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

Trial Summary

What is the purpose of this trial?

The overall goal of this study is to test whether dyadic and focused case management will (1) improve financial wellbeing, (2) improve access to food, (3) increase linkage and retention rates for individuals living with HIV or those taking PrEP (PrEP persistence), and (4) increase the proportion of individuals living with HIV who are virally suppressed (viral suppression) when compared to routine Ryan White Non-Medical Case Management.

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 data supports the effectiveness of the treatment Dyadic Case Management, Focused Case Management, Dyadic Intervention for HIV?

Research shows that case management for HIV patients can lead to better health outcomes, such as increased use of HIV medications, improved engagement in HIV care, and reduced risky behaviors like unprotected sex. These findings suggest that case management can be an effective treatment approach for improving the health and well-being of individuals living with HIV. ^{1 2 3 4 5}

Is case management for HIV generally safe for humans?

The research on case management for HIV, including various forms like Dyadic Case Management and Focused Case Management, does not report any safety concerns. It has been shown to improve health outcomes and reduce risky behaviors in people living with HIV. ^{2 4 6 7 8}

How is the Dyadic Case Management treatment for HIV different from other treatments?

Dyadic Case Management for HIV is unique because it focuses on linking patients with coordinated health and social services, addressing unmet needs, and improving health outcomes by reducing risky behaviors and enhancing engagement in care. This approach is particularly beneficial for populations with specific challenges, such as substance users and the homeless, by providing personalized support and empowerment. ^{1 2 3 4 8}

Research Team

John A Schneider, MD, MPH

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States 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. [2023]

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

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

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

Case management interventions for HIV-infected individuals. [2022]

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

Case Management: Steadfast Resource for Addressing Linkage to Care and Prevention with Hospitalized HIV-Infected Crack Users. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Case management for substance abusers with HIV/AIDS: a randomized clinical trial. [2019]

6. United States 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. [2007]

7. England pubmed.ncbi.nlm.nih.gov

Case management community care for people living with HIV/AIDS (PLHAs). [2022]

8. England 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. [2022]