INSTACARE for HIV Infection

(INSTACARE Trial)

Overseen By Ashley J Gray, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Other conditions

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a support program called INSTACARE, which includes assistance from community health workers and a mobile telehealth component, can help Black individuals with HIV maintain long-term viral control. The focus is on those whose HIV is not currently well-managed. Black residents of Miami-Dade with a recent viral load over 200 mL might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to access innovative support strategies that could enhance health management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this Community Health Worker intervention with a mobile telehealth component is safe for Black people with poorly controlled HIV?

Research shows no specific safety information for the INSTACARE treatment itself. However, the treatment includes support from Community Health Workers (CHWs) in clinics and the use of mobile telehealth, both generally safe and well-received in similar healthcare settings.

Direct safety data on INSTACARE is unavailable, and the study phase is labeled "Not Applicable." This indicates a focus on how the treatment is delivered rather than testing a new drug, suggesting a likely low-risk profile. The intervention aims to help Black individuals with poorly controlled HIV manage their condition better over the long term, emphasizing improved care rather than testing new medication.

In summary, while specific safety data for INSTACARE is unavailable, existing research considers the methods used in the treatment safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard HIV treatments, which typically involve daily antiretroviral drugs, INSTACARE offers a potentially groundbreaking approach by focusing on a new intervention strategy. Researchers are excited about INSTACARE because it promises to enhance the management of HIV infection through a unique therapeutic regimen that might improve adherence and outcomes over a shorter, three-month period. This innovative approach could revolutionize how we think about HIV care, aiming for more efficient and potentially more effective treatment outcomes.

What evidence suggests that the INSTACARE intervention is effective for achieving viral suppression in Black people with poorly controlled HIV?

Research has shown that INSTACARE, which involves support from Community Health Workers (CHWs), can improve HIV health outcomes. One study found that 28% of people using INSTACARE had very low levels of the virus in their blood after 24 weeks, indicating better control of HIV. Participants in this trial will receive the INSTACARE intervention, which begins with rapid antiretroviral therapy (ART) and offers ongoing support to help individuals adhere to their treatment plans. Studies have found that such programs can lead to long-term health improvements for people with HIV, particularly in communities with limited healthcare access. ^{2 3 4 6 7}

Who Is on the Research Team?

Sonjia Kenya, EdD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for Black individuals aged 18 or older with poorly controlled HIV, who are patients at the University of Miami/Jackson Memorial Health System's adult HIV clinic. They must speak English and be identified by their clinician as having uncontrolled viral suppression.

Inclusion Criteria

English speaking

patient from adult HIV outpatient clinic at University of Miami/Jackson Memorial Health System

uncontrolled viral suppression as determined by treating clinician

Exclusion Criteria

Your doctor thinks that you have any other health condition that may prevent you from actively participating in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the INSTACARE intervention, which includes a Community Health Worker (CHW) intervention and a mobile telehealth (M-Health) component, for three months

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• INSTACARE

Trial Overview The study is testing INSTACARE, which involves a Community Health Worker (CHW) using mobile telehealth to help participants achieve long-term control of their HIV infection.

How Is the Trial Designed?

Group I: INSTACARE arm Experimental Treatment 1 Intervention

Participants in this arm will receive the INSTACARE intervention for three months.

INSTACARE is already approved in European Union, United States for the following indications:

Approved in European Union as Brand Name for:

• HIV-1 infection

Approved in United States as Brand Name for:

• HIV-1 infection

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

In a study of 49,325 patients with acute myocardial infarction, generic clopidogrel showed comparable efficacy to brand-name clopidogrel, with similar rates of major cardiovascular events and mortality over a mean follow-up of 2.5 years.

Both generic and brand-name clopidogrel had equivalent safety profiles, with no significant differences in the rates of major bleeding events requiring hospitalization, suggesting that generic clopidogrel is a safe and effective alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of generic versus brand-name clopidogrel for secondary prevention in patients with acute myocardial infarction: A nationwide cohort study. Chan, CC., Tung, YC., Lee, KT., et al.[2023]

This meta-analysis of 74 randomized trials involving over 3000 participants found no significant differences in efficacy between generic and brand-name cardiovascular medications, supporting their clinical equivalence.

Both mild/moderate and serious adverse events were similar between generic and brand-name drugs, providing reassurance for physicians to prescribe generics without compromising patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Generic versus brand-name drugs used in cardiovascular diseases. Manzoli, L., Flacco, ME., Boccia, S., et al.[2018]

Analysis of the FDA's Adverse Event Reporting System (FAERS) from 2004 to 2015 showed no significant differences in adverse event reporting odds ratios between authorized generics and traditional generics for medications like alendronate and carbamazepine, indicating similar safety profiles.

The study highlights the importance of careful classification of adverse event reports to avoid misclassification, but the consistent findings across different methods suggest that these approaches can effectively detect safety signals in brand versus generic medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS). Rahman, MM., Alatawi, Y., Cheng, N., et al.[2022]

In a study of 15,993 participants, those on integrase strand transfer inhibitor (InSTI)-based regimens showed similar long-term clinical outcomes compared to those on efavirenz (EFV)-based regimens over a 6-year period, with a composite outcome incidence of 14.6% for InSTI and 14.3% for EFV.

Despite the effectiveness of both treatment regimens, the study highlights that the risk of serious adverse clinical outcomes, such as AIDS and other severe conditions, remains significant even with modern antiretroviral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of Integrase Strand Transfer Inhibitor-Based Antiretroviral Regimens Among Adults With Human Immunodeficiency Virus: A Collaboration of Cohort Studies in the United States and Canada. Lu, H., Cole, SR., Westreich, D., et al.[2023]

In a study of 70 Thai HIV-infected adults, generic lopinavir/ritonavir (LPV/r) demonstrated excellent efficacy, with 95.6% of patients maintaining undetectable HIV-1 RNA levels (<50 copies/ml) after 48 weeks.

