N/A
N=17
Providing Suboxone and PrEP Using Telemedicine
Opioid Use · Opioid-use Disorder · Risk Reduction · Hiv
Bottom Line
View on ClinicalTrials.gov: NCT04521920 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Number of Participants Who Demonstrate no or Minimal Opioid Use at 3 Months — 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Suboxone (Drug); PrEP (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Demonstrate no or Minimal Opioid Use at 3 Months |
6 | — |
| PRIMARY Number of Participants Who Demonstrate no or Minimal Opioid Use at 6 Months |
5 | — |
| PRIMARY Number of Participants Who Remain HIV Negative at 3 Months |
8 | — |
| PRIMARY Number of Participants Who Remain HIV Negative at 6 Months |
3 | — |
| PRIMARY Persistence in Care at 3 Months |
13 | — |
| PRIMARY Persistence in Care at 6 Months |
12 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04521920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.