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.

Assessing readiness to implement long-acting injectable HIV antiretroviral therapy: provider and staff perspectives.

BACKGROUND: Long-acting injectable antiretroviral therapy (LAI-ART) represents the next innovation in HIV therapy. Pre-implementation research is needed to develop effective strategies to ensure equitable access to LAI-ART to individuals living with HIV. METHODS: We conducted focus group discussions (FGDs) with providers and staff affiliated with HIV clinics in San Francisco, Chicago, and Atlanta to understand barriers to and facilitators of LAI-ART implementation. Participants also completed a short survey about implementation intentions. FGDs were held via video conference, recorded, transcribed, and thematically analyzed using domains associated with the Consolidated Framework for Implementation Research (CFIR). RESULTS: Between September 2020 and April 2021, we led 10 FDGs with 49 participants, of whom ~60% were prescribing providers. Organizational readiness for implementing change was high, with 85% agreeing to being committed to figuring out how to implement LAI-ART. While responses were influenced by the unique inner and outer resources available in each setting, several common themes, including implementation mechanisms, dominated: (1) optimism and enthusiasm about LAI-ART was contingent on ensuring equitable access to LAI-ART; (2) LAI-ART shifts the primary responsibility of ART adherence from the patient to the clinic; and (3) existing clinic systems require strengthening to meet the needs of patients with adherence challenges. Current systems in all sites could support the use of LAI-ART in a limited number of stable patients. Scale-up and equitable use would be challenging or impossible without additional personnel. Participants outlined programmatic elements necessary to realize equitable access including centralized tracking of patients, capacity for in-depth, hands-on outreach, and mobile delivery of LAI-ART. Sites further specified unknown logistical impacts on implementation related to billing/payer source as well as shipping and drug storage. CONCLUSIONS: Among these HIV care sites, clinic readiness to offer LAI-ART to a subset of patients is high. The main challenges to implementation include concerns about unequal access and a recognition that strengthening the clinic system is critical.

Are Patients and Their Providers Talking About Long-Acting Injectable Antiretroviral Therapy? Penetration into Clinical Encounters at Three U.S. Care Sites.

Use of long-acting injectable antiretroviral therapy depends on patient awareness, provider discussion, and patient willingness to use. We conducted a postvisit survey with patients at 3 HIV clinics in San Francisco, Chicago, and Atlanta in May 2021 to assess for inequities in these early implementation phases.

A Qualitative Study of the Experience of Immediate Antiretroviral Therapy Among Urban Persons With Newly Diagnosed Human Immunodeficiency Virus.

BACKGROUND: Guidelines recommend immediate antiretroviral therapy (ART) at or shortly after human immunodeficiency virus (HIV) diagnosis, yet little is known about how people living with HIV (PLWH) experience this treatment strategy, including racial/ethnic minorities, cisgender/transgender women, and those with housing instability. METHODS: To assess the acceptability of immediate ART offer among urban PLWH, understand how this approach affects the lived experience of HIV diagnosis, and explore reasons for declining immediate ART, we conducted a cross-sectional qualitative study using semi-structured interviews with individuals who had been offered immediate ART after HIV diagnosis at a safety-net HIV clinic in San Francisco and a federally qualified health center in Chicago. Interviews were analyzed using thematic analysis. RESULTS: Among 40 participants with age range 19-52 years, 27% of whom were cisgender/transgender women or gender-queer, 85% racial/ethnic minority, and 45% homeless/unstably housed, we identified 3 major themes: (1) Individuals experienced immediate ART encounters as supportive; (2) individuals viewed immediate ART as sensible; and (3) immediate ART offered emotional relief by offsetting fears of death and providing agency over one's health. Reasons for declining immediate ART ranged from simply needing a few more days to complex interactions of logistical and psychosocial barriers. CONCLUSIONS: Immediate ART was highly acceptable to urban persons with newly diagnosed HIV infection. Immediate ART was viewed as a natural next step after HIV diagnosis and provided a sense of control over one's health, mitigating anxiety over a decline in physical health. As such, immediate ART somewhat eased but in no way obviated the psychosocial challenges of HIV diagnosis.

Exploring the Shift From HIV Pre-exposure Prophylaxis Awareness to Uptake Among Young Gay and Bisexual Men.

