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

Abstract

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.