Real world utilisation of doravirine among people living with human immunodeficiency virus in England (DRIVE-REAL).

BACKGROUND: Doravirine is a non-nucleoside reverse transcriptase inhibitor recommended for the treatment of virologically suppressed and treatment naïve people living with HIV. The DRIVE-REAL study aimed to describe the characteristics, treatment patterns, and virological outcomes of doravirine users in a real-world cohort in the UK. METHODS: A retrospective, observational, multi-centre chart review was conducted for 300 adults living with HIV initiating doravirine-containing antiretroviral therapy. RESULTS: At baseline 83% of individuals were male, 45% aged ≥50 years, 65% white ethnicity. Median time since HIV diagnosis was 12 years. 96% were antiretroviral therapy-experienced, 87% had a HIV viral load <50 copies/ml, and 15% had resistance to at least one antiretroviral drug. 66% had comorbidities, most commonly depression (26%), and 70% were taking at least one co-medication. At six months, 94% (n = 283/300) were still receiving doravirine. Viral load data were available for n = 266/300 individuals and 95% (n = 253/266) had viral load <50 copies/ml. CONCLUSIONS: Individuals initiating doravirine in this cohort are predominantly treatment-experienced white middle-aged males, with a high frequency of comorbidities and co-medication. The majority of individuals at 6 months remained on doravirine and maintained or achieved HIV viral suppression. This study provides epidemiologic characteristics that can inform clinical care and subsequent hypothesis-testing studies.

Targeted literature review exploring the predictive value of estimated glomerular filtration rate and left ventricular mass index as indicators of clinical events in Fabry disease.

BACKGROUND: Fabry disease is a rare, progressive X-linked lysosomal storage disorder. It is caused by mutations in the GLA gene resulting in deficiency of α-galactosidase A (α-Gal A), leading to peripheral neuropathy, cardiovascular disease, stroke, end-stage renal disease, gastrointestinal disorders and premature death. Given the long-term nature of disease progression, trials in Fabry disease are often not powered to capture these clinical events. Clinical measures such as estimated glomerular filtration rate (eGFR) and left ventricular mass index (LVMI) are often captured instead. eGFR and LVMI are believed to be associated with long-term Fabry disease clinical events of interest, but the precise relationships are unclear. OBJECTIVE: We aimed to identify published literature exploring the link between eGFR/LVMI and long-term clinical events in Fabry disease. METHODS: A comprehensive literature search was conducted in Embase® and MEDLINE® (using Embase.com), and a targeted literature review was conducted. Studies reporting a quantitative relationship between eGFR and/or LVMI and clinical events in Fabry disease were extracted, and narrative synthesis was conducted to understand these predictive relationships. RESULTS: Eight studies, consisting of seven patient-level retrospective analyses plus one prospective cohort study, met the inclusion criteria. Seven of these studies reported eGFR and six reported LVMI, with five reporting both. All studies presented results for either a composite measure including a range of key Fabry disease clinical events, or a composite outcome that included at least one key Fabry disease clinical event. All studies employed Cox proportional hazards survival modelling. The studies consistently reported that eGFR and LVMI are predictors of key clinical events in Fabry disease, with the findings remaining consistent regardless of the therapy received by patients in the studies. CONCLUSIONS: The evidence identified suggests that eGFR and LVMI outcomes may be appropriate indicators for long-term clinical events in Fabry disease, and all identified papers implied the same directional relationship. However, additional research is needed to further understand the specific details of these relationships and to quantify them.

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.

The Architecture of an Internal, Scientific, Presubmission Review Program Designed to Increase the Impact and Success of Grant Proposals and Manuscripts.

Securing extramural grant funding and publishing in peer-reviewed journals are key indicators of success for many investigators in academic settings. As a result, these expectations are also sources of stress for investigators and trainees considering such careers. As competition over grant funding, costs of conducting research, and diffusion of effort across multiple demands increase, the need to submit high-quality applications and publications is paramount. For over 3 decades, the Center for AIDS Prevention Studies at the University of California, San Francisco, has refined an internal, presubmission, peer review program to improve the quality and potential success of products before external submission. In this article, the rationale and practical elements of the system are detailed, and recent satisfaction reports, grant submission outcomes, and plans for ongoing tracking of the success rates of products reviewed are discussed. The program includes both early-stage concept reviews of ideas in their formative state and full product reviews of near-final drafts. Recent evaluation data indicate high levels of reviewee satisfaction with multiple domains of the process, including scheduling the review sessions, preparedness and expertise of the reviewers, and overall quality of the review. Outcome data from reviews conducted over a recent 12-month period demonstrate subsequent funding of 44% of proposals reviewed through the program, a success rate that surpasses the National Institutes of Health funding success rates for the same time period. Suggestions for the sustainability of the program and for its adoption at other institutions and settings less dependent on extramural funding are provided.

Acceptance of the use of HIV surveillance data for care engagement: national and local community perspectives.

