Abstract
BackgroundMany HIV-positive patients do not appropriately adhere to their antiretroviral medication (ART). This leads to higher viral loads and greater probability of HIV transmission. Present bias—a tendency to give in to short-term temptations at the expense of long-term outcomes—is a potential driver of low adherence. In this study we test a novel intervention rooted in behavioral economics that is designed to overcome present bias and increase ART adherence.Methods/designWe will enroll 330 HIV-positive patients at Mildmay Hospital in Kampala, Uganda, into a 2-year randomized controlled trial. Participants will be randomized to one of three groups. The first intervention group (T1, n = 110) will be eligible for small lottery prizes based on timely clinic visits and demonstration of viral suppression. Group 2 (T2, n = 110) will be eligible for the same lottery prizes conditional on high adherence measured by a medication event management system (MEMS) cap. The control group (n = 110) will receive the usual standard of care. Adherence will be measured continuously throughout the intervention period and for 12 months post-intervention to evaluate effect persistence. Surveys will be conducted at baseline and then every 6 months. Viral loads will be measured annually. Primary outcomes are whether the viral load is detectable and MEMS-measured adherence. Secondary outcomes are the log-transformed viral load as a continuous measure and a binary measure for whether the person took at least 90% of their ART pills.DiscussionOur study is one of the first to investigate the effectiveness of lottery incentives for improving ART adherence, and in addition, it compares the relative efficacy of using electronically measured adherence versus viral load to determine lottery eligibility. MEMS caps are relatively costly, whereas viral load testing is now part of routine clinical care in Uganda. BEST will test whether directly incentivizing viral suppression (which can be implemented using readily available clinic data) is as effective as incentivizing electronically measured adherence. Cost-effectiveness analyses of the two implementation modes will also be performed.Trial registrationClinicalTrials.gov, NCT03494777. Registered on 11 April 2018.
Highlights
Many Human immunodeficiency virus (HIV)-positive patients do not appropriately adhere to their antiretroviral medication (ART)
Our study is one of the first to investigate the effectiveness of lottery incentives for improving ART adherence, and in addition, it compares the relative efficacy of using electronically measured adherence versus viral load to determine lottery eligibility
BEST will test whether directly incentivizing viral suppression is as effective as incentivizing electronically measured adherence
Summary
Potential impact and significance of the study Treatment adherence is critical to the success of ART and is largely determined by behavior. The counselor will assess the risk for potential harm and the appropriate action in terms of evaluating the client’s need for mental health services and notifying the appropriate authorities. This assessment should be done as soon as possible and before the client leaves the premises, to the extent possible. Our findings will be relevant to local Ugandan and global communities with an interest in understanding the underlying behavioral mechanisms that affect HIV treatment adherence We will share these findings with senior officials at the Ministry of Health and at Mildmay Uganda, so they can formulate appropriate policies in line with the national recommendations on annual viral load screenings for HIV-positive patients
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