Barriers and facilitators of habit building for long-term adherence to antihypertensive therapy among people with hypertensive disorders in Los Angeles, California: a qualitative study.

OBJECTIVES: The aim of this study was to a) explore barriers and facilitators associated with medication-taking habit formation, and b) elicit feedback on the components of an intervention designed to help form strong habits for long-term medication adherence. DESIGN: The study design was qualitative; we conducted semistructured interviews between September 2021 and February 2022. SETTING: The interviews were conducted online, with 27 participants recruited at the Cedars-Sinai Medical Center in Los Angeles, California. PARTICIPANTS: A purposive sample of 20 patients who were over 18 years of age, had been diagnosed with hypertensive disorder (or reported high blood pressure; >140/90 mm Hg) and who were prescribed antihypertensive therapy at the time of recruitment, along with seven providers were interviewed. RESULTS: Contextual factors included frequent changes to prescription for regimen adjustment, and polypharmacy. Forgetfulness, perceived need for medication, and routine disruptions were identified as possible barriers to habit formation. Facilitators of habit formation included identification of stable routines for anchoring, planning, use of external reminders (including visual reminders) and pillboxes for prescription management, and extrinsic motivation for forming habits. Interestingly, experiencing medication side effects was identified as a possible barrier and a possible facilitator of habit formation. Feedback on study components included increasing text size, and visual appeal of the habit leaflet; and imparting variation in text message content and adjusting their frequency to once a day. Patients generally favoured the use of conditional financial incentives to support habit formation. CONCLUSION: The study sheds light on some key considerations concerning the contextual factors for habit formation among people with hypertension. As such, future studies may evaluate the generalisability of our findings, consider the role of visual reminders in habit formation and sustenance, and explore possible disruptions to habits. TRIAL REGISTRATION NUMBER: NCT04029883.

INcentives and ReMINDers to Improve Long-Term Medication Adherence (INMIND): impact of a pilot randomized controlled trial in a large HIV clinic in Uganda.

INTRODUCTION: Habits are a common strategy for successfully countering medication non-adherence, yet existing interventions do not support participants during the long habit formation period, resulting in high attrition. We test a novel intervention combining text messages and incentives with anchoring to support antiretroviral therapy (ART) pill-taking habits. METHODS: In a randomized, parallel controlled trial, a sample of 155 participants 18 years and older who initiated ART within 3 months were recruited at Mildmay Uganda between October 2021 and April 2022. All participants were educated on the anchoring strategy and chose an anchor, that is existing routines, to pair with pill-taking. Participants were randomized to either usual care (C = 49), daily text message reminders to follow their anchoring plan (Messages group; T1 = 49) or messages and incentives conditional on pill-taking in line with their anchor (Incentives group; T2 = 57). Assessments occurred at baseline, month 3 (end of intervention) and month 9 (end of observation period). The primary outcomes are electronically measured mean adherence and pill-taking consistent with participants' anchor time. RESULTS: The primary outcome of pill-taking in line with the anchoring plan was higher in the Incentives group during the 3-month intervention (12.2 p.p. [95% CI: 2.2 22.2; p = .02]), and remained significantly higher after the incentives were withdrawn (months 4-6 (14.2 p.p. [95% CI 1.1 27.2; p = .03]); months 7-9 (14.1 p.p. [95% CI -0.2 28.5; p = .05])). Mean adherence was higher in both treatment groups relative to the control group during the intervention (T1 vs. C, p = .06; T2 vs. C, p = .06) but not post-intervention. CONCLUSIONS: The promising approach of using incentives to support habit formation among ART treatment initiators needs to be evaluated in a fully powered study to further our understanding of the habit formation process and to evaluate its cost-effectiveness.

Digital Adherence Technologies Linked to Mobile Money Incentives for Medication Adherence Among People Living With Tuberculosis: Mixed Methods Feasibility and Acceptability Study.

