What is the mechanism of action of this treatment?

Antiretroviral therapy (ART) is the primary treatment for HIV/AIDS, involving a combination of drugs that target different stages of the HIV life cycle. These include nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. By reducing the viral load, ART helps maintain immune function and prevent the progression to AIDS. The Integrated Drop-in/Mobile HIV Care approach enhances ART effectiveness by providing flexible, multidisciplinary, and mobile services, ensuring better engagement in care and viral suppression, which is vital for improving patient outcomes and reducing HIV transmission.

What side effects are associated with this type of intervention?

The most common treatments for HIV/AIDS involve antiretroviral therapy (ART), which can have several side effects impacting patients' quality of life and medication adherence. Common side effects include gastrointestinal issues such as nausea, vomiting, and diarrhea; metabolic changes like lipodystrophy and insulin resistance; and neurological symptoms such as headaches and dizziness. Some patients may also experience fatigue, skin rashes, and liver toxicity. These side effects can vary in severity and may lead some individuals to modify or discontinue their treatment regimen.

What prior FDA approvals exist?

The FDA has approved numerous antiretroviral therapies (ART) for the treatment of HIV/AIDS, which are often used in multidisciplinary and mobile care settings to improve patient engagement and viral suppression. Key drugs include single-tablet regimens like Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and Triumeq (abacavir/dolutegravir/lamivudine), which simplify treatment by combining multiple antiretrovirals into one pill. Other important drugs include Truvada (emtricitabine/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide), which are used both for treatment and pre-exposure prophylaxis (PrEP). These medications are integral to flexible, multidisciplinary approaches that aim to enhance retention in care and achieve viral suppression.

What other types of research exist?

Promising alternatives to Integrated Drop-in/Mobile HIV Care for HIV/AIDS patients include: 1) Telemedicine and virtual care platforms, which provide remote consultations and continuous monitoring; 2) Multi-month antiretroviral therapy (ART) dispensing, reducing the frequency of clinic visits; 3) Community-based ART distribution, leveraging local resources to improve access; 4) Digital adherence tools, such as mobile apps and SMS reminders, to support medication adherence; 5) Peer support programs, which connect patients with trained peers for emotional and practical support.

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Mobile HIV Care for HIV/AIDS

N/A

Recruiting

Led By Katerina Christopoulos, MD, MPH

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Summary

This trial is testing a flexible HIV care approach for people who have trouble attending scheduled visits. The care can be accessed without appointments or through mobile units that visit patients. The level of care can be adjusted based on what each patient needs.

Who is the study for?

This trial is for adults and teens (15+) living with HIV who aren't currently on effective treatment or engaged in regular care, especially those facing major challenges like unstable housing, mental health issues, or substance use.

What is being tested?

The study tests a new approach to HIV care that includes drop-in services, mobile clinics, training for healthcare workers, and active referrals. It compares the effectiveness of this model over 12 months against traditional care methods.

What are the potential side effects?

Since this trial focuses on service delivery rather than medication, it doesn't have typical drug side effects. However, participants may experience stress or discomfort related to changes in their routine HIV care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with HIV viral suppression

Reach

Secondary study objectives

Evaluate sustained engagement in HIV care

Participants with durable viral suppression

Trial Design

1Treatment groups

Experimental Treatment

Group I: Low-barrier drop-in and mobile careExperimental Treatment12 Interventions

This is a single-arm trial of a set of implementation strategies to encourage uptake of drop-in and mobile HIV care for people living with HIV who experience barriers to engage in usual scheduled appointments.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antiretroviral therapy (ART) is the primary treatment for HIV/AIDS, involving a combination of drugs that target different stages of the HIV life cycle. These include nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. By reducing the viral load, ART helps maintain immune function and prevent the progression to AIDS. The Integrated Drop-in/Mobile HIV Care approach enhances ART effectiveness by providing flexible, multidisciplinary, and mobile services, ensuring better engagement in care and viral suppression, which is vital for improving patient outcomes and reducing HIV transmission.

Effect of female sex work-targeted community-based interventions along the HIV treatment cascade in sub-Saharan Africa: a systematic review protocol.Mutations Related to Antiretroviral Resistance Identified by Ultra-Deep Sequencing in HIV-1 Infected Children under Structured Interruptions of HAART.Text message intervention designs to promote adherence to antiretroviral therapy (ART): a meta-analysis of randomized controlled trials.

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Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,551 Previous Clinical Trials

15,257,486 Total Patients Enrolled

San Francisco AIDS FoundationUNKNOWN

2 Previous Clinical Trials

348 Total Patients Enrolled

La Clínica de La Raza Inc.OTHER

3 Previous Clinical Trials

745 Total Patients Enrolled

Media Library

Low-barrier drop-in and mobile care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05887557 — N/A

~267 spots leftby Mar 2027

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