Team-Based Care for HIV

(ARTAS Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Loma Linda University

Must not be taking: ART

Disqualifiers: Virally suppressed, Under HIV care, others

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.

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.

What data supports the effectiveness of the treatment Team-Based Care for HIV?

Combination antiretroviral therapy (ART) has been shown to significantly improve survival rates and reduce hospitalizations for people with HIV. This suggests that team-based approaches, which often include ART, could be effective in managing HIV. ^{1 2 3 4 5}

Is team-based care for HIV generally safe for humans?

The safety of antiretroviral therapy (ART), which is part of team-based care for HIV, has been studied, and some patients experience adverse events like skin issues, mood changes, and stomach problems. These side effects can lead to changes in medication, but ART is generally considered safe with proper monitoring. ^{1 6 7 8 9}

How is the Team-Based Inpatient ARTAS treatment for HIV different from other treatments?

The Team-Based Inpatient ARTAS treatment is unique because it focuses on a team-based approach to enhance adherence to antiretroviral therapy (ART) for HIV patients, providing organized support and resources from initiation to maintenance, unlike the minimal and ad hoc adherence support typically offered in standard care. ^{2 3 7 10 11}

Research Team

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.

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 has not been under the care of an HIV specialist within the past 6 months

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.

Trial Timeline

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

Treatment Details

Interventions

• Standard of Care (Behavioral Intervention)
• Team Based Inpatient ARTAS (Behavioral Intervention)

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.

Participant Groups

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+

Adrian Cotton

Loma Linda University

Chief Medical Officer since 2020

MD

Richard H. Hart

Loma Linda University

Chief Executive Officer since 2015

MD, DrPH

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

Findings from Research

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]

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 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]

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]

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]

References

1. United States 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. [2018]

2. United States 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. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Antiretroviral therapy: a primer for dermatologists. [2006]

4. Canada 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Survival of HIV-infected patients in the intensive care unit in the era of highly active antiretroviral therapy. [2022]

6. Brazil pubmed.ncbi.nlm.nih.gov

Factors associated to modification of first-line antiretroviral therapy due to adverse events in people living with HIV/AIDS. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Structured treatment interruptions (STI) in chronic suppressed HIV infection in adults. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Adverse drug reactions to antiretroviral therapy (ARVs): incidence, type and risk factors in Nigeria. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Laboratory adverse events and discontinuation of therapy according to CD4(+) cell count at the start of antiretroviral therapy. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Standard of care: promoting antiretroviral adherence in clinical care. [2007]

11. Spain 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). [2017]