BACKGROUND: Complementing digital adherence technologies (DATs) with mobile money incentives may improve their utility in supporting tuberculosis medication adherence, yet the feasibility and acceptability of this integrated approach remain unclear. OBJECTIVE: This study aims to describe the feasibility and acceptability of a novel DAT intervention called My Mobile Wallet composed of real-time adherence monitoring, SMS text message reminders, and mobile money incentives for tuberculosis medication adherence in a low-income setting. METHODS: We purposively recruited people living with tuberculosis from the Mbarara Regional Referral Hospital in Mbarara, Uganda, who (1) were starting tuberculosis treatment at enrollment or within the past 4 weeks, (2) owned a mobile phone, (3) were able to use SMS test messaging, (4) were aged ≥18 years, and (5) were living in Mbarara district. At study exit (month 6), we used interviews and questionnaires informed by the unified theory of acceptance and use of technology (UTAUT) to collect feasibility and acceptability data, reflecting patients' experiences of using each component of My Mobile Wallet. Feasibility also included tracking the functionality of the adherence monitor (ie, an electronic pillbox) as well as SMS text message and mobile money delivery. We used a content analytical approach to inductively analyze qualitative data and Stata (version 13; StataCorp LLC) to analyze quantitative data. RESULTS: All 39 participants reported that the intervention was feasible because it was easy for them to use (eg, access and read SMS text messages) and worked as expected. Almost all SMS text messages (6880/7064, 97.4%) were sent as planned. The transmission of adherence data from the monitor worked well, with 98.37% (5682/5776) of the data transmitted as planned. All participants additionally reported that the intervention was acceptable because it helped them take their tuberculosis medication as prescribed; the mobile money incentives relieved them of tuberculosis-related financial burdens; SMS text message reminders and electronic pillbox-based alarms reminded them to take their medication on time; and participants perceived real-time adherence monitoring as "being watched" while taking their medication, which encouraged them to take their medication on time to demonstrate their commitment. The intervention was perceived as a sign of care, which eventually created emotional support and a sense of connectedness to health care. Participants preferred daily SMS text message reminders (32/39, 82%) to reminders linked to missed doses (7/39, 18%), citing the fact that tuberculosis medication is taken daily. CONCLUSIONS: The use of real-time adherence monitoring linked to SMS text message reminders and mobile money incentives for tuberculosis medication adherence was feasible and acceptable in a low-resource setting where poverty-based structural barriers heavily constrain tuberculosis treatment and care.

Behavioral Economic Incentives to Support HIV Care: Results From a Randomized Controlled Trial in Uganda.

BACKGROUND: This study tests behavioral economics incentives to improve adherence to antiretroviral treatment (ART), with 1 approach being low cost. SETTING: Three hundred twenty-nine adults at Mildmay Hospital in Kampala, Uganda, on ART for at least 2 years and showing adherence problems received the intervention for about 15 months until the study was interrupted by a nation-wide COVID-19 lockdown. METHODS: We randomized participants into 1 of 3 (1:1:1) groups: usual care ("control" group; n = 109) or 1 of 2 intervention groups where eligibility for nonmonetary prizes was based on showing at least 90% electronically measured ART adherence ("adherence-linked" group, n = 111) or keeping clinic appointments as scheduled ("clinic-linked"; n = 109). After 12 months, participants could win a larger prize for consistently high adherence or viral suppression. Primary outcomes were mean adherence and viral suppression. Analysis was by intention-to-treat using linear regression. This trial is registered with ClinicalTrials.gov, NCT03494777 . RESULTS: Neither incentive arm increased adherence compared with the control; we estimate a 3.9 percentage point increase in "adherence-linked" arm [95% confidence interval (CI): -0.70 to 8.60 ( P = 0.10)] and 0.024 in the "clinic-linked" arm [95% CI: -0.02 to 0.07 ( P = 0.28)]. For the prespecified subgroup of those with initial low adherence, incentives increased adherence by 7.60 percentage points (95% CI: 0.01, 0.15; P = 0.04, "adherence-linked") and 5.60 percentage points (95% CI: -0.01, 0.12; P = 0.10, "clinic-linked"). We find no effects on clinic attendance or viral suppression. CONCLUSIONS: Incentives did not improve viral suppression or ART adherence overall but worked for the prespecified subgroup of those with initial low adherence. More effectively identifying those in need of adherence support will allow better targeting of this and other incentive interventions.

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.

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.

A virtual pilot optimization trial for African American/Black and Latino persons with non-suppressed HIV viral load grounded in motivational interviewing and behavioral economics.

