Providing Suboxone and PrEP Using Telemedicine

Providing Comprehensive Harm Reduction Via Telemedicine for PWID Using Syringe Services Programs: a Feasibility Study

The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program.

The initial visit will be conducted in person or remotely via telemedicine given COVID-19 protocols at the SSP sites in Charlotte and Wilmington, North Carolina (NC); follow-up visits will be conducted via telemedicine.

Study Overview

• Status: Completed
• Conditions: Hiv; Opioid Use; Opioid-use Disorder; Risk Reduction
• Intervention / Treatment: Drug: Suboxone; Drug: PrEP

Detailed Description

The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program.

The study objectives are the following:

1. To assess uptake and persistence to bup/nx and PrEP as part of a comprehensive harm reduction program among people who inject drugs using SSPs.
2. To assess feasibility and acceptability of implementing a telemedicine-based MOUD and PrEP program

The study population is people who inject drugs, specifically opioids, and who access services at SSPs in Charlotte and Wilmington, NC. The study team will enroll 20 PWID accessing the participating SSPs in Charlotte and Wilmington, NC (10 from each site). Participants will be enrolled in the study for 6 months. At the end of the study, they will be referred to MOUD and PrEP providers identified in the community.

Data collection

Enrollment visit:

The study coordinator will administer the SOCRATES 8D and a baseline survey to collect demographics, HIV risk behaviors, and substance use history. Participants will undergo laboratory testing at the SSP to determine eligibility and enrolled participants will be prescribed bup/nx and PrEP free of charge.

Follow up visits:

Follow-up visits will be conducted via telemedicine at the SSPs. For the first month (Month 1), telemedicine visits will be weekly with each study participant to ensure that they are stable on the appropriate bup/nx dose. Starting at Month 2, the telemedicine visits will take place monthly. Participants will be asked to complete a questionnaire at Month 3 and Month 6 which include questions on HIV risk and drug use, as well as adherence evaluation for both bup/nx and PrEP.

By the end of the study, we hope to determine the following:

• The proportion of persons who demonstrate no or minimal opioid use
• The proportion of persons who remain HIV negative.
• Retention or persistence in care

We will also examine whether participants are more apt to remain on paired/combined therapy compared to individual treatment.

Under the secondary ID, IRB Pro00104148, we will conduct an ancillary study to contribute to the overall feasibility purpose of the primary study (Pro00104147) by collecting qualitative data from program users. The ancillary study will include conducting in-depth interviews (IDIs) with 10 to 20 participants in the primary study at the end of their month 1 telemedicine visit and at the end of their month 6 telemedicine visit (completion of the primary study). We will use applied thematic analysis to analyze participants' narratives. We chose to position this assessment within an ancillary protocol rather that embed it within the primary study in order to reduce the potential for socially desirable responses.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28215
      • Queen City Needle Exchnge
    • Durham, North Carolina, United States, 27701
      • Duke Department of Population Health Sciences
    • Wilmington, North Carolina, United States, 28403
      • North Carolina Harm Reduction Coalition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• History of self-report injection opioid use in the past 6 months
• Participate in SSPs,
• HIV negative
• Willing to take bup/nx and PrEP for 6 months
• No medical contraindications for these medications
• Not pregnant
• 18 years or older
• Not currently taking PrEP
• Not currently taking any form of MOUD
• History of sharing injection or drug preparation equipment or risk of sexual acquisition of HIV (such as engaging in sex work or men who have sex with men) in the past 6 months

Exclusion Criteria:

• Positive pregnancy test including during the course of the study
• Positive HIV test at enrollment
• Altered mental status in which participant cannot sign a consent form
• Renal insufficiency/failure
• Hepatitis B surface antigen positive
• Becoming incarcerated during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Medication and telemedicine follow up; All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine

Drug: Suboxone; Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.; Drug: PrEP; Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.; Other Names: Pre-Exposure Prophylaxis (PrEP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Remain HIV Negative at 3 Months	Measured via negative HIV test.	3 months
Number of Participants Who Remain HIV Negative at 6 Months	Measured via negative HIV test.	6 months
Persistence in Care at 3 Months	Defined as the number of participants who remain on treatment (MOUD or PrEP).	3 months
Persistence in Care at 6 Months	Defined as the number of participants who remain on treatment (MOUD or PrEP).	6 months
Number of Participants Who Demonstrate no or Minimal Opioid Use at 3 Months	Defined as self-reported opioid use in prior month	3 months
Number of Participants Who Demonstrate no or Minimal Opioid Use at 6 Months	Defined as self-reported opioid use in prior month.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivators and Barriers Affecting Medication Adherence and Persistence	Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)	6 month
Motivators and Barriers Affecting Program Persistence	Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)	6 month
Participant Perceived Usefulness of the Program	Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)	6 month
Participant Perceived Usefulness of the Program	Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)	1 month
Participant Satisfaction With the Program	Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)	6 month
Participant Satisfaction With the Program	Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)	1 month
Perceptions of Medical Care Quality Via a Telemedicine Video Platform	Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)	6 month
Ease/Difficulty of Accessing the Telemedicine Video Platform	Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)	1 month
Ease/Difficulty of Visiting a SSP to Meet With a Provider Via Telemedicine	Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant over time (qualitative method)	6 month
Ease/Difficulty of Visiting a SSP to Meet With a Provider Via Telemedicine	Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)	1 month

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Mehri McKellar, MD, Duke Health

