Results From a Pilot Study of an Automated Directly Observed Therapy Intervention Using Artificial Intelligence With Conditional Economic Incentives Among Young Adults With HIV.

BACKGROUND: Despite improvements in antiretroviral therapy (ART) availability, suboptimal adherence is common among youth with HIV (YWH) and can increase drug resistance and poor clinical outcomes. Our study examined an innovative mobile app-based intervention that used automated directly observed therapy (aDOT) using artificial intelligence, along with conditional economic incentives (CEIs) to improve ART adherence and enhance viral suppression among YWH. SETTING: We conducted a pilot study of the aDOT-CEI intervention, informed by the operant framework of Key Principles in Contingency Management Implementation, to improve ART adherence among YWH (18-29) in California and Florida who had an unsuppressed HIV viral load. METHODS: We recruited 28 virally unsuppressed YWH from AIDS Healthcare Foundation clinics, who used the aDOT platform for 3 months. Study outcomes included feasibility and acceptability, self-reported ART adherence, and HIV viral load. RESULTS: Participants reported high satisfaction with the app (91%), and 82% said that it helped them take their medication. Comfort with the security and privacy of the app was moderate (55%), and 59% indicated the incentives helped improve daily adherence. CONCLUSIONS: Acceptability and feasibility of the aDOT-CEI intervention were high with potential to improve viral suppression, although some a priori metrics were not met. Pilot results suggest refinements which may improve intervention outcomes, including increased incentive amounts, provision of additional information, and reassurance about app privacy and security. Additional research is recommended to test the efficacy of the aDOT-CEI intervention to improve viral suppression in a larger sample.

Estimating The Impact Of Out-Of-Pocket Cost Changes On Abandonment Of HIV Pre-Exposure Prophylaxis.

Oral HIV pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV. Several different developments in the US either threaten to increase or promise to decrease PrEP out-of-pocket costs and access in the coming years. In a sample of 58,529 people with a new insurer-approved PrEP prescription, we estimated risk-adjusted percentages of patients who abandoned (did not fill) their initial prescription across six out-of-pocket cost categories. We then simulated the percentage of patients who would abandon PrEP under hypothetical changes to out-of-pocket costs, ranging from $0 to more than $500. PrEP abandonment rates of 5.5 percent at $0 rose to 42.6 percent at more than $500; even a small increase from $0 to $10 doubled the rate of abandonment. Conversely, abandonment rates that were 48.0 percent with out-of-pocket costs of more than $500 dropped to 7.3 percent when those costs were cut to $0. HIV diagnoses were two to three times higher among patients who abandoned PrEP prescriptions than among those who filled them. These results imply that recent legal challenges to the provision of PrEP with no cost sharing could substantially increase PrEP abandonment and HIV rates, upending progress on the HIV/AIDS epidemic.

Youth Ending the HIV Epidemic (YEHE): Protocol for a pilot of an automated directly observed therapy intervention with conditional economic incentives among young adults with HIV.

BACKGROUND: Young adults have a disproportionately high rate of HIV infection, high rates of attrition at all stages of the HIV care continuum, and an elevated probability of disease progression and transmission. Tracking and monitoring objective measures of antiretroviral therapy (ART) adherence in real time is critical to bolster the accuracy of research data, support adherence, and improve clinical outcomes. However, adherence monitoring often relies on self-reported and retrospective data or requires additional effort from providers to understand individual adherence patterns. In this study, we will monitor medication-taking using a real-time objective measure of adherence that does not rely on self-report or healthcare providers for measurement. METHODS: The Youth Ending the HIV Epidemic (YEHE) study will pilot a novel automated directly observed therapy-conditional economic incentive (aDOT-CEI) intervention to improve ART adherence among youth with HIV (YWH) in California and Florida who have an unsuppressed HIV viral load. The aDOT app uses facial recognition to record adherence each day, and then economic incentives are given based on a participant's confirmed adherence. We will enroll participants in a 3-month pilot study to assess the feasibility and acceptability of the aDOT-CEI intervention using predefined metrics. During and after the trial, a subsample of the pilot participants and staff/providers from participating AIDS Healthcare Foundation (AHF) clinics will participate in individual in-depth interviews to explore intervention and implementation facilitators and barriers. DISCUSSION: YEHE will provide data on the use of an aDOT-CEI intervention to improve adherence among YWH who are not virologically suppressed. The YEHE study will document the feasibility and acceptability and will explore preliminary data to inform a trial to test the efficacy of aDOT-CEI. This intervention has the potential to effectively improve ART adherence and virologic suppression among a key population experiencing health disparities. TRIAL REGISTRATION: The trial registration number is NCT05789875.

iVY: protocol for a randomised clinical trial to test the effect of a technology-based intervention to improve virological suppression among young adults with HIV in the USA.

