Acceptability of Long-Acting Injectable Antiretroviral Therapy Among People with HIV Receiving Care at Three Ryan White Funded Clinics in the United States.

Understanding the acceptability of long-acting injectable antiretroviral therapy (LAI-ART) among people with HIV (PWH), especially priority populations, is essential for effective implementation. We conducted semi-structured interviews with patients in three Ryan White-funded HIV clinics in San Francisco, Chicago, and Atlanta. We employed maximal variation sampling across age, gender, race, ethnicity, and time living with HIV and oversampled for individuals with suboptimal clinical engagement. An 8-step hybrid deductive and inductive thematic analysis approach guided data analysis. Between August 2020 and July 2021, we conducted 72 interviews. Median age was 46 years; 28% were ciswomen, 7% transwomen, 44% Black/African-American and 35% Latinx, 43% endorsed a psychiatric diagnosis, 35% were experiencing homelessness/unstable housing, and 10% had recent substance use. Approximately 24% were sub-optimally engaged in care. We observed a spectrum of LAI-ART acceptability, ranging from enthusiasm to hesitancy to rejection. We also characterized four emergent orientations towards LAI-ART: innovator, pragmatist, deliberator, and skeptic. Overall, the majority of participants expressed favorable initial reactions towards LAI-ART. Most approached LAI-ART pragmatically, but acceptability was not static, often increasing over the course of the interview. Participants considered their HIV providers as essential for affirming personal relevance. HIV stigma, privacy concerns, and medical mistrust had varied impacts, sometimes facilitating and other times hindering personal relevance. These findings held across priority populations, specifically young adults, cis/trans women, racial/ethnic minorities, and individuals with suboptimal clinical engagement. Further research is needed to explore the transition from hypothetical acceptance to uptake and to confirm the actual benefits and drawbacks of this treatment.

RESUMEN: La aceptabilidad de la terapia antirretroviral inyectable de acción prolongada (LAI-ART, por su sigla en inglés) entre personas con VIH es esencial para una implementación efectiva. Durante el periodo de agosto de 2020 a julio de 2021, realizamos 72 entrevistas semiestructuradas con personas con VIH en clínicas públicas ubicadas en San Francisco, Chicago y Atlanta. Un análisis temático, tanto deductivo como inductivo, guio nuestra investigación. Observamos un espectro de aceptabilidad de LAI-ART que va desde el entusiasmo hasta la indecisión y el rechazo. También caracterizamos cuatro orientaciones actitudinales emergentes hacia LAI-ART: innovadora, pragmática, deliberativa y escéptica. Los participantes también señalaron la importancia de sus proveedores de VIH para validar su relevancia personal. El estigma asociado al VIH, preocupaciones sobre la privacidad y desconfianza en el sistema médico tuvieron diversos impactos, a veces facilitando y otras veces obstaculizando la relevancia personal. Entre las poblaciones prioritarias del estudio, los resultados fueron consistentes.

The Brief Human Immunodeficiency Virus (HIV) Index: A Rapid 3-Item Scale to Measure Engagement in HIV Care.

We created a brief version of The Index, a validated patient-reported measure that has potential to quickly identify patients at risk for poor retention. We analyzed Index scores from 2406 patients from 2016 to 2017 in a national cohort of patients in human immunodeficiency virus (HIV) care. Index scores predicted poor retention 12 months after administered.

"I'm both smoking and vaping": a longitudinal qualitative study of US young adults who tried to quit smoking cigarettes by using electronic cigarettes.

OBJECTIVE: To describe how young adults use electronic cigarettes (electronic nicotine delivery systems (ENDS)) for smoking cessation and reasons why they may or may not successfully quit smoking. METHODS: Longitudinal qualitative data were collected annually from 2017 to 2019 for 25 young adult tobacco users (aged 18-29 years) in California (USA) who used ENDS to quit/reduce smoking. Thematic and trajectory analyses were used to identify key within-person and between-person changes in tobacco/nicotine use over time. RESULTS: Five types of tobacco use transition were identified among baseline dual users of cigarettes and ENDS: sustained dual use without reduced smoking (n=8), transition to exclusive daily ENDS use (n=6), sustained dual use with reduced smoking (n=5), transition back to exclusive smoking (n=4) and transition to neither smoking nor vaping (n=2). Participants' ENDS use behaviour varied over time in terms of vaping quantity and device characteristics (eg, changing nicotine concentrations/flavours, switching between multiple devices). Three themes that related to successfully replacing cigarettes with ENDS were perceived positive physical effects, perceived satisfaction and enjoyment and context changes. Four themes for unsuccessful replacement were perceived negative physical discomforts, perceived addictiveness and harm, unsatisfactory substitution for cigarettes and device malfunction. CONCLUSIONS: Young adults' experiences with using ENDS as a smoking cessation aid were highly variable. Adequate nicotine delivery and perceived safety and benefits contributed to successfully reducing or quitting cigarettes. Providing behavioural counselling and standardising ENDS products may enhance cessation for young adults.