Introduction: Virtual and low-touch behavioral interventions are needed for African American/Black and Latino persons living with HIV (PLWH) with barriers to HIV viral suppression, particularly during COVID-19. Guided by the multiphase optimization strategy, we explored three components for PLWH without viral suppression, grounded in motivational interviewing and behavioral economics: (1) motivational interviewing counseling, (2) 21-weeks of automated text messages and quiz questions about HIV management, and (3) financial rewards for viral suppression (lottery prize vs. fixed compensation). Methods: This pilot optimization trial used sequential explanatory mixed methods to explore the components' feasibility, acceptability, and preliminary evidence of effects using an efficient factorial design. The primary outcome was viral suppression. Participants engaged in baseline and two structured follow-up assessments over an 8-month period, and provided laboratory reports to document HIV viral load. A subset engaged in qualitative interviews. We carried out descriptive quantitative analyses. Then, qualitative data were analyzed using directed content analysis. Data integration used the joint display method. Results: Participants (N = 80) were 49 years old, on average (SD = 9), and 75% were assigned male sex at birth. Most (79%) were African American/Black, and the remainder were Latino. Participants were diagnosed with HIV 20 years previously on average (SD = 9). Overall, components were feasible (>80% attended) and acceptability was satisfactory. A total of 39% (26/66) who provided laboratory reports at follow-up evidenced viral suppression. Findings suggested no components were entirely unsuccessful. The lottery prize compared to fixed compensation was the most promising component level. In qualitative analyses, all components were seen as beneficial to individual wellbeing. The lottery prize appeared more interesting and engaging than fixed compensation. However, structural barriers including financial hardship interfered with abilities to reach viral suppression. The integrated analyses yielded areas of convergence and discrepancy and qualitative findings added depth and context to the quantitative results. Conclusions: The virtual and/or low-touch behavioral intervention components tested are acceptable and feasible and show enough potential to warrant refinement and testing in future research, particularly the lottery prize. Results must be interpreted in the context of the COVID-19 pandemic. Trial registration: NCT04518241 (https://clinicaltrials.gov/ct2/show/NCT04518241).

Assessing behavioral economic biases among young adults who have increased likelihood of acquiring HIV: a mixed methods study in Baltimore, Maryland.

BACKGROUND: Behavioral economic (BE) biases have been studied in the context of numerous health conditions, yet are understudied in the field of HIV prevention. This aim of this study was to quantify the prevalence of four common BE biases-present bias, information salience, overoptimism, and loss aversion-relating to condom use and HIV testing in economically-vulnerable young adults who had increased likelihood of acquiring HIV. We also qualitatively examined participants' perceptions of these biases. METHODS: 43 participants were enrolled in the study. Data were collected via interviews using a quantitative survey instrument embedded with qualitative questions to characterize responses. Interviews were transcribed and analyzed using descriptive statistics and deductive-inductive content analyses. RESULTS: 56% of participants were present-biased, disproportionately discounting future rewards for smaller immediate rewards. 51% stated they were more likely to spend than save given financial need. Present-bias relating to condom use was lower with 28% reporting they would engage in condomless sex rather than wait one day to access condoms. Most participants (72%) were willing to wait for condom-supported sex given the risk. Only 35% knew someone living with HIV, but 67% knew someone who had taken an HIV test, and 74% said they often think about preventing HIV (e.g., high salience). Yet, 47% reported optimistically planning for condom use, HIV discussions with partners, or testing but failing to stick to their decision. Most (98%) were also averse (b = 9.4, SD ±.9) to losing their HIV-negative status. Qualitative reasons for sub-optimal condom or testing choices were having already waited to find a sex partner, feeling awkward, having fear, or not remembering one's plan in the moment. Optimal decisions were attributed qualitatively to self-protective thoughts, establishing routine care, standing on one's own, and thinking of someone adversely impacted by HIV. 44% of participants preferred delayed monetary awards (e.g., future-biased), attributed qualitatively to fears of spending immediate money unwisely or needing time to plan. CONCLUSION: Mixed methods BE assessments may be a valuable tool in understanding factors contributing to optimal and sub-optimal HIV prevention decisions. Future HIV prevention interventions may benefit from integrating savings products, loss framing, commitment contracts, cues, or incentives.

Combining Behavioral Economics-Based Incentives With the Anchoring Strategy: Protocol for a Randomized Controlled Trial.

