RESUMO
In 2020, the HIV prevention clinical trials, HPTN (HIV Prevention Trials Network) 083 and 084, reported that long-acting injectable cabotegravir (CAB-LA) for HIV prevention was statistically superior to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for pre-exposure prophylaxis (PrEP) in cisgender men and transgender women who have sex with men, and cisgender women. However, clinical efficacy does not translate to real-world effectiveness and clinical practice as evidenced by current global use of oral PrEP. There are ~626,000 users of PrEP, which is significantly below the 3 million goal set by UNAIDS for 2020. Implementation will be key to ensuring that CAB-LA reaches those who desire to use it. We describe the Layer Plus Approach for CAB-LA for PrEP dissemination and implementation. The "Layer" is focused on integrating CAB-LA into existing PrEP models of care and understanding the best delivery channels that could be established in existing programs. Important implications of layering include preparing health professionals to provide CAB-LA, improving access for potential users, and addressing existing PrEP structural and facility barriers. "Plus," which accounts for the existing disparities in PrEP access and use, means expanding CAB-LA to reach individuals for whom HIV prevention options have not been accessible or who have lapsed on oral PrEP. Implications for Plus include the development of new structures, systems, policies, and processes. A key aspect to the Approach is building collaborations to aid successful implementation. The Layer Plus Approach is a simple but strategic framework or a tailored approach to guide dissemination research and implementation.
Assuntos
Fármacos Anti-HIV , Infecções por HIV , Profilaxia Pré-Exposição , Masculino , Feminino , Humanos , Profilaxia Pré-Exposição/métodos , Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/prevenção & controle , Infecções por HIV/tratamento farmacológico , Emtricitabina/uso terapêutico , Tenofovir/uso terapêuticoRESUMO
BACKGROUND: Long-acting injectable antiretroviral therapy (LA ART) has been shown to be non-inferior to daily oral ART, with high patient satisfaction and preference to oral standard of care in research to date, and has recently been approved for use in the United States and Europe. This study examined the perspectives of health care providers participating in LA ART clinical trials on potential barriers and solutions to LA ART roll-out into real world settings. METHODS: This analysis draws on two data sources: (1) open-ended questions embedded in a structured online survey of 329 health care providers participating in the ATLAS-2 M trial across 13 countries; and (2) in-depth interviews with 14 providers participating in FLAIR/ ATLAS/ATLAS-2 M trials in the United States and Spain. Both assessments explored provider views and clinic dynamics related to the introduction of LA ART and were analyzed using thematic content analysis. The Consolidated Framework for Implementation Research (CFIR) was drawn on as the conceptual framework underpinning development of a model depicting study findings. RESULTS: Barriers and proposed solutions to LA ART implementation were identified at the individual, clinic and health system levels. Provider perceptions of patient level barriers included challenges with adhering to frequent injection appointments and injection tolerability. Proposed solutions included patient education, having designated staff for clinic visit retention, and clinic flexibility with appointment scheduling. The main provider concern was identifying appropriate candidates for LA ART; proposed solutions focused on patient provider communication and decision making. Clinic level barriers included the need for additional skilled individuals to administer injections, shifts in workflow as demand increases and the logistics of cold-chain storage. Proposed solutions included staff hiring and training, strategic planning around workflow and logistics, and the possibility of offering injections in other settings, including the home. Health system level barriers included cost and approvals from national regulatory bodies. Potential solutions included governments subsidizing treatment, ensuring cost is competitive with oral ART, and offering co-pay assistance. CONCLUSIONS: Results suggest the importance of multi-level support systems to optimize patient-provider communication and treatment decision-making; clinic staffing, workflow, logistics protocols and infrastructure; and cost-related factors within a given health system.
Assuntos
Infecções por HIV , Antirretrovirais/uso terapêutico , Europa (Continente) , Infecções por HIV/tratamento farmacológico , Pessoal de Saúde , Humanos , EspanhaRESUMO
We are in a new era of partner-based implementation research, and we need clear strategies for how to navigate this new era. Drawing on principles from community-based participatory research, the Clinical Public Health group of the Department of Veterans Affairs and the HIV/Hepatitis Quality Enhancement Research Initiative (HHQUERI) forged a longstanding partnership that has improved the care of Veterans with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus. An exemplar HIV testing project epitomizes this partnership and is discussed in terms of the lessons learned as a result of our high level of collaboration around design, analysis, implementation, and dissemination across projects over the past several years. Lessons learned through this partnered testing program involve respecting different time horizons among the partners, identifying relevant research questions for both parties, designing flexible studies, engaging all partners throughout the research, and placing an emphasis on relationship building at all times. These lessons and strategies can benefit others conducting partner-based research both within the Veterans Health Administration (VA) and in other integrated healthcare systems.
