Case Management and Peer Support for HIV

Overseen By Jennifer Walsh, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Must be taking: Antiretrovirals

Disqualifiers: Under 50, Urban residence, others

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

Compensation: Varies

Number of Visits: 4

352 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 improving adherence to HIV medications, so it's likely you will continue your current HIV treatment.

What data supports the effectiveness of the treatment Case Management and Peer Support for HIV?

Research shows that case management, especially when strength-based, helps HIV-positive individuals by improving their health outcomes, reducing risky behaviors, and increasing their engagement in HIV care. This approach has been particularly beneficial for those with additional challenges like substance abuse or depression, leading to better physical, social, and mental health. ^{1 2 3 4 5}

Is the case management and peer support intervention for HIV safe for humans?

The research on strengths-based case management and peer support interventions for HIV does not report any safety concerns, suggesting it is generally safe for humans. ^{1 2 4 5 6}

How does the Case Management and Peer Support treatment for HIV differ from other treatments?

This treatment is unique because it combines strengths-based case management with peer support, focusing on enhancing social support, self-efficacy, and psychological flexibility. It is particularly effective for individuals with depression and substance abuse issues, helping them stay in treatment longer and reducing risky behaviors. ^{1 2 4 5 7}

What is the purpose of this trial?

Engagement in HIV medical care and adherence to HIV medications are both essential in improving health outcomes among people living with HIV (PLH), but PLH living in rural areas-who suffer higher mortality rates than their urban counterparts-can confront multiple barriers to care engagement and adherence, especially as they face the logistical, medical, and social challenges associated with aging. This project will test the efficacy of two interventions to determine their impact on HIV health outcomes and quality of life among rural, older PLH living in the Southern U.S. The two interventions, adapted from evidence-based interventions and delivered remotely, are: (1) supportive-expressive peer social support groups and (2) strengths-based case management. We hypothesize that both interventions will increase viral suppression, antiretroviral therapy adherence, and health-related quality of life and decrease depressive symptoms. Results from this study will provide us with tools to improve health outcomes for rural older people living with HIV.

Research Team

Andrew Petroll, MD

Principal Investigator

Center for AIDS Intervention Research, Medical College of Wisconsin

Jennifer Walsh, PhD

Principal Investigator

Center for AIDS Intervention Research, Medical College of Wisconsin

Eligibility Criteria

This trial is for older adults living with HIV in rural areas of the Southern U.S. who may struggle with accessing care and adhering to their medication regimen. The study aims to help them overcome barriers they face due to aging, location, and medical needs.

Inclusion Criteria

Living in a county with a score of .4 or higher on the index of relative rurality (IRR)

Living with HIV

Has a telephone at home

Exclusion Criteria

Not meeting eligibility criteria described above

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive supportive-expressive peer social support groups and/or strengths-based case management interventions delivered remotely

12 months

Remote sessions

Follow-up

Participants are monitored for health outcomes, quality of life, and adherence to HIV medications

12 months

Follow-up assessments at 4, 8, and 12 months

Treatment Details

Interventions

• Individual Strengths-Based Case Management Intervention
• Supportive-Expressive Peer Social Support Group Intervention

Trial Overview The study is testing two remote interventions: a supportive-expressive peer social support group and strengths-based case management. It will evaluate how these approaches affect viral suppression, medication adherence, quality of life, and depressive symptoms among participants.

Participant Groups

Group I: Supportive-Expressive Peer Social Support Group + Individual Strengths-Based Case Management Experimental Treatment 2 Interventions

Group II: Supportive-Expressive Peer Social Support Group Experimental Treatment 1 Intervention

Group III: Individual Strengths-Based Case Management Experimental Treatment 1 Intervention

Group IV: HIV Information Only Active Control 1 Intervention

This arm will not receive either of the interventions but will receive information on successfully aging with HIV.

Individual Strengths-Based Case Management Intervention is already approved in United States for the following indications:

Approved in United States as Individual Strengths-Based Case Management Intervention for:

• Improving HIV care engagement and adherence among rural older adults living with HIV

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

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]

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]

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]

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]

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 pilot study involving 48 HIV positive participants (19 not in care and 29 already in care) showed that a strengths-based case management intervention significantly increased the number of participants achieving an undetectable HIV viral load, from 32% to 74% in the intervention group compared to a decrease in the comparison group.

The intervention, which included coordinated care by a social worker and an HIV physician, demonstrated that targeted support can effectively engage marginalized individuals in sustained HIV care, leading to better health outcomes over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Strengths-Based Case Management Intervention to Reduce HIV Viral Load Among People Who Use Drugs. Kral, AH., Lambdin, BH., Comfort, M., et al.[2019]

A qualitative study involving 23 HIV-positive peers highlighted that their shared experiences and characteristics significantly enhance their ability to engage and support clients in HIV care.

Peers provide a wide range of support types—informational, emotional, instrumental, and affiliational—indicating that effective peer programs should be flexible and recognize the diverse roles peers play beyond direct HIV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Positive Examples": a bottom-up approach to identifying best practices in HIV care and treatment based on the experiences of peer educators. Dutcher, MV., Phicil, SN., Goldenkranz, SB., et al.[2022]

References

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

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

2. 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]

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

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

4. England pubmed.ncbi.nlm.nih.gov

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

5. 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]

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

A Strengths-Based Case Management Intervention to Reduce HIV Viral Load Among People Who Use Drugs. [2019]

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

"Positive Examples": a bottom-up approach to identifying best practices in HIV care and treatment based on the experiences of peer educators. [2022]