BACKGROUND: Chronic (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. OBJECTIVE: This 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. METHODS: This 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. RESULTS: Continuous 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. CONCLUSIONS: This 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 REGISTRATION: ClinicalTrials.gov NCT05217602; https://clinicaltrials.gov/ct2/show/NCT05217602. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39930.

Digital Adherence Technologies and Mobile Money Incentives for Management of Tuberculosis Medication Among People Living With Tuberculosis: Mixed Methods Formative Study.

BACKGROUND: Although there is an increasing use of digital adherence technologies (DATs), such as real-time monitors and SMS reminders in tuberculosis medication adherence, suboptimal patient engagement with various DATs has been reported. Additionally, financial constraints can limit DAT's utility. The perceived usefulness and the design mechanisms of DATs linked to mobile money financial incentives for tuberculosis medication management remain unclear. OBJECTIVE: The aim of this study is to describe the perceived usefulness and design mechanisms for a DAT intervention called My Mobile Wallet, which is composed of real-time adherence monitors, SMS reminders, and mobile money incentives to support tuberculosis medication adherence in a low-income setting. METHODS: This study used mixed methods approaches among persons with tuberculosis recruited from the Tuberculosis Clinic in the Mbarara Regional Referral Hospital. We purposively sampled 21 persons with tuberculosis aged 18 years and older, who owned cell phones and were able to use SMS text messaging interventions. We also enrolled 9 participants who used DATs in our previous study. We used focus group discussions with the 30 participants to solicit perceptions about the initial version of the My Mobile Wallet intervention, and then iteratively refined subsequent versions of the intervention following a user-centered design approach until the beta version of the intervention that suited their needs was developed. Surveys eliciting information about participants' cell phone use and perceptions of the intervention were also administered. Content analysis was used to inductively analyze qualitative data to derive categories describing the perceived usefulness of the intervention, concerns, and design mechanisms. Stata (version 13; StataCorp) was used to analyze survey data. RESULTS: Participants expressed the perceived usefulness of the My Mobile Wallet intervention in terms of being reminded to take medication, supported with transport to the clinic, and money to meet other tuberculosis medication-related costs, all of which were perceived to imply care, which could create a sense of connectedness to health care workers. This could consequently cause participants to develop a self-perceived need to prove their commitment to adherence to health care workers who care for them, thereby motivating medication adherence. For fear of unintended tuberculosis status disclosure, 20 (67%) participants suggested using SMS language that is confidential-not easily related to tuberculosis. To reduce the possibilities of using the money for other competing demands, 25 (83%) participants preferred sending the money 1-2 days before the appointment to limit the time lag between receiving the money and visiting the clinic. CONCLUSIONS: DATs complemented with mobile money financial incentives could potentially provide acceptable approaches to remind, support, and motivate patients to adhere to taking their tuberculosis medication. TRIAL REGISTRATION: ClinicalTrials.gov NCT05656287; https://clinicaltrials.gov/ct2/show/NCT05656287.

Food Insecurity During the COVID-19 Pandemic: A Longitudinal Mixed-Methods Study from a Cohort of HIV Clients in Uganda.

The COVID-19 pandemic threatens the food security of people in low-income countries. This is important for people living with HIV (PLWH) because HIV medication should be taken with food to avoid side-effects. We used survey data (n = 314) and qualitative interviews (n = 95) to longitudinally explore how the pandemic impacted food insecurity among PLWH in Kampala, Uganda. Prior to March 2020, 19.7% of respondents were food insecure. Our regression models estimate that food insecurity rose by 9.1 percentage points in our first round of surveys (June-September 2020; p < 0.05; t = 2.17), increasing to 17.2 percentage points in the second round of surveys (July-November 2021; p < 0.05; t = 2.32). Qualitative interviews reveal that employment loss and deteriorating support systems led to reduced meals and purchasing of cheaper foods. Respondents reported continuing to take their HIV medication even in the presence of food insecurity. Strategies for ensuring that PLWH have enough food should be prioritized so that the millions of PLWH in sub-Saharan Africa can take their medication without experiencing uncomfortable side-effects.Clinical Trials Registration Number NCT03494777.

Behavioural Economics to Improve Antihypertensive Therapy Adherence (BETA): protocol for a pilot randomised controlled trial in Los Angeles.