INTRODUCTION: Young adults with HIV (YWH) experience worse clinical outcomes than adults and have high rates of substance use (SU) and mental illness that impact their engagement in care and adherence to antiretroviral therapy (ART). The intervention for Virologic Suppression in Youth (iVY) aims to address treatment engagement/adherence, mental health (MH) and SU in a tailored manner using a differentiated care approach that is youth friendly. Findings will provide information about the impact of iVY on HIV virological suppression, MH and SU among YWH who are disproportionately impacted by HIV and at elevated risk for poor health outcomes. METHODS AND ANALYSIS: The iVY study will test the effect of a technology-based intervention with differing levels of resource requirements (ie, financial and personnel time) in a randomised clinical trial with an adaptive treatment strategy among 200 YWH (18-29 years old). The primary outcome is HIV virological suppression measured via dried blood spot. This piloted and protocolised intervention combines: (1) brief weekly sessions with a counsellor via a video-chat platform (video-counselling) to discuss MH, SU, HIV care engagement/adherence and other barriers to care; and (2) a mobile health app to address barriers such as ART forgetfulness, and social isolation. iVY has the potential to address important, distinct and changing barriers to HIV care engagement (eg, MH, SU) to increase virological suppression among YWH at elevated risk for poor health outcomes. ETHICS AND DISSEMINATION: This study and its protocols have been approved by the University of California, San Francisco Institutional Review Board. Study staff will work with a Youth Advisory Panel to disseminate results to YWH, participants and the academic community. TRIAL REGISTRATION NUMBER: NCT05877729.

Acceptability of the LetSync App Wireframes for an mHealth Intervention to Improve HIV Care Engagement and Treatment Among Black Partnered Sexual Minority Men: Findings from In-Depth Qualitative Interviews.

BACKGROUND: HIV disparities continue to be a significant challenge affecting Black sexual minority men in the United States. Inadequate engagement and retention of patients in HIV care has been associated with poor health outcomes. Interventions to improve sustained commitment to HIV care are needed. Mobile health interventions can help facilitate access to and use of HIV health services, particularly among individuals at risk for disengaging with care. OBJECTIVE: We designed the LetSync app wireframes for a mobile health intervention using a couple-centered design approach to improve HIV engagement and treatment among Black sexual minority men and their partners. The objective of this study was to gauge future app user interest and elicit feedback to improve the design, development, and usability of the LetSync app. METHODS: We conducted in-depth interviews with 24 Black sexual minority men to assess the acceptability of the LetSync app wireframes between May 2020 and January 2021. Participants reviewed the LetSync app wireframes and provided feedback regarding perceived usefulness and interest in future app use and suggestions for improvement. RESULTS: Participants indicated interest in the future LetSync app and noted that the wireframes' features were acceptable and usable. In our study, the future LetSync app was frequently referred to as a potential resource that could help facilitate users' engagement in HIV care through the following mechanisms: enable scheduling of appointments and timely reminders for clinic visits; help improve HIV medication adherence; encourage and motivate participants to ask questions to their health care provider and stay engaged in conversations during clinic visits; facilitate effective communication by assisting couples with planning, coordination, and management of daily routines; help participants understand their partner's health needs, including access to and use of health care services; and facilitate participants' ability to improve their relationship skills, partner support, and self-efficacy in managing conflict. In addition to near-universal interest in potential daily app use, study participants indicted that they would recommend the LetSync app to other family members, friends, and people in their social networks who are living with HIV. CONCLUSIONS: Our findings revealed considerable interest in future app use for HIV care management, which could possibly increase the chance of the LetSync app being successfully adopted by Black sexual minority men in couples. Owing to its interactive and couple-centered approach, the LetSync app could help improve communication between Black sexual minority men and their partners and health providers. In addition, the LetSync app could provide an acceptable modality for these men to receive support in accessing HIV care services.

