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Providing PrEP, Hepatitis C Treatment, and MOUD Through Telemedicine at Greensboro SSP (PARTNERUP)

Primary Purpose

Opioid Use, Opioid Use Disorder, Risk Reduction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Suboxone
Truvada
Mavyret
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid Use focused on measuring opioid, medication for opioid use disorder, Drug user health hub, syringe services program, syringe exchange, PrEP, HIV prevention, retention in care, Suboxone, Hepatitis C treatment, hepatitis C, Opioid use disorder, feasibility, acceptability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • Participant in SSP
  • History of self-report injection opioid use in the past 6 months
  • Willing to take bup/nx, PrEP, and/or hepatitis C treatment for 6 months
  • Not currently taking PrEP
  • HIV negative
  • Not pregnant
  • Either a history of sharing injection or drug preparation equipment or risk of sexual acquisition of HIV* in the past 6 months

    *Individuals are considered at risk of sexual acquisition of HIV if they answer yes to any of the items in the below question: In the last 6 months, have any of the following applied to you?

  • Traded sex for money or drugs
  • Had a sexual partner who is HIV positive
  • Did not consistently use condoms when having sex
  • Had a bacterial sexually transmitted infections (like gonorrhea, chlamydia, or syphilis)
  • No medical contraindications for these medications such as history of renal failure or bone diseases

Exclusion Criteria:

  • Have altered mental status in which participant cannot sign a consent form
  • Receive a positive pregnancy test (will be checked at screening visit)
  • Receive a positive HIV test at enrollment (will be checked at screening visit)
  • Have evidence of renal failure (will be checked at screening visit)
  • Have a history of hepatitis B (will be checked at screening visit)
  • Becoming incarcerated during the study

Additional considerations:

The following are not exclusion criteria for the study overall, but will affect which treatment(s) they can receive:

  • Are currently receiving some form of MOUD (buprenorphine, naltrexone, methadone) - this makes them ineligible for MOUD treatment through the study, but they can still receive PrEP and/or hepatitis C treatment
  • Have received treatment for hepatitis C prior to enrollment - this makes them ineligible for hepatitis C treatment through study, but they can still receive PrEP and/or MOUD

Sites / Locations

  • Duke Department of Population Health Sciences
  • NC Survivors Union

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Medication and telemedicine follow up

Arm Description

Enrolled participants will be prescribed PrEP Mavyret and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.

Outcomes

Primary Outcome Measures

Proportion who demonstrate no or minimal opioid use.
Defined as self-reported opioid use on ≤4 days in the past month and/or 2 or more consecutive negative urine tests.
Proportion who demonstrate no or minimal opioid use.
Defined as self-reported opioid use on ≤4 days in the past month and/or 2 or more consecutive negative urine tests.
Proportion who remain HIV negative.
Measured via negative HIV test.
Proportion who remain HIV negative.
Measured via negative HIV test.
Among participants who undergo hepatitis C treatment, the hepatitis C cure rate
Measured via negative hepatitis C test.
Persistence in care
Defined as the proportion who remain on treatment.
Persistence in care
Defined as the proportion who remain on treatment.
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)
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)
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)
Acceptability of medical care via a telemedicine video platform
Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
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)
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)
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)
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)
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)
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)

Secondary Outcome Measures

Full Information

First Posted
October 26, 2021
Last Updated
April 25, 2023
Sponsor
Duke University
Collaborators
Center for AIDS Research (CFAR), National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT05108935
Brief Title
Providing PrEP, Hepatitis C Treatment, and MOUD Through Telemedicine at Greensboro SSP
Acronym
PARTNERUP
Official Title
Providing A Resource: Telemedicine at Needle Exchanges to Reach Under-served Populations - Greensboro
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Center for AIDS Research (CFAR), National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, pre-exposure prophylaxis (PrEP) for HIV prevention, and/or hepatitis C treatment 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 site in Greensboro, 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, pre-exposure prophylaxis (PrEP) for HIV prevention and/or hepatitis C treatment 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, PrEP, and hepatitis C treatment as part of a comprehensive telemedicine-based harm reduction program among people who inject drugs using SSPs. To assess feasibility and acceptability of implementing a telemedicine-based care harm reduction program among program implementers To assess feasibility and acceptability of participating in a telemedicine-based harm reduction program among users The study population is people who inject drugs, specifically opioids, and who access services at an SSP in Greensboro, NC. The study team will enroll 30 people who inject drugs accessing the participating SSP. 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 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 SSP. Participants on any combination of treatment including MOUD: For the first month (Month 1), telemedicine visits will be weekly with each to ensure that participants are stable on the appropriate bup/nx dose. Starting at Month 2, the telemedicine visits will take place monthly. For participants on any combination of treatment NOT including MOUD: Participants will attend telemedicine follow up visits at month 3 and month 6 to check in and provide labs. All 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. All participants will also be asked to participate in qualitative interviews on their experiences with the program at month 1 and month 6. By the end of the study, we hope to determine the following: The proportion of persons who demonstrate no or minimal opioid use 1a. Defined as completing Month 3 and Month 6 visits with self-reported opioid use on ≤4 days in the past month and/or 2 The proportion of persons who remain HIV negative. 2a.Measured via negative HIV test at Month 3 and Month 6 Among participants who undergo hepatitis C treatment, the hepatitis C cure rate Retention or persistence in care 4a. Defined as the proportion who remain on treatment (all or any combination of MOUD, PrEP, and hepatitis C treatment) at Month 3 and Month 6 4b. We will also examine whether participants are more apt to remain on paired/combined therapy compared to individual treatment. Organizational facilitators and barriers to establishing a telehealth program in an SSP 5a. We will iteratively collect programmatic data and document challenges and problem-solving that occurs throughout the implementation period of providing bup/nx, PrEP, and/or hepatitis C treatment. We will identify and describe organizational factors using the framework of the Implementation Research Logic Model. Patient perspectives on telehealth delivery of PrEP, MOUD, and/or hepatitis C treatment via SSP 6a. Analysis of interview data at Month 1 and Month 6 to measure attitudes toward PrEP, MOUD, and hepatitis C treatment in general, and on delivery of treatment via telehealth and at the SSP 6b. Analysis of questionnaire data at baseline, Month 3, and Month 6