INTRODUCTION: Non-adherence to antihypertensive therapy is one of the major barriers to reducing the risk of cardiovascular disease. Several interventions have targeted higher medication adherence, yet most do not result in sustained adherence. Routinisation has emerged as a potential method for mitigating this problem, but requires high motivation during the relatively long habit formation phase. This pilot randomised controlled trial aims to test the feasibility, acceptability, and preliminary efficacy of behavioural economics-based incentives and text messages to support the routinisation of the medication-taking behaviour for promoting long-term medication adherence. METHODS AND ANALYSIS: This study will recruit and randomly assign 60 adult patients seeking care for hypertension at the Cedars-Sinai Medical Center in Los Angeles to one of the three groups, Control (n=20), Messages (n=20) and Incentives (n=20) in a 1:1:1 ratio. All participants will receive information about the importance of routinisation and will select an existing behavioural routine ('anchor') to which they will tie their pill-taking to, and the corresponding time. Additionally, participants in the Messages group will receive daily text messages reminding them of the importance of routines, while those in the Incentives group will receive daily text messages and conditional prize drawings. The interventions will be delivered over three months. Participants will be followed for six months post-intervention to measure behavioural persistence. Surveys will be administered at baseline, month-3 and month-9 visits. Primary outcomes include: (1) electronically measured mean medication adherence during the intervention period and (2) post-intervention period; and (3) mean timely medication adherence based around the time of the participants' anchor during the intervention period, and (4) post-intervention period. ETHICS AND DISSEMINATION: The study was approved by the Cedars-Sinai Institutional Review Board (Study ID: Pro00057764). Findings will be published in scientific peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04029883.

A qualitative exploration of health-related present bias among HIV-positive adults in Uganda.

Decision-making errors such as present bias (PB) can have important consequences for health behaviors, but have been largely studied in the financial domain. We conducted a mixed-method study on PB in the context of ART adherence among clinic-enrolled adults in Uganda (n = 39). Specifically, we quantified PB by asking about preferences between medication available sooner to minimize headaches versus available later to cure headaches. We describe demographic similarities among PB participants and qualitatively explored how participants reflected on their PB (or absence thereof) in the context of health. Participants reporting PB were predominantly male, single/unmarried, older, had higher levels of education and income and more advanced HIV progression. Three common reasons for more present-biased choices provided were: (1) wanting to avoid pain, (2) wanting to return to work, and (3) fear of one's health worsening if s/he did not address their illness immediately. While PB in the financial domain often suggests that poorer individuals are more likely to prefer immediate rewards over their wealthier counterparts, our results suggest poor health is potentially a driving factor of PB. Further research is needed to build on these finding and inform how programs can frame key messages regarding ART adherence to patients displaying PB.Trial registration: ClinicalTrials.gov identifier: NCT03494777.

Barriers and facilitators of antiretroviral therapy (ART) adherence habit formation in Sub-Saharan Africa: Evidence from a qualitative study in Kampala, Uganda.

RATIONALE: In 2020, nearly 40 million people lived with HIV/AIDS (PLWHA) worldwide, of whom 70% were receiving antiretroviral therapy (ART). Two-thirds of PLWHA reside in Sub-Saharan Africa (SSA), where rates of viral load suppression are often suboptimal and frequently attributed to low ART adherence. Strong pill-taking habits are often reported as a key strategy among those who successfully maintain medication adherence, yet not enough is known about the barriers and facilitators in SSA to pill-taking in response to the same contextual cue, which is a necessary step in the habit formation process. OBJECTIVE: To address this knowledge gap and to inform a subsequent intervention to promote context-dependent repetition, called anchoring, we used a formative qualitative approach to collect in-depth narratives about barriers and facilitators of the anchoring intervention for establishing ART pill-taking habits at the Mildmay Hospital in Kampala, Uganda. METHODS: We conducted interviews with 25 randomly selected patients starting ART, 5 expert patients, and 10 providers at Mildmay, and performed a rapid analysis to inform the intervention in a timely manner. RESULTS: We found that pill taking in response to the same contextual cue, or anchor, was threatened by stigma and food insecurity and that the COVID-19 pandemic exacerbated these barriers. We also determined that important linguistic changes were needed to the instructional materials and reminder messages in the subsequent intervention to avoid words and phrases with negative connotations for this target population. CONCLUSIONS: Several important barriers and facilitators to context-dependent pill taking in Uganda were identified through our formative research that helped to inform important revisions to our subsequent intervention. These findings underscore the importance of understanding local barriers and facilitators when designing and planning interventions, particularly when implementing theory-based intervention approaches that have yet to be tested in a new setting.