Medical mistrust of health systems as a moderator of resilience and self-reported HIV care engagement in Black and Latinx young adults living with HIV.

OBJECTIVE: To study resilience and its association with HIV care engagement in a sample of young adult Black and Latinx people living with HIV (PLWH) in the United States and to test if a systems-level barrier, medical mistrust, would moderate the resilience-engagement association. METHOD: Between April and August 2021, we recruited participants through social media and dating apps (N = 212) and verified age and HIV status through a review process of digital text-messaged and emailed photos. Participants completed a one-time online survey consisting of the Connor-Davidson Resilience Scale, The Index of Engagement in HIV Care, and the Medical Mistrust Index. We ran a regression-based moderation analysis using the Johnson-Neyman Technique to estimate regions of significance. RESULTS: The sample (N = 212) was 80.5% Black and 19.5% Latinx with a mean age of 25.8 years (SD = 2.84). Higher resilience scores were associated with higher HIV care engagement scores (b = 0.72, p = .003), and medical mistrust moderated this relationship as evidenced by a mistrust by resilience interaction (b = -0.16, p = .01). Our regions of statistical significance showed that as mistrust increased, the size of the resilience-engagement association decreased. CONCLUSION: Resilience may be a protective factor associated with greater participation and sense of connection to HIV care, but is diminished by mistrust of the medical system at large. This suggest that systems-level changes, in addition to individual-level interventions, are needed to address medical mistrust to fully harness the resilience of young PLWH. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Pharmacy Deserts and Pharmacies' Roles Post-Extreme Weather and Climate Events in the United States: A Scoping Review.

BACKGROUND: The effects of climate change are seen with a rise of extreme weather and climate events (EWCEs) which lead to the closures of many healthcare facilities, such as community pharmacies. Pharmacists in community pharmacies are seen as the most accessible healthcare professional to the public and are responsible for the continued delivery of care to patients. However, amid closures due to EWCEs and the emergence of pharmacy deserts, there is decreased access to pharmacies and a disruption of care. OBJECTIVE: It is important to address the preparedness and accessibility of pharmacies post-EWCEs to guide future research and policy. Additionally, to tackle health disparities that arise due to pharmacy deserts, the populations most affected by a decreased access to pharmacies should be identified. We conducted a scoping review to assess the preparedness and accessibility of pharmacies post-EWCEs and to identify populations most affected by pharmacy deserts. METHODS: We searched PubMed, Embase, and Web of Science from January 1, 2012 to September 30, 2022 and included all English-language, peer-reviewed primary literature that examined the preparedness and accessibility of community pharmacies in the United States post-EWCEs and addressed disparities within pharmacy deserts. Studies meeting these criteria were screened of their titles and abstracts by the first author and discrepancies were resolved with co-authors. We used Covidence for data extraction. RESULTS: A total of 472 studies were identified (196 duplicates removed) and after screening, 53 studies were assessed for eligibility. The results of included publications (N = 26) showed that pharmacists and pharmacies are not equipped with the necessary emergency protocols which could lead to decreased access of pharmacies in the wake of EWCEs. Pharmacy deserts disproportionately affect residents living in rural, lower income, and Black/African American and Hispanic/Latino neighborhoods. The lack of preparedness of pharmacies post-EWCEs could worsen medication access. CONCLUSION: This scoping review addresses challenges impacting pharmacies and patients post-EWCEs and within pharmacy deserts. In times of increased need, these challenges implicate the well-being of communities affected by EWCEs by breaking the continuum of care and access to medications. Here we offer suggestions for future research and directions for policy change.

Extreme weather events and HIV: development of a conceptual framework through qualitative interviews with people with HIV impacted by the California wildfires and their clinicians.

