Team-Based Care for HIV (ARTAS Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Loma Linda University
No Placebo Group
Trial Summary
What is the purpose of this trial?Exploring the effect of team-based ARTAS intervention in an inpatient setting on HIV linkage to care and hospital readmission rates.
Is Team-Based Inpatient ARTAS a promising treatment for HIV?Yes, Team-Based Inpatient ARTAS is a promising treatment for HIV because it focuses on improving adherence to antiretroviral therapy (ART), which is crucial for reducing HIV-related health issues and improving survival rates. This approach aims to provide organized support and resources for patients, making it easier for them to stick to their treatment plans.12359
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are actively taking ART and are virally suppressed, you may be excluded from the trial.
What safety data exists for team-based care for HIV?The safety data for team-based care for HIV, which includes standard care and ARTAS interventions, is primarily related to antiretroviral therapy (ART). Adverse events are a significant concern, with studies indicating that 25.7% of ART modifications in the first year are due to adverse events, such as dermatological, neuropsychiatric, and gastrointestinal issues. Efavirenz is frequently modified due to these events. Structured treatment interruptions (STI) are explored to manage drug toxicities and reduce treatment time. Overall, safety surveillance is crucial in clinical care to monitor adverse drug reactions.2681011
What data supports the idea that Team-Based Care for HIV is an effective treatment?The available research shows that Team-Based Care for HIV, which includes combination antiretroviral therapy (ART), has led to significant improvements in the health of people with HIV. For example, it has resulted in fewer deaths, fewer hospital stays, and a decrease in serious HIV-related illnesses. This suggests that Team-Based Care is effective in managing HIV compared to other treatments.345710
Eligibility Criteria
This trial is for adults over 18 who are newly diagnosed with HIV, or those known to have HIV but haven't started antiretroviral therapy (ART) within the last month. It's also open to patients not virally suppressed or those without specialist care in the past 6 months. People actively on ART, virally suppressed, and under recent specialist care can't join.Treatment Details
The study compares a team-based approach called ARTAS for managing HIV in a hospital setting against the usual standard of care. The goal is to see if this method improves patient follow-up treatment and reduces readmissions.
2Treatment groups
Active Control
Group I: Standard of Care Historic ControlActive Control1 Intervention
Control group will get treatment as usual, which consists of medical care by primary admitting service
Group II: Team based inpatient ARTASActive Control1 Intervention
Eligible patients after the study consent process will receive Antiretroviral Treatment Access Study (ARTAS) intervention by social-worker and a medical consultation by an infectious disease physician
Find a clinic near you
Research locations nearbySelect from list below to view details:
Loma Linda University Medical CenterLoma Linda, CA
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Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
Gilead SciencesIndustry Sponsor
References
Standard of care: promoting antiretroviral adherence in clinical care. [2007]Although there has long been demand for programs and procedures that support or enhance adherence to antiretroviral therapy (ART) among HIV+ patients, there is scant evidence about the extent to which medical clinics have been able to incorporate adherence interventions into their standard care. A survey of clinical care settings in New York and Connecticut indicated that the current standard of care is to provide only minimal levels of adherence services, with ad hoc adherence support being offered on an as-needed basis, often by overburdened primary care staff. These results suggest a strong need for the development of ART adherence interventions that are not only easily translatable to real-life clinical settings, but also offer an organized compendium of resources for HIV+ patients, from initiation to maintenance.
Structured treatment interruptions (STI) in chronic suppressed HIV infection in adults. [2018]Although antiretroviral treatment (ART) has led to a decline in morbidity and mortality of HIV-infected patients in developed countries, it has also presented challenges. These challenges include increases in pill burden; adherence to treatment; development of resistance and treatment failure; development of drug toxicities; and increase in cost of HIV treatment and care. These issues stimulated interest in investigating the short-term and long-term consequences of discontinuing ART, thus providing support for research in structured treatment interruptions (STI). Structured treatment interruptions of antiretroviral treatment involve taking supervised breaks from ART. STI are defined as one or more planned, timing pre-specified, cyclical interruptions in ART. STI are attempted in monitored clinical settings in eligible participants. STI have generated hopes of reducing drug toxicities, decreasing costs and total time on treatment in HIV-positive patients. The first STI was attempted in the case of a patient in Germany, who later permanently discontinued treatment. This successful anecdotal case report led to several trials on STI worldwide.
Antiretroviral therapy: a primer for dermatologists. [2006]Combination antiretroviral therapy (ART) has transformed the care of individuals who have HIV infection. Effective ART has resulted in dramatic reductions in mortality, hospitalization rates, and the development of AIDS-defining illnesses. This article discusses the variety of agents that can comprise an effective ART regimen, focusing on the basic principles of ART, the indications for initiating ART in treatment-naive individuals who have established HIV infection, and the challenges associated with the use of antiretroviral medications.
