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.

Decreased Time From Human Immunodeficiency Virus Diagnosis to Care, Antiretroviral Therapy Initiation, and Virologic Suppression during the Citywide RAPID Initiative in San Francisco.

BACKGROUND: Early virologic suppression (VS) after human immunodeficiency virus (HIV) infection improves individual health outcomes and decreases onward transmission. In San Francisco, immediate antiretroviral therapy (ART) at HIV diagnosis was piloted in 2013-2014 and expanded citywide in 2015 in a rapid start initiative to link all new diagnoses to care within 5 days and start ART at the first care visit. METHODS: HIV providers and linkage navigators were trained on a rapid start protocol with sites caring for vulnerable populations prioritized. Dates of HIV diagnosis, first care visit, ART initiation, and VS were abstracted from the San Francisco Department of Public Health HIV surveillance registry. RESULTS: During 2013-2017, among 1354 new HIV diagnoses in San Francisco, median days from diagnosis to first VS decreased from 145 to 76 (48%; P < .0001) and from first care visit to ART initiation decreased from 28 to 1 (96%; P < .0001). By 2017, 28% of new diagnoses had a rapid start, which was independently associated with Latinx ethnicity (AOR, 1.73; 95% CI, 1.15-2.60) and recent year of diagnosis (2017; AOR, 16.84; 95% CI, 8.03-35.33). Persons with a rapid ART start were more likely to be virologically suppressed within 12 months of diagnosis than those with a non-rapid start (RR, 1.17; 95% CI, 1.10-1.24). CONCLUSIONS: During a multisector initiative to optimize ART initiation, median time from diagnosis to VS decreased by nearly half. Immediate ART at care initiation was achieved across many, but not all, populations, and was associated with improved suppression rates.

Lessons learned from U.S. rapid antiretroviral therapy initiation programs.

BACKGROUND: Rapid antiretroviral therapy initiation (R-ART) for treatment of HIV has been recommended since 2017, however it has not been adopted widely across the US. PURPOSE: The study purpose was to understand facilitators and barriers to R-ART implementation in the U.S. RESEARCH DESIGN: This was a qualitative design involving semi-structured interviews. STUDY SAMPLE: The study sample was comprised of the medical leadership of nine US HIV clinics that were early implementers of R-ART. DATA COLLECTION AND ANALYSIS: In-depth, semi-structured interviews were performed. The Consolidated Framework for Implementation Research (CFIR) was used to guide thematic analysis. RESULTS: We identified three main content areas: strong scientific rationale for R-ART, buy-in from multiple key stakeholders, and the condensed timeline of R-ART. The CFIR construct of Evidence Strength and Quality was cited as an important factor in R-ART implementation. Buy-in from key stakeholders and immediate access to medications ensured the success of R-ART implementation. Patient acceptance of the condensed timeline for ART initiation was facilitated when presented in a patient-centered manner, including empathetic communication and addressing other patient needs concurrently. The condensed timeline of R-ART presented logistical challenges and opportunities for the development of intense patient-provider relationships. CONCLUSIONS: Results from the analysis showed that R-ART implementation should address the following: 1) logistical planning to implement HIV treatment with a condensed timeline 2) patients' mixed reactions to a new HIV diagnosis and 3) the high cost of HIV medications.

The Rapid interaction: a qualitative study of provider approaches to implementing Rapid ART.