Assuntos
Pesquisa Participativa Baseada na Comunidade/organização & administração , Comportamento Cooperativo , Saúde Pública , Pesquisadores/organização & administração , United States Department of Veterans Affairs , Infecções por HIV/diagnóstico , Hepatite C/diagnóstico , Humanos , Estados Unidos , Saúde dos Veteranos/estatística & dados numéricosRESUMO
Increasing numbers of women veterans using Department of Veterans Affairs (VA) services has contributed to the need for equitable, high-quality care for women. The VA has evaluated performance measure data by gender since 2006. In 2008, the VA launched a 5-year women's health redesign, and, in 2011, gender disparity improvement was included on leadership performance plans. We examined data from VA Office of Analytics and Business Intelligence quarterly gender reports for trends in gender disparities in gender-neutral performance measures from 2008 to 2013. Through reporting of data by gender, leadership involvement, electronic reminders, and population management dashboards, VA has seen a decreasing trend in gender inequities on most Health Effectiveness Data and Information Set performance measures.
Assuntos
Disparidades em Assistência à Saúde/tendências , Qualidade da Assistência à Saúde/tendências , United States Department of Veterans Affairs/organização & administração , United States Department of Veterans Affairs/tendências , Técnicas e Procedimentos Diagnósticos , Feminino , Humanos , Liderança , Masculino , Programas de Rastreamento , Sistemas de Alerta , Fatores Sexuais , Estados Unidos , Saúde dos VeteranosRESUMO
In the USA, 21% of the estimated 1.1 million people living with human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) are unaware they are HIV-infected. In 2011, Veterans Health Administration (VHA)'s Office of Public Health in conjunction with VHA's Health Care for Homeless Veterans Program funded grants to support rapid HIV testing at homeless outreach events because homeless populations are more likely to obtain emergent rather than preventive care and have a higher HIV seroprevalence as compared to the general population. Because of a Veterans Affairs North Texas Health Care System (VANTHCS)'s laboratory testing requirement, VANTHCS partnered with community agencies to offer rapid HIV testing for the first time at VANTHCS' 2011 Homeless Stand Downs in Dallas, Fort Worth, and Texoma, Texas. Homeless Stand Downs are outreach events that connect Veterans with services. Veterans who declined testing were asked their reasons for declining. Comparisons by Homeless Stand Down site used Pearson χ², substituting Fisher's Exact tests for expected cell sizes <5. Of the 910 Veterans attending the Homeless Stand Downs, 261 Veterans reported reasons for declining HIV testing, and 133 Veterans were tested, where 92% of the tested Veterans obtained their test results at the events - all tested negative. Veterans' reported reasons for declining HIV testing included previous negative result (n=168), no time to test (n=49), no risk factors (n=36), testing is not a priority (n=11), uninterested in knowing serostatus (n=6), and HIV-infected (n=3). Only "no time to test" differed significantly by Homeless Stand Down site. Nonresponse rate was 54%. Offering rapid HIV testing at Homeless Stand Downs is a promising testing venue since 15% of Veterans attending VANTHCS' Homeless Stand Downs were tested for HIV, and majority obtained their HIV test results at point-of-care while further research is needed to determine how to improve these rates.
Assuntos
Infecções por HIV/diagnóstico , Serviços de Saúde/estatística & dados numéricos , Pessoas Mal Alojadas/psicologia , United States Department of Veterans Affairs , Veteranos/estatística & dados numéricos , Relações Comunidade-Instituição , Infecções por HIV/prevenção & controle , Necessidades e Demandas de Serviços de Saúde , Pessoas Mal Alojadas/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Texas , Estados Unidos , Veteranos/psicologiaRESUMO
BACKGROUND: Cabotegravir + rilpivirine long-acting (CAB + RPV LA) dosed every 2 months (Q2M) is a complete regimen for the maintenance of HIV-1 virologic suppression. In this study, we report month 12 clinical outcomes in patient study participants (PSPs) in the CAB and RPV Implementation Study in European Locations (CARISEL) study. SETTING: CARISEL is a phase 3b implementation-effectiveness study. METHODS: CARISEL was designed as a 2-arm, unblinded study with centers randomized to either enhanced or standard implementation arms. For PSPs, this study is single arm, unblinded, and interventional; all PSPs switched from daily oral therapy to CAB + RPV LA dosed Q2M. The primary objective was to evaluate the perceived acceptability, appropriateness, and feasibility of CAB + RPV LA implementation for staff participants (presented separately). Clinical secondary endpoints assessed through month 12 included the proportion of PSPs with plasma HIV-1 RNA ≥50 and <50 copies/mL (Snapshot algorithm), incidence of confirmed virologic failure (CVF; 2 consecutive plasma HIV-1 RNA levels ≥200 copies/mL), adherence to injection visit windows, and safety and tolerability. RESULTS: Four hundred thirty PSPs were enrolled and treated; the mean age was 44 years (30% ≥50 years), 25% were women (sex at birth), and 22% were persons of color. At month 12, 87% (n = 373/430) of PSPs maintained HIV-1 RNA <50 copies/mL, with 0.7% (n = 3/430) having HIV-1 RNA ≥50 copies/mL. One PSP had CVF. The safety profile was consistent with previous findings. Overall, the results were similar between implementation arms. CONCLUSION: CAB + RPV LA Q2M was well tolerated and highly effective in maintaining virologic suppression with a low rate of virologic failure.
