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Behavioral Economics Incentives to Support HIV Treatment Adherence (BEST): Protocol for a randomized controlled trial in Uganda.

ABSTRACT: BACKGROUND:Many 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/DESIGN:We 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. DISCUSSION: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. 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 REGISTRATION:ClinicalTrials.gov, NCT03494777. Registered on 11 April 2018.

SUBMITTER: Linnemayr S

PROVIDER: S-EPMC6942278 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Behavioral Economics Incentives to Support HIV Treatment Adherence (BEST): Protocol for a randomized controlled trial in Uganda.

Linnemayr Sebastian S Stecher Chad C Saya Uzaib U MacCarthy Sarah S Wagner Zachary Z Jennings Larissa L Mukasa Barbara B

Trials 20200103 1

<h4>Background</h4>Many 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.<h4>Methods/design</h4>We ...[more]

PMID: 31900193

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Project description:BackgroundChronic (ie, long-term) elevated stress is associated with a number of mental and physical health conditions. Mindfulness meditation mobile apps are a promising tool for stress self-management that can overcome several barriers associated with in-person interventions; however, to date, poor app-based intervention adherence has limited the efficacy of these mobile health tools. Anchoring, or pairing, a new behavior with an existing routine has been shown to effectively establish habits that are maintained over time, but this strategy typically only works for those with high initial motivation and has yet to be tested for maintaining meditation with a mobile app.ObjectiveThis study will test novel combinations of behavioral economics-based incentives with the anchoring strategy for establishing and maintaining adherence to an effective dose of meditation with a mobile app.MethodsThis 16-week study will use a 5-arm, parallel, partially blinded (participants only), randomized controlled design. We will implement a fractional factorial study design that varies the use of self-monitoring messages and financial incentives to support participants' use of their personalized anchoring strategy for maintaining adherence to a ≥10 minute-per-day meditation prescription during an 8-week intervention period, followed by an 8-week postintervention observation period. Specifically, we will vary the use of self-monitoring messages of either the target behavior (ie, meditation tracking) or the outcome associated with the target behavior (ie, mood symptom tracking). We will also vary the use of financial incentives conditional on either meditation at any time of day or meditation performed at approximately the same time of day as participants' personalized anchors.ResultsContinuous meditation app use data will be used to measure weekly meditation adherence over the 16-week study period as a binary variable equal to 1 if participants complete ≥10 minutes of meditation for ≥4 days per week and 0 otherwise. We will measure weekly anchoring plan adherence as a binary variable equal to 1 if participants complete ≥10 minutes of meditation within +1 or -1 hour of the timing of their chosen anchor on ≥4 days per week and 0 otherwise. In addition to these primary measures of meditation and anchoring plan adherence, we will also assess the secondary measures of stress, anxiety, posttraumatic stress disorder, sleep disturbance, and meditation app habit strength at baseline, week 8, and week 16.ConclusionsThis study will fill an important gap in the mobile health literature by testing novel intervention approaches for establishing and maintaining adherence to app-based mindfulness meditation. If successful, this study will identify an accessible and scalable stress self-management intervention that can help combat stress in the United States.Trial registrationClinicalTrials.gov NCT05217602; https://clinicaltrials.gov/ct2/show/NCT05217602.International registered report identifier (irrid)DERR1-10.2196/39930.

Project description:BackgroundTreatment 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 / designWe 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.DiscussionOur 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 registrationClinicalTrials.gov NCT05378607. Date of registration: May 18, 2022.

Project description:BackgroundThe World Health Organization's End TB Strategy envisions a world free of tuberculosis (TB)-free of deaths, disease, and suffering due to TB-by 2035. Nonadherence reduces cure rates, prolongs infectiousness, and contributes to the emergence of multidrug-resistant TB (MDR-TB). Moreover, MDR-TB is a growing, complex, and costly problem that presents a major obstacle to TB control. Directly observed therapy (DOT) for treatment adherence monitoring is the recommended standard; however, it is challenging to implement at scale because it is labor-intensive. Mobile health interventions can facilitate remote adherence monitoring and minimize the costs and inconveniences associated with standard DOT.ObjectiveThe study aims to evaluate the effectiveness of using video directly observed therapy (VDOT) plus incentives to improve medication adherence in TB treatment versus usual-care DOT in an African context.MethodsThe DOT Selfie study is an open-label, randomized controlled trial (RCT) with 2 parallel groups, in which 144 adult patients with TB aged 18-65 years will be randomly assigned to receive the usual-care DOT monitoring or VDOT as the intervention. The intervention will consist of a smartphone app, a weekly internet subscription, translated text message reminders, and incentives for those who adhere. The participant will use a smartphone to record and send time-stamped encrypted videos showing their daily medication ingestion. This video component will directly substitute the need for daily face-to-face meetings between the health provider and patients. We hypothesize that the VDOT intervention will be more effective because it allows patients to swallow their pills anywhere, anytime. Moreover, patients will receive mobile-phone-based "social bundle" incentives to motivate adherence to continued daily submission of videos to the health system. The health providers will log into a secured computer system to verify treatment adherence, document missed doses, investigate the reasons for missed doses, and follow prespecified protocol measures to re-establish medication adherence. The primary endpoint is the adherence level as measured by the fraction of expected doses observed over the treatment period. The main secondary outcome will be time-to-treatment completion in both groups.ResultsThis study was funded in 2019. Enrollment began in July and is expected to be completed by November 2020. Data collection and follow-up are expected to be completed by June 2021. Results from the analyses based on the primary endpoint are expected to be submitted for publication by December 2021.ConclusionsThis random control trial will be among the first to evaluate the effectiveness of VDOT within an African setting. The results will provide robust scientific evidence on the implementation and adoption of mobile health (mHealth) tools, coupled with incentives to motivate TB medication adherence. If successful, VDOT will apply to other low-income settings and a range of chronic diseases with lifelong treatment, such as HIV/AIDs.Trial registrationClinicalTrials.gov NCT04134689; http://clinicaltrials.gov/ct2/show/NCT04134689.International registered report identifier (irrid)DERR1-10.2196/18029.

