Providing Suboxone and PrEP Using Telemedicine

NCT04521920 | Completed Results

• 2 other identifiers: Pro00104147Pro00104148
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Opioid Use; Opioid-use Disorder; Risk Reduction; Hiv

Keywords

opioid; medication for opioid use disorder; syringe services program; telemedicine; PrEP; HIV prevention; retention in care; suboxone; buprenorphine; feasibility; acceptability

Outcome Measures

Primary Outcomes (6)

• 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

• 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

Other Outcomes (10)

• Motivators and Barriers Affecting Medication Adherence and Persistence

  6 month

• Motivators and Barriers Affecting Program Persistence

  6 month

• Participant Perceived Usefulness of the Program

  6 month

Study Arms (1)

Medication and telemedicine follow up

EXPERIMENTAL

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

Drug: Suboxone; Drug: PrEP

Interventions

Suboxone DRUG

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.

Medication and telemedicine follow up

PrEP DRUG

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.

Also known as: Pre-Exposure Prophylaxis (PrEP)

Medication and telemedicine follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (3)

Queen City Needle Exchnge

Charlotte, North Carolina, 28215, United States

Location

Duke Department of Population Health Sciences

Durham, North Carolina, 27701, United States

Location

North Carolina Harm Reduction Coalition

Wilmington, North Carolina, 28403, United States

Location

Related Publications (17)

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  PMID: 21689917 BACKGROUND

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  PMID: 24300900 BACKGROUND

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  PMID: 18192204 BACKGROUND

• 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.

  PMID: 23769234 BACKGROUND

• Velander JR. Suboxone: Rationale, Science, Misconceptions. Ochsner J. 2018 Spring;18(1):23-29. No abstract available.

  PMID: 29559865 BACKGROUND

• 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.

  PMID: 17933486 BACKGROUND

• 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.

  PMID: 30311777 BACKGROUND

• 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.

  PMID: 27896552 BACKGROUND

• 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.

  PMID: 30732542 BACKGROUND

• 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.

  PMID: 31251376 BACKGROUND

• 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.

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• 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.

  PMID: 30265425 BACKGROUND

• 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.

  PMID: 11718472 BACKGROUND

• McKellar MS, Des Marais AC, Chen H, Choi Y, Lilly R, Ayers D, Bennett J, Kestner L, Perry B, Poley S, Corneli A, Meade CS, Sachdeva N. Providing medication for opioid use disorder and HIV pre-exposure prophylaxis at syringe services programs via telemedicine: a pilot study. Harm Reduct J. 2024 Mar 26;21(1):69. doi: 10.1186/s12954-024-00983-2.

  PMID: 38532395 DERIVED

• Corneli A, Perry B, Des Marais A, Choi Y, Chen H, Lilly R, Ayers D, Bennett J, Kestner L, Meade CS, Sachdeva N, McKellar MS. Participant perceptions on the acceptability and feasibility of a telemedicine-based HIV PrEP and buprenorphine/naloxone program embedded within syringe services programs: a qualitative descriptive evaluation. Harm Reduct J. 2022 Dec 3;19(1):132. doi: 10.1186/s12954-022-00718-1.

  PMID: 36463214 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Risk Reduction Behavior; Acquired Immunodeficiency Syndrome

Interventions

Buprenorphine, Naloxone Drug Combination; Pre-Exposure Prophylaxis

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Mehri McKellar
• Organization: Duke University

mehri.mckellar@duke.edu

(919) 613-6129

Study Officials

• Mehri McKellar, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: November 9, 2020
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: June 9, 2023
• Results First Posted: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)