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.

Moving Antiretroviral Adherence Assessments to the Modern Era: Correlations Among Three Novel Measures of Adherence.

There is no gold standard for estimating antiretroviral therapy (ART) adherence. Feasible, acceptable, and objective measures that are cost- and time-effective are needed. US adults (N = 93) on ART for ≥ 3 months, having access to a mobile phone and internet, and willing to mail in self-collected hair samples, were recruited into a pilot study of remote adherence data collection methods. We examined the correlation of self-reported adherence and three objective remotely collected adherence measures: text-messaged photographs of pharmacy refill dates for pharmacy-refill-based adherence, text-messaged photographs of pills for pill-count-based adherence, and assays of home-collected hair samples for pharmacologic-based adherence. All measures were positively correlated. The strongest correlation was between pill-count- and pharmacy-refill-based adherence (r = 0.68; p < 0.001), and the weakest correlation was between self-reported adherence and hair drug concentrations (r = 0.14, p = 0.34). The three measures provide objective adherence data, are easy to collect, and are viable candidates for future HIV treatment and prevention research.

Use of technology for delivery of mental health and substance use services to youth living with HIV: a mixed-methods perspective.

Disparities in HIV treatment outcomes among youth living with HIV (YLWH) present a challenge for ending the HIV epidemic. Antiretroviral therapy (ART) adherence can be impacted by comorbidities such as mental health and substance use. Technology use has shown promise in increasing access to mental health and substance use services. Using a mixed-methods approach, we conducted formative research to describe the relationship between mental health, substance use, and medication adherence in 18-29 year-old YLWH, and explored technology use as an approach to supporting these services. Among 101 YLWH, ART adherence was significantly negatively associated with mental health measures such as depression, trauma, and adverse childhood experiences and marijuana and stimulants use. Depression had the highest level of relative importance in its association with ART adherence. During in-depth interviews with 29 participants, barriers to and facilitators of accessing and maintaining mental health services were identified. Most participants favored technology use for mental health and substance use service delivery, including videoconferencing with a counselor. Provision of ongoing mental health and substance use treatment is an important mechanism to achieving HIV treatment engagement. Technology, particularly videoconferencing, may have the capacity to overcome many barriers to care by increasing accessibility of these services.

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.

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.

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.

Lessons Learned from an HIV Pre-Exposure Prophylaxis Coordination Program in San Francisco Primary Care Clinics.

HIV pre-exposure prophylaxis (PrEP) has shown high efficacy and effectiveness for HIV prevention; however, many individuals with PrEP indications are not receiving PrEP. PrEP Coordinators work closely with patients and health care providers to increase PrEP access, and they provide unique insights into the inner workings of PrEP care and service delivery. In this study, we discuss key challenges and recommendations for improved PrEP service delivery (including training PrEP Coordinators to manage PrEP panels, making PrEP a part of routine care and optimizing electronic health records, designating a PrEP "champion" who can strengthen communication and leadership, using a proactive approach to increase PrEP retention, and training providers and PrEP Coordinators to meet youth-specific needs) from our discussions with the PrEP Coordinators who led PrEP panel management in San Francisco Department of Public Health primary care clinics.

Feasibility and Acceptability of Home-Collected Samples for Human Immunodeficiency Virus Preexposure Prophylaxis and Severe Acute Respiratory Syndrome Coronavirus 2 Laboratory Tests in San Francisco Primary Care Clinics.

BACKGROUND: Due to the difficulty of conducting laboratory testing during the pandemic shelter-in-place orders, the objective of this study was to examine the feasibility and acceptability of conducting home-collected samples for preexposure prophylaxis (PrEP) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) laboratory tests. METHODS: We conducted a pilot study among patients on PrEP in San Francisco primary care clinics. Individuals on PrEP provided home-collected laboratory samples using dried blood spot for fourth-generation human immunodeficiency virus antigen/antibody test, serum creatinine, syphilis antibody, and hepatitis C antibody, as needed; 3-site (oropharyngeal, rectal, and urine) swabbing for sexually transmitted infections; and nasopharyngeal swabbing for SARS-CoV-2 polymerase chain reaction. We examined feasibility and acceptability of collecting these laboratory samples using predefined benchmarks to determine feasibility or acceptability. RESULTS: Of 92 individuals who consented to participate, 73 (79.3%) mailed back their home-collected kit. Nearly 87.7% noted being extremely to moderately satisfied with the ability to complete the laboratory tests without having to come into a clinic. Approximately 49.3% of participants chose this home-collection method as their first choice for providing laboratory samples. Mean time from collection of samples by the participant to receipt of test results was reduced from the first quarter of the study (17 days) to the last quarter of the study (5 days). CONCLUSIONS: We report high levels of feasibility and acceptability with the use of home-collected laboratory samples for patients on PrEP. Our results indicate that home-collected laboratory samples for patients on PrEP is a viable option that should be offered as an alternative to clinic-collected laboratory samples.

The effect of an HIV preexposure prophylaxis panel management strategy to increase preexposure prophylaxis prescriptions.