Rapid start antiretroviral therapies for improved engagement in HIV care: implementation science evaluation protocol.

BACKGROUND: In 2020, the Health Resources and Services Administration's HIV/AIDS Bureau funded an initiative to promote implementation of rapid antiretroviral therapy initiation in 14 HIV treatment settings across the U.S. The goal of this initiative is to accelerate uptake of this evidence-based strategy and provide an implementation blueprint for other HIV care settings to reduce the time from HIV diagnosis to entry into care, for re-engagement in care for those out of care, initiation of treatment, and viral suppression. As part of the effort, an evaluation and technical assistance provider (ETAP) was funded to study implementation of the model in the 14 implementation sites. METHOD: The ETAP has used implementation science methods framed by the Dynamic Capabilities Model integrated with the Conceptual Model of Implementation Research to develop a Hybrid Type II, multi-site mixed-methods evaluation, described in this paper. The results of the evaluation will describe strategies associated with uptake, implementation outcomes, and HIV-related health outcomes for patients. DISCUSSION: This approach will allow us to understand in detail the processes that sites to implement and integrate rapid initiation of antiretroviral therapy as standard of care as a means of achieving equity in HIV care.

'The High Five Club': Social Relations and Perspectives on HIV-Related Stigma During an HIV Outbreak in West Virginia.

In the United States, HIV outbreaks are occurring in areas most affected by the opioid epidemic, including West Virginia (WV). Cultural Theory contends that multiple cultures co-exist within societies distinguished by their differing intensities of rules or norms of behavior ('grid') or degree of group allegiance/individual autonomy ('group'). Accordingly, we would expect that perceptions about HIV, including stigma, correspond with individuals' grid/group attributes. To explore this, we conducted qualitative interviews with people who inject drugs (PWID) recruited from a WV syringe service program. This paper focuses on our unexpected findings on stigma during a coinciding HIV outbreak. PWID living homeless identified as belonging to a 'street family'. Its members were mutually distrustful and constrained by poverty and drug dependence but despite their conflicts, reported openness between each other about HIV + status. Interviewees living with HIV perceived little enacted stigma from peers since the local outbreak. Contrasting stigmatizing attitudes were attributed to the town's mainstream society. The 'High Five' (Hi-V) Club, expressing defiance towards stigmatizing behavior outside the street family, epitomized the tensions between a desire for solidary and mutual support and a fatalistic tendency towards division and distrust. Fatalism may hinder cooperation, solidarity and HIV prevention but may explain perceived reductions in stigma.

Essential elements of and challenges to rapid ART implementation: a qualitative study of three programs in the United States.

BACKGROUND: Antiretroviral therapy (ART) initiation on the day of an HIV diagnosis or as soon as possible after diagnosis, known as rapid ART (henceforth "RAPID"), is considered to be a safe and effective intervention to quickly reduce viral load and potentially improve engagement in care over time. However, implementation of RAPID programming is not yet widespread. To facilitate broader dissemination of RAPID, we sought to understand health care worker experiences with RAPID implementation and to identify essential programmatic elements. METHODS: We conducted 27 key informant interviews with medical providers and staff involved in RAPID service delivery in three distinct clinical settings: an HIV clinic, a Federally Qualified Health Center and a sexual health and wellness clinic. Interviews were structured around domains associated with the Consolidated Framework for Implementation Research and were audio-recorded, transcribed, and thematically analyzed. FINDINGS: We identified seven (7) essential elements across settings associated with successful RAPID program implementation. These high-impact elements represent essential components without which a RAPID program could not function. There was no one requisite formation. Instead, we observed a constellation of essential elements that could be operationalized in various formations and by various people in various roles. The essential elements included: (1) presence of an implementation champion; (2) comfort and competence prescribing RAPID ART; (3) expedited access to ART medications; (4) expertise in benefits, linkage, and care navigation; (5) RAPID team member flexibility and organizations' adaptive capacity; (6) patient-centered approach; and (7) strong communication methods and culture. CONCLUSIONS: The RAPID model can be applied to a diverse range of clinical contexts. The operational structure of RAPID programs is shaped by the clinical setting in which they function, and therefore the essential elements identified may not apply equally to all programs. Based on the seven essential elements described above we recommend future implementers identify where these elements currently exist within a practice; leverage them when possible; strengthen them when necessary or develop them if they do not yet exist; and look to these elements when challenges arise for potential solutions.