Survival of HIV-infected patients in the intensive care unit in the era of highly active antiretroviral therapy. [2022]Several studies have described improved outcomes for HIV-infected patients admitted to the intensive care unit (ICU) since the introduction of highly active antiretroviral therapy (HAART). A study was undertaken to examine the outcome from the ICU for HIV-infected patients and to identify prognostic factors.
Survival for patients With HIV admitted to the ICU continues to improve in the current era of combination antiretroviral therapy. [2021]The combination antiretroviral therapy (ART) era (1996 to the present) has been associated with improved survival among HIV-infected outpatients, but ICU data from 2000 to the present are limited.
Adverse drug reactions to antiretroviral therapy (ARVs): incidence, type and risk factors in Nigeria. [2022]Data on adverse drug reactions (ADRs) related to antiretroviral (ARV) use in public health practice are few indicating the need for ART safety surveillance in clinical care.
Socio-economic- and sex-related disparities in rates of hospital admission among patients with HIV infection in Ontario: a population-based study. [2021]Among people living with HIV infection in the era of combination antiretroviral therapy (cART), admission to hospital may indicate inadequate community-based care. As such, population-based assessments of the utilization of inpatient services represent a necessary component of evaluating the quality of HIV-related care.
Laboratory adverse events and discontinuation of therapy according to CD4(+) cell count at the start of antiretroviral therapy. [2022]Few data describe antiretroviral treatment (ART)-related adverse events when treatment is initiated at CD4(+) cell counts more than 350 cells/μl. We compared rates of laboratory-defined adverse events (LDAEs) according to CD4(+) cell count at ART initiation.
Executive summary of the GESIDA/National AIDS Plan Consensus Document on antiretroviral therapy in adults infected by the human immunodeficiency virus (updated January 2015). [2017]In this update, antiretroviral therapy (ART) is recommended for all patients infected by type 1 human immunodeficiency virus (HIV-1). The strength and grade of the recommendation vary depending on the CD4+ T-lymphocyte count, the presence of opportunistic infections or comorbid conditions, age, and the efforts to prevent the transmission of HIV. The objective of ART is to achieve an undetectable plasma viral load (PVL). Initial ART should comprise three drugs, namely, two nucleoside reverse transcriptase inhibitors (NRTI) and one drug from another family. Three of the recommended regimens, all of which have an integrase strand transfer inhibitor (INSTI) as the third drug, are considered a preferred regimen; a further seven regimens, which are based on an INSTI, an non-nucleoside reverse transcriptase inhibitor (NNRTI), or a protease inhibitor boosted with ritonavir (PI/r), are considered alternatives. The reasons and criteria for switching ART are presented both for patients with an undetectable PVL and for patients who experience virological failure, in which case the rescue regimen should include three (or at least two) drugs that are fully active against HIV. The specific criteria for ART in special situations (acute infection, HIV-2 infection, pregnancy) and comorbid conditions (tuberculosis and other opportunistic infections, kidney disease, liver disease, and cancer) are updated.
Acute Care Management of the HIV-Infected Patient: A Report from the HIV Practice and Research Network of the American College of Clinical Pharmacy. [2018]Patients infected with human immunodeficiency virus (HIV) admitted to the hospital have complex antiretroviral therapy (ART) regimens with an increased medication error rate upon admission. This report provides a resource for clinicians managing HIV-infected patients and ART in the inpatient setting.
Factors associated to modification of first-line antiretroviral therapy due to adverse events in people living with HIV/AIDS. [2022]Antiretroviral therapy (ART) has modified the outcome of patients with HIV infection, providing virological control and reducing mortality. However, there are several reasons as to why patients may discontinue their antiretroviral therapy, with adverse events being one of the main reasons reported in the literature. This is a case-control nested in a cohort of people living with HIV/AIDS, conducted to identify the incidence of ART modification due to adverse events and the associated factors, in two referral services in Recife, Brazil, between 2011 and 2014. Of the modifications occurred in the first year of ART, 25.7% were driven by adverse events. The median time elapsed between initiating ART and the first modification due to adverse events was 70.5 days (95% CI: 26-161 days). The main adverse events were dermatological, neuropsychiatric and gastrointestinal. Dermatological events were the earliest to appear after initiating ART. Efavirenz was the most prescribed and most modified drug during the study period. The group of participants who used zidovudine, lamivudine, and efavirenz had a 2-fold greater chance (adjusted OR: 2.16 95% CI: 1.28-3.65) of switching ART due to adverse events when compared to the group that used tenofovir with lamivudine and efavirenz.