OBJECTIVE: The HIV preexposure prophylaxis optimization intervention (PrEP-OI) study evaluated the efficacy of a panel management intervention using PrEP coordinators and a web-based panel management tool to support healthcare providers in optimizing PrEP prescription and ongoing PrEP care. DESIGN: The PrEP-OI study was a stepped-wedge randomized clinical trial conducted across 10 San Francisco Department of Public Health primary care sites between November 2018 and September 2019. Each month, clinics one-by-one initiated PrEP-OI in random order until all sites received the intervention by the study team. METHODS: The primary outcome was the number of PrEP prescriptions per month. Secondary outcomes compared pre- and postintervention periods on whether PrEP was discussed and whether PrEP-related counseling (e.g., HIV risk assessment, risk reduction counseling, PrEP initiation/continuation assessment) was conducted. Prescription and clinical data were abstracted from the electronic health records. We calculated incidence rate ratios (IRR) and risk ratios (RR) to estimate the intervention effect on primary and secondary outcomes. RESULTS: The number of PrEP prescriptions across clinics increased from 1.85/month (standard deviation [SD] = 2.55) preintervention to 2.44/month (SD = 3.44) postintervention (IRR = 1.34; 95% confidence interval [CI] = 1.05-1.73; P  = 0.021). PrEP-related discussions during clinic visits (RR = 1.13; 95% CI = 1.04-1.22; P  = 0.004), HIV risk assessment (RR = 1.40; 95% CI = 1.14-1.72; P  = 0.001), and risk reduction counseling (RR = 1.16; 95% CI = 1.03-1.30; P  = 0.011) increased from the pre- to the postintervention period. Assessment of PrEP initiation/continuation increased over time during the postintervention period (RR = 1.05; 95% CI = 0.99-1.11; P  = 0.100). CONCLUSIONS: A panel management intervention using PrEP coordinators and a web-based panel management tool increased PrEP prescribing and improved PrEP-related counseling in safety-net primary care clinics.

"You can't have a PrEP program without a PrEP Coordinator": Implementation of a PrEP panel management intervention.

Lack of healthcare provider knowledge, capacity, and willingness to prescribe PrEP are barriers to PrEP delivery in clinical settings. We implemented the PrEP Optimization Intervention (PrEP-OI) combining a PrEP Coordinator with an online panel management tool to assist providers with PrEP uptake, persistence, and management in 12 San Francisco Department of Public Health Primary Care Clinics. Medical directors (N = 10) identified important factors to consider prior to implementation, including shortage of clinical space for coordinators, medical mistrust, language barriers, and limited lab hours, along with the need for education of providers and staff and patient outreach. Among 110 providers who completed a baseline survey, the majority had reservations in asking about sexual practices and having conversations about PrEP. Providers reported PrEP-OI increased their efficiency and capacity to manage PrEP patients, and served as a gateway to additional services. These results highlight the promise of a provider-based intervention to improve the PrEP continuum and maximize the impact of PrEP.

Improving the HIV PrEP continuum of care using an intervention for healthcare providers: a stepped-wedge study protocol.

INTRODUCTION: Pre-exposure prophylaxis (PrEP) has demonstrated to be a highly effective method for preventing HIV; however, many individuals with PrEP indications are not receiving PrEP. Primary care settings provide an opportunity to offer PrEP to a wide range of patients. In this paper, we describe the PrEP Optimisation Intervention (PrEP-OI), which includes a PrEP Coordinator and a web-based panel management tool (called PrEP-Rx), and is targeted at healthcare providers (HCPs) to increase PrEP uptake and persistence among those at risk for acquiring HIV. METHODS AND ANALYSIS: The PrEP-OI study evaluates the efficacy of the PrEP intervention (PrEP Coordinator + PrEP-Rx) to increase PrEP prescriptions through a stepped-wedge design among 10 primary care clinical sites in the San Francisco Department of Public Health. The number of PrEP initiation prescriptions constitute the primary outcome, and we hypothesise that the mean number of PrEP prescriptions written will significantly increase after the clinics initiate PrEP-OI versus before this intervention. Secondary objectives include: 1-differences in PrEP initiation, duration of use and reasons for discontinuation based on patient's age, race/ethnicity and sex/gender, and by clinic and HCP characteristics, 2-sustainability of the intervention during a 12-month follow-up after the stepped-wedge phase, and 3-facilitators and barriers of PrEP delivery and experiences with the proposed PrEP intervention through qualitative interviews with HCPs. The results of this study can provide valuable insight into methods to reduce the burden of PrEP care on HCPs and improve PrEP continuum of care. ETHICS AND DISSEMINATION: This study and its protocols have been approved by the University of California, San Francisco (UCSF) Institutional Review Board. Study staff will disseminate findings locally (eg, the UCSF Centre for AIDS Prevention Studies' Community Engagement Core), statewide (eg, the California Department of Public Health's Office of AIDS) and nationally and internationally at conferences related to HIV. TRIAL REGISTRATION NUMBER: NCT03532191.

Feasibility and acceptability of novel methods to estimate antiretroviral adherence: A longitudinal study.

