Managed Problem Solving for HIV/AIDS Care

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pennsylvania

Disqualifiers: Incarceration

No Placebo Group

Trial Summary

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.

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}

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 am 18 years old or older.

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

I am living with HIV.

Exclusion Criteria

Incarcerated during the duration of the trial

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) (Behavioural Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Penn Presbyterian Medical Center Infectious Diseases Specialty Clinic at the University of Pennsylvania Philadelphia, PA

Temple Comprehensive HIV Program Philadelphia, PA

Philadelphia FIGHT Philadelphia, PA

Cooper Early Intervention Program and Infectious Diseases Camden, NJ

More Trial Locations

Who Is Running the Clinical Trial?

University of Pennsylvania Lead Sponsor

References

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

Stakeholder Perspectives on MAPS. [2023] Managed problem solving (MAPS) is an evidence-based intervention that can boost HIV medication adherence and increase viral suppression, but it is not widely used in community clinics. Deploying community health workers to deliver MAPS could facilitate broader implementation, in support of the Ending the HIV Epidemic (EHE) initiative's goal of reducing new HIV infections in the US by 90% by 2030.

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] To end the HIV epidemic in Philadelphia, implementation of evidence-based practices (EBP) to increase viral suppression and retention in HIV care is critical. Managed problem solving (MAPS), an EBP for antiretroviral therapy adherence, follows a problem-solving approach to empower people living with HIV (PWH) to manage their health. To overcome barriers to care experienced by PWH in Philadelphia, the EBP was adapted to include a focus on care retention and delivery by community health workers (CHWs). The adapted intervention is MAPS+. To maximise the clinical impact and reach of the intervention, evaluation of the effectiveness and implementation of MAPS+ is necessary.

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

Organization of care for persons with HIV-infection: a systematic review. [2019] The objective of this systematic review was to examine the effectiveness of the organization of care: case management, multidisciplinary care, multi-faceted treatment, hours of service, outreach programs and health information systems on medical, immunological, virological, psychosocial and economic outcomes for persons living with HIV/AIDS. We searched PubMed (MEDLINE) and 10 other electronic databases from 1 January 1980 to April, 2012 for both experimental and controlled observational studies. Thirty-three studies met the inclusion criteria. Eleven studies were randomized controlled trials (RCTs), three of which were conducted in low-middle income settings. Patient characteristics, study design, organization measures and outcomes data were abstracted independently by two reviewers from all studies. A risk of bias tool was applied to RCTs and a separate tool was used to assess the quality of observational studies. This review concludes that case management interventions were most consistently associated with improvements in immunological outcomes but case management demonstrates no clear association with other outcome measures. The same mixed results were also identified for multidisciplinary and multi-faceted care interventions. Eight studies with an outreach intervention were identified and demonstrated improvements or non-inferiority with respect to mortality, receipt of antiretroviral medications, immunological outcomes, improvements in healthcare utilization and lower reported healthcare costs when compared to usual care. Of the interventions examined in this review, sustained in-person case management and outreach interventions were most consistently associated with improved medical and economic outcomes, in particular antiretroviral prescribing, immunological outcomes and healthcare utilization. No firm conclusions can be reached about the impact of any one intervention on patient mortality.

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

Managed problem solving for antiretroviral therapy adherence: a randomized trial. [2022] Adherence to antiretroviral therapy is critical to successful treatment of human immunodeficiency virus (HIV). Few interventions have been demonstrated to improve both adherence and virologic outcomes. We sought to determine whether an intervention derived from problem solving theory, Managed Problem Solving (MAPS), would improve antiretroviral outcomes.

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

Experience with a managed care approach to HIV infection: effectiveness of an interdisciplinary team. [2019] To evaluate the function and effectiveness of a multidisciplinary team for managing human immunodeficiency virus (HIV) infection, we conducted a follow-up cohort study of HIV-positive patients managed according to a clinical care path at a staff-based health maintenance organization (HMO). The study group consisted of 230 HIV-positive health plan members who received care at the Kaiser Permanente Santa Rosa medical center (KPMC-SRO). In 1994, the comparison group consisted of 4747 HIV-positive health plan members who received care at Kaiser Permanente's 18 other medical centers in northern California. The percentages of acquired immunodeficiency syndrome (AIDS) and HIV-positive patients as determined by CD4+ T-cell counts were similar (P = 0.97). Compared with patients at the other Kaiser Permanente medical centers, KPMC-SRO patients had more visits with nurse practitioners (rate ratio [RR] = 1.72) and nutritionists (RR = 12.3) and fewer visits with primary care physicians (RR = 0.82). More HIV-positive members at KPMC-SRO received social workers' services (27% at KPMC-SRO vs 6% for patients at the other Kaiser Permanente medical centers) and fewer used emergency services (RR = 0.92) and psychiatric services (RR = .89). At KPMC-SRO, the mean number of days that AIDS patients spent in the hospital decreased from 7.8 (1991) to 2.01 (1994). Hospital admissions were fewer (AIDS patients, RR = 0.67; HIV-positive patients without AIDS, RR = 0.45), and length of stay was briefer, compared with patients at the other Kaiser Permanente Medical Centers. The mean cost of HIV-related drugs for patients seen at KPMC-SRO ($2343 per infected member) was lower than that for patients seen elsewhere in the region ($3289 per infected member). These results suggest that in an HMO setting, managed care provided by a dedicated interdisciplinary team according to a clinical care path can substantially and favorably affect resource use.

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

Case management of persons with acquired immunodeficiency syndrome in San Francisco. [2018] The acquired immunodeficiency syndrome (AIDS) epidemic represents a growing challenge for the health care system and for case management models applied to persons with AIDS. The experience of San Francisco highlights some of the issues involved in developing a case management system appropriate to the needs of persons with AIDS, as well as providers, and payers. Dramatic growth in the size and complexity of the AIDS caseload and the involvement of public, health maintenance organization, and community providers has required the increasing formalization and centralization of case management roles. Persistent questions about the definition and goals of case management complicate development of these services.

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] This article examines Medicaid managed care's potential impact on people living with HIV/AIDS. The incongruence of the philosophy behind providing health and social services to people living with HIV/AIDS and with the philosophy behind the medical model of managed care is discussed. Health and social policy issues that various states have had to face concerning Medicaid managed care's administration of health benefits for people living with HIV/AIDS are examined. Research on managed care is employed to extrapolate potential managed care models that states might use to administer the health benefits for people living with HIV/AIDS. Finally, policy and research agendas are proposed to begin investigating Medicaid managed care's potential impact on people living with HIV/AIDS.