Assuntos
Fármacos Anti-HIV , Infecções por HIV , HIV-1 , Piridonas , Rilpivirina , Humanos , Rilpivirina/uso terapêutico , Rilpivirina/administração & dosagem , Infecções por HIV/tratamento farmacológico , Feminino , Masculino , Piridonas/uso terapêutico , Fármacos Anti-HIV/uso terapêutico , Fármacos Anti-HIV/administração & dosagem , Adulto , Pessoa de Meia-Idade , HIV-1/efeitos dos fármacos , HIV-1/genética , Europa (Continente) , Carga Viral/efeitos dos fármacos , Resultado do Tratamento , Quimioterapia Combinada , DicetopiperazinasRESUMO
INTRODUCTION: Cabotegravir plus rilpivirine (CAB + RPV) is the first complete long-acting (LA) regimen recommended for maintaining HIV-1 virological suppression. Cabotegravir And Rilpivirine Implementation Study in European Locations (CARISEL) is an implementation-effectiveness study examining the implementation of CAB+RPV LA administered every 2 months (Q2M) in European HIV centres. We present staff study participant (SSP) perspectives on the administration of CAB+RPV LA over 12 months. METHODS: Eighteen clinics were randomized to one of two implementation support packages: standard arm (Arm-S) or enhanced arm (Arm-E). Arm-S included video injection training and provider/patient toolkits. Additionally, Arm-E included skilled wrap-around team meetings, face-to-face injection training and continuous quality improvement (CQI) calls. SSPs completed surveys on the acceptability, appropriateness and feasibility of CAB+RPV LA as an intervention and its implementation into their clinics, as well as barriers and facilitators to implementation. All surveys were completed at Month (M)1 (baseline), M5 and M12; data collection was completed by February 2022. Qualitative data were obtained from semi-structured interviews at M1, M5 and M12. The primary objective was assessed via formal statistical comparisons between study arms of the Acceptability of Implementation Measure, Implementation Appropriateness Measure and Feasibility of Implementation Measure surveys (1-5 Likert scale ranging from 1 = "completely disagree" to 5 = "completely agree"). Equivalent measures anchored to CAB+RPV LA as a therapy were also assessed. RESULTS: Seventy SSPs completed surveys and interviews at M1, 68 at M5 and 62 at M12. Mean acceptability/appropriateness/feasibility scores were ≥3.8 (out of 5) at M12 for implementation- and intervention-based measures. An analysis of covariance showed no significant differences between study arms for these outcomes. Although barriers were noted, most SSPs were not overly concerned that these would impact implementation; concern about these anticipated barriers also decreased over time. At M12, 90.3% (n = 56/62) of SSPs held a positive opinion about CAB+RPV LA implementation. Qualitative interviews and CQI calls highlighted three top practices that supported implementation: implementation planning; education about CAB+RPV LA clinical efficacy; and education around administering injections and managing pain/discomfort after injections. CONCLUSIONS: CARISEL demonstrated that CAB+RPV LA dosed Q2M was successfully implemented across a range of European locations, with SSPs finding implementation highly acceptable, appropriate and feasible. GOV NUMBER: NCT04399551.
