Managed Problem Solving for HIV/AIDS Care

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

780 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Managed Problem Solving (MAPS) for HIV/AIDS care?

Research shows that Managed Problem Solving (MAPS) can improve adherence to HIV medication and increase viral suppression, which means it helps keep the virus under control. Additionally, using community health workers to deliver MAPS may help more people benefit from this treatment. ^{1 2 3 4 5}

How is the treatment Managed Problem Solving (MAPS) unique for HIV/AIDS care?

Managed Problem Solving (MAPS) is unique because it uses a problem-solving approach to help people with HIV manage their health and improve medication adherence, which can lead to better control of the virus. It is delivered by community health workers, making it more accessible and supportive for patients in community settings. ^{1 2 4 6 7}

What is the purpose of this trial?

The Managed Problem Solving (MAPS) behavioral intervention is an EBP for behavior change in people living with HIV (PLWH). The investigators propose that MAPS can be delivered by trained Community Health Workers (CHWs). The use of CHWs to deliver MAPS is justified by their ability to develop trusting relationships with their clients and the need for task shifting in busy clinics. In order to also address retention in care, the investigators will adapt MAPS to also focus on problem solving activities tailored toward retention in care (now termed MAPS+). CHWs will be located in clinics to implement MAPS+ to improve viral suppression and care retention in PLWH. Data-to-care allows for identification of people who are lost to care and link these patients back to care. Currently, medication adherence and retention in HIV care are not targeted in data-to-care so the investigators will build on this approach to facilitate the identification of PLWH who are out of care and not virally suppressed to offer them MAPS+. The set of implementation strategies include task-shifting the delivery of MAPS+ to CHWs, providing the CHWs training and ongoing support, and increasing communication between the CHWs and medical care team via standardized protocols. The investigators will conduct a hybrid type II effectiveness-implementation trial with a stepped-wedge cluster randomized design in 12 clinics to test MAPS+ compared to usual care using a set of implementation strategies that will best support implementation. Each clinic will be randomized to one of three implementation start times. Baseline (usual care) data will be collected from each clinic for 6 months, followed by MAPS+ and the package of implementation strategies for 12 months, in three cohorts of 4 clinics each. Aim 1 will test the effectiveness of MAPS+ on clinical effectiveness outcomes, including viral suppression (primary) and retention (secondary). Aim 2 will examine the effect of the package of implementation strategies on reach. Implementation cost will also be measured. Aim 3 will apply a qualitative approach to understand processes, mechanisms, and sustainment of the implementation approach. The results will guide future efforts to implement behavioral EBPs across the HIV care continuum, consistent with the "treat" pillar of EHE, and move the science of implementation services, consistent with NIH strategic priorities.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

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

Stakeholder Perspectives on MAPS. [2023]

2. England 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. [2023]

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

Organization of care for persons with HIV-infection: a systematic review. [2019]

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

Managed problem solving for antiretroviral therapy adherence: a randomized trial. [2022]

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

Experience with a managed care approach to HIV infection: effectiveness of an interdisciplinary team. [2019]

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

Case management of persons with acquired immunodeficiency syndrome in San Francisco. [2018]

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

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