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.

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.

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.

START (Supporting Treatment Adherence Readiness through Training) Improves Both HIV Antiretroviral Adherence and Viral Reduction, and is Cost Effective: Results of a Multi-site Randomized Controlled Trial.

The START (Supporting Treatment Adherence Readiness through Training) intervention was examined for its effects on ART adherence and virologic suppression relative to usual care. A sample of 176 clients about to start or restart ART were randomized (83 to START, 93 to usual care) at HIV clinics in the Los Angeles area. Primary outcomes included electronically monitored dose-taking adherence and HIV viral load; primary end points were months 6 and 24, with group differences examined using nonresponse-weighted means or proportions, effect sizes, and significance testing. Item nonresponse was addressed using multiple imputation. 166 (94.3%) participants started ART, of whom 124 (74.7%) were still in care at month 6, and 90 (54.2%) at month 24. In comparison to the usual care control group, the START group had higher dose-taking adherence at month 6 (86.2% vs. 71.6%, d = 0.56, p = 0.01), which was sustained through month 24 (86.0% vs. 61.1%, d =1.01, p < 0.0001). While rates of undetectable viral load did not differ between groups at month 6 or 24, the mean reduction in viral load (log10 copies/mm3) at month 24 was significantly greater in the intervention arm (3.0 vs. 2.7; d = 0.40, p = 0.047). An estimated cost of $132 per person was needed to obtain a 10% increase in dose-taking adherence over 24 months from the intervention. These findings suggest that START is cost effective in producing a medium to large effect on dose-taking adherence that is durable over 24 months, and a modest long-term effect on viral reduction.Trial registration Clinicaltrials.gov NCT02329782 (registered December 22, 2014).

The acceptability and feasibility of a pilot study examining the impact of a mobile technology-based intervention informed by behavioral economics to improve HIV knowledge and testing frequency among Latinx sexual minority men and transgender women.

BACKGROUND: We developed a novel intervention that uses behavioral economics incentives and mobile-health text messages to increase HIV knowledge and testing frequency among Latinx sexual minority men and Latinx transgender women. Here we provide a theoretically-grounded assessment regarding the intervention's acceptability and feasibility. METHODS: We conducted 30-min exit interviews with a stratified sample of participants (n = 26 Latinx sexual minority men, 15 Latinx transgender women), supplemented with insights from study staff (n = 6). All interviews were recorded, transcribed, and translated for a content analysis using Dedoose. Cohen's Kappa was 89.4% across coded excerpts. We evaluated acceptability based on how participants cognitively and emotionally reacted to the intervention and whether they considered it to be appropriate. We measured feasibility based on resource, scientific and process assessments (e.g., functionality of text messaging service, feedback on study recruitment procedures and surveys). RESULTS: Regarding acceptability, most participants clearly understood the intervention as a program to receive information about HIV prevention methods through text messages. Participants who did not complete the intervention shared they did not fully understand what it entailed at their initial enrollment, and thought it was a one-time engagement and not an ongoing program. Though some participants with a higher level of education felt the information was simplistic, most appreciated moving beyond a narrow focus on HIV to include general information on sexually transmitted infections; drug use and impaired sexual decision-making; and differential risks associated with sexual positions and practices. Latinx transgender women in particular appreciated receiving information about Pre-Exposure Prophylaxis. While participants didn't fully understand the exact chances of winning a prize in the quiz component, most enjoyed the quizzes and chance of winning a prize. Participants appreciated that the intervention required a minimal time investment. Participants shared that the intervention was generally culturally appropriate. Regarding feasibility, most participants reported the text message platform worked well though inactive participants consistently said technical difficulties led to their disengagement. Staff shared that clients had varying reactions to being approached while being tested for HIV, with some unwilling to enroll and others being very open and curious about the program. Both staff and participants relayed concerns regarding the length of the recruitment process and study surveys. CONCLUSIONS: Our theoretically-grounded assessment shows the intervention is both acceptable and feasible. TRIAL REGISTRATION: The trial was registered on May 5, 2017 with the ClinicalTrials.gov registry [ NCT03144336 ].