The Human Immunodeficiency Virus (HIV) Index: Using a Patient-Reported Outcome on Engagement in HIV Care to Explain Suboptimal Retention in Care and Virologic Control.

BACKGROUND: We investigated the prospective association between a brief self-report measure of engagement in human immunodeficiency virus (HIV) care (the Index of Engagement in HIV Care; hereafter "Index") and suboptimal retention and viral suppression outcomes. METHODS: The Centers for AIDS Research Network of Integrated Clinical Systems cohort study combines medical record data with patient-reported outcomes from 8 HIV clinics in the United States, which from April 2016 to March 2017 included the 10-item Index. Multivariable logistic regression was used to estimate the risk and odds ratios of mean Index scores on 2 outcomes in the subsequent year: (1) not keeping ≥75% of scheduled HIV care appointments; and (2) for those with viral suppression at Index assessment, having viral load >200 copies/mL on ≥1 measurement. We also used generalized linear mixed models (GLMMs) to estimate the risk and odds ratios of appointment nonattendance or unsuppressed viral load at any given observation. We generated receiver operating characteristic curves for the full models overlaid with the Index as a sole predictor. RESULTS: The mean Index score was 4.5 (standard deviation, 0.6). Higher Index scores were associated with lower relative risk of suboptimal retention (n = 2576; logistic regression adjusted risk ratio [aRR], 0.88 [95% confidence interval, .87-.88]; GLMM aRR, 0.85 [.83-.87]) and lack of sustained viral suppression (n = 2499; logistic regression aRR, 0.75 [.68-.83]; GLMM aRR, 0.74 [.68-.80]). The areas under the receiver operating characteristic curve for the full models were 0.69 (95% confidence interval, .67-.71) for suboptimal retention and 0.76 (.72-.79) for lack of sustained viral suppression. CONCLUSIONS: Index scores are significantly associated with suboptimal retention and viral suppression outcomes.

Human Enough: A Qualitative Study of Client Experience With Internet-Based Access to Pre-exposure Prophylaxis.

BACKGROUND: HIV pre-exposure prophylaxis (PrEP) is a way to prevent HIV infection using antiretroviral medications. However, common barriers to PrEP engagement include lack of access to prescribers; discomfort seeking sexual health services; and racism, homophobia, and transphobia in medical contexts. Key populations (eg, communities of color, young men who have sex with men, and transgender women) are underrepresented in terms of PrEP uptake in the United States. Nurx is an innovative company that has offered internet-based access to PrEP since 2016. OBJECTIVE: In this study, in partnership with Nurx, we aim to explore clients' experiences of digital PrEP access-including the difference made by the telehealth format-and to understand whether Nurx helped reduce barriers to PrEP. METHODS: Electronic chart review and semistructured interviews were conducted with 31 PrEP requesters from California, Florida, Illinois, and New York. Interviews were recorded, transcribed, and subjected to inductive and deductive thematic analysis. RESULTS: Some interviewees reported initial skepticism about whether a web-based PrEP service could be legitimate or feasible. Despite this, most clients were effusive about their eventual Nurx experience, and many reported that Nurx eased barriers to PrEP access through the availability of knowledgeable, willing prescribers and minimizing embarrassment and discrimination. Our analysis suggests Nurx produced satisfaction by achieving an acceptable balance between 2 client desires: efficiency and humanity. Efficiency encompasses the simplicity, speed, and convenience of obtaining PrEP, both regarding the Nurx process itself and in comparison with in-person encounters. Humanity covers clients' wish for personalized, responsive interaction and a feeling of connection or care. Nurx's messaging platform was crucial to manifesting these qualities and was largely interpreted through the familiar frame of texting. Clients conceived efficiency and humanity as inversely related in a commercial enterprise and varied in the particular balance they felt was optimal. Those who wished for slightly more humanity than the service afforded used the concept of a trade-off to explain why Nurx remained appealing. CONCLUSIONS: Our findings augment evidence that internet-based PrEP provision can broaden access to this HIV prevention strategy. This important finding, notwithstanding a few provisos, merits mention. Telehealth, as practiced by Nurx, was still dependent on culturally competent medical providers as system inputs, and the very technology used to overcome access barriers (ie, the internet) generated new hurdles for some clients. Furthermore, clients did not interpret Nurx in a vacuum: their past experiences and the social and structural context mattered. Finally, only granular inquiry revealed precisely how Nurx satisfied clients whose experiences and preferences fell within a particular range. Extrapolating from this, we urge scholars not to fetishize technological solutions but rather to interrogate the ways in which any intervention's design works for certain kinds of patients.