BACKGROUND: People with HIV (PWH) are disproportionately vulnerable to the impacts of wildfires, given the need for frequent access to healthcare systems, higher burden of comorbidities, higher food insecurity, mental and behavioral health challenges, and challenges of living with HIV in a rural area. In this study, we aim to better understand the pathways through which wildfires impact health outcomes among PWH. METHODS: From October 2021 through February 2022, we conducted individual semi-structured qualitative interviews with PWH impacted by the Northern California wildfires and clinicians of PWH who were impacted by wildfires. The study aims were to explore the influence of wildfires on the health of PWH and to discuss measures at the individual, clinic, and system levels that helped to mitigate these impacts. RESULTS: We interviewed 15 PWH and 7 clinicians. While some PWH felt that surviving the HIV epidemic added to their resilience against wildfires, many felt that the wildfires compounded the HIV-related traumas that they have experienced. Participants outlined five main routes by which wildfires negatively impacted their health: (1) access to healthcare (medications, clinics, clinic staff), (2) mental health (trauma; anxiety, depression, or stress; sleep disturbances; coping strategies), (3) physical health (cardiopulmonary, other co-morbidities), (4) social/economic impacts (housing, finances, community), and (5) nutrition and exercise. The recommendations for future wildfire preparedness were at the (1) individual-level (what to have during evacuation), (2) pharmacy-level (procedural, staffing), and (3) clinic- or county-level (funds and vouchers; case management; mental health services; emergency response planning; other services such as telehealth, home visits, home laboratory testing). CONCLUSIONS: Based on our data and prior research, we devised a conceptual framework that acknowledges the impact of wildfires at the community-, household-, and individual-level with implications for physical and mental health outcomes among PWH. These findings and framework can help in developing future interventions, programs, and policies to mitigate the cumulative impacts of extreme weather events on the health of PWH, particularly among individuals living in rural areas. Further studies are needed to examine health system strengthening strategies, innovative methods to improve access to healthcare, and community resilience through disaster preparedness. TRIAL REGISTRATION: N/A.

Brief Report: The Influence of the COVID-19 Pandemic on the Physical, Social, and Mental Health of Black and Latinx Young People With HIV in the United States.

BACKGROUND: Whereas national attention has been paid to the ongoing mental health crises among young people triggered by the COVID-19 pandemic, less is known about the social, physical and psychological impacts of COVID-19 on young people living with HIV, especially racial/ethnic minorities. SETTING: Online survey of participants across the U.S. METHOD: A national cross-sectional survey of non-Latinx Black and Latinx young adults (18-29) living with HIV. Between April and August 2021, participants answered survey questions about several domains (eg, stress, anxiety, relationships, work, quality of life) that were worsened, improved, or unchanged during the pandemic. We ran a logistic regression estimating the self-reported impact of the pandemic on these domains between 2 age groups (ages 18-24 versus 25-29). RESULTS: The sample size was 231 (186 non-Latinx Black, 45 Latinx) and mainly male (84.4%) and gay identified (62.2%). Nearly 20% of participants were 18-24 years old and 80% were ages 25-29. Participants who were 18-24 years old reported 2-3 times the odds for having worse sleep quality and mood and greater stress, anxiety, and weight gain compared with those 25-29 years old. CONCLUSION: Our data provide a nuanced picture of the negative impacts that COVID-19 had on non-Latinx Black and Latinx young adults living with HIV in the U.S. Given that these adults represent a priority population for HIV treatment outcomes, it is critical to better understand the ongoing toll that these dual pandemics have on their lives.

Young Adult Perspectives on Sex, Dating, and PrEP Use During the Pandemic and Improving the Future of PrEP Care.

Few studies have researched young adults' experiences taking HIV pre-exposure prophylaxis (PrEP) after the start of California's COVID-19 shelter-in-place (SIP) orders. The purpose of this study was to examine the experiences of young adults with sex, dating, and PrEP use during SIP and their perceptions on how to improve PrEP care in this age group. In this mixed-methods study, PrEP users ages 18-29 living in California between April 2020 and June 2021 completed a quantitative survey (N = 37) and one-on-one qualitative interviews (N = 18). Over half of survey participants reported trouble accessing PrEP care during SIP, citing difficulty obtaining medication refills, clinic appointments, and access to completing lab work. In qualitative interviews, participants expressed their preferences for more accessible PrEP service delivery across the PrEP care continuum. Despite pandemic SIP orders and trouble accessing PrEP services, young adults continued to engage in sexual behaviors.

Willingness of Racially Diverse Young Adults Living with HIV to Participate in HIV Cure Research: A Cross-Sectional Survey in the United States.

