Case Management for HIV

(CM2 Trial)

Overseen By Rebecca Eavou

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must be taking: PrEP

Disqualifiers: Non-Black/African American, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help individuals with HIV or those taking PrEP (a medication to prevent HIV) improve their financial wellbeing, access to food, and healthcare. It compares two dedicated case managers focusing on future planning and stability against the usual care. This approach, known as Dyadic Case Management (also referred to as Focused Case Management or Dyadic Intervention), aims to provide more personalized support. Participants should have experienced difficulty accessing HIV or PrEP care in the past 24 months and report financial or food insecurity. The goal is to determine if this new method helps individuals maintain better health and financial stability compared to the usual care. As an unphased trial, this study offers a unique opportunity to explore innovative support methods that could significantly enhance participants' quality of life.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for specific guidance.

What prior data suggests that Dyadic Case Management is safe?

Research has shown that Dyadic Case Management for HIV is safe. This method involves two case managers assisting a person in setting goals and planning for the future. Studies have not identified any negative effects from this type of support. It aims to improve financial stability and access to food, among other benefits, without any known risks to participants' safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Dyadic Case Management for HIV because it offers a fresh approach by assigning two case managers to each participant, allowing for personalized and comprehensive support. This method focuses on future planning and financial stability, using strategies from Appreciative Inquiry, which is different from the standard care that mainly reacts to immediate needs and relies on client-initiated contact. By emphasizing goal-oriented support, Dyadic Case Management has the potential to enhance long-term outcomes for individuals living with HIV.

What evidence suggests that Dyadic Case Management is effective for improving outcomes in individuals living with HIV?

Research has shown that having two case managers work together can improve the health and well-being of people living with HIV. In this trial, participants in the Dyadic Case Management arm will receive this approach, which past studies have found successful in keeping patients engaged in their HIV care. For example, the "Stronger Together" study found that having two case managers significantly increased patients' involvement in their care compared to traditional methods. Another study, "nGage," demonstrated that this support helped more people stay connected with their healthcare providers. These findings suggest that when two case managers focus on planning for the future and financial stability, individuals with HIV experience better health outcomes and quality of life. ^{2 6 7 8 9}

Who Is on the Research Team?

John A Schneider, MD, MPH

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for Black/African American individuals who are either living with HIV or vulnerable to it, have had a gap in HIV or PrEP care, and face financial or food insecurity. Eligible participants include cis-gender men with male partners in the past year, gender-diverse persons, and cis-gender women prescribed PrEP or with an STI history.

Inclusion Criteria

I am a Black/African American and identify as gender-diverse.

Self-reported financial or food insecurity

I am a Black/African American cis-gender woman living with or at risk for HIV.

Exclusion Criteria

Non-Black/African American persons

I am a cisgender man who has not been sexually active with another man in the past year.

I am a cisgender woman not at risk for HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dyadic case management focused on financial wellness, food security, and linkage to care

18 months

Follow-up

Participants are monitored for outcomes such as viral suppression, food security, and financial wellbeing

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dyadic Case Management

Trial Overview

The study aims to see if focused dyadic case management can improve financial wellbeing, access to food, retention rates for those living with HIV or on PrEP (PrEP persistence), and increase viral suppression compared to standard non-medical case management.

How Is the Trial Designed?

Group I: Dyadic Case Management Experimental Treatment 1 Intervention

Participants will receive dyadic case management, specifically they will have two case managers assigned to their case. Case management services will be goal focused and will utilize components from Appreciative Inquiry to orient work to future planning, goals, and financial stability.

Group II: Treatment as usual Active Control 1 Intervention

Participants will be offered the current standard of care, Ryan White Non-Medical Case Management. Case management services are need focused and contact is client initiated.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

HIV-positive patients with a case manager were more likely to adhere to antiretroviral medications and obtain HIV care within the past six months, indicating that case management improves health-seeking behaviors.

Patients with a case manager were also significantly less likely to engage in unprotected sex, suggesting that case management may help reduce sexual risk behaviors and improve overall clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Management: Steadfast Resource for Addressing Linkage to Care and Prevention with Hospitalized HIV-Infected Crack Users. Kenya, S., Chida, N., Cardenas, G., et al.[2020]

A strength-based case management program for HIV-positive patients who abuse substances showed success in improving healthcare outcomes, including reduced drug use and criminal activity, over a nine-month period.

The study indicated that case management helped patients stay in treatment longer, which correlated with better health outcomes, emphasizing the importance of ongoing support in managing HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV substance abusers encouraged to use new case management program. Study shows program works. [2005]

In a study involving substance-abusing patients with HIV/AIDS, both brief contact and 12 months of case management led to significant improvements in various issues like substance use and psychological status within the first 6 months, but no lasting differences were observed at 12 and 18 months.

