Managed Problem Solving for HIV/AIDS Care

No longer recruiting at 9 trial locations

Overseen By Florence Momplaisir

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Incarceration

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to support people living with HIV through a program called Managed Problem Solving (MAPS+). The researchers aim to determine if Community Health Workers (CHWs) can deliver this program to improve medication adherence and patient engagement, potentially leading to better health outcomes such as viral suppression. The trial seeks participants living with HIV who have struggled to stay in care or maintain viral suppression in the past year. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in HIV care and potentially benefit from personalized support.

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 focuses on behavioral interventions to improve care retention and viral suppression for people living with HIV.

What prior data suggests that the MAPS+ intervention is safe for people living with HIV?

Research has shown that Managed Problem Solving (MAPS) safely aids people with HIV in managing their treatment. Studies have found that MAPS helps individuals adhere to their medication plans and has been used successfully without serious side effects. For instance, one study with 180 participants focused on improving adherence to antiretroviral therapy, and participants did not experience significant negative effects from the MAPS sessions.

Overall, MAPS is well-tolerated, meaning most people do not have adverse reactions. It primarily involves problem-solving sessions designed to enhance HIV treatment management. These sessions have been shown to help patients maintain an undetectable viral load, indicating very low levels of the virus in the body.

In summary, evidence suggests that MAPS is a safe and effective way to support people living with HIV in managing their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Managed Problem Solving (MAPS) for HIV/AIDS care because it offers a fresh approach to managing the condition. Unlike the standard of care, which primarily focuses on medication adherence and clinical interventions, MAPS is a cognitive-behavioral technique that empowers patients to address personal barriers and develop practical solutions for their care. This method emphasizes patient empowerment and problem-solving skills, which could lead to improved health outcomes and quality of life for individuals living with HIV/AIDS.

What evidence suggests that the MAPS+ intervention is effective for improving care in people living with HIV?

Research has shown that Managed Problem Solving (MAPS), which participants in this trial may receive, helps people with HIV adhere to their medication plans and maintain viral control. Keeping the virus under control means it remains at such low levels that it can't significantly harm the body. Studies indicate that MAPS enhances the outcomes of antiretroviral therapy (ART) by using problem-solving techniques to empower patients. This method helps individuals identify and overcome obstacles that might prevent regular medication adherence. Experts have found MAPS to be a valuable tool in maintaining long-term viral control for people living with HIV. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults living with HIV who are not consistently in care or have not achieved viral suppression. It's specifically designed to help those who may benefit from additional support by Community Health Workers.

Inclusion Criteria

I haven't been consistently in care or virally suppressed this past year.

I am living with HIV.

I have not been consistently in care or virally suppressed this past year.

Exclusion Criteria

Incarcerated during the duration of the trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline (Usual Care)

Baseline data collection from each clinic for usual care

6 months

Implementation of MAPS+

Implementation of MAPS+ intervention and strategies in clinics

12 months

Follow-up

Participants are monitored for viral suppression and retention in care

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Managed Problem Solving (MAPS)

Trial Overview

The trial tests a behavioral intervention called Managed Problem Solving (MAPS+), delivered by Community Health Workers, aimed at improving medication adherence and retention in HIV care. The effectiveness of MAPS+ will be compared to usual care across several clinics.

How Is the Trial Designed?

Group I: MAPS+ Experimental Treatment 1 Intervention

Group II: Standard of Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

The Managed Problem Solving (MAPS) intervention significantly improved medication adherence among HIV-1 infected individuals, with participants in the MAPS group being 1.78 times more likely to achieve higher adherence compared to those receiving usual care.

MAPS also showed a positive trend in achieving undetectable HIV viral loads, with odds 1.48 times greater than the usual care group, indicating its potential effectiveness in improving virologic outcomes over a year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managed problem solving for antiretroviral therapy adherence: a randomized trial. Gross, R., Bellamy, SL., Chapman, J., et al.[2022]

A multidisciplinary team approach for managing HIV at Kaiser Permanente Santa Rosa led to significantly fewer hospital admissions and shorter hospital stays for AIDS patients, with a reduction in average days spent in the hospital from 7.8 to 2.01 days between 1991 and 1994.

