Mobile HIV Care for HIV/AIDS

Recruiting at 3 trial locations

Overseen By Jennifer Cohen, MPA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Cognitive impairment, psychosis, intoxication

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a flexible, drop-in, and mobile care approach to assist people with HIV who struggle to maintain regular doctor visits. The goal is to simplify access to treatment and improve health by managing their HIV effectively. Suitable participants include those living with HIV who haven't seen a doctor in the past six months, have difficulty keeping appointments, or face challenges such as homelessness, mental health issues, or substance use. The study will evaluate the effectiveness of this care model at various sites in San Francisco and Alameda counties. As an unphased trial, it offers a unique opportunity to contribute to innovative care solutions that could make treatment more accessible for many.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on improving care engagement for people with HIV, so it's likely you can continue your current medications, but you should confirm with the trial coordinators.

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 seems focused on providing flexible HIV care, so it's best to discuss your current medications with the trial team.

What prior data suggests that this mobile HIV care approach is safe?

Research shows that the drop-in and mobile HIV care approach is well-received. Studies have found that this method can help more people achieve viral suppression, especially those in the Ryan White HIV/AIDS program. This indicates that the care model is safe and effective for individuals who find it hard to attend regular appointments.

Specific safety data for this trial is not available, but the methods resemble those used in public health clinics and needle exchange sites. These places have successfully implemented similar approaches, providing reassurance about safety.

Overall, the drop-in and mobile care method aims to facilitate easier access to HIV treatment without increasing risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mobile HIV care approach because it offers a flexible, low-barrier solution for individuals who face challenges accessing traditional healthcare settings. Unlike standard HIV treatments that rely on scheduled appointments at clinics, this method brings care directly to patients through mobile units and drop-in centers. This approach is designed to adapt to the needs of patients, making it easier for them to receive consistent care and support. By building a coalition among referral and clinical sites and preparing champions at these locations, the trial aims to improve engagement and adherence to treatment, potentially leading to better health outcomes for people living with HIV.

What evidence suggests that this mobile HIV care approach is effective for people living with HIV?

Research has shown that drop-in and mobile HIV care, the focus of this trial, can assist people with HIV who struggle to attend regular appointments. One study on this method found it improved participants' viral suppression rates, meaning they had lower HIV levels in their blood. This approach provides easy access and flexibility, which is particularly beneficial for those facing challenges like transportation issues or complex health needs. Additionally, past efforts like the Ryan White HIV/AIDS program have demonstrated that reducing barriers to care can lead to better health outcomes for people with HIV. Overall, this care model shows promise for reaching those who might not engage in traditional healthcare settings. ^{1 2 3 4 6}

Who Is on the Research Team?

Katerina Christopoulos, MD, MPH

Principal Investigator

University of California, San Francisco

Matthew Hickey, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 15 years or older and living with HIV.

Sub-optimal care engagement by self-report or chart history (defined as no current HIV primary care provider, no HIV primary care visit in the past 6 months, or ≥1 missed HIV primary care visit in the past 6 months)

≥1 major barrier to care engagement by self report or chart history (homelessness/ unstable housing, any mental health diagnosis, any illicit substance use)

Exclusion Criteria

I am able to understand and agree to the study's procedures and risks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation and Adaptation

Formative work to engage stakeholders, finalize implementation strategies, and develop site-specific adaptations of the interventions

Varies

Treatment

Participants receive drop-in and mobile HIV care with staged escalation/de-escalation of care level as needed

12 months

Follow-up

Participants are monitored for viral suppression and engagement in HIV care

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Active Referral
• Assess for readiness and identify barriers
• Audit and feedback at referral sites
• Build a coalition among referral and clinical sites
• Create a learning collaborative
• Develop a formal implementation blueprint
• Develop educational materials; conduct ongoing training
• Drop-In Multidisciplinary HIV Care
• Identify and prepare champions at referral sites
• Mobile HIV Care
• Promote adaptability
• Staged Care

Trial Overview 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.

How Is the Trial Designed?

Group I: Low-barrier drop-in and mobile care Experimental Treatment 12 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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

San Francisco AIDS Foundation

Collaborator

Trials

3

Recruited

750+

San Francisco AIDS Foundation

Collaborator

Trials

3

Recruited

750+

La Clínica de La Raza Inc.