Assuntos
Fármacos Anti-HIV , Infecções por HIV , Piridonas , Rilpivirina , Humanos , Rilpivirina/uso terapêutico , Rilpivirina/administração & dosagem , Infecções por HIV/tratamento farmacológico , Europa (Continente) , Fármacos Anti-HIV/uso terapêutico , Fármacos Anti-HIV/administração & dosagem , Piridonas/uso terapêutico , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , DicetopiperazinasRESUMO
OBJECTIVES: We measured HIV testing and seropositivity among veterans in Veterans Affairs (VA) care for calendar years 2009 through 2011 and analyzed 2011 results by patient demographics. METHODS: We performed a repeated-measures cross-sectional study using standardized electronic data extraction from the VA electronic health records for all veterans with at least 1 outpatient visit during 2009 through 2011. We analyzed testing rates and seropositivity by demographic characteristics for 2011. RESULTS: Of veterans with an outpatient visit, 20.0% had an HIV test in 2011, compared with 9.2% in 2009. Documented HIV testing rates were highest in women and Blacks. Of confirmed positive test results, 67.0% were in outpatients older than 50 years. Seropositivity was highest among men aged 30 to 49 years, women aged 50 to 69 years, and Black outpatients of both genders. Implementation of an electronic clinical reminder was associated with higher testing rates. CONCLUSIONS: The significant effect of an electronic clinical reminder suggests that such decision support tools can substantially increase testing rates. The frequency of positive test results in older individuals suggests the need for additional work to define optimum approaches to HIV testing in this population.
Assuntos
Soropositividade para HIV/diagnóstico , Programas de Rastreamento/estatística & dados numéricos , United States Department of Veterans Affairs , Adulto , Idoso , Estudos Transversais , Registros Eletrônicos de Saúde/estatística & dados numéricos , Feminino , Soropositividade para HIV/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Pacientes Ambulatoriais , Grupos Raciais , Distribuição por Sexo , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Cabotegravir + rilpivirine long-acting (LA) is a novel antiretroviral therapy (ART) administered intramuscularly monthly or every 2 months by a health care provider. The COVID-19 pandemic presents a potential challenge to patients' ability to attend scheduled clinic visits for dosing administration. SETTING: This analysis evaluated implementation fidelity across 6 phase IIb/III/IIIb cabotegravir + rilpivirine LA clinical trials in 16 countries during the COVID-19 pandemic. METHODS: COVID-19-impacted visits were defined as modified dosing visits for which oral therapy was provided to participants unable to attend the clinic or injection visits that were rescheduled. Data from December 1, 2019, to March 1, 2021, were aggregated and analyzed using descriptive statistics. RESULTS: Of 2127 participants in cabotegravir + rilpivirine LA trials, 1997 (94%) had LA dosing visits proceed as planned during the COVID-19 pandemic. Of 130 (6%) participants with injection visits affected by COVID-19, most were from North America (57%) and Europe (26%). Most participants with COVID-19-impacted visits used oral therapy with cabotegravir + rilpivirine (75%) or alternative oral standard-of-care ART (21%) to maintain continuous ART. The most common reasons for missed visits were clinic closure/staffing constraints (48%) and COVID-19-related travel restrictions (23%). Most (98%) participants who used oral ART maintained virologic suppression; 2 participants had viral load between 50 and 100 copies/mL. CONCLUSION: During the COVID-19 pandemic, most trial participants maintained their LA dosing schedules. Flexibility of the LA dosing regimen, with the ability to switch to oral therapy, facilitated continuous ART provision and implementation fidelity.
Assuntos
Fármacos Anti-HIV , Tratamento Farmacológico da COVID-19 , Infecções por HIV , Fármacos Anti-HIV/uso terapêutico , Antirretrovirais/uso terapêutico , Dicetopiperazinas , Infecções por HIV/tratamento farmacológico , Humanos , Pandemias , Piridonas , Rilpivirina/uso terapêuticoRESUMO
INTRODUCTION: CUSTOMIZE evaluated the implementation of long-acting (LA) cabotegravir + rilpivirine, a novel healthcare provider-administered injectable antiretroviral therapy regimen, in diverse US healthcare settings. Findings from staff-study participants (SSPs) through 12 months of implementation are reported. METHODS: CUSTOMIZE was a phase IIIb, 12-month, single-arm, hybrid III implementation-effectiveness study conducted from July 2019 to October 2020 at eight US clinics of five clinic types: private practice (n = 2), federally qualified health centre (n = 2), university (n = 2), AIDS Healthcare Foundation (n = 2) and health maintenance organization (n = 1). Eligible patient participants received monthly cabotegravir + rilpivirine LA injections after a 1-month oral lead-in. At baseline, month 4 and month 12, SSPs (n = 3 each per clinic), including physicians, nurses or injectors, and administrators, completed quantitative surveys and semi-structured interviews to assess implementation outcomes (acceptability, appropriateness and feasibility of intervention measures), programme sustainability and SSP perceptions of, attitudes towards, and expectations for cabotegravir + rilpivirine LA. Month 12 data collection occurred during the COVID-19 pandemic. RESULTS: In surveys, SSPs reported high mean total scores for acceptability, appropriateness and feasibility of cabotegravir + rilpivirine LA implementation at baseline (4.43, 4.52 and 4.38 of 5, respectively) and month 12 (4.45, 4.61 and 4.46 of 5, respectively), regardless of clinic type. At month 12, SSPs were positive about the implementation sustainability (mean Program Sustainability Assessment Tool score, 5.83 out of 7). At baseline, SSPs' top concern was patients' ability to maintain monthly appointments (81%); at month 12, 39% had this concern. The proportion of SSPs reporting patient injection pain or soreness as a barrier was consistent at month 12 versus baseline (48% vs. 46%). Most (78%) SSPs reported optimal implementation of cabotegravir + rilpivirine LA in their clinics was achieved in 1-3 months. In interviews, SSP-reported strategies for successful implementation included teamwork, using a web-based treatment planner and having a designated person to track appointment scheduling. In month 12 interviews, SSP-reported structural changes needed for implementation included changing clinic hours and purchasing refrigerators. CONCLUSIONS: In CUSTOMIZE, cabotegravir + rilpivirine LA was successfully implemented across a range of US healthcare settings. Barriers were mitigated with minor process adjustments.