Publications and helpful links

General Publications

• Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Kitisin P, Natrujirote P, Kittimunkong S, Chuachoowong R, Gvetadze RJ, McNicholl JM, Paxton LA, Curlin ME, Hendrix CW, Vanichseni S; Bangkok Tenofovir Study Group. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2013 Jun 15;381(9883):2083-90. doi: 10.1016/S0140-6736(13)61127-7. Epub 2013 Jun 13.
• Mars SG, Bourgois P, Karandinos G, Montero F, Ciccarone D. "Every 'never' I ever said came true": transitions from opioid pills to heroin injecting. Int J Drug Policy. 2014 Mar;25(2):257-66. doi: 10.1016/j.drugpo.2013.10.004. Epub 2013 Oct 19.
• Lankenau SE, Teti M, Silva K, Jackson Bloom J, Harocopos A, Treese M. Initiation into prescription opioid misuse amongst young injection drug users. Int J Drug Policy. 2012 Jan;23(1):37-44. doi: 10.1016/j.drugpo.2011.05.014. Epub 2011 Jun 20.
• Young AM, Havens JR. Transition from first illicit drug use to first injection drug use among rural Appalachian drug users: a cross-sectional comparison and retrospective survival analysis. Addiction. 2012 Mar;107(3):587-96. doi: 10.1111/j.1360-0443.2011.03635.x. Epub 2011 Oct 26.
• Al-Tayyib AA, Rice E, Rhoades H, Riggs P. Association between prescription drug misuse and injection among runaway and homeless youth. Drug Alcohol Depend. 2014 Jan 1;134:406-409. doi: 10.1016/j.drugalcdep.2013.10.027. Epub 2013 Nov 7.
• Valdez A, Neaigus A, Cepeda A. Potential risk factors for injecting among Mexican American non-injecting heroin users. J Ethn Subst Abuse. 2007;6(2):49-73. doi: 10.1300/J233v06n02_05.
• Velander JR. Suboxone: Rationale, Science, Misconceptions. Ochsner J. 2018 Spring;18(1):23-29. No abstract available.
• Sullivan LE, Moore BA, Chawarski MC, Pantalon MV, Barry D, O'Connor PG, Schottenfeld RS, Fiellin DA. Buprenorphine/naloxone treatment in primary care is associated with decreased human immunodeficiency virus risk behaviors. J Subst Abuse Treat. 2008 Jul;35(1):87-92. doi: 10.1016/j.jsat.2007.08.004. Epub 2007 Oct 15.
• Bazzi AR, Biancarelli DL, Childs E, Drainoni ML, Edeza A, Salhaney P, Mimiaga MJ, Biello KB. Limited Knowledge and Mixed Interest in Pre-Exposure Prophylaxis for HIV Prevention Among People Who Inject Drugs. AIDS Patient Care STDS. 2018 Dec;32(12):529-537. doi: 10.1089/apc.2018.0126. Epub 2018 Oct 11.
• Edelman EJ, Moore BA, Calabrese SK, Berkenblit G, Cunningham C, Patel V, Phillips K, Tetrault JM, Shah M, Fiellin DA, Blackstock O. Primary Care Physicians' Willingness to Prescribe HIV Pre-exposure Prophylaxis for People who Inject Drugs. AIDS Behav. 2017 Apr;21(4):1025-1033. doi: 10.1007/s10461-016-1612-6.
• Molfenter T, Fitzgerald M, Jacobson N, McCarty D, Quanbeck A, Zehner M. Barriers to Buprenorphine Expansion in Ohio: A Time-Elapsed Qualitative Study. J Psychoactive Drugs. 2019 Jul-Aug;51(3):272-279. doi: 10.1080/02791072.2019.1566583. Epub 2019 Feb 7.
• Haffajee RL, Lin LA, Bohnert ASB, Goldstick JE. Characteristics of US Counties With High Opioid Overdose Mortality and Low Capacity to Deliver Medications for Opioid Use Disorder. JAMA Netw Open. 2019 Jun 5;2(6):e196373. doi: 10.1001/jamanetworkopen.2019.6373.
• Zheng W, Nickasch M, Lander L, Wen S, Xiao M, Marshalek P, Dix E, Sullivan C. Treatment Outcome Comparison Between Telepsychiatry and Face-to-face Buprenorphine Medication-assisted Treatment for Opioid Use Disorder: A 2-Year Retrospective Data Analysis. J Addict Med. 2017 Mar/Apr;11(2):138-144. doi: 10.1097/ADM.0000000000000287.
• Weintraub E, Greenblatt AD, Chang J, Himelhoch S, Welsh C. Expanding access to buprenorphine treatment in rural areas with the use of telemedicine. Am J Addict. 2018 Dec;27(8):612-617. doi: 10.1111/ajad.12805. Epub 2018 Sep 28.
• Centers for Disease Control and Prevention. Revised guidelines for HIV counseling, testing, and referral. MMWR Recomm Rep. 2001 Nov 9;50(RR-19):1-57; quiz CE1-19a1-CE6-19a1.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: buprenorphine; opioid; PrEP; telemedicine; HIV prevention; feasibility; retention in care; suboxone; acceptability; medication for opioid use disorder; syringe services program
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine, Naloxone Drug Combination
• Other Study ID Numbers: Pro00104147; Pro00104148 (Other Identifier: Duke University Health System)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not share IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No