Randomized Controlled Trial of Rise, A Community-Based Culturally Congruent Counseling Intervention to Support Antiretroviral Therapy Adherence Among Black/African American Adults Living with HIV.

Structural inequities have led to HIV disparities, including relatively low antiretroviral therapy adherence and viral suppression rates among Black Americans living with HIV. We conducted a randomized controlled trial of Rise, a community-based culturally congruent adherence intervention, from January 2018 to December 2021 with 166 (85 intervention, 81 control) Black adults living with HIV in Los Angeles County, California [M (SD) = 49.0 (12.2) years-old; 76% male]. The intervention included one-on-one counseling sessions using basic Motivational Interviewing style to problem solve about adherence, as well as referrals to address unmet needs for social determinants of health (e.g., housing services, food assistance). Assessments included electronically monitored adherence; HIV viral load; and baseline, 7-month follow-up, and 13-month follow-up surveys of sociodemographic characteristics, HIV stigma, medical mistrust, and HIV-serostatus disclosure. Repeated-measures intention-to-treat regressions indicated that Rise led to significantly (two-fold) higher adherence likelihood, lower HIV stigmatizing beliefs, and reduced HIV-related medical mistrust. Effects on HIV viral suppression, internalized stigma, and disclosure were non-significant. Moreover, Rise was cost-effective based on established standards: The estimated cost per person to reach optimal adherence was $335 per 10% increase in adherence. Interventions like Rise, that are culturally tailored to the needs of Black populations, may be optimal for Black Americans living with HIV (ClinicalTrials.gov #NCT03331978).

RESUMEN: Las desigualdades estructurales han dado lugar a disparidades relacionadas con el VIH, incluyendo la relativamente baja adherencia a la terapia antirretroviral (TAR) y las tasas de supresión viral entre los afroamericanos que viven con el VIH. Conducimos una prueba controlada aleatoria de Rise, una intervención de adherencia culturalmente congruente basada en la comunidad, desde Enero de 2018 hasta Diciembre de 2021 con 166 (85 intervención, 81 controlada) adultos afroamericanos que viven con el VIH en el condado de Los Ángeles, California [M (SD) = 49.0 (12,2) años; 76% de hombres]. La intervención incluyó sesiones de asesoramiento individualizadas, usando el estilo básico Motivacional para las entrevistas, para resolver los problemas de adherencia como también referencias para confrontar sus necesidades insatisfechas de los determinantes sociales de la salud (por ejemplo, servicios de vivienda y asistencia de alimentos). Las evaluaciones incluyeron la adherencia monitoreada electrónicamente; la carga viral del VIH; y encuestas de referencia, seguimiento a los 7 meses y seguimiento a los 13 meses sobre características sociodemográficas, el estigma del VIH, la desconfianza médica y divulgación del estado serológico respecto al VIH. Los efectos sobre la supresión viral del VIH, el estigma interiorizado y la revelación de información no fueron significativos. Además, Rise fue rentable según los estándares establecidos: El costo estimado por persona para alcanzar la adherencia óptima fue de 335 dólares por cada 10% de aumento en la adherencia. Las intervenciones como Rise, que se adaptan culturalmente a las necesidades de las poblaciones afroamericana, podrían ser óptimas para los estadounidenses afroamericanos que viven con el VIH.

Let's Talk About Antibiotics: a randomised trial of two interventions to reduce antibiotic misuse.