Due to marked reductions in morbidity and mortality, antiretroviral (ARV) adherence monitoring is of high interest. Researchers and clinicians often resort to the most feasible and cost-effective adherence methods possible, which may result in biased or inaccurate estimates and require the physical presence of a participant at a research or clinic site. The objective of our study was to evaluate the feasibility and acceptability of three objective, innovative, and remote methods to estimate ARV adherence which may be conducted with less time and financial resources in a wide range of clinic and research settings. These three methods included: (a) text-messaged photographs of pharmacy refill dates to measure refill-based adherence, (b) text-messaged photographs of ARV medications to estimate pill-count-based adherence, and (c) home-collected hair samples for the measurement of ARV concentration to determine pharmacologic-based adherence. We conducted a pilot study from March through October 2017 to examine the feasibility and acceptability of these three adherence measures and the remotely conducted study procedures in 93 adults living with HIV nationwide. From our diverse national sample of participants, 95.7% were retained until the end of the study, 89.9% sent all text messages, and 84.3% sent all hair samples. Approximately 74.2% of participants reported excellent overall experience with the study, 60.2% were very or extremely satisfied with participating in a hair collection study, and 76.3% noted extremely high likelihood of participating in a similar study including text messaging pictures of medications or refill dates. We noted high levels of feasibility and acceptability with the remote study methodology, collection of photographed and text messaged pharmacy refill dates and pill counts, and home-collected hair samples. Here we describe the feasibility and acceptability metrics, results from the exit qualitative interviews with the participants, and lessons learned. These adherence measures represent innovative approaches to expand monitoring tools for HIV treatment and prevention adherence in future research.

What does it mean to be youth-friendly? Results from qualitative interviews with health care providers and clinic staff serving youth and young adults living with HIV.

PURPOSE: Given the consistent associations between younger age and numerous suboptimal clinical outcomes, there is a critical need for more research in youth living with human immunodeficiency virus (YLWH) and tailoring of health care delivery to the unique and complex needs of this population. The objective of this study was to examine the facilitators of and barriers to engagement in care among YLHW at the system and provider/staff level, as well as the barriers to using technology-based forms of communication with YLWH to improve retention and engagement in care. PATIENTS AND METHODS: We conducted in-depth qualitative interviews with health care providers and staff members at the clinics and organizations serving YLWH in the San Francisco Bay Area. RESULTS: We interviewed 17 health care providers and staff members with a mean of 8 years of experience in providing clinical care to YLWH. Interviewees noted various facilitators of and barriers to engagement in care among YLWH, including the environment of the clinic (e.g., clinic location and service setting), provision of youth-friendly services (e.g., flexible hours and use of technology), and youth-friendly providers/staff (e.g., nonjudgmental approach). With regard to barriers to using technology in organizations and clinics, interviewees discussed the challenges at the system level (e.g., availability of technology, clinic capacity, and Health Insurance Portability and Accountability Act compliance), provider/staff level (e.g., time constraints and familiarity with technology), and youth level (e.g., changing of cellular telephones and relationship with provider/staff). CONCLUSION: Given the need for improved clinical outcomes among YLWH, our results can provide guidance for clinics and institutions providing care for this population to enhance the youth-friendliness of their services and examine their guidelines around the use of technology.

Novel methods to estimate antiretroviral adherence: protocol for a longitudinal study.

BACKGROUND: There is currently no gold standard for assessing antiretroviral (ARV) adherence, so researchers often resort to the most feasible and cost-effective methods possible (eg, self-report), which may be biased or inaccurate. The goal of our study was to evaluate the feasibility and acceptability of innovative and remote methods to estimate ARV adherence, which can potentially be conducted with less time and financial resources in a wide range of clinic and research settings. Here, we describe the research protocol for studying these novel methods and some lessons learned. METHODS: The 6-month pilot study aimed to examine the feasibility and acceptability of a remotely conducted study to evaluate the correlation between: 1) text-messaged photographs of pharmacy refill dates for refill-based adherence; 2) text-messaged photographs of pills for pill count-based adherence; and 3) home-collected hair sample measures of ARV concentration for pharmacologic-based adherence. Participants were sent monthly automated text messages to collect refill dates and pill counts that were taken and sent via mobile telephone photographs, and hair collection kits every 2 months by mail. At the study end, feasibility was calculated by specific metrics, such as the receipt of hair samples and responses to text messages. Participants completed a quantitative survey and qualitative exit interviews to examine the acceptability of these adherence evaluation methods. The relationship between the 3 novel metrics of adherence and self-reported adherence will be assessed. DISCUSSION: Investigators conducting adherence research are often limited to using either self-reported adherence, which is subjective, biased, and often overestimated, or other more complex methods. Here, we describe the protocol for evaluating the feasibility and acceptability of 3 novel and remote methods of estimating adherence, with the aim of evaluating the relationships between them. Additionally, we note the lessons learned from the protocol implementation to date. We expect that these novel measures will be feasible and acceptable. The implications of this research will be the identification and evaluation of innovative and accurate metrics of ARV adherence for future implementation.