Nearly half of new HIV cases in the United States are among youth. Little is known about the willingness of young adults living with HIV (YLWH) to participate in HIV cure-related research. In 2021, we recruited 271 YLWH aged 18-29 for an online survey. We asked questions about willingness to participate in HIV cure research, perceived risks and benefits, acceptable trade-offs, and perceptions on analytical treatment interruptions. We conducted descriptive analyses to summarize data and bivariate analyses to explore correlations by demographics. Most respondents (mean age = 26) identified as men (86%) and Black Americans (69%). YLWH expressed high willingness to consider participating in cell- and gene-based approaches (75%) and immune-based approaches (71%). Approximately 45% would be willing to let their viral load become detectable for a period of time during an HIV cure study, 27% would not be willing, and 28% did not know. The social risk most likely to deter participation was the possibility of transmitting HIV to sex partners while off HIV medications (65% of respondents would be deterred a great deal or a lot). Compared to the 25-29 age group (n = 192), the 18-24 age group (n = 79) was more likely to indicate that having to disclose HIV status would matter a great deal in considering participation in HIV cure research (38% vs. 21%, p = .003). Inclusion and engagement of YLWH are critical for advancing novel HIV curative agents. Our article concludes with possible considerations for engaging YLWH in HIV cure research. Physical, clinical, and social risks will need to be kept to a minimum, and research teams will need to proactively mitigate the possibility of transmitting HIV to sex partners while off HIV medications.

Understanding HIV Pre-Exposure Prophylaxis Questions of U.S. Health Care Providers: Unique Perspectives from the PrEPline Clinical Teleconsultation Service.

Introduction: Fewer than a quarter of people considered to have factors associated with HIV acquisition are prescribed pre-exposure prophylaxis (PrEP) in the United States. Prior studies demonstrate disparities in provider comfort and knowledge regarding PrEP, suggesting a need for provider capacity building to support widespread PrEP availability. This study examined real-world PrEP clinical questions/cases from providers to a teleconsultation service to identify knowledge gaps and improve PrEP-related training materials and clinical guidelines. Methods: The National Clinician Consultation Center (NCCC) PrEPline provides educational teleconsultation services on clinical decision-making related to PrEP for U.S. health care providers. The NCCC PrEP consultation data collected between 2017 and 2020 were reviewed and systematically categorized by clinical topics, subtopics, and complexity levels (low, moderate, and high). Results: Within the study period, the PrEPline provided 1,754 teleconsultations. More than three quarters came from advanced practice nurses and physicians. The topics of questions commonly focused on medication-based HIV prevention strategies (22.7%), PrEP laboratory ordering/monitoring (17.4%), and side effects and contraindications (14.6%). The majority of teleconsultations (57.9%) involved sharing information that was directly available/addressed in the Centers for Disease Control and Prevention (CDC) 2017 PrEP Guidelines (i.e., low complexity). Discussion: The low frequency of consultations from nonphysician and non-nurse practitioner providers may suggest a need for increased training and collaborative opportunities for other types of providers. The high percentage of low-complexity inquiries may reveal a desire for capacity-building materials specifically designed for practicing providers (e.g., abridged versions of guidelines). This study may inform future research, best clinical practices, and aid in the development of training materials to increase providers' HIV prevention comfort and knowledge.

Drought, HIV Testing, and HIV Transmission Risk Behaviors: A Population-Based Study in 10 High HIV Prevalence Countries in Sub-Saharan Africa.

Droughts are associated with poor health outcomes and disruption of public health programming. Data on the association between drought and HIV testing and transmission risk behaviors are limited. We combined data from Demographic and Health Surveys from 10 high HIV prevalence sub-Saharan African countries with a high-resolution measure of drought. We estimated the association between drought and recent HIV testing, report of condomless sex, and number of sexual partners in the last year. Respondents exposed to drought were less likely to have an HIV test and more likely to have condomless sex, although effect sizes were small. We found evidence for effect modification by sex and age for the association between drought and HIV testing, such that the negative association between drought and HIV testing was strongest among men (marginal risk ratio [mRR] 0.92, 95% CI 0.89-0.95) and adolescents (mRR 0.90, 95% CI 0.86-0.93). Drought may hinder HIV testing programs in countries with high HIV prevalence.

Overcoming Challenges of Online Research: Measures to Ensure Enrollment of Eligible Participants.