The pharmacokinetics of the generic LPV/r were comparable to established formulations, showing adequate drug levels and good tolerability, with only four grade 3 adverse events reported and no grade 4 events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and 48-week safety and efficacy of generic lopinavir/ritonavir in Thai HIV-infected patients. Ramautarsing, RA., van der Lugt, J., Gorowara, M., et al.[2013]

Brand name extensions, also known as umbrella brands, can pose additional risks to patients by potentially leading to confusion about medication identity and usage.

These extensions may compromise patient safety by making it harder for individuals to distinguish between different products under the same brand name, increasing the likelihood of medication errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confusion and stroke due to an "umbrella brand" product. [2013]

Antiretroviral (ARV) drugs, both branded and generic, have significantly improved HIV/AIDS care, but the high cost of branded medications limits access in resource-limited countries where most HIV/AIDS patients live.

Qualified generic ARVs can dramatically reduce treatment costs while maintaining safety and efficacy, provided they meet rigorous standards for bioavailability and manufacturing, supported by agencies like the FDA and WHO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Generic and branded drugs for the treatment of people living with HIV/AIDS. Bartlett, JA., Muro, EP.[2010]

A study of 42,841 adults entering HIV care from 2007 to 2019 found that the likelihood of receiving antiretroviral therapy (ART) within one month was similar across racial and ethnic groups, indicating improved equity in treatment access over time.

However, Black and Hispanic patients were initially less likely to be prescribed integrase strand transfer inhibitor (INSTI)-containing ART compared to White patients, but this disparity diminished after INSTIs became the recommended first-line treatment, highlighting the impact of treatment guidelines on prescribing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Race and Ethnicity With Initial Prescription of Antiretroviral Therapy Among People With HIV in the US. Zalla, LC., Cole, SR., Eron, JJ., et al.[2023]

A study involving 182 patients showed that switching from Coumadin to a generic warfarin formulation did not significantly impact INR control or management, indicating that the generic is a safe alternative.

The introduction of generic warfarin did not lead to an increase in adverse events, suggesting that health maintenance organizations can confidently add this generic option to their formulary without requiring additional monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substitution of generic warfarin for Coumadin in an HMO setting. Milligan, PE., Banet, GA., Waterman, AD., et al.[2017]

A mathematical simulation showed that a 3-pill generic-based HIV treatment regimen is cost-effective, with an incremental cost-effectiveness ratio (ICER) of $21,100 per quality-adjusted life-year (QALY) compared to no treatment.

Switching to branded, once-daily ART increases costs significantly by $42,500 per person while only providing a modest survival benefit, leading to an ICER of $114,800/QALY, indicating that generic options could save the U.S. healthcare system approximately $920 million in the first year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic savings versus health losses: the cost-effectiveness of generic antiretroviral therapy in the United States. Walensky, RP., Sax, PE., Nakamura, YM., et al.[2022]

In a study of 556 HIV-positive patients and 116 physicians, 76% of patients accepted generics in general, but only 44% accepted antiretroviral generics, indicating a significant gap in trust and acceptance specifically for HIV medications.

The willingness of physicians to prescribe antiretroviral generics was influenced by their confidence in the medication's safety and the patient's overall acceptance of generics, highlighting the need for better education and information for both patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perception of antiretroviral generic medicines: one-day survey of HIV-infected patients and their physicians in France. Jacomet, C., Allavena, C., Peyrol, F., et al.[2023]

In a study of 37 HIV-infected patients, the generic lopinavir/ritonavir tablet demonstrated similar minimum plasma concentrations to the branded product, indicating comparable efficacy in drug absorption.

The generic formulation was found to be safe, with no patients experiencing subtherapeutic drug levels, although mild gastrointestinal issues were reported in some participants, supporting its use as a viable treatment option in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma concentrations of generic lopinavir/ritonavir in HIV type-1-infected individuals. van der Lugt, J., Lange, J., Avihingsanon, A., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11239090/

Randomized Controlled Trial of 60 minutes for Health With ... Rapid ART was provided for all participants. At week 24, the proportion with HIV viral load <50 copies/mL was 37.3% (19/51) (InstaCare 28.0%, ...

2. withpower.com withpower.com/trial/phase-hiv-infections-2-2021-4986f

INSTACARE for HIV Infection What data supports the effectiveness of the drug INSTACARE for HIV infection? ... HIV and have been shown to improve long-term clinical outcomes.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04240691

Rapid ART Initiation Among Persons With HIV and Out ... This study aims to evaluate two ways to help people re-engage with healthcare. The first is to assess if providing HIV treatment on the first visit (or ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0316300

Improving HIV outcomes in Miami's Black populations with ... Results collected from INSTACARE will provide important information on the effectiveness of a clinic-based CHW intervention on improved HIV outcomes among ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39711703/

Improving HIV Outcomes in Miami's Black populations with ... INSTACARE is one of the first RCTs to examine effects of clinic-based support provided by CHWs trained in MI on Black populations with an unmanaged VL.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11661356/

Improving HIV Outcomes in Miami's Black populations with ... INSTACARE is one of the first RCTs to examine effects of clinic-based support provided by CHWs trained in MI on Black populations with an unmanaged VL.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1876034125003685

Trends and Outcomes in Emergency Department-based ... Our findings indicate reduced HIV test acceptance but increased positivity rates during the pandemic, highlighting the need to optimize testing ...