Practice transformations to optimize the delivery of HIV primary care in community healthcare settings in the United States: A program implementation study.

BACKGROUND: The United States HIV care workforce is shrinking, which could complicate service delivery to people living with HIV (PLWH). In this study, we examined the impact of practice transformations, defined as efficiencies in structures and delivery of care, on demonstration project sites within the Workforce Capacity Building Initiative, a Health Resources and Services Administration (HRSA) Ryan White HIV/AIDS Program Special Projects of National Significance (SPNS). METHODS AND FINDINGS: Data were collected at 14 demonstration project sites in 7 states and the District of Columbia. Organizational assessments were completed at sites once before and 4 times after implementation. They captured 3 transformation approaches: maximizing the HIV care workforce (efforts to increase the number of existing healthcare workforce members involved in the care of PLWH), share-the-care (team-based care giving more responsibility to midlevel providers and staff), and enhancing client engagement in primary HIV care to reduce emergency and inpatient care (e.g., care coordination). We also obtained Ryan White HIV/AIDS Program Services Reports (RSRs) from sites for calendar years (CYs) 2014-2016, corresponding to before, during, and after transformation. The RSR include data on client retention in HIV care, prescription of antiretroviral therapy (ART), and viral suppression. We used generalized estimating equation (GEE) models to analyze changes among sites implementing each practice transformation approach. The demonstration projects had a mean of 18.5 prescribing providers (SD = 23.5). They reported data on more than 13,500 clients per year (mean = 969/site, SD = 1,351). Demographic characteristics remained similar over time. In 2014, a majority of clients were male (71% versus 28% female and 0.2% transgender), with a mean age of 47 (interquartile range [IQR] 37-54). Racial/ethnic characteristics (48% African American, 31% Hispanic/Latino, 14% white) and HIV risk varied (31% men who have sex with men; 31% heterosexual men and women; 7% injection drug use). A substantial minority was on Medicaid (41%). Across sites, there was significant uptake in practices consistent with maximizing the HIV care workforce (18% increase, p < 0.001), share-the-care (25% increase, p < 0.001), and facilitating patient engagement in HIV primary care (13% increase, p < 0.001). There were also significant improvements over time in retention in HIV care (adjusted odds ratio [aOR] = 1.03; 95% confidence interval [CI] 1.02-1.04; p < 0.001), ART prescription levels (aOR = 1.01; 95% CI 1.00-1.01; p < 0.001), and viral suppression (aOR = 1.03; 95% CI 1.02-1.04; p < 0.001). All outcomes improved at sites that implemented transformations to maximize the HIV care workforce or improve client engagement. At sites that implemented share-the-care practices, only retention in care and viral suppression outcomes improved. Study limitations included use of demonstration project sites funded by the Ryan White HIV/AIDS Program (RWHAP), which tend to have better HIV outcomes than other US clinics; varying practice transformation designs; lack of a true control condition; and a potential Hawthorne effect because site teams were aware of the evaluation. CONCLUSIONS: In this study, we found that practice transformations are a potential strategy for addressing anticipated workforce challenges among those providing care to PLWH. They hold the promise of optimizing the use of personnel and ensuring the delivery of care to all in need while potentially enhancing HIV care continuum outcomes.

Attitudes about community pharmacy access to HIV prevention medications in California.

