NCT04521920

Providing Suboxone and PrEP Using Telemedicine

Completed NA Results posted Last updated 9 June 2023

What this trial tests

NA trial testing Suboxone in Opioid Use in 17 participants. Completed in 30 August 2021.

Timeline

9 November 2020

Primary endpoint
30 August 2021

30 August 2021

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	17
Start date	9 November 2020
Primary completion	30 August 2021
Estimated completion	30 August 2021
Sites	3 locations across United States

Drugs / interventions tested

• Suboxone — full drug profile →
• PrEP — full drug profile →

Conditions studied

• Opioid Use — all drugs for Opioid Use →
• Opioid-use Disorder — all drugs for Opioid-use Disorder →
• Risk Reduction — all drugs for Risk Reduction →
• Hiv — all drugs for Hiv →

Sponsor

Duke University

Who can join

18 and older, any sex, with Opioid Use or Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Demonstrate no or Minimal Opioid Use at 3 Months Primary · 3 months

Defined as self-reported opioid use in prior month

Group	Value	95% CI
Medication and Telemedicine Follow up	6

Number of Participants Who Demonstrate no or Minimal Opioid Use at 6 Months Primary · 6 months

Defined as self-reported opioid use in prior month.

Group	Value	95% CI
Medication and Telemedicine Follow up	5

Number of Participants Who Remain HIV Negative at 3 Months Primary · 3 months

Measured via negative HIV test.

Group	Value	95% CI
Medication and Telemedicine Follow up	8

Number of Participants Who Remain HIV Negative at 6 Months Primary · 6 months

Measured via negative HIV test.

Group	Value	95% CI
Medication and Telemedicine Follow up	3

Persistence in Care at 3 Months Primary · 3 months

Defined as the number of participants who remain on treatment (MOUD or PrEP).

Group	Value	95% CI
Medication and Telemedicine Follow up	13

Persistence in Care at 6 Months Primary · 6 months

Defined as the number of participants who remain on treatment (MOUD or PrEP).

Group	Value	95% CI
Medication and Telemedicine Follow up	12

Sponsor's own 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 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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Corneli A, Perry B, Des Marais A, Choi Y, et al · · 2022 · cited 11× · PMID 36463214 · DOI 10.1186/s12954-022-00718-1
2. Providing medication for opioid use disorder and HIV pre-exposure prophylaxis at syringe services programs via telemedicine: a pilot study.
   McKellar MS, Des Marais AC, Chen H, Choi Y, et al · · 2024 · cited 8× · PMID 38532395 · DOI 10.1186/s12954-024-00983-2
3. Providing medication for opioid use disorder and HIV pre-exposure prophylaxis at syringe services programs via telemedicine: A pilot study
   McKellar MS, Des Marais AC, Chen H, Choi Y, et al · · 2023 · DOI 10.21203/rs.3.rs-3518005/v1