Rapid mixed-methods assessment of COVID-19 impact on Latinx sexual minority men and Latinx transgender women.

We conducted a rapid, mixed-methods assessment to understand how COVID-19 affected Latinx sexual minority men (LSMM) and transgender women (LTGW). Using a computer-assisted telephone interviewing software, one interviewer called 52 participants (randomly sampled from a larger HIV prevention pilot study aiming to increase HIV knowledge and testing frequency; n = 36 LSMM and n = 16 LTGW) between 04/27/20-05/18/20. We quantified core domains using the Epidemic-Pandemic Impacts Inventory scale and provided important context through open-ended qualitative questions assessing: 1) COVID-19 infection history and experiences with quarantine; 2) Health and healthcare access; 3) Employment and economic impact of COVID-19. Participants reported increases in physical conflict or verbal arguments with a partner (13.5%) or other adult(s) (19.2%) due to stressors associated with the safer-at-home order. Participants also reported increased alcohol consumption (23.1%), problems with sleep (67.3%) and mental health (78.4%). Further, disruptions in access to Pre-Exposure Prophylaxis or PrEP-a daily pill to prevent HIV-occurred (33.3% of 18 participants who reported being on PrEP). Many said they received less medical attention than usual (34.6%), and LTGW reported delays in critical gender-affirming hormones/procedures. Half of the participants lost their jobs (50.0%); many undocumented participants relayed additional financial concerns because they did not qualify for financial assistance. Though no COVID-19 infections were noted, COVID-19 dramatically impacted other aspects of health and overall wellbeing of LSMM and LTGW. Public health responses should address the stressors faced by LSMM and LTGW during the COVID-19 pandemic and the impact on wellbeing.

Brief Report: Using Behavioral Economics to Increase HIV Knowledge and Testing Among Latinx Sexual Minority Men and Transgender Women: A Quasi-Experimental Pilot Study.

OBJECTIVE: To determine how weekly text messages and small incentives impact HIV knowledge and frequency of HIV testing among Latinx sexual minority men (LSMM) and transgender women (LTGW). DESIGN: Prospectively randomized participants into 2 intervention arms compared with a nonrandomized comparison group. SETTING: Bienestar, a primarily Latinx focused HIV service provider located across Los Angeles County. SUBJECTS, PARTICIPANTS: Two hundred eighteen participants self-identifying as LSMM or LTGW, HIV negative, having regular mobile phone access, ≥18 years, and fluent in English or Spanish. INTERVENTION: The "information only" (IO) group received text messages with HIV prevention information. The "information plus" (IP) group additionally could win incentives by answering weekly quiz questions correctly and testing for HIV once every 3 months. We followed participants for 12 months. MAIN OUTCOME MEASURE(S): HIV knowledge and frequency of HIV testing. RESULTS: We found no effect on HIV knowledge in the IO group but a statistically significant improvement in the IP group (79.2%-88.1%; P = 0.007). The frequency of HIV testing was higher in both intervention groups relative to the comparison group: On average, 22.0% of IO participants and 24.9% of IP participants tested at a Bienestar site within a given 3-month period, compared with 13.0% in the comparison group. This represents unadjusted relative risk ratios of 1.69 for the IO group (95% CI: 1.25 to 2.1; P < 0.01) and 1.91 for the IP group (95% CI: 1.51 to 2.31; P < 0.01), respectively. CONCLUSIONS: This study demonstrates that a simple, low-cost intervention may help increase HIV testing frequency among LSMM and LTGW, 2 groups at high HIV risk.

Feasibility of Assessing Economic and Sexual Risk Behaviors Using Text Message Surveys in African-American Young Adults Experiencing Homelessness and Unemployment: Single-Group Study.