OBJECTIVE: Increasing access to human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) is a high priority for the Ending the HIV Epidemic Initiative. Expanding access to PrEP and PEP through a variety of health care settings, including community pharmacies, may increase access in communities most in need. California is the first state to allow community pharmacists to furnish PrEP and PEP directly to consumers. Our objective was to assess attitudes among key stakeholders about a California policy to allow community pharmacists to furnish HIV PrEP and PEP. METHODS: We conducted a qualitative case study with key pharmacy stakeholders. Semistructured phone interviews were audio-recorded and transcribed verbatim. We generated analytical memos for each interview and working with these analytical memos, we conducted a constant comparison across cases to identify commonalities and differences. RESULTS: We launched the study in October 2018 and interviewed pharmacists (n = 7) working in a variety of settings, including retail-, clinic-, and community-based pharmacies. We also interviewed medical providers (n = 2) working in high-volume PrEP clinics and sought input from representatives of large retail chain pharmacies (n = 2). Overall, pharmacists and medical provider informants shared similar opinions about the central benefits as well as the key challenges related to pharmacist-delivered PrEP and PEP services. Benefits included: community pharmacists are widely accessible, PrEP and PEP protocols are similar to other preventative medications, policy may lead to efficiencies in the health care workforce, and community pharmacists are authorities on medication adherence. Challenges included: implementation issues may limit pharmacist involvement, and missed opportunities to diagnose and treat other health conditions. CONCLUSION: This study characterizes the types of benefits and challenges that can be expected when PrEP and PEP prescribing privileges are extended to community pharmacists. This information may be useful to policymakers and other stakeholders considering legislation to permit direct prescription of PrEP and PEP by pharmacists.

"I don't have to do this all by myself": Systems Navigation to Ensure Continuity of HIV Care for Persons Leaving Prison.

Ensuring continuity of and retention in care after release from prison is critical for optimizing health outcomes among people living with HIV. As part of a large federal initiative, we conducted qualitative interviews (n = 24) with individuals living with HIV and recently released from prison in four states to understand their experiences in different navigation interventions to improve access to HIV care post-release. Interventions were delivered only in prison, only in the community, or in both settings. While the interventions varied by design, overall, participants appreciated the breadth of support received from interventionists, including health system navigation, case management and social support. Even when individuals leaving prison were returning to clinics that they were familiar with, systems navigation supported continuity of care. Our findings elucidate why navigational support was instrumental, and underscore the value of a variety of types of navigation programs in facilitating continuity of care and reintegration post-prison.

"Closing the Loop" Developing State-Level Data Sharing Interventions to Promote Optimum Outcomes Along the HIV Continuum of Care.

This manuscript describes the experiences of three state departments of health (SDoH) that successfully launched data sharing interventions involving surveillance and/or patient data collected in clinics to improve care outcomes among people living with HIV. We examined 58 key informant interviews, gathered at two time points, to describe the development and implementation of data sharing interventions. We identified three common themes across states' experiences: creating standard practices, fostering interoperability, and negotiating the policy environment. Projects were successful when state teams adapted to changing circumstances and were committed to a consistent communication process. Once implemented, the interventions streamlined processes to promote linkage and retention in care among low-income populations living with HIV. Despite using routinely collected data, key informants emphasized the labor-intensive process to develop and sustain the interventions. Lessons learned from these three state experiences can help inform best practices for other SDoH that are considering launching similar interventions.

The Effect of Patient Navigation on the Likelihood of Engagement in Clinical Care for HIV-Infected Individuals Leaving Jail.

OBJECTIVES: To compare the effectiveness of patient navigation-enhanced case management in supporting engagement in HIV care upon release from jail relative to existing services. METHODS: We randomized 270 HIV-infected individuals to receive navigation-enhanced case management for 12 months or standard case management for 90 days following release from jail between 2010 and 2013. Participants were interviewed at 2, 6, and 12 months after release. We abstracted medical data from jail and city health records. RESULTS: Patient navigation-enhanced case management resulted in greater linkage to care within 30 days of release (odds ratio [OR] = 2.15; 95% confidence interval [CI] = 1.23, 3.75) and consistent retention over 12 months (OR = 1.95; 95% CI = 1.11, 3.46). Receipt of treatment for substance use disorders in jail also resulted in early linkage (OR = 4.06; 95% CI = 1.93, 8.53) and retention (OR = 2.52; 95% CI = 1.21, 5.23). Latinos were less likely to be linked to (OR = 0.35; 95% CI = 0.14, 0.91) or retained in (OR = 0.28; 95% CI = 0.09, 0.82) HIV care. CONCLUSIONS: Patient navigation supports maintaining engagement in care and can mitigate health disparities, and should become the standard of care for HIV-infected individuals leaving jail.