Project description:BackgroundViral suppression among HIV-positive individuals is essential for protecting health and preventing HIV transmission. Financial incentives have shown promise in modifying various health behaviours in low-income countries but few studies have assessed whether they can improve HIV treatment outcomes. We aimed to determine the impact of time-limited financial incentives on viral suppression among HIV-positive adults in rural Uganda.MethodsWe did a randomised controlled trial in four rural Ugandan parishes. We recruited HIV-positive individuals (aged ≥18 years) from community health campaigns that included HIV testing services or at a local government health facility where HIV treatment is offered. Participants included those who were initiating antiretroviral therapy (ART) or already receiving ART. Eligibility to participate in the study did not depend on current ART or viral suppression status. Participants were randomly allocated (1:1) to the financial incentive intervention or the control group in computer-generated blocks (block size 10 participants) and pre-printed scratch cards were used to reveal study group assignment. We measured participants' viral load at baseline and at weeks 6, 12, 24, and 48. At each timepoint, we provided results and viral load counselling. Participants in the intervention group received financial incentives for viral suppression at weeks 6, 12, and 24, with incentive amounts increasing from US$4 to $12·5. The primary outcome was viral suppression (viral load <400 copies per mL) at 24 weeks in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02890459.FindingsBetween June 27, 2016, and May 25, 2018, we enrolled 400 adults in the study, of whom 203 were randomly assigned to the intervention group and 197 to the control group. Of these, 324 were enrolled from community health campaigns and 76 from the government clinic. Eight (2%) withdrew from the study and were not included in analyses. Over the 48-week follow-up period, 35 (9%) died or were lost-to-follow-up. Participants' median daily income was $0·79. At baseline, 300 participants (77%) were virally suppressed. In intention-to-treat analyses, 168 participants (84%) in the intervention group and 156 (82%) in the control group were virally suppressed at 24 weeks (odds ratio 1·14, 95% CI 0·68-1·93, p=0·62). Six participants (3%) in the control group and four (2%) in the intervention group had adverse events. Six of the adverse events were serious, including two deaths in the intervention group, three deaths in the control group, and one serious injury (tibia fracture) after an auto accident. No adverse events or deaths were related to study participation.InterpretationFinancial incentives had no effect on viral suppression among HIV-positive adults. High baseline viral suppression and provision of viral load results might have contributed to high viral suppression among participants. These findings highlight the need for interventions that promote achievement of viral suppression among unsuppressed individuals.FundingNational Institute of Mental Health at the US National Institutes of Health.

Project description:BackgroundNonadherence to antiretroviral therapy (ART) among people living with HIV is a crucial barrier to attaining viral suppression globally. Existing behavioral interventions have successfully increased ART adherence, but typically show only short-term impact that dissipates after the interventions are withdrawn.ObjectiveThis study aims to test the feasibility, acceptability, and preliminary efficacy of a novel intervention that uses SMS text messages and conditional incentives to support ART initiators in establishing pill-taking habits.MethodsA sample of 150 participants aged ≥18 years who have initiated ART in the preceding 3 months will be recruited from Mildmay Uganda in Kampala, Uganda. All (150/150, 100%) participants will be educated on the anchoring strategy and will choose an existing routine to pair with their daily ART adherence from a set of 3 suggested routines: getting dressed in the morning, eating breakfast, or eating dinner. Then, participants will be randomized to receive either usual care (control group: 50/150, 33.3%) or 1 of the 2 interventions delivered over 3 months: daily SMS text message reminders to follow their chosen anchoring plan (messages group; treatment group 1: 50/150, 33.3%) or daily SMS text messages and incentives conditional on taking their ART medication around the time of their chosen anchor (incentives group; treatment group 2: 50/150, 33.3%). Long-term ART adherence will be evaluated for 6 months after the intervention, and survey assessments will be conducted at baseline, 3 months, and 9 months. Outcomes include feasibility and acceptability measures and intervention efficacy outcomes defined by electronically measured mean medication adherence during the intervention and during the 6 months after the intervention, along with a measure of routine ART adherence based on taking medications around the time of participants' anchor during the intervention and during the 6 months after intervention.ResultsAs of February 18, 2022, recruitment was completed. A total of 150 participants were recruited, and data collection is expected to end in December of 2022. Final results are expected to be submitted for publication by April 2023.ConclusionsThis study is the first to use behavioral economics-based interventions in combination with the anchoring strategy to improve long-term ART adherence among treatment initiators. We hypothesize that the combination of SMS text message reminders and incentives will increase participants' use of their anchoring strategy, and thus medication adherence will be better maintained after the intervention ends in our intervention groups relative to the control group that uses only the anchoring strategy. Results of this pilot study will help to refine this combined intervention approach for testing at scale and broaden our understanding of the habit formation process.Trial registrationClinicalTrials.gov NCT05131165; https://clinicaltrials.gov/ct2/show/NCT05131165.International registered report identifier (irrid)DERR1-10.2196/42216.

Dataset Information

Behavioral Economics Incentives to Support HIV Treatment Adherence (BEST): Protocol for a randomized controlled trial in Uganda.

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Behavioral Economics Incentives to Support HIV Treatment Adherence (BEST): Protocol for a randomized controlled trial in Uganda.

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