BACKGROUND: Children with acute respiratory tract infections (ARTIs) receive ≈11.4 million unnecessary antibiotic prescriptions annually. A noted contributor is inadequate parent-clinician communication, however, efforts to reduce overprescribing have only indirectly targeted communication or been impractical. OBJECTIVES: Compare two feasible (higher vs lower intensity) interventions for enhancing parent-clinician communication on the rate of inappropriate antibiotic prescribing. DESIGN: Multisite, parallel group, cluster randomised comparative effectiveness trial. Data collected between March 2017 and March 2019. SETTING: Academic and private practice outpatient clinics. PARTICIPANTS: Clinicians (n=41, 85% of eligible approached) and 1599 parent-child dyads (ages 1-5 years with ARTI symptoms, 71% of eligible approached). INTERVENTIONS: All clinicians received 20 min ARTI diagnosis and treatment education. Higher intensity clinicians received an additional 50 min communication skills training. All parents viewed a 90 second antibiotic education video. MAIN OUTCOMES AND MEASURES: Inappropriate antibiotic treatment was assessed via blinded medical record review by study clinicians and a priori defined as prescriptions for the wrong diagnosis or use of the wrong agent. Secondary outcomes were revisits, adverse drug reactions (both assessed 2 weeks after the visit) and parent ratings of provider communication, shared decision-making and visit satisfaction (assessed at end of the visit on Likert-type scales). RESULTS: Most clinicians completed the study (n=38, 93%), were doctors (n=25, 66%), female (n=30, 78%) and averaged 8 years in practice. All parent-child dyad provided data for the main outcome (n=855 (54%) male, n=1043 (53%) <2 years). Inappropriate antibiotic prescribing was similar among patients who consulted with a higher intensity (54/696, 7.8%) versus a lower intensity (85/904, 9.4%) clinician. A generalised linear mixed effect regression model (adjusted for the two-stage nested design, clinician type, clinic setting and clinician experience) revealed that the odds of receiving inappropriate antibiotic treatment did not significantly vary by group (AOR 0.99, 95% CI: 0.52 to 1.89, p=0.98). Secondary outcomes of revisits and adverse reactions did not vary between arms, and parent ratings of satisfaction with quality of parent-provider communication (5/5), shared decision making (9/10) and visit satisfaction (5/5) were similarly high in both arms. CONCLUSIONS AND RELEVANCE: Rate of inappropriate prescribing was low in both arms. Clinician education coupled with parent education may be sufficient to yield low inappropriate antibiotic prescribing rates. The absence of a significant difference between groups indicates that communication principles previously thought to drive inappropriate prescribing may need to be re-examined or may not have as much of an impact in practices where prescribing has improved in recent years. TRIAL REGISTRATION NUMBER: NCT03037112.

Incentives and Reminders to Improve Long-term Medication Adherence (INMIND): Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Nonadherence 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. OBJECTIVE: This 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. METHODS: A 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. RESULTS: As 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. CONCLUSIONS: This 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 REGISTRATION: ClinicalTrials.gov NCT05131165; https://clinicaltrials.gov/ct2/show/NCT05131165. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42216.

Behavioral intervention grounded in motivational interviewing and behavioral economics shows promise with Black and English-speaking Latino persons living with HIV with unsuppressed HIV viral load in New York City: A mixed methods pilot study.

Introduction: Sustained HIV viral suppression is the ultimate goal of HIV treatment. African American/Black and Latino persons with HIV (PWH) in the United States are less likely than their White peers to achieve and sustain viral suppression. To address these disparities, we developed a "low-touch" behavioral intervention drawing on motivational interviewing and behavioral economics. The intervention had three main components: (1) a motivational interviewing counseling session, (2) 16 weeks of automated text messages and quiz questions about HIV management, where participants earned points by answering quiz questions, and 3) a lottery prize, based on viral suppression status, number of points earned, and chance (max. $275). Materials and methods: The intervention was tested in a pre-test/post-test design. The present pilot study used mixed methods to explore the intervention's feasibility, acceptability, impact, and ways it could be improved. Participants engaged in a baseline assessment, qualitative interview, and two structured follow-up assessments over an 8-month period, and provided laboratory reports to document HIV viral load. We carried out descriptive quantitative analyses. Qualitative data were analyzed using a directed content analysis approach. Data integration was carried out using the joint display method. Findings: Participants (N = 40) were 50 years old, on average (SD = 11), and approximately half (58%) were male. Close to two-thirds (68%) were African American/Black and 32% were Latino. Participants were diagnosed with HIV 22 years ago on average (SD = 8). The intervention was feasible (e.g., mean number of quiz questions answered = 13/16) and highly acceptable. While not powered to assess efficacy, the proportion with suppressed HIV viral load increased from baseline to follow-up (46% participants at the first, 52% participants at the second follow-up evidenced HIV viral suppression). In qualitative analyses, perspectives included that overall, the intervention was acceptable and useful, it was distinct from other programs, lottery prizes were interesting and appreciated but not sufficient to motivate behavior change, and the structure of lottery prizes was not sufficiently clear. Regarding data integration, qualitative data shed light on and extended quantitative results, and added richness and context. Conclusion: This low-touch intervention approach is sufficiently promising to warrant refinement and study in future research.