Collaborator

Trials

4

Recruited

1,100+

Lifelong Medical Care

Collaborator

Trials

3

Recruited

730+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

A study involving 12 individuals living with HIV and 8 healthcare providers in western Kenya identified major barriers to care engagement for highly mobile populations, including stigma, rigid work schedules, and inflexible clinic hours.

Participants preferred solutions that enhance flexibility and privacy, such as coded cards for treatment details and alternative drug packaging, to improve their engagement in care and address the challenges posed by their mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving care engagement for mobile people living with HIV in rural western Kenya. Ayieko, J., Charlebois, ED., Maeri, I., et al.[2023]

The START-ART study demonstrated that a multi-faceted intervention, including coaching from opinion leaders and the use of point-of-care CD4 testing, significantly increased the initiation of antiretroviral therapy (ART) among healthcare providers in Uganda.

Qualitative interviews revealed that strong relationships between healthcare providers, peer counselors, and institutional support were crucial for the successful implementation of the intervention, leading to improved patient satisfaction and quicker ART initiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding uptake of an intervention to accelerate antiretroviral therapy initiation in Uganda via qualitative inquiry. Semitala, FC., Camlin, CS., Wallenta, J., et al.[2022]

To effectively provide highly active antiretroviral therapy (HAART) in Africa, new care models must be developed that utilize nursing or non-clinically qualified staff to alleviate the burden on physicians, as traditional physician-based models may not be feasible in resource-limited settings.

Research into alternative delivery methods, such as treatment at peripheral health centers or through home visits, is crucial to improve adherence and cost-effectiveness of HAART, highlighting the need for investment in studies that address these delivery challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiretroviral treatment in resource-poor settings: public health research priorities. Jaffar, S., Govender, T., Garrib, A., et al.[2007]

A pilot project in Chiang Mai, Thailand, successfully shifted HIV care from physician-led clinics to nurse-led primary healthcare teams, with 198 patients reporting higher satisfaction in accessibility and convenience of the service.

After one year, patients receiving task-shifted ART showed similar immunological outcomes (CD4 counts) compared to those in traditional physician-led care, indicating that the shift did not compromise patient health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction of HIV patients with task-shifted primary care service versus routine hospital service in northern Thailand. Aung, MN., Moolphate, S., Kitajima, T., et al.[2022]

A systematic review of nine studies on interventions for re-engaging people living with HIV found that while various strategies were employed, none significantly improved viral suppression, highlighting a gap in effective methods for re-engagement into care.

The review suggests that standardizing definitions for being out-of-care and re-engagement could help in comparing different interventions, and emphasizes the need for more rigorous study designs to evaluate effective strategies for enhancing HIV care re-engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Re-Engagement into HIV Care: A Systematic Review. Blanco, N., Lavoie, MC., Koech, E., et al.[2022]

The effectiveness of global HIV care programs is significantly hindered by patient drop-off at various stages of the HIV care continuum, which includes testing, enrollment, ART eligibility, initiation, and adherence.

To improve health outcomes and reduce transmission, it is essential to implement targeted interventions that address the diverse barriers individuals face at each step of the care continuum and to evaluate program performance rigorously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The HIV care continuum: no partial credit given. McNairy, ML., El-Sadr, WM.[2022]

A systematic review of 388 studies on HIV care interventions found that empowering patients through integrative approaches significantly improved linkage to care (LTC) and initiation of antiretroviral therapy (ART) in low- and middle-income countries.

Tailoring care strategies, such as incorporating ART initiation into existing healthcare infrastructures like maternal clinics, and using home-based HIV counseling and testing alongside motivational counseling, were particularly effective in enhancing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Linkage-to-Care and Antiretroviral Initiation Implementation Strategies in Low- and Middle-Income Countries Across Sub-Saharan Africa. Okonkwo, NE., Blum, A., Viswasam, N., et al.[2023]

Immediate initiation of antiretroviral treatment (iART) is recognized by clinic staff in New York City as beneficial for achieving viral suppression and improving patient retention, although most reported starting medication within three to four days after a reactive HIV test rather than on the same day.