BACKGROUND: Offering antiretroviral therapy (ART) to patients directly following an HIV diagnosis ("Rapid ART") improves clinical outcomes and is feasible and acceptable for patients and providers. Despite this, implementation of Rapid ART is not yet standard practice in the USA. Structural-level implementation guidance is available, but research at the individual provider level that explores the patient-provider interaction itself remains scarce. The Consolidated Framework for Implementation Research (CFIR) provides a nuanced guide to investigating the less visible, more social elements of implementation like the knowledge and feelings of people, and the influences of culture and resources on individual approaches. METHODS: We conducted a multi-site qualitative study, exploring intervention commonalities across three HIV clinic environments: an HIV primary care clinic; an HIV/STI testing, treatment, and prevention clinic; and a large federally qualified health center (FQHC). Qualitative data were gathered from 27 provider informants-Rapid ART program staff and clinicians-using an interview guide developed using the CFIR. An experienced qualitative team conducted a comprehensive thematic analysis and identified cross-cutting themes in how providers approach and engage in the Rapid interaction, as well as longer-form narratives from providers that describe more fully what this interaction looks like for them. RESULTS: Three main themes represent the range and content of individual provider approaches to the Rapid interaction: (1) patient-centeredness; (2) emotional support and partnership; and (3) correcting misperceptions about HIV. Each theme encompassed both conceptual approaches to offering Rapid ART and concrete examples of messaging to the patient that providers used in the Rapid interaction. We describe and show examples of these themes, offer key take-aways for implementation, and provide expanded narratives of providers' personal approaches to the Rapid interaction. CONCLUSIONS: Exploration of provider-level approaches to Rapid ART implementation, as carried out in the patient-provider Rapid interaction, contributes a critical layer of evidence for wider implementation. It is our hope that, together with existing research showing positive outcomes and core components of systems-level implementation, these findings add to an instructive body of findings that facilitates the implementation of Rapid ART as an enhanced model of HIV care.

Development of a Citywide Rapid Antiretroviral Therapy Initiative in San Francisco.

INTRODUCTION: Ending the HIV epidemic in the U.S. holds rapid antiretroviral therapy as a key strategy to improve the health of those with HIV and to decrease transmission. In 2015, Getting to Zero San Francisco, a multisector consortium, expanded rapid antiretroviral therapy citywide. METHODS: A Getting to Zero San Francisco Rapid ART Program Initiative for HIV Diagnoses Committee (academic, community, service delivery, health department partners) designed the program, protocol, dissemination plan, and monitoring strategy. Newly diagnosed patients were linked to an HIV medical home or Rapid ART Program Initiative for HIV Diagnoses initiation hub to best deliver rapid antiretroviral therapy across a diverse patient mix, with a goal of ≤5 working days from diagnosis to care and ≤1 day from care to antiretroviral therapy. Stakeholders were trained on rapid antiretroviral therapy via Getting to Zero San Francisco meetings, in-services, public health detailing, and peer-to-peer recruiting, prioritizing HIV clinics serving patients of color, Latinx ethnicity, youth, and the uninsured or publicly insured. Rapid ART Program Initiative for HIV Diagnoses-specific metrics were derived from surveillance data; stratified by sex/gender, age, race/ethnicity, and housing status; and presented at public meetings. Data were analyzed between January and April 2021. RESULTS: From 2014 to 2018, median time from diagnosis to care decreased 71% (7 to 2 days), care to antiretroviral therapy decreased from 19 to 0 days, and diagnosis to virologic suppression decreased 51% (94 to 46 days). Improvements occurred regardless of age, race/ethnicity, sex/gender, exposure, or housing status. CONCLUSIONS: During a citywide initiative to optimize antiretroviral therapy initiation, time from HIV diagnosis to care, antiretroviral therapy, and virologic suppression decreased across all affected groups to varying degrees. The Rapid ART Program Initiative for HIV Diagnoses Committee continues to address challenges to retention and expand implementation.

Concurrent COVID-19 and Acute HIV: A Case Report and Diagnostic Review.

A 26-year-old male presented to the emergency department feeling unwell in February of 2021 with symptoms including diaphoresis, loose stools, and loss of taste sensation. Workup not only confirmed a diagnosis of COVID-19 but also revealed discordant HIV test results, with a reactive fourth-generation antigen/antibody test but a negative HIV-1/2 differentiation immunoassay. Subsequent HIV viral load testing obtained two days later ultimately established a diagnosis of acute HIV (AHI). Screening for HIV and other sexually transmitted infections decreased during the COVID-19 pandemic. It is critical that providers (1) continue recommended screening for HIV as an essential service; (2) consider acute HIV in the differential when evaluating patients with acute viral syndromes; (3) recognize that AHI can occur concurrently with other infections, including COVID-19; and (4) understand the differential diagnosis for discordant HIV test results and know when HIV viral load testing is needed to resolve such discordant results.

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.

RAPID antiretroviral therapy: high virologic suppression rates with immediate antiretroviral therapy initiation in a vulnerable urban clinic population.

