Clinical trial NCT04521920: Providing Suboxone and PrEP Using Telemedicine
Official title: Providing Comprehensive Harm Reduction Via Telemedicine for PWID Using Syringe Services Programs: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Demonstrate no or Minimal Opioid Use at 3 Months
timeFrame: 3 months
measure: Number of Participants Who Demonstrate no or Minimal Opioid Use at 6 Months
timeFrame: 6 months
measure: Number of Participants Who Remain HIV Negative at 3 Months
timeFrame: 3 months
measure: Number of Participants Who Remain HIV Negative at 6 Months
timeFrame: 6 months
measure: Persistence in Care at 3 Months
timeFrame: 3 months
measure: Persistence in Care at 6 Months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Motivators and Barriers Affecting Medication Adherence and Persistence
timeFrame: 6 month
measure: Motivators and Barriers Affecting Program Persistence
timeFrame: 6 month
measure: Participant Perceived Usefulness of the Program
timeFrame: 6 month
measure: Participant Perceived Usefulness of the Program
timeFrame: 1 month
measure: Participant Satisfaction With the Program
timeFrame: 6 month
measure: Participant Satisfaction With the Program
timeFrame: 1 month
measure: Perceptions of Medical Care Quality Via a Telemedicine Video Platform
timeFrame: 6 month
measure: Ease/Difficulty of Accessing the Telemedicine Video Platform
timeFrame: 1 month
measure: Ease/Difficulty of Visiting a SSP to Meet With a Provider Via Telemedicine
timeFrame: 6 month
measure: Ease/Difficulty of Visiting a SSP to Meet With a Provider Via Telemedicine
timeFrame: 1 month
Locations:
city: Charlotte
country: United States
facility: Queen City Needle Exchnge
state: North Carolina
city: Durham
country: United States
facility: Duke Department of Population Health Sciences
state: North Carolina
city: Wilmington
country: United States
facility: North Carolina Harm Reduction Coalition
state: North Carolina
Study officials:
affiliation: Duke Health
name: Mehri McKellar, MD
role: PRINCIPAL_INVESTIGATOR
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