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Opioid Use Disorder, Risk Reduction, Hiv, Hepatitis C
Keywords
opioid, medication for opioid use disorder, Drug user health hub, syringe services program, syringe exchange, PrEP, HIV prevention, retention in care, Suboxone, Hepatitis C treatment, hepatitis C, Opioid use disorder, feasibility, acceptability

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medication and telemedicine follow up
Arm Type
Experimental
Arm Description
Enrolled participants will be prescribed PrEP Mavyret and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
Intervention Type
Drug
Intervention Name(s)
Suboxone
Other Intervention Name(s)
Buprenorphine Naloxone
Intervention Description
Enrolled participants will be prescribed PrEP Mavyret and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
Intervention Type
Drug
Intervention Name(s)
Truvada
Other Intervention Name(s)
Pre-Exposure Prophylaxis (PrEP)
Intervention Description
Enrolled participants will be prescribed PrEP Mavyret and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
Intervention Type
Drug
Intervention Name(s)
Mavyret
Other Intervention Name(s)
Hepatitis C treatment
Intervention Description
Enrolled participants will be prescribed PrEP Mavyret and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
Primary Outcome Measure Information:
Title
Proportion who demonstrate no or minimal opioid use.
Description
Defined as self-reported opioid use on ≤4 days in the past month and/or 2 or more consecutive negative urine tests.
Time Frame
3 months
Title
Proportion who demonstrate no or minimal opioid use.
Description
Defined as self-reported opioid use on ≤4 days in the past month and/or 2 or more consecutive negative urine tests.
Time Frame
6 months
Title
Proportion who remain HIV negative.
Description
Measured via negative HIV test.
Time Frame
3 months
Title
Proportion who remain HIV negative.
Description
Measured via negative HIV test.
Time Frame
6 months
Title
Among participants who undergo hepatitis C treatment, the hepatitis C cure rate
Description
Measured via negative hepatitis C test.
Time Frame
6 months
Title
Persistence in care
Description
Defined as the proportion who remain on treatment.
Time Frame
3 months
Title
Persistence in care
Description
Defined as the proportion who remain on treatment.
Time Frame
6 months
Title
Ease/difficulty of visiting a SSP to meet with a provider via telemedicine
Description
Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Time Frame
month 1
Title
Ease/difficulty of visiting a SSP to meet with a provider via telemedicine
Description
Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Time Frame
month 6
Title
Ease/difficulty of accessing the telemedicine video platform
Description
Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Time Frame
month 1
Title
Acceptability of medical care via a telemedicine video platform
Description
Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Time Frame
6 month
Title
Participant satisfaction with the program
Description
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)
Time Frame
1 month
Title
Participant satisfaction with the program
Description
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Time Frame
month 6
Title
Participant perceived usefulness of the program
Description
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)
Time Frame
month 1
Title
Participant perceived usefulness of the program
Description
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)
Time Frame
month 6
Title
Motivators and barriers affecting program persistence
Description
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Time Frame
month 6
Title
Motivators and barriers affecting medication adherence and persistence
Description
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Participant in SSP History of self-report injection opioid use in the past 6 months Willing to take bup/nx, PrEP, and/or hepatitis C treatment for 6 months Not currently taking PrEP HIV negative Not pregnant Either a history of sharing injection or drug preparation equipment or risk of sexual acquisition of HIV* in the past 6 months *Individuals are considered at risk of sexual acquisition of HIV if they answer yes to any of the items in the below question: In the last 6 months, have any of the following applied to you? Traded sex for money or drugs Had a sexual partner who is HIV positive Did not consistently use condoms when having sex Had a bacterial sexually transmitted infections (like gonorrhea, chlamydia, or syphilis) No medical contraindications for these medications such as history of renal failure or bone diseases Exclusion Criteria: Have altered mental status in which participant cannot sign a consent form Receive a positive pregnancy test (will be checked at screening visit) Receive a positive HIV test at enrollment (will be checked at screening visit) Have evidence of renal failure (will be checked at screening visit) Have a history of hepatitis B (will be checked at screening visit) Becoming incarcerated during the study Additional considerations: The following are not exclusion criteria for the study overall, but will affect which treatment(s) they can receive: Are currently receiving some form of MOUD (buprenorphine, naltrexone, methadone) - this makes them ineligible for MOUD treatment through the study, but they can still receive PrEP and/or hepatitis C treatment Have received treatment for hepatitis C prior to enrollment - this makes them ineligible for hepatitis C treatment through study, but they can still receive PrEP and/or MOUD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehri McKellar, MD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Department of Population Health Sciences
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Facility Name
NC Survivors Union
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not share IPD with other researchers.

Learn more about this trial

Providing PrEP, Hepatitis C Treatment, and MOUD Through Telemedicine at Greensboro SSP

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