Introduction: HIV pre-exposure prophylaxis (PrEP) in the form of a daily oral medication is highly effective at preventing HIV. In the United States, awareness about PrEP has steadily increased over time among individuals vulnerable to HIV, however awareness has not translated into widescale uptake. Estimates are that fewer than 20% of 1.2 million Americans for whom PrEP is indicated are utilizing it. We sought to understand how individuals moved from PrEP awareness to PrEP utilization. Methods: We conducted a series (n = 31) of in-depth interviews with young people, predominantly gay and bisexual men, ages 18-29 years old between February 2015 and January 2016, as part of the evaluation of a multi-year demonstration project funded to test innovative approaches to improve sexual health outcomes and curb the HIV epidemic in California. Interviews were audio-recorded and transcribed verbatim. We conducted a thematic analysis. Results: We present a continuum of PrEP awareness that spans three phases-basic, moderate and advanced. Participants rarely reported becoming well-informed about PrEP over the course of an initial exposure to PrEP information. Learning occurred after multiple exposures to PrEP information through numerous intersecting forms, messengers and formal and informal communication channels. Positively framed messages delivered by formal messengers emphasizing PrEP as a sensible HIV prevention strategy and explicitly communicating a regard for sexual wellness were overwhelmingly persuasive and facilitated movement to the advanced awareness phase. Once participants reached the advanced phase of PrEP awareness, uptake was possible. Conclusions: Our analysis provides insights into how PrEP awareness led to PrEP uptake among young gay and bi-sexual men. Building demand among those in the basic awareness phase took longer than those in the moderate phase. Individuals involved in formal and informal PrEP education can set reasonable expectations about whether, when and how eventual uptake may occur when keeping the continuum of PrEP awareness framework in mind. Many young, gay and bi-sexual male prospective PrEP users will benefit from positively framed messages that emphasize personal well-being, including social, sexual and emotional benefits of PrEP use.

A Mobile Health App (WYZ) for Engagement in Care and Antiretroviral Therapy Adherence Among Youth and Young Adults Living With HIV: Single-Arm Pilot Intervention Study.

BACKGROUND: Youth are globally recognized as being vulnerable to HIV. Younger age has been correlated with worse health outcomes. Mobile health (mHealth) interventions have the potential to interact with youth where they are, using a device they already access. OBJECTIVE: Using predefined benchmarks, we sought to evaluate the feasibility and acceptability of WYZ, an mHealth app, for improved engagement in care and antiretroviral therapy (ART) adherence among youth and young adults living with HIV. WYZ was designed and developed with input from youth and young adults living with HIV using a human-centered design approach and was based on the information, motivation, and behavioral skills framework to address common barriers to care and ART adherence among youth and young adults living with HIV. METHODS: We recruited youth and young adults living with HIV (18-29 years old) from the San Francisco Bay Area to take part in a 6-month pilot trial. Their participation included completing baseline and exit surveys, and participating in seven phone check-ins about their use of WYZ. RESULTS: Youth and young adults living with HIV (N=79) reported high levels of feasibility and acceptability with WYZ use. We met predefined benchmarks for recruitment (79/84, 94%), mean logins per week (5.3), tracking ART adherence (5442/9393, 57.9%), posting chat topics per week (4.8), and app crashes reported per week (0.24). The ease of app download, install, and setup, and comfort with security, privacy, and anonymity were highly rated (all over 91%). Additionally, participants reported high satisfaction for a research project that was remotely conducted. Participants used the app for shorter timeframes compared to the predefined benchmark. CONCLUSIONS: We noted high feasibility and acceptability with WYZ. Further research to examine the efficacy of WYZ will enable youth and young adults living with HIV and their providers to make informed decisions when using, recommending, and prescribing the app for improved engagement in HIV care and ART adherence. TRIAL REGISTRATION: ClinicalTrials.gov NCT03587857; https://clinicaltrials.gov/ct2/show/NCT03587857.

Development of the Mobile Technology Vulnerability Scale among Youth and Young Adults Living with HIV.

INTRODUCTION: Youth and young adults living with HIV (YLWH) in the US have the lowest viral suppression percentage. Lack of sufficient technology access may be correlated with HIV health outcomes in this population. METHODS: We developed a Mobile Technology Vulnerability Scale (MTVS; 18 items) among 18-29-year-olds. Exploratory factor analysis (EFA) was performed on baseline data (N = 79), followed by a confirmatory factor analysis (CFA) of 6-month follow-up data (N = 69). Cronbach's alpha for internal consistency and test-retest reliability were examined. We also correlated the scale with self-report antiretroviral therapy (ART) adherence. RESULTS: EFA yielded a single-factor solution at baseline after dropping one item. CFA at follow-up corroborated the single-factor. Cronbach's alpha was high and MTVS was correlated with ART adherence at both time points. MTVS at baseline and 6 months were correlated. CONCLUSION: The 17-item MTVS scale was found to be valid and reliable and related to ART adherence.

The collaborative care model for HIV and depression: Patient perspectives and experiences from a safety-net clinic in the United States.

