Patient Navigation Models for HIV Prevention and Treatment

Not yet recruiting at 3 trial locations

Overseen By Cynthia Frank, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Severe disability, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods to assist individuals in starting and maintaining treatments for HIV and substance use issues. One group will receive guidance from a Patient Navigator who helps set goals and schedule appointments. The other group will choose from various local health services that meet their needs, with assistance from their guide. Suitable participants include those recently involved with the justice system, not currently taking HIV prevention or treatment, and with a history of opioid or stimulant use. As an unphased trial, this study provides a unique opportunity to explore personalized support strategies for managing health challenges.

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 seems to focus on people not currently taking certain HIV medications, but it doesn't mention other medications.

What prior data suggests that these Patient Navigation models are safe for HIV prevention and treatment?

Research has shown that the Patient Choice model, which allows participants to select from community-based treatment options, has been developed and tested in similar settings. While specific safety data for this exact model is unavailable, shared decision-making approaches like this often increase patient involvement in their care.

For both the Patient Choice and Standard Patient Navigation treatments in this trial, previous studies have not reported any safety issues or negative effects. These models focus on service delivery and decision-making processes, rather than introducing new drugs or technologies, which generally ensures safety.

Participants in similar models have demonstrated better engagement with HIV prevention and treatment services, indicating that these approaches are safe and effective in facilitating access to necessary care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the patient navigation models for HIV prevention and treatment because they offer a personalized approach to care. Unlike standard patient navigation, which involves professionals assisting participants based on shared experiences, the PN + Patient Choice model empowers participants to select from a menu of services tailored to their community. This model not only provides a more customized care experience but also actively involves individuals in their treatment decisions, potentially enhancing engagement and outcomes. By discussing personal histories and offering choices, this approach aims to motivate individuals towards starting or continuing PrEP/ART and substance use disorder treatments, addressing barriers in a more responsive way than traditional methods.

What evidence suggests that this trial's treatments could be effective for HIV prevention and treatment?

This trial will compare two models: Standard Patient Navigation (PN) and Patient Navigation plus Patient Choice (PN+PC). Research has shown that the PN+PC model can increase the number of people starting HIV prevention and treatment, such as PrEP (pre-exposure prophylaxis) and ART (antiretroviral therapy), as well as treatments for substance use. Studies have found that when patients help choose their care options, they are more likely to follow through and stay involved. This approach customizes care to fit each person's needs, improving the chances of successful treatment. Meanwhile, the Standard PN model effectively helps people overcome obstacles to accessing care by offering support and guidance. Both models in this trial aim to improve health outcomes by making it easier for individuals to start and continue their treatment plans. ^{6 7 8 9 10}

Who Is on the Research Team?

Sandra Springer, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for individuals involved with the justice system who are dealing with substance abuse or have a substance use disorder. It aims to help them start treatment for HIV prevention (PrEP) or management (ART), as well as address their substance issues.

Inclusion Criteria

Living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well)

Those with current justice involvement (within the past 6 months) (e.g., prison, jail, community supervision)

Willing to have HIV testing to determine negative or positive status

Exclusion Criteria

Severe medical or psychiatric disability making participation unsafe

Persons self-reporting pregnancy

I am unable to give my consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Study (R61)

Initial pilot study to inform the randomized controlled trial

Not specified

Randomized Controlled Trial (R33)

Participants are randomized to either Standard Patient Navigation or PN + Patient Choice to evaluate outcomes

6 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient Choice
• Standard PN

Trial Overview The study compares two types of support: Standard Patient Navigation (PN), which guides patients through treatment, and Patient Choice (PC), where patients choose from a menu of community health services. The goal is to see which method leads to more people starting HIV and substance use treatments.

How Is the Trial Designed?

Group I: PN + Patient Choice (PC) (PN+PC) Experimental Treatment 2 Interventions

PNs working in the PN + PC arm will be trained to engage participants in selecting from a menu of service options in their community. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our Community Advisory Boards (CAB). PNs will also be trained to discuss sexual and substance use history with participants in order to provide education and motivation towards starting PrEP/ART and SUD treatment.

Group II: Standard Patient Navigation (PN) Active Control 1 Intervention

PNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked to PrEP/ART and SUD services. This manualized PN approach provides a complete assessment of participant needs, goal setting, and help with appointment scheduling.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07223398

Shared Decision Making to Treat Or Prevent (STOP) HIV in ... This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and ...

2. reporter.nih.gov reporter.nih.gov/search/foTzb8LrQ0mMWUHALHjrow/project-details/10908913

Section Menu PN+PC to assess acceptability, feasibility, and proportion who (a) access a clinician and (b) receive treatment (ART, PrEP, SUD, harm reduction); (4) seek ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11841254/

Patient preferences for long-acting HIV treatment Long-acting antiretroviral therapy (LA-ART) is an emerging alternative to daily oral ART pills that may improve HIV treatment adherence.

4. natap.org natap.org/2019/HIV/PIIS2352301819303455.pdf

Patient-reported outcomes to enhance person-centred HIV ... One of the most efficient ways to ensure that care reflects patients' needs and priorities is by collecting and using patient-reported outcome ( ...

5. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003959

Evaluation of HIV treatment outcomes with reduced frequency ... We conducted a systematic review and meta-analysis to evaluate the effect of implementation strategies that reduce the frequency of clinical appointments and ...

6. reporter.nih.gov reporter.nih.gov/project-details/10908913

STOP (Shared decision making to Treat Or Prevent) HIV ... Aim 1 (R61) is to develop and pilot test the PN+PC menu of options of PrEP/ART and SUD treatment services for justice-involved PWUD compared to established PN ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4127109/

Outcomes of a Brief Risk Reduction Intervention for Newly HIV ... In this study, we evaluate whether Positive Choices (PC), a brief risk reduction intervention for newly-diagnosed MSM in HIV care, reduced sexual risk behavior ...

8. academic.oup.com academic.oup.com/ofid/article/9/7/ofac196/6568524

Longitudinal Improvements in Viral Suppression for Persons ... Between 2009 and 2018, the median number of days from HIV diagnosis to first PC visit decreased from 58.5 to 8.5 days, and ART initiation ...

9. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2827545

Antiretroviral Drugs for Treatment and Prevention of HIV in ... Viral suppression to HIV RNA levels below 50 copies/mL at week 24 was observed for 97% of participants in both groups, and tuberculosis outcomes ...

10. viivhealthcare.com viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/july/viiv-healthcare-to-announce-data-from-largest-head-to-head-randomised/

ViiV Healthcare to announce data from largest head ... Findings from the SEIMC-GeSIDA Foundation (FSG) PASO-DOBLE study will include treatment efficacy, safety, and weight gain experienced by ...