"The one who doesn't take ART medication has no wealth at all and no purpose on Earth" - a qualitative assessment of how HIV-positive adults in Uganda understand the health and wealth-related benefits of ART.

BACKGROUND: Increases in life expectancy from antiretroviral therapy (ART) may influence future health and wealth among people living with HIV (PLWH). What remains unknown is how PLWH in care perceive the benefits of ART adherence, particularly in terms of improving health and wealth in the short and long-term at the individual, household, and structural levels. Understanding future-oriented attitudes towards ART may help policymakers tailor care and treatment programs with both short and long-term-term health benefits in mind, to improve HIV-related outcomes for PLWH. METHODS: In this qualitative study, we conducted semi-structured interviews among a subsample of 40 PLWH in care at a clinic in Uganda participating in a randomized clinical trial for treatment adherence in Uganda (clinicaltrials.gov: NCT03494777). Interviews were transcribed verbatim and translated from Luganda into English. Two co-authors independently reviewed transcripts, developed a detailed codebook, achieved 93% agreement on double-coded interviews, and analyzed data using inductive and deductive content analysis. Applying the social-ecological framework at the individual, household, and structural levels, we examined how PLWH perceived health and wealth-related benefits to ART. RESULTS: Our findings revealed several benefits of ART expressed by PLWH, going beyond the short-term health benefits to also include long-term economic benefits. Such benefits largely focused on the ability of PLWH to live longer and be physically and mentally healthy, while also fulfilling responsibilities at the individual level pertaining to themselves (especially in terms of positive long-term habits and motivation to work harder), at the household level pertaining to others (such as improved relations with family and friends), and at the structural level pertaining to society (in terms of reduced stigma, increased comfort in disclosure, and higher levels of civic responsibility). CONCLUSIONS: PLWH consider short and long-term health benefits of ART. Programming designed to shape ART uptake and increase adherence should emphasize the broader benefits of ART at various levels. Having such benefits directly integrated into the design of clinic-based HIV interventions can be useful especially for PLWH who face competing interests to increase medication adherence. These benefits can ultimately help providers and policymakers better understand PLWH's decision-making as it relates to improving ART-related outcomes.

The role of material deprivations in determining ART adherence: Evidence from a conjoint analysis among HIV-positive adults in Uganda.

Despite sustained global scale-up of antiretroviral therapy (ART), adherence to ART remains low. Less than half of those in HIV care in Uganda achieve 85% adherence to their ART medication required for clinically meaningful viral suppression, leaving them at higher risk of transmission. Key barriers to ART adherence include poverty-related structural barriers that are inter-connected and occur simultaneously, making it challenging to examine and disentangle them empirically and in turn design effective interventions. Many people living with HIV (PLWH) make tradeoffs between these various barriers (e.g., between expenses for food or transportation) and these can influence long-term health behavior such as adherence to ART. To be able to estimate the distinct influence of key structural barriers related to poverty, we administered a conjoint analysis (CA) to 320 HIV-positive adults currently taking ART at an urban clinic in Uganda between July 2019 and September 2020. We varied the levels of four poverty-related attributes (food security, sleep deprivation, monthly income, and physical pain) that occur simultaneously and asked respondents how they would adhere to their medication under different combinations of attribute levels. This allows us to disentangle the effect of each attribute from one another and to assess their relative importance. We used regression analysis to estimate the effects of each attribute level and found that food security impacts expected adherence the most (treatment effect = 1.3; 95% CI 1.11-1.49, p<0.001), followed by income (treatment effect = 0.99; 95% CI 0.88-1.10, p<0.001. Sleep and pain also impact adherence, although by a smaller magnitude. Sub-group analyses conducted via regression analysis examine heterogeneity in results and suggest that the effects of material deprivations on expected adherence are greater among those with high levels of existing food insecurity. Results from this CA indicate that external factors inherent in the lives of the poor and unrelated to direct ART access can be important barriers to ART adherence. This study applies a CA (typically administered in marketing applications) among PLWH to better understand individual-level perceptions relating to poverty that often occur simultaneously. Policy interventions should address food insecurity and income to improve adherence among HIV-positive adults.