagner et al.. 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). https://doi.org/10.1186/s13063-023-07449-z

AUTHORS

6 · 3 CENTRES

Sebastian Linnemayr, Haijing Crystal Huang, Zachary Wagner, Faith Kemunto Onkundi, Barbara Mukasa, Mary Odiit

1https://ror.org/00f2z7n96grid.34474.300000 0004 0370 7685RAND Corporation, Santa Monica, USA
2https://ror.org/05ds5y270grid.479416.9IDinsight, San Francisco, USA
3https://ror.org/00xas1432grid.463428.f0000 0004 0648 1159Mildmay Uganda, Kampala, Uganda