There was no evidence that the more intensive case management provided better outcomes than the brief contact, suggesting that simpler interventions may be equally effective for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case management for substance abusers with HIV/AIDS: a randomized clinical trial. Sorensen, JL., Dilley, J., London, J., et al.[2019]

A mixed-methods study involving 118 HIV-positive patients in addiction care in St. Petersburg, Russia, found that strengths-based case management effectively connected patients to HIV services, enhancing their self-efficacy and motivation.

Participants who successfully linked to HIV care credited case managers for their support, while those who struggled to connect often cited personal drug use and systemic stigma as barriers, highlighting the need for integrated substance use treatment and empowerment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linking HIV-positive people in addiction care to HIV services in St. Petersburg, Russia - Mixed-methods implementation study of strengths-based case management. Lunze, K., Kiriazova, T., Blokhina, E., et al.[2022]

A case management approach significantly improved the physical, social, and mental health of people living with HIV/AIDS (PLHAs) who were very depressed, compared to those receiving only self-directed care.

Participants in the case management group showed a reduction in risk behaviors and a potential cost-saving of $3,300 per person per year in health and social service expenditures, suggesting economic benefits alongside health improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case management community care for people living with HIV/AIDS (PLHAs). Husbands, W., Browne, G., Caswell, J., et al.[2022]

Case management models for HIV-positive individuals significantly improve health outcomes by linking patients to necessary health and social services, addressing their unique needs such as substance use or homelessness.

The review of 28 studies indicates that effective case management can lead to decreased mortality, better retention in care, reduced unmet needs, and lower risky behaviors among people living with or at risk of HIV/AIDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case management interventions for HIV-infected individuals. Ko, NY., Liu, HY., Lai, YY., et al.[2022]

Training and reimbursing case managers to provide adherence coordination services can significantly enhance adherence rates to antiretroviral therapy among HIV-positive clients, which is crucial for effective treatment and prevention of drug resistance.

Despite their potential, case managers face barriers such as lack of reimbursement, inadequate training, and insufficient knowledge about HIV/AIDS, which need to be addressed to maximize their effectiveness in supporting client adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of the HIV/AIDS case manager: analysis of a case management adherence training and coordination program in North Carolina. Shelton, RC., Golin, CE., Smith, SR., et al.[2007]

A study involving 120 AIDS patients showed that combining routine management with case-based nursing significantly improved self-management abilities and psychological flexibility compared to routine management alone.

After the intervention, patients in the observation group reported better physical function, pain management, and overall symptom response, along with lower depression scores, indicating enhanced quality of life and self-efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Routine Management Combined with Case Management Model on Social Support, Self-Efficacy, Self-Management Ability, and Psychological Flexibility of AIDS Patients. Liu, L., Zhou, J., Xiao, H., et al.[2023]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06162897

Study Details | NCT06162897 | Case Management Dyad

The purpose of this research is to test the impact of dyadic, focused case management on financial well-being, access to food, linkage to and retention in care ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10421639/

Implementation of a Dyad-Based Intervention to Improve ...

The purpose of this paper is to describe the implementation process of a dyad-based intervention among HIV-positive PWID and their treatment support partners.

3.

escholarship.org

escholarship.org/content/qt4pf504rm/qt4pf504rm_noSplash_4ad82f8c06112969f3d62c0e7d401240.pdf

Stronger Together

This paper reports on the results of a randomized controlled trial to assess the efficacy of Stronger Together, a dyadic counseling intervention aimed at.

4.

commons.case.edu

commons.case.edu/cgi/viewcontent.cgi?article=1257&context=facultyworks

Project nGage: Results of a Randomized Controlled Trial of a ...

Project nGage is a client-centered intervention consisting of a 90-minute session that included an individual SC and a dyadic SC-index component ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3932296/

MSM's Perceptions of Dyadic HIV Care for Same-Sex Male ...

Results. Participants identified the need for comprehensive dyadic care and differences in care for seroconcordant positive versus serodiscordant couples.

6.

bmjopen.bmj.com

bmjopen.bmj.com/content/11/9/e055448

Study protocol: a pilot randomised waitlist-controlled trial of ...

We will compare HIV clinical outcomes and dyadic ... Couples-focused intervention to improve engagement in HIV care: protocol for a randomised controlled trial.

7.

reporter.nih.gov

reporter.nih.gov/project-details/11146488

RePORT RePORTER - National Institutes of Health (NIH) |

We will conduct a Hybrid Type II effectiveness-implementation randomized controlled trial of a Case Management Dyad (CM2) intervention, an evidence-based ...

8.

withpower.com

withpower.com/trial/phase-pre-exposure-prophylaxis-8-2022-864e6

Case Management for HIV (CM2 Trial)

The research on case management for HIV, including various forms like Dyadic Case Management and Focused Case Management, does not report any safety concerns.

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6051888/

A Conceptual Model of Dyadic Coordination in HIV Care ...

Dyadic analysis of couple data allows a richer, in-depth analysis to elucidate dyadic aspects of HIV care engagement. Thus, the goal of this study is to use ...