Assuntos
Fármacos Anti-HIV , Tratamento Farmacológico da COVID-19 , Infecções por HIV , Fármacos Anti-HIV/uso terapêutico , Antirretrovirais/uso terapêutico , Atenção à Saúde , Dicetopiperazinas , Infecções por HIV/tratamento farmacológico , Pessoal de Saúde , Humanos , Pandemias , Piridonas , Rilpivirina/uso terapêuticoRESUMO
INTRODUCTION: The CUSTOMIZE hybrid III implementation-effectiveness study evaluated implementation of once-monthly long-acting (LA) cabotegravir + rilpivirine in diverse US healthcare settings. Here, we report patient participant perspectives after 12 months in CUSTOMIZE. METHODS: CUSTOMIZE was a phase IIIb, 12-month study conducted from July 2019 to October 2020 at eight diverse US HIV clinics that enrolled virologically suppressed people living with HIV-1 (PLHIV) on a stable oral regimen to receive monthly cabotegravir + rilpivirine LA injections after a 1-month oral lead-in. Participants were administered quantitative surveys before injections at months 1 (baseline), 4 and 12. A randomly selected subset of participants was interviewed at baseline and month 12. Data collection at month 12 was completed by October 2020 (during the COVID-19 pandemic). RESULTS: At baseline, 109 and 34 participants completed surveys and interviews, respectively; 87% were male; 35% were Black or African American. All participants who remained in the study at month 12 (n = 102) maintained HIV-1 RNA <50 copies/ml; two participants withdrew due to injection-related reasons. Mean total scores measuring acceptability and appropriateness of cabotegravir + rilpivirine LA were high at baseline (4.5-4.6 out of 5) and month 12 (4.7-4.9). At month 12, 74% of participants reported nothing interfered with receiving LA injections; injection pain or soreness was the most common concern (15%). Time spent in the clinic and coming to the clinic for monthly injections was very or extremely acceptable after 12 months for most participants (93% and 87%, respectively), with 64% reporting having spent ≤30 minutes in the clinic for injection visits. At month 12, 92% of participants preferred LA injections to daily oral tablets (3%); 97% plan to continue LA treatment going forward. In month 12 interviews, 24 (77%) of 31 participants reported the COVID-19 pandemic did not impact their ability to receive treatment. CONCLUSIONS: Once-monthly cabotegravir + rilpivirine LA was highly acceptable among PLHIV who were virologically suppressed on a stable antiretroviral regimen and interested in trying LA therapy, with few participants reporting challenges receiving LA injections. Implementation data from CUSTOMIZE suggest that monthly LA injections provide a convenient and appealing treatment option for PLHIV.
