Providing Suboxone and PrEP Using Telemedicine

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. 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.

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

Conditions
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Opioid Use, Opioid-use Disorder, Risk Reduction, Hiv

Intervention / Treatment
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* Drug: Suboxone
* Drug: PrEP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication and telemedicine follow up<br>All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine | Drug: Suboxone<br>* 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.<br>Drug: PrEP<br>* 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.<br>* Other names: Pre-Exposure Prophylaxis (PrEP);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid, medication for opioid use disorder, syringe services program, telemedicine, PrEP, HIV prevention, retention in care, suboxone, buprenorphine, feasibility, acceptability