Sexual Behavior, Risk Compensation, and HIV Prevention Strategies Among Participants in the San Francisco PrEP Demonstration Project: A Qualitative Analysis of Counseling Notes.

Pre-exposure prophylaxis (PrEP) is a viable HIV prevention strategy but risk compensation could undermine potential benefits. There are limited data that examine this phenomenon outside of clinical trials. We conducted a qualitative analysis of counseling notes from the San Francisco site of the US PrEP demonstration project to assess how men who have sex with men used PrEP as a prevention strategy and its impact on their sexual practices. Four major themes emerged from our analysis of 130 distinct notes associated with 26 participants. Prevention strategy decision-making was dynamic, often influenced by the context and perceived risk of a sexual encounter. Counselors noted that participants used PrEP in conjunction with other health promotion strategies like condoms, asking about HIV status of their sex partners, and seroadaptation. With few exceptions, existing risk reduction strategies were not abandoned upon initiation of PrEP. Risk-taking behavior was 'seasonal' and fluctuations were influenced by various personal, psychosocial, and health-related factors. PrEP also helped relieve anxiety regarding sex and HIV, particularly among serodiscordant partners. Understanding sexual decision-making and how PrEP is incorporated into existing prevention strategies can help inform future PrEP implementation efforts.

Retained in HIV Care But Not on Antiretroviral Treatment: A Qualitative Patient-Provider Dyadic Study.

BACKGROUND: Patients retained in HIV care but not on antiretroviral therapy (ART) represent an important part of the HIV care cascade in the United States. Even in an era of more tolerable and efficacious ART, decision making in regards to ART offer and uptake remains complex and calls for exploration of both patient and provider perspectives. We sought to understand reasons for lack of ART usage in patients meeting the Health Resources Services Administration definition of retention as well as what motivated HIV primary care appointment attendance in the absence of ART. METHODS AND FINDINGS: We conducted a qualitative study consisting of 70 in-depth interviews with ART-naïve and ART-experienced patients off ART and their primary care providers in two urban safety-net HIV clinics in San Francisco and New York. Twenty patients and their providers were interviewed separately at baseline, and 15 dyads were interviewed again after at least 3 mo and another clinic visit in order to understand any ART use in the interim. We applied dyadic analysis to our data. Nearly all patients were willing to consider ART, and 40% of the sample went on ART, citing education on newer antiretroviral drugs, acceptance of HIV diagnosis, social support, and increased confidence in their ability to adhere as facilitators. However, the strength of the provider recommendation of ART played an important role. Many patients had internalized messages from providers that their health was too good to warrant ART. In addition, providers, while demonstrating patient-centered care through sensitivity to patients experiencing psychosocial instability, frequently muted the offer of ART, at times unintentionally. In the absence of ART, lab monitoring, provider relationships, access to social services, opiate pain medications, and acute symptoms motivated care. The main limitations of this study were that treatment as prevention was not explored in depth and that participants were recruited from academic HIV clinics in the US, making the findings most generalizable to this setting. CONCLUSIONS: Provider communication with regard to ART is a key focus for further exploration and intervention in order to increase ART uptake for those retained in HIV care.

Acceptability of drug detection monitoring among participants in an open-label pre-exposure prophylaxis study.

In the world of HIV pre-exposure prophylaxis (PrEP) research, there is emerging interest in providing study participants with pharmacokinetic results from drug level testing to guide adherence counseling. The iPrEx randomized control trial was the first study to produce meaningful results of PrEP in humans. In the iPrEx open-label extension (OLE) study, blood plasma samples collected in the first 12 weeks of study participation were tested for the presence of tenofovir/emtricitabine--the drugs which compromise PrEP. Study clinicians shared results (detectable/undetectable) with participants at their 24-week visit. We evaluated the acceptability of receiving these results among a subset of iPrEx OLE participants. We conducted in-depth interviews (n = 59) with participants (those with and those without drug detected) enrolled in Boston, Chicago, and San Francisco to assess their experiences with receiving drug detection feedback. Incorporating drug detection results into the clinical study visit was well received and no negative reactions were expressed. For about half of participants, receiving their drug detection lab result was useful while for others it was not important. In a few cases, no drug detected results led to increased efforts to take PrEP consistently and in most cases enhanced open discussion of missed doses. Participants reported a desire for greater specificity, particularly quantitative drug levels needed for protection. We recommend exploring strategies to increase the salience of drug level results, including using feedback to target adherence counseling, and reducing the time between specimen collection, testing, and receipt of results. Future studies should evaluate the feasibility and impact of providing more specific quantitative drug levels using biomarkers of longer term PrEP exposure, i.e., hair/dried blood spots.