Assuntos
Fármacos Anti-HIV , Tratamento Farmacológico da COVID-19 , Infecções por HIV , Soropositividade para HIV , HIV-1 , Fármacos Anti-HIV/uso terapêutico , Antirretrovirais/uso terapêutico , Atenção à Saúde , Dicetopiperazinas , Feminino , Infecções por HIV/tratamento farmacológico , Soropositividade para HIV/tratamento farmacológico , Humanos , Masculino , Pandemias , Piridonas , Rilpivirina/uso terapêuticoRESUMO
OBJECTIVE: The Veterans Health Administration established comprehensive women's health clinics (CWHCs) to provide coordinated, high-quality primary care to women veterans. Intimate partner violence (IPV) is prevalent among women using these clinics. The Veterans Health Administration recommends screening women for IPV, yet screening uptake is low in CWHCs nationwide. We describe a multisite quality improvement initiative to enhance the adoption of IPV screening practices in the Veterans Health Administration's CWHCs. METHODS: This quality improvement initiative, implemented in 2017-2018, included 4 steps in which we (1) conducted a baseline survey of screening practices at CWHCs throughout the United States; (2) selected and tailored evidence-based implementation strategies based on identified barriers and facilitators; (3) deployed multicomponent implementation support, targeting low-adopting facilities; and (4) conducted a follow-up survey to evaluate changes in IPV screening practices from baseline (winter 2017) to 1-year follow-up (winter 2018) using quantitative and qualitative analyses. RESULTS: Responders from 62 CWHC sites provided information on IPV screening practices and barriers; 42 low-adopting sites were targeted for implementation support. At follow-up, responders provided information on IPV screening practices, perceived usefulness of implementation support strategies, and continued barriers. Among sites that responded to both surveys (n = 47), the number of sites that implemented recommended screening practices increased by 66.7%, from 15 at baseline to 25 at follow-up (P = .02). Emergent themes reflected barriers and facilitators for IPV screening implementation. CONCLUSIONS: Improvement in IPV screening practices in CWHCs is a pivotal step toward enhancing care for women. Yet, even with numerous implementation supports, barriers to adoption persist at many sites. Findings on modifiable barriers and unique facilitators can inform next steps for increasing screening uptake.
Assuntos
Programas de Triagem Diagnóstica/organização & administração , Violência por Parceiro Íntimo/prevenção & controle , Atenção Primária à Saúde , Melhoria de Qualidade , Serviços de Saúde para Veteranos Militares , Saúde da Mulher , Feminino , Humanos , Avaliação de Programas e Projetos de Saúde , Estados Unidos , United States Department of Veterans AffairsRESUMO
BACKGROUND: A recent study reported a lower than expected specificity and positive predictive value of the rapid oral HIV test in the setting of routine emergency department (ED) screening. These results appeared inconsistent with the findings in another urban Emergency Department during the same time period. OBJECTIVE: To compare the specificity and positive predictive vale (PPV) of an oral rapid HIV test used in an ED screening program in Washington DC with that performed in the USHER clinical trial. DESIGN: Period cross-sectional analysis of rapid oral HIV testing conducted in an ongoing HIV screening program emergency department patients. SETTING: The George Washington University Emergency Department (Washington DC) from 7 February to 1 October 2007. PATIENTS: 1,560 adults seen in the ED for non-HIV-related presenting complaints, who participated in the HIV screening program. INTERVENTION: Rapid HIV testing with the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test (OraSure Technologies, Bethlehem, Pennsylvania). PATIENTS with reactive rapid test results were offered Western blot testing for confirmation. MEASUREMENTS: Specificity and positive predictive value for the program were determined. Findings were compared to those found in the USHER trial. RESULTS: Of 1,560 patients screened for HIV, 13 [0.8%, 95% CI 0.38% to 1.28%] had a reactive HIV screening test, and all were confirmed to be positive by Western Blot. The specificity was 100% (95% CI 99.6%-100%). LIMITATION: Since non-reactive tests were not confirmed, the test sensitivity cannot be determined. CONCLUSION: Review of our data conflict with findings from the USHER study surrounding false positive OraQuick HIV screening. Our data suggest that rapid HIV screening protocols implemented in EDs outside of the clinical trial paradigm perform effectively without an excess of false positive results. Compared with other screening tests, HIV rapid screening should remain an essential component of ED practice.
RESUMO
BACKGROUND: The key to maximizing the value of implementation science data is to get the learnings early. A critical contributor to early clinical research data is the biopharmaceutical industry. In partnership with the implementation research community, industry has an opportunity to play a major role to increase the value of implementation research data through earlier integration of implementation questions in the development continuum. METHODS: This article suggests that by using more hybrid implementation-effectiveness study designs in phase III trials, researchers can accelerate the availability of implementation data closer to the initial introduction of novel treatments into community settings. The biopharmaceutical industry is uniquely poised to lead or collaborate on these trials. RESULTS: The first LAI HIV medications are being studied for both HIV prevention and treatment. This paradigm shift in the provision of HIV care is an opportunity to blend implementation research into clinical trials earlier so that the public health community is armed with tested implementation strategies to maximize access and impact when these new medications become available. CUSTOMIZE, a novel phase IIIB-hybrid III implementation-effectiveness trial-is the first-of-its-kind study to examine different implementation strategies to overcome challenges of delivering a LAI antiretroviral medication in various types of HIV clinical settings the US health care system. CONCLUSIONS: Industry can play a complimentary and additive role by partnering with implementation science researchers to understand the implementation strategies sooner in the development pipeline. These collaborations may allow for earlier, more informed, and strategic HIV public health programs in the future.