BACKGROUND: Text messages offer the potential to better evaluate HIV behavioral interventions using repeated longitudinal measures at a lower cost and research burden. However, they have been underused in US minority settings. OBJECTIVE: This study aims to examine the feasibility of assessing economic and sexual risk behaviors using text message surveys. METHODS: We conducted a single-group study with 17 African-American young adults, aged 18-24 years, who were economically disadvantaged and reported prior unprotected sex. Participants received a text message survey once each week for 5 weeks. The survey contained 14 questions with yes-no and numeric responses on sexual risk behaviors (ie, condomless sex, sex while high or drunk, and sex exchange) and economic behaviors (ie, income, employment, and money spent on HIV services or products). Feasibility measures were the number of participants who responded to the survey in a given week, the number of questions to which a participant responded in each survey, and the number of hours spent from sending a survey to participants to receiving their response in a given week. One discussion group was used to obtain feedback. RESULTS: Overall, 65% (n=11/17) of the participants responded to at least one text message survey compared with 35% (n=6/17) of the participants who did not respond. The majority (n=7/11, 64%) of the responders were women. The majority (n=4/6, 67%) of nonresponders were men. An average of 7.6 participants (69%) responded in a given week. Response rates among ever responders ranged from 64% to 82% across the study period. The mean number of questions answered each week was 12.6 (SD 2.7; 90% of all questions), ranging from 72% to 100%. An average of 6.4 participants (84%) answered all 14 text message questions in a given week, ranging from 57% to 100%. Participants responded approximately 8.7 hours (SD 10.3) after receiving the survey. Participants were more likely to answer questions related to employment, condomless sex, and discussions with sex partners. Nonresponse or skip was more often used for questions at the end of the survey relating to sex exchange and money spent on HIV prevention services or products. Strengths of the text message survey were convenience, readability, short completion time, having repeated measures over time, and having incentives. CONCLUSIONS: Longitudinal text message surveys may be a valuable tool for assessing HIV-related economic and sexual risk behaviors. TRIAL REGISTRATION: ClinicalTrials.gov NCT03237871; https://clinicaltrials.gov/ct2/show/NCT03237871.

Microenterprise Intervention to Reduce Sexual Risk Behaviors and Increase Employment and HIV Preventive Practices Among Economically-Vulnerable African-American Young Adults (EMERGE): A Feasibility Randomized Clinical Trial.

Economic vulnerability, such as homelessness and unemployment, contributes to HIV risk among U.S. racial minorities. Yet, few economic-strengthening interventions have been adapted for HIV prevention in this population. This study assessed the feasibility of conducting a randomized clinical trial of a 20-week microenterprise intervention for economically-vulnerable African-American young adults. Engaging MicroenterprisE for Resource Generation and Health Empowerment (EMERGE) aimed to reduce sexual risk behaviors and increase employment and uptake of HIV preventive behaviors. The experimental group received text messages on job openings plus educational sessions, mentoring, a start-up grant, and business and HIV prevention text messages. The comparison group received text messages on job openings only. Primary feasibility objectives assessed recruitment, randomization, participation, and retention. Secondary objectives examined employment, sexual risk behaviors, and HIV preventive behaviors. Outcome assessments used an in-person pre- and post-intervention interview and a weekly text message survey. Several progression criteria for a definitive trial were met. Thirty-eight participants were randomized to experimental (n = 19) or comparison group (n = 19) of which 95% were retained. The comparison intervention enhanced willingness to be randomized and reduced non-participation. Mean age of participants was 21.0 years; 35% were male; 81% were unemployed. Fifty-eight percent (58%) of experimental participants completed ≥ 70% of intervention activities, and 74% completed ≥ 50% of intervention activities. Participation in intervention activities and outcome assessments was highest in the first half (~ 10 weeks) of the study. Seventy-one percent (71%) of weekly text message surveys received a response through week 14, but responsiveness declined to 37% of participants responding to ≥ 70% of weekly text message surveys at the end of the study. The experimental group reported higher employment (from 32% at baseline to 83% at week 26) and lower unprotected sex (79% to 58%) over time compared to reported changes in employment (37% to 47%) and unprotected sex (63% to 53%) over time in the comparison group. Conducting this feasibility trial was a critical step in the process of designing and testing a behavioral intervention. Development of a fully-powered effectiveness trial should take into account lessons learned regarding intervention duration, screening, and measurement.Trial Registration ClinicalTrials.gov. NCT03766165. Registered 04 December 2018. https://clinicaltrials.gov/ct2/show/NCT03766165.