Barriers to same-day iART initiation include concerns about patient readiness and differences in practices among medical and non-medical staff, particularly in clinics serving predominantly people of color, suggesting that targeted resources could help improve access and equity in HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate initiation of antiretroviral treatment: knowledge, attitudes, and practices among clinic staff in New York City. Bertolino, D., Baim-Lance, A., D'Aquila, E., et al.[2023]

The study employs the multiphase optimization strategy (MOST) to develop a culturally tailored intervention aimed at increasing engagement in HIV care and ART adherence among African American/Black and Hispanic individuals, with a sample size of 512 participants.

By evaluating five distinct intervention components, the research aims to identify which elements most effectively improve HIV viral suppression and care engagement, while also optimizing the intervention for cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations: a study protocol. Gwadz, MV., Collins, LM., Cleland, CM., et al.[2022]

A study involving 41 in-depth interviews with various stakeholders in Atlanta identified significant barriers to implementing mobile HIV clinics, including concerns about confidentiality, continuity of care, and community acceptance.

Participants suggested that careful planning regarding the design, location, and timing of mobile clinics, as well as offering additional non-HIV services, could help overcome these barriers and improve the effectiveness of mobile clinics in re-engaging people living with HIV who are out of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to use of a mobile HIV care model to re-engage and retain out-of-care people living with HIV in Atlanta, Georgia. Henkhaus, ME., Hussen, SA., Brown, DN., et al.[2021]

The ARTAS intervention significantly improved linkage to HIV primary care for 86% of participants, particularly among Hispanic individuals, those with unstable housing, and those without depressive symptoms.

To enhance its effectiveness, the ARTAS intervention may need to be customized for specific subgroups that did not respond as well, indicating that a one-size-fits-all approach may not be sufficient for all recently diagnosed HIV-positive individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demographic, psychological, and behavioral modifiers of the Antiretroviral Treatment Access Study (ARTAS) intervention. Gardner, LI., Marks, G., Craw, J., et al.[2018]

This systematic review aims to evaluate the impact of shifting antiretroviral therapy (ART) dispensing from specialized pharmacy personnel to non-pharmacy workers in low and middle-income countries, potentially increasing access to ART.

The review will analyze controlled trials to assess the effectiveness and safety of this shift, which could inform healthcare policy and improve ART distribution in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of shifting tasks from pharmacy to non-pharmacy personnel for providing antiretroviral therapy to people living with HIV: a systematic review protocol. Mbeye, NM., Kredo, T., Wiysonge, CS.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05887557

Multidisciplinary Low-Barrier and Mobile HIV Care to ... The purpose of this study is to evaluate the implementation and effectiveness of a flexible, multidisciplinary, integrated drop-in/mobile HIV care approach ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05887557

Multidisciplinary Low-Barrier and Mobile HIV Care to ... This HIV/AIDS study at UCSF is now recruiting people ages 15 years and up.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10233499/

Drop-in HIV Primary Care Model for People Experiencing ... For many served by the Ryan White HIV/AIDS program, disparities in viral suppression decreased, 2010–14. Health Aff (Millwood) 2017; 36:116–23. [DOI] ...

4. reporter.nih.gov reporter.nih.gov/project-details/10886517

Project Details - NIH RePORTER The proposed study will provide robust evidence for a drop-in/mobile HIV ... AIDS; Health Disparities Research; Health Disparities and Racial or Ethnic ...

5. ajph.aphapublications.org ajph.aphapublications.org/doi/full/10.2105/AJPH.2018.304732

Mobile Multidisciplinary HIV Medical Care for Hard-to-Reach ... The HHOME project targets the most complex persons living with HIV/AIDS who are not engaged in HIV treatment, specifically those with a low CD4 ...

6. researchgate.net researchgate.net/publication/361576564_HIV_treatment_outcomes_in_POP-UP_drop-in_HIV_primary_care_model_for_people_experiencing_homelessness

(PDF) HIV treatment outcomes in POP-UP: drop- ... POP-UP Mobile: A Mixed Methods Study of Mobile Outreach for People with HIV with Housing Instability... March 2025 · AIDS patient care and STDs. Madellena Conte ...