Team-Based Care for HIV

(ARTAS Trial)

Overseen By Jennifer Veltman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Must not be taking: ART

Disqualifiers: Virally suppressed, Under HIV care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: During hospitalization

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a team-based approach can enhance how people with HIV connect to care and reduce hospital readmissions. Participants will receive either the usual care (Standard of Care) or the ARTAS intervention, which involves working with a social worker and an infectious disease doctor. It suits individuals over 18 who have HIV but are not currently on treatment or have not seen an HIV specialist in the last six months. The goal is to discover better ways to support those with HIV in managing their health effectively. As an unphased trial, this study provides a unique opportunity to contribute to innovative strategies for improving HIV care.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are actively taking ART (HIV medication) and are under the care of an HIV specialist, you may not be eligible for this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Team-Based Inpatient ARTAS program helps people with HIV connect to healthcare and reduces their chances of returning to the hospital. Studies have examined the safety of the antiretroviral therapy (ART) used in this program. Some participants have experienced side effects, such as skin problems. However, the Centers for Disease Control and Prevention (CDC) supports the ARTAS program and offers free training, indicating its general acceptance and widespread use.

While the ARTAS program has shown promising results in community settings, studies have reported some side effects of ART. These reports are important to consider when thinking about joining a trial. For specific concerns about side effects, consulting a healthcare professional before participating may be helpful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial because it explores a new approach to HIV care that could improve patient outcomes. Unlike the standard care, which typically involves treatment managed solely by a primary care team, the team-based inpatient ARTAS approach brings together social workers and infectious disease specialists to support patients. This method aims to enhance access to antiretroviral therapy and provide comprehensive care, potentially leading to better adherence to treatment and improved health outcomes for individuals with HIV.

What evidence suggests that this trial's treatments could be effective for HIV?

Research has shown that the team-based ARTAS approach, a treatment option in this trial, can significantly improve outcomes for people with HIV. Studies have found that this method connects about 78% to 79% of participants to essential HIV medical care within six months. It also reduces hospital readmissions by helping patients adhere to their treatment plans. By combining social support with medical care, this approach is crucial for better health outcomes. Overall, team-based care enables more effective HIV management and decreases hospitalization needs. Meanwhile, the other arm of this trial involves the Standard of Care, serving as a control group receiving conventional medical care. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have recently been diagnosed with HIV.

I have HIV and haven't started antiretroviral therapy in the last 30 days.

Known HIV and not virally suppressed based on interview

Exclusion Criteria

I am not excluded because I don't meet all three: virally suppressed, on ART, and seen by an HIV specialist in the last 6 months.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Eligible patients receive the ARTAS intervention by a social worker and medical consultation by an infectious disease physician

During hospitalization

Inpatient visits

Follow-up

Participants are monitored for linkage to HIV care and readmission rates post-discharge

Up to 12 weeks

Phone interviews and medical chart reviews

What Are the Treatments Tested in This Trial?

Interventions

• Standard of Care
• Team Based Inpatient ARTAS

Trial Overview 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.

How Is the Trial Designed?

Group I: Standard of Care Historic Control Active Control 1 Intervention

Control group will get treatment as usual, which consists of medical care by primary admitting service

Group II: Team based inpatient ARTAS Active Control 1 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

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Published Research Related to This Trial

Timed-cycle structured treatment interruptions (STI) of antiretroviral therapy (ART) have been shown to be unsafe in the short term, with reports of resistance development and no significant immunological or virological benefits.

The CD4-guided STI strategy may offer short-term advantages such as reduced costs and better tolerability, but concerns about its long-term safety and efficacy remain unresolved, indicating that more research is needed before it can be considered standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structured treatment interruptions (STI) in chronic suppressed HIV infection in adults. Pai, NP., Tulsky, JP., Lawrence, J., et al.[2018]

In a study of 2650 patients on antiretroviral therapy in Nigeria, the incidence of adverse drug reactions (ADRs) was found to be 4.6 per 100 person-years, with the majority of ADRs occurring in the first six months of treatment, highlighting the need for close monitoring during this period.

Most ADRs were mild (grade 1), with pain and skin rash being the most common types reported, and patients on tenofovir (TDF) experienced fewer ADRs compared to those on zidovudine (AZT) or stavudine (d4T), suggesting that TDF may be a safer option in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions to antiretroviral therapy (ARVs): incidence, type and risk factors in Nigeria. Eluwa, GI., Badru, T., Agu, KA., et al.[2022]

The introduction of combination antiretroviral therapy (cART) in 1996 significantly reduced hospital admission rates for people living with HIV, with men experiencing a greater reduction than women.

Socio-economic status and sex were key factors influencing hospital admission rates, with women and individuals from lower socio-economic backgrounds showing higher rates of both total and HIV-related admissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Socio-economic- and sex-related disparities in rates of hospital admission among patients with HIV infection in Ontario: a population-based study. Antoniou, T., Zagorski, B., Loutfy, MR., et al.[2021]

A survey of clinical care settings in New York and Connecticut revealed that most medical clinics provide only minimal adherence support for HIV+ patients on antiretroviral therapy (ART), often relying on overburdened primary care staff to offer help as needed.

There is a significant need for structured ART adherence interventions that can be easily implemented in clinical settings, providing comprehensive resources for patients from the start of their treatment through to maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standard of care: promoting antiretroviral adherence in clinical care. Harman, JJ., Amico, KR., Johnson, BT.[2007]

In a study of people living with HIV/AIDS in Brazil, 25.7% of patients modified their antiretroviral therapy (ART) within the first year due to adverse events, with the median time to modification being 70.5 days after starting treatment.

