Providing Suboxone and PrEP Using Telemedicine

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04521920
• Other study ID #: Pro00104147
• Secondary ID: Pro00104148
• Status: Completed
• Phase: N/A
• Start date: November 9, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: June 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv
• Opioid Use
• Opioid-Related Disorders
• Opioid-use Disorder
• Risk Reduction

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Queen City Needle Exchnge	Charlotte	North Carolina
United States	Duke Department of Population Health Sciences	Durham	North Carolina
United States	North Carolina Harm Reduction Coalition	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (15)

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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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

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