Client-Centered Care Coordination for HIV Prevention

Overseen By Darren L Whitfield, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must be taking: PrEP

Disqualifiers: HIV-positive, Transgender, Others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

350 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine the efficacy of a client-center care coordination intervention (C4) in improving pre-exposure prophylaxis (PrEP) adherence in Black men who have sex with men (MSM). The main aims of the study are: 1. Determine the efficacy of C4 for increasing PrEP adherence among Black MSM. 2. Identify the optimal dose of C4 implementation for maximizing its effect on PrEP adherence. 3. Describe the acceptability and feasibility of C4 implementation in community settings. Participants in the clinical trial will be randomized to receive the intervention or standard of care for PrEP in two sites. Researchers will compare administration of C4 to standard of care to see if C4 improves adherence to PrEP. C4 is a longitudinal intervention which provides individualized client-centered HIV prevention and support services designed to address health and psychosocial needs that impact the success of PrEP use and adherence (i.e., co-morbidities, substance use, mental health, housing, etc.). The intervention pulls from the Centers for Disease Control and Prevention (CDC) Comprehensive Risk Counseling and Services (CRCS) and Self-Determination Theory (SDT) to support client-identified HIV prevention goals to promote, adopt, and maintain PrEP use. CRCS is a public health strategy to assist persons in developing behavioral goals to reduce HIV acquisition and transmission. In this intervention, the HIV prevention plan element of CRCS will be the foundation of the C4 intervention. After the initial prevention plan is developed, elements of SDT will be used to implement a client-centered care approach to assist in addressing issues which many arise which impede successful PrEP adherence.

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 PrEP, so it's best to discuss your current medications with the trial coordinators.

What data supports the effectiveness of the treatment Client-Centered Care Coordination for HIV Prevention?

Research shows that having a case manager, a key part of care coordination, helps people with HIV take their medications, get regular care, and reduce risky behaviors like unprotected sex. This suggests that client-centered care coordination can improve health outcomes for people with HIV. ^{1 2 3 4 5}

Is Client-Centered Care Coordination safe for humans?

The research articles reviewed do not provide specific safety data for Client-Centered Care Coordination, but they discuss the role of case managers and care coordination in improving health outcomes for HIV patients, suggesting that these interventions are generally well-regarded in healthcare settings. ^{1 3 6 7 8}

How is the Client-Centered Care Coordination treatment for HIV prevention different from other treatments?

Client-Centered Care Coordination is unique because it focuses on personalized care by addressing both medical and social needs, using a comprehensive approach that includes case management and community health workers to improve access and quality of care for individuals with HIV. ^{1 9 10 11 12}

Eligibility Criteria

This trial is for Black men who have sex with men, aged 18 or older, at high risk for HIV. They must be new to PrEP or stopped it early and not currently in another HIV prevention study. Participants cannot have a prior HIV diagnosis and must identify as cisgender male.

Inclusion Criteria

No HIV diagnosis has been verified through testing.

You are not already involved in a different HIV prevention study.

I have never taken PrEP or I stopped taking it early.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the C4 intervention or standard of care for PrEP adherence

18 months

Regular visits as per intervention or standard of care protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Client-Centered Care Coordination

Trial Overview The trial tests a client-centered care coordination (C4) intervention against standard PrEP care to see if C4 improves adherence in participants. It involves personalized support services addressing health and psychosocial needs that affect PrEP use.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

C4 is a longitudinal intervention which provides individualized client-centered HIV prevention and support services designed to address health and psychosocial needs that impact the success of PrEP use and adherence (i.e., co-morbidities, substance use, mental health, housing, etc.).

Group II: Control Group Active Control 1 Intervention

Individuals in the control group will receive standard of care for PrEP use at each clinic. The standard of care is PrEP clinical care includes identifying and engaging patients in need of PrEP, conducting necessary exams and lab tests and prescribing PrEP for the patients, as well as ongoing patient monitoring with follow-up visits and prescriptions-for as long as the patient needs PrEP.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Albert Einstein College of Medicine

Collaborator

Trials

302

Recruited

11,690,000+

George Washington University

Collaborator

Trials

263

Recruited

476,000+

Us Helping Us, People Into Living, Inc.

Collaborator

Trials

3

Recruited

480+

Findings from Research

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]

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]

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]

The study aims to develop a care coordination intervention (CCI) that integrates HIV and substance use disorder (SUD) services using a tablet-based mobile platform, with the goal of improving communication and care for people living with HIV who also have SUD.

Preliminary evaluations will involve 60 treatment providers and assess the CCI's impact on patient retention in dual care, communication quality, and relational coordination over a 6-month period, potentially enhancing treatment efficiency in a fragmented healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile technology intervention to improve care coordination between HIV and substance use treatment providers: development, training, and evaluation protocol. Claborn, K., Becker, S., Ramsey, S., et al.[2018]

References

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

Evolving trends in medical care-coordination for patients with HIV and AIDS. [2019]

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

Impact of an HIV Care Coordination Program on Durable Viral Suppression. [2022]

3. 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]

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

Shaping the Patient-Centered Medical Home to the Needs of HIV Safety Net Patients: The Impact of Stigma and the Need for Trust. [2022]

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

Conformity of pediatric/adolescent HIV clinics to the patient-centered medical home care model. [2021]

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

Categorical funding to seamless systems of care: the challenge for community-based primary care providers. [2022]

7. 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]

8. 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]

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

Costs and Cost-Effectiveness of the Patient-Centered HIV Care Model: A Collaboration Between Community-Based Pharmacists and Primary Medical Providers. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Mobile technology intervention to improve care coordination between HIV and substance use treatment providers: development, training, and evaluation protocol. [2018]

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

HIV prevention through case management for HIV-infected persons--selected sites, United States, 1989-1992. [2015]

12. England pubmed.ncbi.nlm.nih.gov

Organizing health care for families affected by HIV. [2019]