Habit formation in support of antiretroviral medication adherence in clinic-enrolled HIV-infected adults: a qualitative assessment using free-listing and unstructured interviewing in Kampala, Uganda.

BACKGROUND: Despite initial high motivation, individuals receiving antiretroviral therapy (ART) for several years may experience incomplete adherence over time, increasing their risk of HIV-related morbidity and mortality. Habits, defined as automatic and regular practices, do not rely on conscious effort, and may therefore support high long-term ART adherence. METHODS: This qualitative study contributes to the evidence on how clients with adherence problems remember and form habits to take ART medications. Free-listing and unstructured interviewing were used among 42 clinic-enrolled adults in Kampala, Uganda who were receiving ART and participating in a randomized clinical trial for treatment adherence (clinicaltrials.gov: NCT03494777). Data were coded and analyzed using inductive content analysis. RESULTS: Findings indicated that clients' most routine habits (eating, bathing, sleeping) did not always occur at the same time or place, making it difficult to reliably link to pill-taking times. Efforts to improve ART habits included having a relative to ask about pill-taking, re-packaging medications, leaving medications in view, using alarms, carrying water, or linking pill-taking to radio/prayer schedules. Reported challenges were adhering to ART schedules during changing employment hours, social activities, and travel. CONCLUSION: While habit-forming interventions have the potential to improve ART adherence, targeting treatment-mature clients' existing routines may be crucial in this population.

A randomized controlled trial study of the acceptability, feasibility, and preliminary impact of SITA (SMS as an Incentive To Adhere): a mobile technology-based intervention informed by behavioral economics to improve ART adherence among youth in Uganda.

BACKGROUND: Studies report serious adherence problems among youth (individuals age 15-24 years of age) in Uganda. Recent growth in mobile phone ownership has highlighted the potential of using text-based interventions to improve antiretroviral treatment (ART) adherence among Ugandan youth. We piloted a randomized controlled trial of a text-based intervention providing weekly real-time antiretroviral adherence feedback, based on information from a smart pill box, to HIV-positive Ugandan youth. In this paper, we report the acceptability, feasibility, and preliminary impact of the intervention. METHODS: We randomized participants to a control group, or to receive messages with information on either their own adherence levels (Treatment 1 - T1), or their own adherence and peer adherence levels (Treatment 2 - T2). We conducted six focus groups from December 2016 to March 2017 with providers and youth ages 15-24, double coded 130 excerpts, and achieved a pooled Cohen's Kappa of 0.79 and 0.80 based on 34 randomly selected excerpts. RESULTS: The quantitative and qualitative data show that the intervention was deemed acceptable and feasible. After controlling for baseline adherence, the T1 group had 3.8 percentage point lower adherence than the control group (95% CI -9.9, 2.3) and the T2 group had 2.4 percentage points higher adherence than the control group (95% CI -3.0, 7.9). However, there was an increasing treatment effect over time for the T2 group with the largest effect towards the end of the study; a 2.5 percentage point increase in the initial 9-weeks that grows steadily to 9.0 percentage points by the last 9-weeks of the study. We find negative treatment effects for T1 in 3 of the 4 9-week intervals. This pilot study was not designed to detect statistically significant differences. CONCLUSIONS: Improving youth's adherence by supplementing information about their adherence with information about the adherence of peers is a promising new strategy that should be further evaluated in a fully-powered study. Providing one's own adherence information alone appears to have less potential. TRIAL REGISTRATION: NCT02514356 07/30/2015.

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

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.