Peer Partnerships for Methamphetamine-Associated Heart Failure

(PEER-Heart Trial)

Overseen By Kellie Pertl, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must not be taking: Heart failure medications

Disqualifiers: Heart failure care, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of PEER-Heart is to implement and assess feasibility and preliminary effectiveness of a community peer-facilitated screening for methamphetamine-associated heart failure (MAHF) and linkage to evidence-based cardiology care for people who use methamphetamine in rural areas.

Will I have to stop taking my current medications?

If you are currently taking medications for heart failure, you cannot participate in this trial. The trial does not specify if you need to stop other medications, so it's best to discuss with the trial team.

What data supports the effectiveness of the treatment Rural Community Peer Partnerships for Improving Methamphetamine-Associated Heart Failure Screening and Engagement?

Research shows that peer-based approaches, like those used in the PROUD-R2 study, can effectively engage rural people who use drugs in treatment and research. Additionally, peer recovery specialists have been successful in improving treatment retention for opioid use disorder, suggesting that similar peer-driven methods could be beneficial for methamphetamine-associated heart failure. ^{1 2 3 4 5}

How is the Rural Community Peer Partnerships treatment different from other treatments for methamphetamine-associated heart failure?

The Rural Community Peer Partnerships treatment is unique because it involves peer support from individuals with similar experiences to help improve screening and engagement for methamphetamine-associated heart failure, especially in rural areas. This approach leverages community connections and shared experiences, which is different from traditional medical treatments that typically focus on medication or clinical interventions. ^{1 6 7 8 9}

Research Team

Brian Chan, MD, MPH

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

This trial is for individuals in rural areas who use methamphetamine and may have heart failure linked to drug use. They should be willing to undergo screening and follow-up care via telehealth with a cardiology specialist.

Inclusion Criteria

I have never been diagnosed with heart failure.

Patient-defined regular use of methamphetamine in the last year

Any methamphetamine use in the past 30 days

Exclusion Criteria

I am currently on medication for heart failure.

I have been actively seeking treatment for heart failure in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Peer-supported Treatment

Participants receive a peer-supported referral to a local primary care provider for heart failure treatment

2 months

1 visit (in-person), multiple virtual consultations

Peer-Supported Telehealth Cardiology

Participants receive a virtual consultation with a cardiovascular specialist and transitional care management

2 months

1 virtual consultation, ongoing remote management

Follow-up

Participants are monitored for engagement in cardiac care and completion of diagnostic echocardiogram

6 months

Treatment Details

Interventions

• Rural Community Peer Partnerships

Trial Overview The study is testing if having community peers help with screening for heart issues caused by methamphetamine, plus getting cardiology care through telehealth, can work well in rural settings.

Participant Groups

Group I: Peer-Supported Telehealth Cardiology Experimental Treatment 1 Intervention

Participants will receive a virtual consultation with a cardiovascular specialist, referral for a locally performed echocardiogram (ECG), and transitional care management facilitated by a remote nurse care manager and the peer to treat the participants heart failure.

Group II: Peer-supported Treatment as Usual Active Control 1 Intervention

Participants will receive a peer-supported referral to a local primary care provider who will create a plan to treat the participants heart failure.

Rural Community Peer Partnerships is already approved in United States for the following indications:

Approved in United States as PEER-Heart for:

• Methamphetamine-associated heart failure screening and engagement

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Bay Area First Step

Collaborator

Trials

1

Recruited

200+

Findings from Research

The PROUD-R2 study aims to improve retention in clinical trials for rural people who use drugs (PWUD) by testing a peer-driven intervention, involving 'study buddies' to support participants, across 21 rural counties in Kentucky, Ohio, and Oregon.

Participants in the study will be randomly assigned to either a control group receiving standard outreach or an intervention group with a study buddy, with assessments conducted at 6 and 12 months to evaluate the effectiveness of these retention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R2): a multisite, randomised, 12-month trial to compare efficacy of standard versus peer-based approaches to retain rural people who use drugs in research. Young, AM., Lancaster, KE., Bielavitz, S., et al.[2022]

A study involving 32 participants indicated that a peer recovery specialist-delivered behavioral activation intervention could be both feasible and acceptable for supporting retention in methadone treatment for opioid use disorder.

Participants highlighted the potential of this intervention to address challenges related to unstructured time in treatment, suggesting that peer support could enhance engagement and outcomes for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Sometimes you have to take the person and show them how": adapting behavioral activation for peer recovery specialist-delivery to improve methadone treatment retention. Kleinman, MB., Anvari, MS., Bradley, VD., et al.[2023]

Training drug users from Puerto Rico in methadone maintenance programs to conduct HIV-related peer outreach led to positive short-term outcomes, including increased community engagement and discussions about HIV.