Patients at KPMC-SRO had lower costs for HIV-related medications ($2343 per member) compared to those at other Kaiser Permanente centers ($3289 per member), indicating that this model not only improves patient outcomes but also reduces healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with a managed care approach to HIV infection: effectiveness of an interdisciplinary team. Lê, CT., Winter, TD., Boyd, KJ., et al.[2019]

The AIDS epidemic poses significant challenges for healthcare systems, particularly in developing effective case management models tailored to the complex needs of individuals with AIDS.

San Francisco's experience illustrates the necessity for formalized and centralized case management roles due to the growing complexity of AIDS cases and the involvement of various healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case management of persons with acquired immunodeficiency syndrome in San Francisco. Benjamin, AR., Lee, PR., Solkowitz, SN.[2018]

Managed problem solving (MAPS) is an effective intervention for improving HIV medication adherence and viral suppression, and stakeholders in Philadelphia clinics are supportive of using community health workers (CHWs) to deliver this intervention.

Interviews with clinic stakeholders revealed important factors for successful MAPS implementation, such as the need for clear patient identification processes and strong communication within care teams, which can help facilitate broader use of MAPS in line with national HIV reduction goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder Perspectives on MAPS. Sanchez, AL., Hoskins, K., Pettit, AR., et al.[2023]

The MAPS+ intervention, which is led by community health workers, aims to improve viral suppression and retention in HIV care among 390 participants in Philadelphia, with effectiveness evaluated one year after implementation.

This study also explores the cost and reach of various implementation strategies, providing valuable insights into how to effectively deliver behavioral interventions to enhance medication adherence and care retention for people living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing antiretroviral therapy adherence and retention in care among adults living with HIV in Philadelphia: a study protocol for a stepped-wedge cluster-randomised type 2 hybrid effectiveness-implementation trial of managed problem-solving plus (MAPS+) delivered by community health workers. Van Pelt, AE., Bilker, WB., Nkwihorez, H., et al.[2023]

Case management interventions were most consistently linked to improvements in immunological outcomes for people living with HIV/AIDS, although they did not show clear benefits for other health measures.

Outreach interventions demonstrated significant improvements in mortality rates, access to antiretroviral medications, and overall healthcare utilization, suggesting they are effective strategies for enhancing care for HIV/AIDS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organization of care for persons with HIV-infection: a systematic review. Handford, CD., Tynan, AM., Agha, A., et al.[2019]

The article highlights the philosophical differences between the holistic approach needed for providing health and social services to people living with HIV/AIDS and the more rigid medical model of managed care, which may not fully address their needs.

It suggests that states need to carefully consider how they administer Medicaid managed care benefits for people with HIV/AIDS, and proposes research and policy agendas to better understand and improve these health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Containing the cost of care for people living with HIV/AIDS: an examination of the Medicaid managed care approach. Keefe, RH.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5053821/

Managed Problem Solving for Antiretroviral Therapy ...

We sought to determine whether an intervention derived from problem solving theory, Managed Problem Solving (MAPS), would improve antiretroviral outcomes.

2.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT04560621/managed-problem-solving-for-art-adherence-and-hiv-care-retention-delivered-by-community-health-workers

Managed Problem Solving for ART Adherence and HIV ...

Aim 1 will test the effectiveness of MAPS+ on clinical effectiveness outcomes, including viral suppression (primary) and retention (secondary).

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10603537/

Increasing antiretroviral therapy adherence and retention ...

Managed problem solving (MAPS), an EBP for antiretroviral therapy adherence, follows a problem-solving approach to empower people living with ...

4.

withpower.com

withpower.com/trial/phase-hiv-infections-8-2021-dd504

Managed Problem Solving for HIV/AIDS Care · Info for Participants

Managed problem solving (MAPS) is an effective intervention for improving HIV medication adherence and viral suppression, and stakeholders in Philadelphia ...

5.

frontiersin.org

frontiersin.org/journals/public-health/articles/10.3389/fpubh.2022.872746/full

Implementation mapping to plan for a hybrid trial testing the ...

Managed Problem Solving (MAPS) is an EBP with long-term impact on viral suppression in PWH (9). MAPS consists of four individual-level sessions during the ...

6.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0084952

The Effects of a Problem Solving-Based Intervention on ...

We previously demonstrated that Managed Problem Solving (MAPS) focused on HIV medication adherence improved adherence and viral load in patients initiating a ...