OBJECTIVE: Little is known about long-term viral suppression rates for patients who start antiretroviral therapy (ART) soon after diagnosis. We describe virologic outcomes from the San Francisco-based Ward 86 Rapid ART Program for Individuals with an HIV Diagnosis (RAPID) ART program. DESIGN: Retrospective review of clinic-based cohort. METHODS: In 2013, Ward 86 adopted immediate ART at the first visit after HIV diagnosis. Patients were referred from testing sites, offered same or next-day intakes, and received multidisciplinary evaluation, support, and insurance enrollment/optimization. Patients were provided ART starter packs and close follow-up. Demographics and labs were extracted from medical records. Subsequent viral loads were obtained from public health surveillance data. Kaplan-Meier curves summarized distribution of times to first viral suppression; viral suppression rates at last viral load recorded were calculated. RESULTS: Of 225 patients referred to RAPID ART from 2013 to 2017, 216 (96%) were started on immediate-ART: median age 30; 7.9% women; 11.6% African-American, 26.9% Hispanic, 36.6% white; 51.4% with substance use; 48.1% with mental health diagnoses; 30.6% unstably housed; baseline median CD4 cell count 441 cells/µl median viral load 37 011. By 1 year after intake, 95.8% achieved viral suppression to less than 200 cells/µl at least once. Over a median follow-up time of 1.09 years (0-3.92), 14.7% of patients had viral rebound, but most (78%) resuppressed. Viral suppression rates were 92.1% at last recorded viral load. CONCLUSION: In an urban clinic with high rates of mental illness, substance use and housing instability, immediate ART provided through a RAPID program resulted in viral suppression at last viral load measurement for more than 90% of patients over a median of 1.09 years. RAPID ART for vulnerable populations is acceptable, feasible, and successful with multidisciplinary care and municipal support.

Acquisition of tenofovir-susceptible, emtricitabine-resistant HIV despite high adherence to daily pre-exposure prophylaxis: a case report.

BACKGROUND: Pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir disoproxil fumarate is highly protective against HIV infection. We report a case of tenofovir-susceptible, emtricitabine-resistant HIV acquisition despite high adherence to daily PrEP. METHODS: Adherence to PrEP was assessed by measuring concentrations of emtricitabine and tenofovir disoproxil fumarate or their metabolites in plasma, dried blood spots, and hair. After seroconversion, genotypic and phenotypic resistance of the acquired virus was determined by standard clinical tests and by single-genome sequencing of proviral genomes. HIV partner services identified the likely transmission partner. FINDINGS: A 21-year-old Latino man tested positive for HIV infection 13 months after PrEP initiation. He had a negative HIV antibody test, but detectable HIV RNA with 559 copies per mL. He reported good adherence to daily PrEP. He was linked to care and immediately started antiretroviral therapy, at which point his RNA was 1544 copies per mL and his HIV antibody test was positive. The HIV genotype revealed Met184Val, Leu74Val, Leu100Ile, and Lys103Asn mutations in reverse transcriptase, and the phenotype showed susceptibility to tenofovir disoproxil fumarate and resistance to emtricitabine. Segmental hair analysis of tenofovir disoproxil fumarate concentrations measured in 1 cm segments of hair from the scalp indicated consistently high adherence to PrEP in each of the 6 months before HIV diagnosis (0·0672-0·0889 ng/mg). Concentrations of tenofovir diphosphate (1012 fmol per punch) and emtricitabine triphosphate (0·266 fmol per punch) in a dried blood spot indicated high adherence over the preceding 6 weeks. Concentrations of emtricitabine (870·5 ng/mL) and tenofovir disoproxil fumarate (188·2 ng/mL) measured in plasma 3 months before HIV seroconversion confirmed adherence in the days preceding that visit. The likely transmission partner was not engaged in HIV primary care and had a similar viral genotype. INTERPRETATION: Acquisition of HIV virus that is susceptible to tenofovir disoproxil fumarate, but resistant to emtricitabine can occur despite high adherence to PrEP. Quarterly screening for HIV and sexually transmitted diseases facilitates early diagnosis in people on PrEP; when combined with prompt linkage to care and partner services this can prevent onward transmission of HIV. FUNDING: US National Institutes of Health.