BACKGROUND: Internet-based surveys are increasingly used for health research because they offer several advantages including greater geographic reach, increased participant anonymity, and reduced financial/time burden. However, there is also a need to address inherent challenges, such as the likelihood of fraudulent responses and greater difficulty in determining eligibility. METHODS: We conducted an online nationwide survey of 18-29 year olds living with HIV in the United States, to assess willingness to participate in HIV cure research. To ensure that respondents met age and HIV serostatus inclusion criteria, we instituted screening procedures to identify ineligible respondents using tools that were built into the survey platform (eg, reCAPTCHA, geolocation) and required documentation of age and serostatus before providing access to the incentivized study survey. RESULTS: Of 1308 eligibility surveys, 569 were incomplete or ineligible because of reported age or serostatus. Of the remaining 739 potentially eligible respondents, we determined that 413 were from fraudulent, bot, or ineligible respondents. We sent individual study survey links to 326 participants (25% of all eligibility survey respondents) whose eligibility was reviewed and confirmed by our study team. CONCLUSION: Our multicomponent strategy was effective for identifying ineligible and fraudulent responses to our eligibility survey, allowing us to send the study survey link only to those whose eligibility we were able to confirm. Our findings suggest that proactive fraud prevention can be built into the screening phase of the study to prevent wasted resources related to data cleaning and unretrievable study incentives and ultimately improve the quality of data.

Exploration of a Mobile Technology Vulnerability Scale's association with antiretroviral adherence among young adults living with HIV in the United States.

Background: Young adults living with HIV (YLWH) have suboptimal adherence to antiretroviral therapy (ART) and HIV care outcomes. Mobile health technologies are increasingly used to deliver interventions to address HIV health outcomes. However, not all YLWH have equal and consistent access to mobile technologies. Methods: Using our novel Mobile Technology Vulnerability Scale (MTVS) to evaluate how vulnerable an individual feels with regard to their personal access to mobile technology in the past 6 months, we conducted a cross-sectional online survey with 271 YLWH (18-29 years) in the US to evaluate the relationships between MTVS and self-reported ART adherence. Results: Participants reported changes in phone numbers (25%), stolen (14%) or lost (22%) phones, and disconnections of phone service due to non-payment (39%) in the past 6 months. On a scale of 0 to 1 (0 having no mobile technology vulnerability and 1 having complete mobile technology vulnerability), participants had a mean MTVS of 0.33 (SD =0.26). Black and financially constrained participants had the highest MTVS, which was significantly higher that other racial/ethnic and financially non-constrained groups, respectively. Higher MTVS was significantly associated with ART non-adherence and non-persistence. Conclusions: Findings suggest the need to measure MTVS to recognize pitfalls when using mobile health interventions and identify populations whose inconsistent mobile technology access may be related to worse health outcomes.

Digital directly observed therapy to monitor adherence to medications: a scoping review.

Background: Technology-based directly observed therapy (DOT) is more cost-effective and efficient compared with in-person monitoring visits for medication adherence. While some evidence shows these technologies are feasible and acceptable, there is limited evidence collating information across medical conditions or in the context of HIV prevention, care, and treatment.Objectives: We conducted a scoping review to understand the current evidence on the acceptability, feasibility, and efficacy of digital DOT to improve medication adherence and, specifically, to determine if digital DOT had been used to improve adherence for HIV prevention, care, and treatmentMethods: We searched the electronic databases PubMed, Embase, and the Web of Science in January 2021 for any published studies with terms related to digital technologies and DOT. We included peer-reviewed studies in any population, from any country, for any outcome, and excluded conference abstracts. We included three types of digital DOT interventions: synchronous DOT, asynchronous DOT, and automated DOT. We provide an assessment of the current evidence, gaps in literature, and opportunities for intervention development regarding the use digital DOT to improve antiretroviral therapy (ART) adherence, specifically in the field of HIV.Results: We identified 28 studies that examined digital DOT. All studies found digital DOT to be acceptable and feasible. Patients using digital DOT had higher rates of treatment completion, observed doses, and adherence compared with in-person DOT, although data were limited on adherence. Only one study examined HIV prevention, and none examined ART adherence for HIV treatment.Conclusions: Digital DOT is acceptable and feasible but has not been used to remotely monitor and support ART adherence for people living with HIV.