Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-31 @ 10:02 AM
Study NCT ID:
NCT05108935
Status:
COMPLETED
Last Update Posted:
2023-04-27
First Post:
2021-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Providing PrEP, Hepatitis C Treatment, and MOUD Through Telemedicine at Greensboro SSP
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Providing A Resource: Telemedicine at Needle Exchanges to Reach Under-served Populations - Greensboro
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARTNERUP
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.
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:
1. 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
2. The proportion of persons who remain HIV negative. 2a.Measured via negative HIV test at Month 3 and Month 6
3. Among participants who undergo hepatitis C treatment, the hepatitis C cure rate
4. 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.
5. 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.
6. 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
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:
1. 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
2. The proportion of persons who remain HIV negative. 2a.Measured via negative HIV test at Month 3 and Month 6
3. Among participants who undergo hepatitis C treatment, the hepatitis C cure rate
4. 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.
5. 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.
6. 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5P30AI064518-17 | NIH | None | https://reporter.nih.gov/quic… | View |