BACKGROUND: Use of surveillance data including laboratory results (e.g., CD4 and HIV RNA) by public health departments to facilitate linkage, retention, and reengagement of HIV-infected individuals in health care is on the rise. This is part of the goal of increasing the proportion of infected persons achieving virologic suppression. However, this use of surveillance data is not without controversy, particularly among some providers and people living with HIV. METHODS: We conducted informal discussions with key stakeholders and a literature search and held a national think tank in November 2012, bringing together 31 representatives of the federal government, county and state officials, health care providers, and community-based organizations. A follow-up community consultation specific to San Francisco was held January 24, 2014, with 10 participants. Notes from these activities were used as data for this analysis. RESULTS: The think tank identified 3 strategies using HIV surveillance data to aid in care engagement: (1) provider-mediated, where health department staff work with the provider of record on reengagement, (2) electronic linkages between surveillance databases and medical records databases, and (3) direct outreach, where trained health department staff reach out to persons out of care. Participants also developed recommendations for minimizing harm, guidance on meaningful stakeholder involvement, and a consensus statement in support of the use of HIV surveillance data in care engagement. CONCLUSIONS: Acceptance of the use of surveillance data for HIV care linkage, retention, and reengagement is achievable, particularly if stakeholders have been engaged in the design, conduct, and evaluation of programs.

California's "Bridge to Reform": identifying challenges and defining strategies for providers and policymakers implementing the Affordable Care Act in low-income HIV/AIDS care and treatment settings.

BACKGROUND: In preparation for full Affordable Care Act implementation, California has instituted two healthcare initiatives that provide comprehensive coverage for previously uninsured or underinsured individuals. For many people living with HIV, this has required transition either from the HIV-specific coverage of the Ryan White program to the more comprehensive coverage provided by the county-run Low-Income Health Programs or from Medicaid fee-for-service to Medicaid managed care. Patient advocates have expressed concern that these transitions may present implementation challenges that will need to be addressed if ambitious HIV prevention and treatment goals are to be achieved. METHODS: 30 semi-structured, in-depth interviews were conducted between October, 2012, and February, 2013, with policymakers and providers in 10 urban, suburban, and rural California counties. Interview topics included: continuity of patient care, capacity to handle payer source transitions, and preparations for healthcare reform implementation. Study team members reviewed interview transcripts to produce emergent themes, develop a codebook, build inter-rater reliability, and conduct analyses. RESULTS: Respondents supported the goals of the ACA, but reported clinic and policy-level challenges to maintaining patient continuity of care during the payer source transitions. They also identified strategies for addressing these challenges. Areas of focus included: gaps in communication to reach patients and develop partnerships between providers and policymakers, perceived inadequacy in new provider networks for delivering quality HIV care, the potential for clinics to become financially insolvent due to lower reimbursement rates, and increased administrative burdens for clinic staff and patients. CONCLUSIONS: California's new healthcare initiatives represent ambitious attempts to expand and improve health coverage for low-income individuals. The state's challenges in maintaining quality care and treatment for people living with HIV experiencing these transitions demonstrate the importance of setting effective policies in anticipation of full ACA implementation in 2014.

HIV surveillance in theory and practice: assessing the acceptability of California's non-name HIV surveillance regulations.

In 2002, California adopted a non-name system for HIV case reporting. This study focused on the acceptability of a non-name reporting system among key stakeholders implementing the system. We conducted qualitative research during the pre- and post-implementation period of the non-name HIV reporting regulations. During both study periods we conducted key informant in-depth interviews (n = 48 and 52, respectively) with health department surveillance staff, laboratory personnel, health care providers and clinic staff; and we conducted four focus group discussions (n = 28 and 30, respectively) with representatives of community-planning group members and advocacy groups. We found that overall, California's non-name HIV reporting regulations were acceptable to most key stakeholders. Acceptability of a non-name system was highest among advocates and healthcare providers. Views of health department staff varied across the four counties, with some expressing a strong preference of a names based system and others accepting the non-name system.

Potential deterrent effect of name-based HIV infection surveillance.

To meet federal recommendations to collect case reports of HIV infection, California has adopted a non-name code system to conduct HIV surveillance. The objective of this study was to evaluate among HIV test takers the acceptability and preferences for the 3 major types of HIV infection reporting-name, name-to-code, and non-name code. Interviewer-administered exit surveys with spoken scripts and matching printed materials clearly outlining the 3 HIV reporting options were conducted among HIV test takers immediately following appointments for pretest HIV counseling and blood collection. The study enrolled 208 HIV test takers at 14 publicly funded HIV testing sites in 4 California counties (Los Angeles, Riverside, Fresno, and Santa Clara). Overall with respect to which would be the most acceptable system, 67% reported non-name code, 19% reported name-to-code, and 12% reported name-based HIV reporting (P < 0.0001). A second sample of 226 exit surveys taken 1 year following implementation of California's non-name code HIV infection reporting system continued to show a significant preference for non-name code HIV infection reporting. Significant independent predictors of a preference for coded HIV reporting in both the pre- and postimplementation period were men who have sex with men (odds ratio [OR] = 5.7, 95% CI: 1.2-26 in the preperiod) and having just taken an anonymous HIV test (OR = 3.6, 95% CI: 1.4-9.3, P = 0.009 preperiod). Were the state to adopt name-based HIV reporting, significantly fewer individuals report being likely in the next 12 months to have a confidential HIV test than report being likely to have an anonymous HIV test (51% likely confidential vs. 76% likely anonymous, P < 0.0001). This analysis documents strong support, among HIV test takers in California, for a non-name coded HIV reporting system and indicates a high probability of a shift away from confidential testing toward anonymous testing under a scenario of name-based reporting. This shift is of concern as confidential HIV testing is the basis of US HIV surveillance systems.