The most common adverse events leading to ART modification were dermatological, neuropsychiatric, and gastrointestinal issues, with patients on a specific combination of zidovudine, lamivudine, and efavirenz being twice as likely to switch therapies compared to those on tenofovir with lamivudine and efavirenz.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated to modification of first-line antiretroviral therapy due to adverse events in people living with HIV/AIDS. Azevedo, LN., Ximenes, RAA., Monteiro, P., et al.[2022]

In a study of 9,406 individuals starting antiretroviral treatment (ART) from 2000 to 2010, those initiating ART with CD4(+) cell counts of at least 500 cells/μl experienced a higher rate of laboratory-defined adverse events (LDAEs) compared to those starting with lower counts, indicating potential safety concerns for this group.

While patients starting ART with CD4(+) counts between 351-499 cells/μl did not show a significant difference in LDAE rates compared to those with counts below 350 cells/μl, they had a higher risk of discontinuing ART, suggesting that starting treatment at higher CD4(+) levels may lead to different management challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory adverse events and discontinuation of therapy according to CD4(+) cell count at the start of antiretroviral therapy. Jose, S., Quinn, K., Hill, T., et al.[2022]

HIV-infected patients admitted to the hospital face a high risk of medication errors due to complex antiretroviral therapy (ART) regimens, necessitating thorough medication histories and communication with outpatient providers to ensure continuity of care.

Drug-drug interactions (DDIs) are common during hospital stays, and clinicians must carefully review these interactions, especially when adjusting ART for patients with altered liver or kidney function, to prevent complications and ensure effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Care Management of the HIV-Infected Patient: A Report from the HIV Practice and Research Network of the American College of Clinical Pharmacy. Durham, SH., Badowski, ME., Liedtke, MD., et al.[2018]

Combination antiretroviral therapy (ART) has significantly improved the health outcomes for individuals with HIV, leading to lower mortality rates, fewer hospitalizations, and a reduced incidence of AIDS-related illnesses.

The article highlights the importance of understanding the different components of ART regimens and the criteria for starting treatment in individuals who have not previously received therapy, while also addressing the challenges faced in managing antiretroviral medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiretroviral therapy: a primer for dermatologists. Kim, HN., Harrington, RD.[2006]

Antiretroviral therapy (ART) is now recommended for all patients with HIV-1, with treatment strategies tailored based on factors like CD4+ T-lymphocyte count and presence of opportunistic infections, aiming to achieve an undetectable plasma viral load.

Initial ART should consist of three drugs, including two nucleoside reverse transcriptase inhibitors (NRTIs) and one additional drug, with integrase strand transfer inhibitors (INSTIs) being preferred for their efficacy in treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Executive summary of the GESIDA/National AIDS Plan Consensus Document on antiretroviral therapy in adults infected by the human immunodeficiency virus (updated January 2015). Berenguer, J., Polo, R., Aldeguer, JL., et al.[2017]

A study of 311 ICU admissions for HIV-infected patients from 2000 to 2004 showed that hospital survival rates significantly improved over the years, indicating better outcomes for critically ill patients in the ART era.

While the use of antiretroviral therapy (ART) at ICU admission did not directly correlate with survival, it was linked to better health indicators such as higher CD4 counts and lower HIV levels, suggesting that ART contributes to overall patient health even if it doesn't directly affect survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival for patients With HIV admitted to the ICU continues to improve in the current era of combination antiretroviral therapy. Powell, K., Davis, JL., Morris, AM., et al.[2021]

In a retrospective study of 102 HIV-infected patients admitted to the ICU, survival rates were high, with 77% surviving to ICU discharge and 68% to hospital discharge, comparable to general medical patients.

Factors influencing survival included higher hemoglobin levels and CD4 counts, while mechanical ventilation was associated with lower survival rates; however, receiving highly active antiretroviral therapy (HAART) did not significantly improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival of HIV-infected patients in the intensive care unit in the era of highly active antiretroviral therapy. Dickson, SJ., Batson, S., Copas, AJ., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05866523

NCT05866523 | Teamwork Makes the Dream Work Exploring the effect of team-based ARTAS intervention in an inpatient setting on HIV linkage to care and hospital readmission rates. Official Title. Teamwork ...

2. withpower.com withpower.com/trial/phase-hiv-infections-7-2023-d8e82

Team-Based Care for HIV (ARTAS Trial) Combination antiretroviral therapy (ART) has been shown to significantly improve survival rates and reduce hospitalizations for people with HIV. This suggests ...

3. aidsetc.org aidsetc.org/sites/default/files/resources_files/artas_implementation_manual.pdf

Anti-Retroviral Treatment and Access to Services (ARTAS) This intervention is intended to be used with persons who are recently diagnosed with HIV and who are voluntarily participating in the intervention. The ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7508967/

Modified Antiretroviral Treatment Access Study (MARTAS) Both studies found similar rates of linkage to HIV medical care within 6 months among the intervention participants (ARTAS-I, 78%; ARTAS- II, 79%) [5, 21].

5. clinicalinfo.hiv.gov clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/adherence-continuum-care

Adherence to the Continuum of Care | NIH The results from the ARTAS intervention have been replicated in a community-based study.26 The CDC supports free training in the ARTAS ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10918579/

Linkage Case Management and Posthospitalization ... In this randomized clinical trial that involved 500 hospitalized people with HIV, a linkage case management intervention did not reduce 12-month mortality.