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Greetings from the DC Clinical Trials Unit

In this newsletter we discuss harm reduction within the DC Clinical Trials Unit and across the city of Washington, particularly after recent findings from HPTN 094.

Harm Reduction

A definition according to the Substance Abuse and Mental Health Services Administration:


Harm reduction is an evidence-based approach that incorporates community-driven public health strategies that center the lived and living experience of people who use drugs, especially those in underserved communities. It is critical to engaging with people who use drugs and equipping them with life-saving tools and information to create positive change in their lives.

Investigator Spotlight

Dr. Jillian Catalanotti

Dr. Jill Catalanotti, MD, MPH, is a professor of medicine and health policy and management at George Washington University in the School of Medicine and Health Sciences. She also serves as the Associate Dean for Clinical Public Health and Population Health Practice. As a highly respected clinician and author, Dr. Catalanotti has been published in high-impact journals and has been an invited speaker at national meetings. In recent years, she has studied barriers to opioid use disorder (OUD) training for residents, has worked on three grants related to delivering treatment to patients with OUD, and has started a support line to advise providers caring for inpatients with OUD at GW Hospital. Please read an interview with Dr. Catalanotti below on her recent work in harm reduction. She is an investigator within the DC CTU for HPTN 094 and CHOICE-STAR (funded by the NIH HEAL Initiative), which is a new research study launching soon although not technically a HPTN study, it is led by HPTN investigators. Please read more about these projects and Dr. Jill's work below.

What does your experience working around harm reduction look like?

I love the harm reduction approach: accepting the fact that we cannot stop all potentially harmful activities from happening, but empowering people with knowledge, skills and methods so that they can keep themselves as safe as possible should they participate in those activities. It is very patient-centered and education-focused, and the desire to practice in that way drew me to become a physician in the first place. For those who are skeptical of harm reduction for something like drug use or sexual activity, I like to remind them that even diabetes care benefits from a harm reduction approach; it is unlikely that a patient will eat zero carbohydrates, so let’s focus on teaching them the differences between them, motivate them to eat them only in moderation, and advise them about other things they can do, like exercise, on days when they have eaten more carbohydrates to try to counteract their effect. For me it feels natural to maintain this approach while shifting between different medical conditions or potentially health-harming activities.


What role do you think research plays in harm reduction?

There are so many important roles for research! One is drug development, such as in the development of buprenorphine-naloxone for the treatment of opioid use disorder. This is an opioid substitution therapy, like methadone, but it is so much more convenient to take because it can be prescribed by any clinician with a DEA number and stable patients can receive up to a one month prescription at a time. Further research has clarified how we can dose the medication best for patients, especially as fentanyl has flooded the recreational drug supply. Other important roles for research are what we are doing with 094 and in CHOICE, which is to say performing observational studies to see what opportunities we may be missing (the original CHOICE project) and performing interventions to seek better ways to deliver care that are patient-centered and may be more effective (integrating care on a mobile unit in 094 and the interventional arms of CHOICE-STAR).


What role do you play in HPTN 094?

I provide clinical consultation for participants receiving buprenorphine-naloxone. This means that initially provided training to our advance practice providers who work in the field with patients, and I provide consultation for any clinical questions that may arise related to the use of buprenorphine-naloxone for the treatment of opioid use disorder among study participants.


How does being a provider inform your approach to research science?

I think that being a provider gives me a practical approach to research science. I find I am most interested in research that translates knowledge from the bench to the bedside and answers the question “how can we best apply this in practice?” I find that I am skeptical of research that uses care delivery approaches that are too complex or expensive because they will be unlikely to be replicable and scalable in the real-world practice setting.


What is the CHOICE Project and what are you looking forward to most about it starting?

The initial CHOICE project was a chart-review study across 4 institutions (University of Maryland, GW, West Virginia University and Emory University/Grady Hospital) assessing how well we use hospitalization as a potential time to intervene on Opioid Use Disorder (OUD) and its infectious risks among people who were hospitalized for acute infections as a result of drug infection. Not surprisingly, we found that we don’t do well at things like offering MOUD to these patients and connecting them to continuing care, screening for HIV and offering PrEP to those who screen negative, or screening for HCV and connecting patients with it to potentially-curative treatment after hospitalization, and other similar outcomes. The next project, CHOICE-STAR, is a randomized controlled trial which will enroll participants who have been admitted to each of the 4 institutions for infections related to injection drug use into one of three arms: treatment as usual, intensive patient navigation for linkage to outpatient care, or receiving post-hospitalization care at an integrated infectious diseases-opioid use disorder clinic which will provide care from both an ID physician and a physician focusing on OUD all in one visit monthly for 6 months. In addition to serving as co-PI on the study along with Dr. Irene Kuo, I will be one of the physicians providing OUD care in the integrated clinic arm. I am most excited about this study providing an opportunity for GW to provide innovative and more intentional care in this space to our patients, as to-date, OUD care at GW has been what I would call fledgling. I am excited to work with colleagues to learn whether either of these alternative interventions may result in improved outcomes for our patients who inject drugs. I hope that if we achieve the primary outcome, decreasing hospital readmissions for sentinel infections, we may be able to demonstrate potential cost-savings and justify investment on the part of our health care system to implement one of these approaches as standard care in the future.


New Publications from the DC CTU

What exactly is HPTN 094?


HPTN 094 is a study designed to address the epidemics of HIV and opioid use disorder in the United States. It explores the effectiveness of a mobile, integrated health service model (a "one-stop shop") to provide a comprehensive range of services to people who inject drugs and are living with or at risk for HIV. The goal of HPTN 094 is to determine if this integrated approach is more effective in improving health outcomes for this vulnerable population.


Read more about HPTN 094 and preliminary findings in this Implementation Science Article here.

Harm Reduction Resources from Whitman-Walker

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Therapy groups


A non-judgmental, non-abstinence based space for folks to reflect on their drug use, drinking, or other behaviors to be curious and honest about the contributing factors and impact of these behaviors as well as experimenting with making changes.

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Outpatient Abstinence-based Substance Use Treatment


This program’s purpose is to help people achieve abstinence, sobriety, and recovery from alcohol and substance use, avoid or manage returns to use, and stabilize common mental health challenges. This multi-format program includes group-based education and counseling; individual therapy; family/support system education; and building social support.

Medication Assisted Treatment


Whitman-Walker Health offers medications for the treatment of prescription opioid/heroin/fentanyl use, alcohol use, and stimulant use disorders. Medication for Opioid Use Disorder (MOUD) can be accessed the same day through our SMART clinics at either location.

Other Resources from Whitman-Walker

  • Free Narcan and fentanyl test strips
  • Harm reduction vending machine
  • For more information, please check out the website here

Other Resources in the District

Bread for the City

Community of Hope

Family & Medical Counseling Services

HIPS

La Clinica Del Pueblo

Mary’s Center

So Others Might Eat (SOME)

CTU Updates

CAB Meeting 

October 10th, 2024 at 1pm Virtual 

Register Here

We appreciate your interest in contributing to the DC CTU Joint Community Advisory Board! Participants are not compensated for attendance.

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Opportunity for Community Input

We would love to hear from you! Please take a moment to complete the survey below to share ideas on community engagement in research! We look forward to learning and growing more together.



https://redcap.link/DCCTU-CAB-Survey-2024

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