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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to support people living with HIV in rural areas of the Southern U.S. The goal is to determine if these methods improve health by boosting medication adherence and quality of life while reducing depression. Participants will either join a peer support group (Supportive-Expressive Peer Social Support Group Intervention), receive one-on-one case management (Individual Strengths-Based Case Management Intervention), both, or receive information on aging with HIV. The trial seeks individuals aged 50 and older who have HIV, live in rural areas, and have a phone at home. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance support systems for individuals living with HIV.

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 prior data suggests that these interventions are safe for improving health outcomes in rural older people living with HIV?

Research shows that strengths-based case management is generally easy for people to handle. Previous studies found that this method effectively connects people with HIV to medical care. Reports of negative effects are absent, suggesting it is safe for participants.

Evidence from wealthy countries indicates that supportive-expressive peer social support groups can enhance health and well-being for people living with HIV. These groups increase social support and reduce stigma. No data shows any safety issues, making them a safe choice for participants.

Both approaches aim to improve the quality of life and care for people living with HIV. Current research suggests they are safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for HIV because they focus on holistic support rather than solely medical treatment. Unlike traditional approaches that heavily rely on antiretroviral therapy, these interventions emphasize personal empowerment and community support. The Individual Strengths-Based Case Management Intervention helps individuals leverage their unique strengths to manage their condition more effectively. Meanwhile, the Supportive-Expressive Peer Social Support Group provides a platform for shared experiences and emotional support, fostering a sense of community and belonging. By addressing both personal and social aspects, these interventions aim to improve overall well-being and quality of life for people living with HIV.

What evidence suggests that this trial's interventions could be effective for improving health outcomes in rural older people living with HIV?

This trial will evaluate different approaches to support individuals with HIV. Participants in one arm will receive Individual Strengths-Based Case Management, which research has shown can help people stay engaged in HIV care more effectively by focusing on their strengths. Another arm will involve participation in Supportive-Expressive Peer Social Support Groups, where people with HIV can share experiences and support each other, improving health outcomes by increasing social support and reducing stigma. Additionally, some participants will receive a combination of both interventions, while others will receive HIV information only. Evidence suggests that combining peer support with regular medical care proves more effective than just attending standard clinic visits. Together, these strategies can help people with HIV adhere to their medication and improve their quality of life. ^{1 2 5 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6635053/

A strengths-based case management intervention to link HIV ... The LINC study was an RCT designed to assess the effectiveness of a strengths-based case management intervention among HIV-positive Russian PWID compared with ...

2. journals.lww.com journals.lww.com/aidsonline/fulltext/2019/07150/a_strengths_based_case_management_intervention_to.7.aspx

A strengths-based case management intervention to link... The Linking Infectious and Narcology Care strengths-based case management intervention was more effective than usual care in linking Russian PWID to HIV care.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2840993

Cost-Effectiveness of Linkage Case Management for ... Importance The Daraja randomized clinical trial was a linkage case management intervention designed to improve HIV care engagement.

4. aidsetc.org aidsetc.org/sites/default/files/resources_files/artas_implementation_manual.pdf

Anti-Retroviral Treatment and Access to Services (ARTAS) This intervention is intended to be used with persons who are recently diagnosed with HIV and who are voluntarily participating in the intervention. The ...

5. researchgate.net researchgate.net/publication/5565774_Brief_Strengths-Based_Case_Management_Promotes_Entry_Into_HIV_Medical_Care_Results_of_the_Antiretroviral_Treatment_Access_Study-II

Results of the Antiretroviral Treatment Access Study-II [6][7][8][9] In brief, strengths-based case management proved efficacious in enhancing linkage to care within 6 months in ARTAS (Antiretroviral ...

6. dshs.texas.gov dshs.texas.gov/sites/default/files/hivstd/contractor/TexasHIVCaseManagementProject.pdf

Texas HIV Case Management Project The strengths-based model is based upon six principles: 1) the focus is on the client and their potential to be independent rather than the disease itself; 2) ...

7. ochealthinfo.com ochealthinfo.com/sites/healthcare/files/2023-01/Case%20Management%20SOC%20Approved%20by%20PC%202022-03-09.pdf

Case Management Standards of Care for HIV ... It is recommended to incorporate a strengths-based approach, by helping clients identify barriers to accessing care and subsequently identifying personal ...