Assuntos
Antirretrovirais/administração & dosagem , Preparações de Ação Retardada/administração & dosagem , Infecções por HIV/tratamento farmacológico , Ciência da Implementação , Ensaios Clínicos Fase III como Assunto , Infecções por HIV/prevenção & controle , Humanos , Saúde PúblicaRESUMO
OBJECTIVES: To investigate whether gender is associated with three recommended stages of the HIV care continuum and whether gender modifies known associations between level of alcohol use and HIV care among US veterans. DESIGN: Retrospective cohort. METHODS: Veterans Aging Cohort Study data were used to identify Veterans Health Administration (VA) patients with HIV and AUDIT-C alcohol screening from 1 February 2008 to 30 September 2014. Modified Poisson regression models estimated the relative risk and predicted prevalences of engagement in HIV care (documented CD4âcells/µl or viral load copies/ml lab values), ART treatment (at least one prescription), and viral suppression (HIV RNA <500âcopies/ml) in the year following AUDIT-C (1) for women compared to men, and (2) for each level of alcohol use compared to nondrinking among women and among men. A multiplicative interaction between gender and alcohol use was tested. RESULTS: Among 33â224 patients, women (nâ=â971) were less likely than men (nâ=â32â253) to receive HIV care (P values <0.001). Respective predicted prevalences for women and men were 71.9% (95% CI 69.1-74.7%) and 77.9% (77.5-78.4%) for engagement, 60.0% (57.0-73.14%) and 73.8% (73.4-74.3%) for ART treatment, and 46.4% (43.3-49.6%) and 55.8% (55.3-56.3%) for viral suppression. Although the interaction between gender and alcohol use was not statistically significant, stratified analyses suggested worse outcomes for women than men at higher levels of alcohol use. CONCLUSION: In this large national cohort, women were less likely than men to be engaged in HIV medical care, prescribed ART, and virally suppressed. Interventions to improve HIV care for women are needed at all levels of alcohol use.
Assuntos
Alcoolismo/epidemiologia , Continuidade da Assistência ao Paciente , Infecções por HIV/complicações , Adesão à Medicação/estatística & dados numéricos , Fatores Sexuais , Adulto , Idoso , Idoso de 80 Anos ou mais , Contagem de Linfócito CD4 , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Retrospectivos , Estados Unidos/epidemiologia , Veteranos , Carga ViralRESUMO
BACKGROUND: The Department of Veterans Affairs (VA), the largest integrated HIV care provider in the United States (US), used the HIV Care Continuum to compare clinical care within the VA HIV population with the general US HIV population and to identify areas for improvement. METHODS: National data from the VA's HIV Clinical Case Registry were used to construct measures along the Continuum for Veterans in VA care diagnosed with HIV by June 2013 and alive by December 31, 2013. Comparisons were made to recent estimates for the same measures for the US HIV population. Additional comparisons were performed for demographic subgroups of sex, race/ethnicity, and age. RESULTS: Of 25,480 Veterans diagnosed with HIV, 77.4% were engaged in care compared with 46.3% in the US population diagnosed with HIV (P < 0.001). Seventy-three percent of Veterans diagnosed with HIV received antiretroviral therapy compared with 43% of the US population diagnosed with HIV (P < 0.001). Nearly two-thirds (65.3%) of HIV-diagnosed Veterans had suppressed HIV viral loads compared with 35.0% of the US population diagnosed with HIV (P < 0.001). CONCLUSIONS: The VA health care system performed better at every stage of the HIV Care Continuum compared with the general US estimates. Comparable high rates with some variation were noted among the demographic groups in the VA cohort. The high viral suppression rate in VA, which was almost double the estimate for the HIV-diagnosed US population, demonstrates that improved outcomes along the HIV Care Continuum can be achieved in a comprehensive integrated health care system.