Attitudes about providing HIV care: voices from publicly funded clinics in California.

BACKGROUND: As the enactment of health care reform becomes a reality in the USA, it has been widely predicted that HIV+ patients will increasingly be cared for by primary care physicians (PCPs), many of whom lack the experience to deliver full-spectrum HIV care. OBJECTIVE: To describe PCPs' preparedness for an influx of HIV+ patients. METHODS: This qualitative study included interviews with 20 PCPs from community health centres in California. We inquired about clinicians' experiences with HIV, their strategies for dealing with unfamiliar aspects of medicine and their management of complicated patients. We also identified the clinicians' preferred types of information and consultation resources. RESULTS: PCPs are not yet comfortable as providers of comprehensive HIV care; however, they are dedicated to delivering excellent care to all of their patients, regardless of disease process. Although they prefer to refer HIV+ patients to centres of excellence, they are willing to adopt full responsibility when necessary and believe they can deliver high-quality HIV care if provided with adequate consultation and informational resources. CONCLUSIONS: The Affordable Care Act will insure an estimated 20000 more HIV+ patients in California. With a dwindling supply of HIV specialists, many of these patients will be principally cared for by PCPs. PCPs will go to great lengths to ensure that HIV+ patients receive superior care, but they need the support of HIV specialists to expand their skills. Priority should be given to ensuring that expert consultation is widely available to PCPs who find themselves caring for HIV+ patients.

Classification of patterns of tobacco and cannabis co-use based on temporal proximity: A qualitative study among young adults.

PURPOSE: Co-use of tobacco and cannabis is a common and complex behavior. The lack of harmonized measures of co-use yields confusion and inconsistencies in synthesizing evidence about the health effects of co-use. We aimed to classify co-use patterns based on temporal proximity and describe preferred products and motives for each pattern in order to improve co-use surveillance. METHODS: We conducted semi-structured interviews in a sample of 34 young adults (Mage = 22.8 years, 32.4 % female) during 2017-2019 in California, USA. We employed a qualitative thematic analysis to identify timing, reasons, and contexts for tobacco and cannabis co-use and classify co-use patterns. RESULTS: Four emergent patterns of co-use with increasing temporal proximity between tobacco use and cannabis use were: Same-month different-day co-use (Pattern 1); Same-day different-occasion co-use (Pattern 2); Same-occasion sequential co-use (Pattern 3); and Same-occasion simultaneous co-use (Pattern 4). Participants used various product combinations within each pattern. Similar motives for all patterns were socialization, product availability, and coping with stress/anxiety. Unique motive for temporally distant patterns (Patterns 1 and 2) was seeking substance-specific effects (e.g., stimulant effect from nicotine, relaxation effects from cannabis), while unique motives for temporally close patterns (Patterns 3 and 4) were seeking combined effects from both substances (e.g., more intense psychoactive effects, mitigating cannabis adverse effects) and behavioral trigger (e.g., cannabis use triggers tobacco use). CONCLUSIONS: Our classification of co-use patterns can facilitate consistency for measuring co-use and assessing its health impacts. Future research should also measure product types and motives for different patterns to inform intervention efforts.

Adapting mHealth Interventions (PrEPmate and DOT Diary) to Support PrEP Retention in Care and Adherence Among English and Spanish-Speaking Men Who Have Sex With Men and Transgender Women in the United States: Formative Work and Pilot Randomized Trial.

