Client-Centered Care Coordination for HIV Prevention

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Black men who have sex with men (MSM) adhere to their PrEP (pre-exposure prophylaxis) routine, a medication that helps prevent HIV. Researchers seek to determine if a personalized support program called C4 (Client-Centered Care Coordination) can facilitate consistent PrEP use. Participants will receive either this specialized support or the usual PrEP care to compare outcomes. Those who are Black or African American, identify as male, and have not been diagnosed with HIV may be suitable candidates, particularly if they have not recently used PrEP. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve HIV prevention strategies for the community.

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 prior data suggests that this client-centered care coordination intervention is safe for improving PrEP adherence?

Research shows that the Client-Centered Care Coordination (C4) program helps people adhere to their PrEP medication and improve their sexual health. This program uses strategies from the Centers for Disease Control and Prevention (CDC) to support individuals in achieving their HIV prevention goals.

While data on side effects or safety remains limited, the program's focus on individual needs and a personalized approach suggests it is likely well-tolerated. Based on proven public health strategies, it aims to be both safe and effective.

As the program is not a drug or medical treatment, it doesn't carry the same risks as trying new medications. Instead, it provides support and guidance to help people maintain their PrEP routine. This focus on behavior and support, rather than medical procedures, suggests the program is likely safe and easy to manage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Client-Centered Care Coordination (C4) for HIV prevention because it offers a personalized approach that goes beyond the standard of care. Unlike the typical method, which focuses mainly on prescribing and monitoring PrEP, C4 addresses a broader range of personal health and psychosocial needs that can affect PrEP adherence, such as mental health, substance use, and housing stability. By tailoring support to these individual needs, C4 has the potential to improve PrEP usage and effectiveness significantly, providing a more comprehensive support system for those most at risk.

What evidence suggests that this client-centered care coordination is effective for improving PrEP adherence in Black MSM?

Research has shown that the Client-Centered Care Coordination (C4) approach, which participants in this trial may receive, can significantly improve adherence to PrEP, a medication that prevents HIV. In past studies, 79% of participants used PrEP, with 91% starting within 30 days. The C4 program maintained engagement for 92% of participants over 12 months. C4 focuses on personal needs, such as mental health or housing, which can influence adherence to PrEP. By addressing these issues, C4 aims to help individuals start and continue using PrEP effectively. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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

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

No HIV diagnosis has been verified through testing.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11412310/

Client-Centered Care Coordination (C4™) for HIV/STI ...

PrEP use was 79%, with 91% of PrEP users starting within 30-days. 12-month retention in C4™ was 92%. Care coordination encounters focused primarily on clients' ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06056544

Client-Centered Care Coordination for Black Men Who ...

The main aims of the study are: Determine the efficacy of C4 for increasing PrEP adherence among Black MSM. Identify the optimal dose of C4 implementation for ...

3.

link.springer.com

link.springer.com/article/10.1007/s40615-021-01209-y

Activities, Personnel Costs, and Outcomes—HPTN 073

Client-centered care coordination (C4) is a multi-level intervention designed to address clinical, psychosocial, and structural barriers to HIV ...

4.

hptn.org

hptn.org/research/publications/847

The HIV Prevention Trials Network

This research reports on the HIV Prevention Trials Network 073 (HPTN 073) study aimed to examine PrEP initiation, utilization and adherence among Black MSM ...

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withpower.com

withpower.com/trial/phase-hiv-prevention-8-2023-a5592

Client-Centered Care Coordination for HIV Prevention

The goal of this clinical trial is to determine the efficacy of a client-center care coordination intervention (C4) in improving pre-exposure prophylaxis ...

6.

nachc.org

nachc.org/wp-content/uploads/2022/06/PrEP-Guide.pdf

PrEP ADHERENCE AND RETENTION MANAGEMENT

The Centers for Disease Control and Prevention (CDC) also emphasizes the importance of adherence and retention in maximizing PrEP outcomes.

7.

bmjopen.bmj.com

bmjopen.bmj.com/content/15/6/e097918

Are client and provider preferences for HIV care ...

Client and provider preferences clearly diverged regarding CCP service intensity: in the aggregate, clients tended to prefer lower-intensity services.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12324821/

A Community-led, Multicomponent HIV Prevention Strategy ...

Preliminary data from August 2022 through January 2024 showed promising implementation and effectiveness outcomes. During that time, 113 ...

9.

cdc.gov

cdc.gov/mmwr/volumes/69/rr/rr6903a1.htm

Preexposure Prophylaxis for Prevention of HIV Acquisition ...

Preexposure prophylaxis (PrEP) with antiretroviral medication has been proven effective in reducing the risk for acquiring human immunodeficiency virus (HIV).