Assuntos
Fármacos Anti-HIV/uso terapêutico , Prestação Integrada de Cuidados de Saúde/estatística & dados numéricos , Infecções por HIV/terapia , United States Department of Veterans Affairs , Adolescente , Adulto , Idoso , Feminino , Infecções por HIV/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Grupos Raciais , Estados Unidos/epidemiologia , Adulto JovemRESUMO
We have reported that dietary inorganic phosphate (Pi) deprivation induces a Pi-seeking behavior in juvenile male rats. The purpose of the present study was to determine whether the Pi appetite is present in adult animals, and if so, whether it is altered during times of increased demand for Pi, such as pregnancy and lactation. Both male and female animals fed a low-phosphate diet (LPD) ingested significantly greater amounts of PiH(2)O daily than their normal phosphate diet (NPD) controls, and per 100 g of body weight (BW), the female animals fed LPD tended to ingest greater amounts of PiH(2)O than male rats fed LPD. Pregnant and lactating rats fed LPD ingested significantly more PiH(2)O than those fed NPD, however, neither group displayed a Pi appetite different than virgin females. However, lactation further reduced Pi levels in plasma and cerebral spinal fluid compared with control values. Despite the additional Pi from the PiH(2)O in the mothers fed LPD, pup birth weight was significantly lower than in NPD litters, and this was exacerbated 9 days after birth. This attenuated BW gain was associated with lower plasma Pi levels in the pups. In conclusion, a mild but consistent Pi-seeking behavior is induced in adult male and female rats after only 2 days of dietary Pi restriction. On a relative basis, the amount of PiH(2)O ingested is greater in female than in male animals, but does not increase further during pregnancy and lactation.
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Motivação , Fosfatos/administração & dosagem , Animais , Feminino , Masculino , Fosfatos/sangue , Fosfatos/líquido cefalorraquidiano , Gravidez , Ratos , Ratos WistarAssuntos
Sorodiagnóstico da AIDS , Infecções por HIV/diagnóstico , Programas de Rastreamento , Sorodiagnóstico da AIDS/métodos , Sorodiagnóstico da AIDS/estatística & dados numéricos , Adolescente , Adulto , Testes Diagnósticos de Rotina/estatística & dados numéricos , Política de Saúde , Humanos , Pessoa de Meia-Idade , Estados Unidos , Adulto JovemRESUMO
Early diagnosis of persons infected with human immunodeficiency virus (HIV) through diagnostic testing and screening is a critical priority for individual and public health. Emergency departments (EDs) have an important role in this effort. As EDs gain experience in HIV testing, it is increasingly apparent that implementing testing is conceptually and operationally complex. A wide variety of HIV testing practice and research models have emerged, each reflecting adaptations to site-specific factors and the needs of local populations. The diversity and complexity inherent in nascent ED HIV testing practice and research are associated with the risk that findings will not be described according to a common lexicon. This article presents a comprehensive set of terms and definitions that can be used to describe ED-based HIV testing programs, developed by consensus opinion from the inaugural meeting of the National ED HIV Testing Consortium. These definitions are designed to facilitate discussion, increase comparability of future reports, and potentially accelerate wider implementation of ED HIV testing.
Assuntos
Infecções por HIV/diagnóstico , Terminologia como Assunto , Comunicação , Serviço Hospitalar de Emergência/economia , Serviço Hospitalar de Emergência/organização & administração , Guias como Assunto , Infecções por HIV/economia , Humanos , Notificação de AbusoRESUMO
BACKGROUND: In 2006, the US Centers for Disease Control and Prevention (CDC) released new recommendations for routine HIV testing. Among these were recommendations that emergency departments (EDs) offer routine opt-out HIV screening to their patients. We established a screening program implementing these recommendations at an urban university hospital ED in Washington, DC. We report the results of this program. METHODS: During a 3-month period, ED patients being treated for a wide range of conditions were approached by trained HIV screeners and offered point-of-care rapid HIV testing. Patients with positive results were referred to hospital or community resources for confirmatory testing and treatment. RESULTS: During the program period, 14,986 patients were treated in the ED and 4151 (27.6%) were offered HIV screening. The mean patient age was 37.5 years; 48.5% were black, 39.0% were non-Hispanic white, 4.1% were Hispanic, 1.7% were Asian, and 6.7% responded as being other race. A total of 56.1% were female, and most lived within the Washington, DC metropolitan area. Of the patients offered HIV screening, 2476 (59.7%) accepted the test. Of the 26 patients with a preliminary positive screen, 13 were lost to follow-up, 9 were confirmed positive by Western blot, and 4 were confirmed negative by Western blot. Eight of the 9 patients with confirmed HIV infection were successfully linked to follow-up care. CONCLUSIONS: The implementation of the CDC recommendations establishing routine opt-out HIV screening programs in EDs is feasible. Further efforts to establish routine ED HIV testing are therefore warranted.