BACKGROUND: A growing number of mobile health (mHealth) technologies are being developed to support HIV preexposure prophylaxis (PrEP) adherence and persistence; however, most tools have focused on men who have sex with men (MSM), and few are available in Spanish. To maximize the potential impact of these tools in reducing gender and racial/ethnic disparities and promoting health equity, mHealth tools tailored to Spanish-speaking people and transgender women are critically needed. OBJECTIVE: The aim of this study is to adapt and tailor 2 mHealth technologies, PrEPmate and DOT Diary, to support daily PrEP adherence and persistence among Spanish-speaking MSM and English- and Spanish-speaking transgender women and to evaluate the feasibility and acceptability of these tools. METHODS: PrEPmate, an interactive, bidirectional, text messaging intervention that promotes personalized communication between PrEP users and providers, and DOT Diary, a mobile app that promotes self-management of PrEP use and sexual health through an integrated electronic pill-taking and sexual activity diary, were previously developed for English-speaking MSM. We conducted 3 focus groups with 15 English- and Spanish-speaking transgender women and MSM in San Francisco and Miami to culturally tailor these tools for these priority populations. We then conducted a 1-month technical pilot among 21 participants to assess the usability and acceptability of the adapted interventions and optimize the functionality of these tools. RESULTS: Participants in focus groups liked the "human touch" of text messages in PrEPmate and thought it would be helpful for scheduling appointments and asking questions. They liked the daily reminder messages, especially the fun facts, gender affirmations, and transgender history topics. Participants recommended changes to tailor the language and messages for Spanish-speaking and transgender populations. For DOT Diary, participants liked the adherence tracking and protection level feedback and thought the calendar functions were easy to use. Based on participant recommendations, we tailored language within the app for Spanish-speaking MSM and transgender women, simplified the sexual diary, and added motivational badges. In the technical pilot of the refined tools, mean System Usability Scale scores were 81.2/100 for PrEPmate and 76.4/100 for DOT Diary (P=.48), falling in the "good" to "excellent" range, and mean Client Satisfaction Questionnaire scores were 28.6 and 28.3 for PrEPmate and DOT Diary, respectively (maximum possible score=32). Use of both tools was high over the 1-month pilot (average of 10.5 messages received from each participant for PrEPmate; average of 17.6 times accessing the DOT Diary app), indicating good feasibility for both tools. CONCLUSIONS: Using a user-centered design approach, we culturally tailored PrEPmate and DOT Diary to support daily PrEP use among Spanish-speaking MSM and English- and Spanish-speaking transgender women. Our positive findings in a technical pilot support further testing of these mHealth interventions in an upcoming comparative effectiveness trial.

Patient Attitudes Toward Self- or Partner-, Friend-, or Family-Administered Long-acting Injectable Antiretroviral Therapy: A Mixed-Methods Study Across 3 Urban Human Immunodeficiency Virus Clinics.

Background: Long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) offers a novel drug delivery option for persons with human immunodeficiency virus (PWH) but requires administration every 4 or 8 weeks by a medical professional. Methods: To facilitate LAI antiretroviral therapy (ART) scale-up, we evaluated patient interest in alternative administration approaches via a mixed-methods, serial cross-sectional study across 3 US HIV clinics. We surveyed PWH (December 2021 to May 2022) on appeal of self- or partner/friend/family-administered LAI-CAB/RPV; multivariable ordinal logistic regression explored associated characteristics. To contextualize survey results, we thematically analyzed semi-structured interview data collected from PWH (August 2020 to July 2021) on attitudes toward out-of-clinic LAI-ART administration. Results: Among 370 surveyed PWH (median age, 46 years; 26% cisgender female, 59% Black, 56% sexual minority, 34% housing instability), self-administering LAI-CAB/RPV appealed to 67%. PWH who were White (adjusted odds ratio [aOR], 3.30 [95% confidence interval {CI}, 1.42-7.64]), stably housed (aOR, 2.16 [95% CI, 1.30-3.59]), or gay/bisexual (aOR, 1.81 [1.14-2.89]) were more likely to endorse self-administration. Fewer PWH (60%) reported partner/friend/family administration as appealing; adjusted models revealed similar sociodemographic preferences for this outcome. In 72 interviews, PWH noted that acceptability of out-of-clinic LAI-ART administration was qualified by convenience, prior injection experience, and potential fear of self-inflicted pain, dependence on others, and/or HIV disclosure. Conclusions: In a multisite sample of PWH, self- and, to a lesser extent, partner/friend/family-administration of LAI-CAB/RPV appealed to most; however, was less appealing among populations more impacted by health disparities. Innovative LAI-ART delivery options could free up in-clinic resources to focus scale-up among marginalized populations.