Health and Employment Services for HIV/AIDS

(J-RISE Trial)

Overseen By Mainza Durrell, DrPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Informed consent, Location, HIV status, others

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

Compensation: Varies

Number of Visits: 4

350 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare two interventions - Health Navigation and Health Navigation Plus among individuals who have been impacted by the criminal legal system. The main question it aims to answer is: • Compared with the Health Navigation group, are participants in the Health Navigation Plus group more likely to a) access HIV care, treatment, and prevention services and employment services and b) access employment services and be employed in community? Participants on the study will be: * Randomly assigned (like a flip of a coin) to participate in either Health Navigation or Health Navigation Plus. Participants will have an equal chance of being placed in either group. * Complete three surveys over the course of 13 months * Participants in the Health Navigation group will have two in person meetings and seven check-ins with the health navigator over 6 months * Participants in the Health Navigation Plus group will have two in person meetings and seven check-ins with the health navigator over 6 months, two in person and 10 check ins with the employment navigator over 12 months and up to $200 to support employment and career development needs and receive up to $140 to support health goals. Samples of blood, urine and swabs may be collected to meet the health goals.

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 is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Health Navigation, Health Navigation Services, Patient Navigation, Health Navigation Plus for HIV/AIDS?

Research shows that patient navigation helps people with HIV connect to medical care, especially after being released from jail, and supports them in staying in care. This approach is effective in addressing social factors that affect health and ensuring people receive the necessary services. ^{1 2 3 4 5}

How does the Health Navigation treatment for HIV/AIDS differ from other treatments?

Health Navigation and Health Navigation Plus are unique because they focus on guiding patients through healthcare systems, addressing social factors like housing and mental health, and connecting them to necessary services, rather than directly treating the virus itself. This approach helps improve engagement in care and overall health outcomes for people living with HIV, especially those facing additional challenges like unstable housing. ^{4 6 7 8 9}

Research Team

Russell Brewer, DrPH

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for justice-involved Black men who have sex with men and other key populations affected by HIV. Participants should be impacted by the criminal legal system, willing to complete surveys, and attend meetings with health navigators.

Inclusion Criteria

I identify as either cisgender, transgender, or gender fluid.

Be currently incarcerated in jail or prison and report an expected release within 90 days, or under community supervision, or report a recent incarceration within the last 12 months, or in the last 12 months has been stopped, searched, physically or verbally abused, or had any negative interaction with law enforcement that did not lead to an arrest or jail or prison time, AND has not already been linked and/or retained in HIV or PrEP care in the community

Self-identify as African American, Black, or multi-ethnic Black

Exclusion Criteria

Unwilling/unable to provide informed consent

Does not live or intend to live in one of the study locations

Unable to confirm HIV status

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Health Navigation

Participants receive health navigation services to enhance access to HIV, mental health, substance use, and other supportive services

6 months

2 in-person meetings and 7 check-ins with health navigator

Health Navigation Plus

Participants receive additional employment navigation and financial incentives for health goals

12 months

2 in-person meetings and 10 check-ins with employment navigator

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Health Navigation
• Health Navigation Plus

Trial Overview The study compares Health Navigation alone versus Health Navigation Plus Employment services. It checks if adding employment support helps participants more in accessing HIV care/prevention services and achieving employment compared to just health navigation.

Participant Groups

Group I: Health Navigation, Employment Navigation plus Contingency Management Intervention Experimental Treatment 1 Intervention

Referrals to HIV, mental health, substance use, and other supportive services Referrals for employment including training, and career development needs; Provision of financial incentives for the uptake and achievement of specific HIV care and prevention milestones.

Group II: Health Navigation Active Control 1 Intervention

Referrals to HIV, mental health, substance use, and other supportive services

Health Navigation is already approved in United States for the following indications:

Approved in United States as Health Navigation for:

• Improving HIV care engagement and retention
• Supporting individuals impacted by the criminal legal system

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Frontline Legal Services

Collaborator

Trials

1

Recruited

350+

NORC at the University of Chicago

Collaborator

Trials

6

Recruited

430,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Capitol Area Reentry Program

Collaborator

Trials

1

Recruited

350+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Nefuse Case Management and Training Services

Collaborator

Capitol Area Reentry Program Inc.

Industry Sponsor

Trials

2

Recruited

1,700+

Findings from Research

Patient navigators reported that financial incentives significantly motivated HIV-positive participants to attend navigation sessions and engage in HIV care, especially in the early stages of the program.

While contingency management effectively encouraged attendance and health-related behaviors, its application for substance use behaviors was more complex, with varying responses among participants, particularly those facing financial difficulties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How patient navigators view the use of financial incentives to influence study involvement, substance use, and HIV treatment. Mitchell, SG., Monico, LB., Stitzer, M., et al.[2020]

Patient navigation programs significantly enhance the coordination of medical and support services for individuals living with HIV who are released from jail, addressing their diverse needs during the critical first two months post-release.