Participants who conducted outreach reported feeling more helpful to their community and showed a trend towards more vocational activities compared to those who did not participate in outreach, indicating the potential effectiveness of peer outreach models in addressing HIV risk behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conducting peer outreach to migrants: outcomes for drug treatment patients. Deren, S., Kang, SY., Mino, M., et al.[2021]

In a study of 710 rural stimulant users over three years, 34-39% reported using outpatient medical care (OMC), with an average of 1-2 visits, highlighting a significant but underutilized resource for managing substance use.

Factors such as having medical insurance and previous engagement in substance use disorder care increased the likelihood and frequency of OMC use, while being male and having more severe addiction issues were linked to lower usage rates, indicating a need for targeted public health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlates of three-year outpatient medical care use among rural stimulant users. Cucciare, MA., Han, X., Timko, C., et al.[2018]

The Risk Avoidance Partnership trained active drug users as peer health advocates (PHAs), who effectively conducted harm reduction outreach from 2001 to 2005, demonstrating their ability to provide critical HIV prevention materials in both public and high-risk settings.

PHAs were seen as credible and trusted sources of information by their peers, which highlights the importance of peer-led interventions in HIV prevention and the need for process evaluations to refine such programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Times and places: Process evaluation of a peer-led HIV prevention intervention. Dickson-Gomez, J., Weeks, M., Martinez, M., et al.[2021]

Peer outreach initiatives in Dakar, Senegal, show promise in reducing harm related to drug use by fostering community-level change and responsibilization among individuals who use drugs, based on qualitative interviews with 44 participants.

The study highlights the importance of peer educators in delivering harm reduction activities, but emphasizes that for these initiatives to be truly effective, broader structural changes are necessary to support sustainable health improvements and prevent the potential for these programs to shift responsibility solely onto individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"They accept me, because I was one of them": formative qualitative research supporting the feasibility of peer-led outreach for people who use drugs in Dakar, Senegal. Stengel, CM., Mane, F., Guise, A., et al.[2019]

The W3 Project, a 5-year study involving peer organizations and researchers, highlighted the importance of recognizing people who use drugs (PWUD) as active participants in research, rather than just subjects or consultants.

The study identified that meaningful participation of PWUD in research is influenced by system-level factors, suggesting that enhancing their involvement requires addressing broader community and policy systems, not just focusing on research methodologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving meaningful participation of people who use drugs and their peer organizations in a strategic research partnership. Brown, G., Crawford, S., Perry, GE., et al.[2020]

The study outlines a successful low-barrier hiring process for Peer Research Associates (PRAs) from affected communities, specifically targeting people living with HIV who have a history of illicit drug use, to enhance community engagement in research.

Over a 2-year period, this model effectively employed five PRAs, demonstrating that meaningful involvement of affected communities can lead to better research outcomes and opportunities for future employment in community-based participatory research projects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaningful engagement of people living with HIV who use drugs: methodology for the design of a Peer Research Associate (PRA) hiring model. Closson, K., McNeil, R., McDougall, P., et al.[2018]

The PEER program effectively identified clients with substance use disorders who had high needs for social support and were at risk of recidivism, demonstrating its potential to address complex health and social issues among this population.

Despite challenges in client contact and funding stability, the program's sustainability was rated as stable, suggesting that with adjustments to service delivery and risk stratification, it could be further optimized for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Where It Really Counts: Feasibility and Potential of the Peer Engaged Empowered Recovery Program for Substance-Dependent Jail Inmates. Parekh, T., Cuellar, AE., Farina-Morse, M., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R2): a multisite, randomised, 12-month trial to compare efficacy of standard versus peer-based approaches to retain rural people who use drugs in research. [2022]

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

"Sometimes you have to take the person and show them how": adapting behavioral activation for peer recovery specialist-delivery to improve methadone treatment retention. [2023]

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

Conducting peer outreach to migrants: outcomes for drug treatment patients. [2021]

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

Correlates of three-year outpatient medical care use among rural stimulant users. [2018]

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

Times and places: Process evaluation of a peer-led HIV prevention intervention. [2021]

6. England pubmed.ncbi.nlm.nih.gov

"They accept me, because I was one of them": formative qualitative research supporting the feasibility of peer-led outreach for people who use drugs in Dakar, Senegal. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Achieving meaningful participation of people who use drugs and their peer organizations in a strategic research partnership. [2020]

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

Meaningful engagement of people living with HIV who use drugs: methodology for the design of a Peer Research Associate (PRA) hiring model. [2018]

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

Where It Really Counts: Feasibility and Potential of the Peer Engaged Empowered Recovery Program for Substance-Dependent Jail Inmates. [2022]