OBJECTIVES: Collaborative care models may improve outcomes for both HIV and depression. The model includes routine screening and re-assessment of depressive symptoms as well as care coordination services delivered by an ancillary provider focused on mental health. We sought to explore patient experiences and attitudes about the services received through the collaborative care model, including measurement-based care using the Patient Health Questionnaire-9. METHODS: We conducted 17 qualitative interviews with patients in a collaborative care model implemented at an HIV primary care clinic in a safety-net hospital in the United States. Interviews were analyzed using Framework Analysis. RESULTS: Our findings illustrate the ways in which the collaborative care model for depression may be meaningful to patients in HIV care settings. Participants appreciated the support offered through the collaborative care model. Most participants perceived measurement-based care as useful to their providers, and an additional subset used the Patient Health Questionnaire-9 for their own self-management and awareness of depression. Over time, the collaborative care model appeared to motivate some patients to address depressive symptoms. CONCLUSION: The collaborative care model may be particularly helpful to patients in the way that it reinforces how depressive symptoms can be measured and managed. Furthermore, routine screening and re-measurement for depressive symptoms using the Patient Health Questionnaire-9 hold promise as an additional self-management tool to complement other clinical and supportive services.

WYZ: a pilot study protocol for designing and developing a mobile health application for engagement in HIV care and medication adherence in youth and young adults living with HIV.

INTRODUCTION: Youth and young adults bear a disproportionate share of the HIV burden and there is a critical need for interventions to curb health disparities experienced among these age groups. The purpose of our research is to build on our theory-guided model and formative research to develop a mobile health application, called WYZ, for improved engagement in HIV care and antiretroviral therapy adherence, and pilot test it among youth and young adults living with HIV (YLWH). In this paper, we explain the design and development of WYZ for YLWH, describe the design of a forthcoming pilot trial for evaluating the feasibility and acceptability of WYZ and compare WYZ with other mobile health applications being developed to improve engagement in HIV care and antiretroviral medication adherence. METHODS AND ANALYSIS: We used an agile methodology, shown to be useful in software development, and elicited feedback during beta testing to develop WYZ. WYZ is a modular, adaptive and personalised intervention delivered via a mobile phone. It is grounded in the information, motivation, behaviouralskills model which has been valuable for understanding and guiding the development of interventions for complex health behaviours. WYZ was created in collaboration with YLWH aged 18-29 years using a human-centred design approach that emphasises understanding the perspective of the users of the technology. WYZ is intended to improve engagement in HIV care by: (1) enhancing medication adherence self-efficacy, (2) increasing awareness and use of community resources, (3) reducing barriers to communication between youth and their healthcare team, and (4) providing a secure platform for the formation of a private online community of YLWH. We will conduct a 6-month single-arm pilot study to examine feasibility and acceptability of WYZ among 76 YLWH who live or receive care in the San Francisco Bay Area. All study activities, including recruitment, screening, enrolment, study assessments, provision of incentives and exit interviews, will be conducted remotely. We will explore feasibility and acceptability outcomes of the intervention using quantitative and qualitative methods. ETHICS AND DISSEMINATION: Study staff will obtain written consent for study participation from all participants. This study and its protocols have been approved by the University of California San Francisco (UCSF) Institutional Review Board. Study staff will work with the UCSF Center for AIDS Prevention Studies' Community Engagement Core and the Youth Advisory Panel to disseminate results to the participants and the community using presentations, community forums, journal publications and/or social media. TRIAL REGISTRATION NUMBER: NCT03587857; Pre-results.

"Losing the Phobia:" Understanding How HIV Pre-exposure Prophylaxis Facilitates Bridging the Serodivide Among Men Who Have Sex With Men.

The use of HIV serostatus information has played a pivotal role in partner selection norms. A phenomenon known as serosorting is the practice of selecting a partner based on a perception that they are of the same HIV status in order to avoid transmission from one partner to the other. An understudied aspect of serosorting is that it has a divisive effect-one accepts or rejects a potential partner based on a singular characteristic, the partner's HIV status, and thus excludes all others. This division has been formally referred to as the HIV serodivide. In this study, we explored partner selection strategies among a group of HIV-negative, young men who have sex with men (n = 29) enrolled in a PrEP demonstration project in Northern California. We found that trends in serosorting were in fact shifting, and that a new and opposite phenomenon was emerging, something we labeled "seromixing" and that PrEP use played a part in why norms were changing. We present three orientations in this regard: (1) maintaining the phobia: in which men justified the continued vigilance and exclusion of people living with HIV as viable sex or romantic partners, (2) loosening/relaxation of phobia: among men who were reflecting on their stance on serosorting and its implications for future sexual and/or romantic partnerships, and (3) losing the phobia: among men letting go of serosorting practices and reducing sentiments of HIV-related stigma. The majority of participants spoke of changing or changed attitudes about intentionally accepting rather than rejecting a person living with HIV as a sex partner. For those who maintained strict serosorting practices, their understandings of HIV risk were not erased as a result of PrEP use. These overarching themes help explain how PrEP use is contributing to a closing of the HIV serodivide.