These programs are essential for retaining individuals in care and preventing the transmission of HIV, highlighting the importance of implementing navigator programs for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigators effectively support HIV-infected individuals returning to the community from jail settings. Myers, JJ., Koester, KA., Kang Dufour, MS., et al.[2018]

Patient navigation-enhanced case management significantly improved linkage to HIV care within 30 days of release from jail, with an odds ratio of 2.15, indicating it is more effective than standard case management.

This approach also led to better retention in care over 12 months, with an odds ratio of 1.95, suggesting that patient navigation can help individuals maintain their health after incarceration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Patient Navigation on the Likelihood of Engagement in Clinical Care for HIV-Infected Individuals Leaving Jail. Myers, JJ., Kang Dufour, MS., Koester, KA., et al.[2019]

Patient navigation is essential for linking individuals to HIV pre-exposure prophylaxis (PrEP) and re-engaging them in HIV care, as highlighted by a study involving 20 agency staff interviews and 300 patient surveys in Chicago.

Key navigation activities included screening for social determinants of health and providing guidance and referrals, although barriers such as limited staff and clinic capacity were noted, emphasizing the need for adequate resources to support these services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and evaluation of patient navigation in Chicago: Insights on addressing the social determinants of health and integrating HIV prevention and care services. Greene, GJ., Reidy, E., Felt, D., et al.[2022]

A systematic review of 39 studies found that various intervention strategies, including patient navigation and psychosocial support, significantly improve re-engagement in HIV care (odds ratio of 1.79), retention in care (odds ratio of 2.01), and viral suppression (odds ratio of 2.50) among people with HIV who are out of care.

While most strategies showed effectiveness across all outcomes, the 'data-to-care' approach specifically improved re-engagement and retention but lacked sufficient evidence for enhancing viral suppression, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to improve HIV care outcomes for people with HIV who are out of care. Higa, DH., Crepaz, N., Mullins, MM., et al.[2023]

In a study of 471 unstably housed individuals with HIV, achieving stable housing within 6 months was significantly linked to better viral suppression at 12 months, highlighting the importance of housing stability in improving health outcomes.

While navigation activities did not directly influence housing stability, they were associated with improved retention in HIV care, suggesting that support services can help individuals stay engaged in their treatment despite housing challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathways to housing stability and viral suppression for people living with HIV/AIDS: Findings from the Building a Medical Home for Multiply Diagnosed HIV-positive Homeless Populations initiative. Rajabiun, S., Davis-Plourde, K., Tinsley, M., et al.[2022]

In a study involving 700 people living with HIV over four years, 59.6% of participants transitioned to more stable housing after receiving patient navigation support.

Those who achieved stable housing had significantly better HIV outcomes, including higher rates of retention in care, increased likelihood of being prescribed antiretroviral therapy, and improved viral suppression rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influence of Housing Status on the HIV Continuum of Care: Results From a Multisite Study of Patient Navigation Models to Build a Medical Home for People Living With HIV Experiencing Homelessness. Rajabiun, S., Tryon, J., Feaster, M., et al.[2020]

The PrIDE project, which ran from 2016 to 2019, successfully implemented a hybrid model of PrEP navigation that combined patient, peer, and systems navigation, leading to effective linking of clients to PrEP and social services across 12 health departments.

Having all PrEP services located in one place significantly boosted PrEP uptake, while challenges such as staff turnover and lack of health insurance were identified, with payment assistance shown to enhance client PrEP use in areas with insurance issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informing the future of PrEP navigation: Findings from a five-site cluster evaluation. Salabarría-Peña, Y., Douglas, C., Brantley, M., et al.[2022]

The HIV-specific patient navigation program in Wisconsin aimed to improve care engagement and viral suppression among individuals at risk for poor health outcomes, particularly those out of care or with persistent viremia.

Over a nine-month period, patient navigators helped identify and address barriers to care, which is crucial since these individuals account for two-thirds of new HIV infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Patient Navigation Program to Improve Engagement in HIV Medical Care and Viral Suppression: A Demonstration Project Protocol. Schumann, CL., Westergaard, RP., Meier, AE., et al.[2022]

References

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

How patient navigators view the use of financial incentives to influence study involvement, substance use, and HIV treatment. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Patient navigators effectively support HIV-infected individuals returning to the community from jail settings. [2018]

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

The Effect of Patient Navigation on the Likelihood of Engagement in Clinical Care for HIV-Infected Individuals Leaving Jail. [2019]

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

Implementation and evaluation of patient navigation in Chicago: Insights on addressing the social determinants of health and integrating HIV prevention and care services. [2022]

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

Strategies to improve HIV care outcomes for people with HIV who are out of care. [2023]

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

Pathways to housing stability and viral suppression for people living with HIV/AIDS: Findings from the Building a Medical Home for Multiply Diagnosed HIV-positive Homeless Populations initiative. [2022]

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

The Influence of Housing Status on the HIV Continuum of Care: Results From a Multisite Study of Patient Navigation Models to Build a Medical Home for People Living With HIV Experiencing Homelessness. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Informing the future of PrEP navigation: Findings from a five-site cluster evaluation. [2022]

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

Developing a Patient Navigation Program to Improve Engagement in HIV Medical Care and Viral Suppression: A Demonstration Project Protocol. [2022]