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

Trial Summary

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 data supports the idea that Mobile HIV Care for HIV/AIDS is an effective treatment?

The available research shows that Mobile HIV Care can be effective because it addresses barriers to accessing treatment and helps keep patients engaged in their care. For example, shifting tasks from specialized healthcare workers to those with less formal training can increase access to antiretroviral therapy (ART) in resource-limited settings. Additionally, strategies that integrate care into existing infrastructures, like maternal clinics, and provide home-based counseling and testing, have shown positive results. These approaches make it easier for people to start and stick with their treatment, which is crucial for managing HIV effectively. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for HIV/AIDS?

Research shows that integrating antiretroviral therapy (ART) into existing healthcare infrastructures and using flexible, patient-centered approaches can improve engagement and outcomes in HIV care. Strategies like home-based counseling and testing, along with motivational support, have been effective in enhancing linkage to care and ART initiation. ^{1 2 3 4 5}

What safety data exists for Mobile HIV Care treatment?

The provided research does not directly address safety data for Mobile HIV Care or its related interventions. The studies focus on improving care engagement, identifying barriers, and optimizing interventions for HIV care, particularly for mobile and vulnerable populations. They highlight the importance of immediate ART initiation and engagement in the HIV care continuum but do not provide specific safety data for the interventions mentioned. ^{4 6 7 8 9}

Is Mobile HIV Care safe for humans?

The research articles provided do not contain specific safety data for Mobile HIV Care or its related interventions. They focus on improving care engagement and access to treatment for people living with HIV. ^{4 6 7 8 9}

Is the mobile HIV care treatment a promising treatment for HIV/AIDS?

Yes, mobile HIV care is a promising treatment for HIV/AIDS. It helps re-engage and retain people living with HIV who are out of care by bringing healthcare services directly to them. This approach can improve access to treatment, especially for those who have difficulty visiting traditional clinics, and can help ensure they continue their medication, which is crucial for managing HIV effectively. ^{4 6 10 11 12}

How does the mobile HIV care treatment differ from other treatments for HIV/AIDS?

The mobile HIV care treatment is unique because it uses mobile clinics to re-engage and retain people living with HIV who are out of care, addressing barriers like care interruptions and mobility issues. This approach is novel compared to traditional stationary clinics, as it aims to improve access and continuity of care for mobile populations. ^{4 6 10 11 12}

What is the purpose of this trial?

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.

Research Team

Matthew Hickey, MD

Principal Investigator

University of California, San Francisco

Katerina Christopoulos, MD, MPH

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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)

I am 15 years or older and living with HIV.

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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]

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 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 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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Satisfaction of HIV patients with task-shifted primary care service versus routine hospital service in northern Thailand. [2022]

2. United States 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Antiretroviral treatment in resource-poor settings: public health research priorities. [2007]

4. England pubmed.ncbi.nlm.nih.gov

The HIV care continuum: no partial credit given. [2022]

5. England 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. [2019]

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

Improving care engagement for mobile people living with HIV in rural western Kenya. [2023]

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

Demographic, psychological, and behavioral modifiers of the Antiretroviral Treatment Access Study (ARTAS) intervention. [2018]

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

Immediate initiation of antiretroviral treatment: knowledge, attitudes, and practices among clinic staff in New York City. [2023]

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

Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations: a study protocol. [2022]

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

Re-Engagement into HIV Care: A Systematic Review. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Understanding uptake of an intervention to accelerate antiretroviral therapy initiation in Uganda via qualitative inquiry. [2022]

12. United States 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. [2021]