Hepatitis CNCT04314414
Coaching for HCV and HIV
A study testing PRC brief motivational interview intervention and Phone contact in people with Hepatitis C and HIV Infections, run by Boston Medical Center at 1 site in United States.
Trial summary
The objective of this study is to determine the feasibility and acceptability of a peer recovery coach (PRC) intervention to improve linkage to hepatitis C (HCV) and/or human immunodeficiency virus (HIV) care, treatment initiation, and evaluation for HIV pre-exposure prophylaxis (PrEP) (when applicable) among… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, HIV Infections, Opioid-use Disorder
- What is being tested?
- PRC brief motivational interview intervention and Phone contact
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2020to 28 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with opioid use disorder, non-reactive HIV antibody test and reactive HCV antibody testing at the BMC LBA walk-in clinic
- Able to speak English
- Individuals providing contact information of two family members or friends
- Individuals signing a medical records release form
Who cannot join
- Individuals already linked to substance use care
- Individuals co-infected with HIV and HCV and engaged in care
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Medical Center - Low-Barrier-Access (LBA) walk-in clinic
Boston, Massachusetts, 02118
About this study
Official title: Peer Recovery Coaching to Facilitate Comprehensive HCV, HIV and Opioid Use Disorder Treatment: A Pilot Study
The objective of this study is to determine the feasibility and acceptability of a peer recovery coach (PRC) intervention to improve linkage to hepatitis C (HCV) and/or human immunodeficiency virus (HIV) care, treatment initiation, and evaluation for HIV pre-exposure prophylaxis (PrEP) (when applicable) among individuals with a history of opioid use disorder accessing a substance use low-barrier-to-access (LBA) walk-in clinic.
In-depth interviews will be administered to participants at baseline, three- and six-months for study participants (40 total participants). The investigator will also follow-up with the per recovery coach and administer surveys to assess the feasibility of a peer recovery coaching intervention in improving HCV/HIV related linkage to care and management. Patient medical records and peer recovery coach monthly reports will be accessed and reviewed to determine fidelity to research protocols.
Read the detailed description
*NOTE* Due to the COVID-19 pandemic, surveys were conducted via telephone and not all participants could be contacted. Therefore, the number of results from participants at three months and six months vary. The data gathered are from participants that were reachable and completed the surveys.
- Conditions
- Hepatitis C, HIV Infections, Opioid-use Disorder
- Being tested
- PRC brief motivational interview intervention, Phone contact
- Keywords
- Peer recovery coach (PRC), Pre-exposure prophylaxis (PrEP), HIV care, HCV care, Low-barrier-to-access (LBA)
- Medical subject headings
- Hepatitis C, HIV Infections, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRC brief motivational interview interventionOther
The intervention will involve the following elements: establishing rapport, asking permission to discuss drugs, discussing the pros and cons associated with drug use, uncovering the gaps between current and desired quality of life and determining readiness to change. The intervention will last approximately 20 minutes and take place at the time of the clinical visit while participants are waiting to be seen by a clinician or are awaiting laboratory testing.
Phone contactOther
The PRC will remain in at least weekly contact by phone with each participant.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in the intervention group will receive a semi-scripted brief motivational interview from the peer recovery coach (PRC) in addition to the standard of care at Boston Medical Center (BMC) for HIV, HCV, and opioid use disorder. Receives: Other: PRC brief motivational interview intervention; Other: Phone contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention
As part of an investigator developed survey a 5-point LIkert scale question will be asked on how acceptable the intervention/care was where 1 is not acceptable and 5 is very acceptable.
Measured: 6 months
Secondary outcomes (6)
Participant Linkage to HIV Care
Participants will be interviewed and asked investigator developed questions about linkage to HIV care
Measured: 3 months and 6 months
Participant Linkage to HCV Care
Participants will be interviewed and asked investigator developed questions about linkage to HCV care
Measured: 6 months
Participant Linkage to Care for Opioid Use
Participants will be interviewed and asked investigator developed questions about their linkage to care for opioid use
Measured: 3 months and 6 months
Number of Participants Who Received Pre-exposure Prophylaxis (PrEP)
Whether participants received PrEp treatment will be abstracted from their electronic medical records (EMR) system.
Measured: 6 months
Number of Participants Who Received HCV Care
Whether participants received HCV care will be abstracted from their electronic medical records (EMR) system.
Measured: 6 months
Number of Participants Who Received Opioid Use Treatment
Whether participants received opioid use treatment will be abstracted from their electronic medical records (EMR) system.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start20 Dec 2020
- Primary completion28 Jan 2022
- Study completion28 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Boston University
- Responsible party
- Sponsor
- Investigators
- Sabrina A Assoumou, MD MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314414
- Sponsor's protocol ID
- H-39712
- Other IDs
- 1UL1TR001430, 5P30AI042853
- Status last verified
- Nov 2022
- First submitted
- 13 Mar 2020
- Last updated
- 19 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Recovery Coaching to Facilitate Comprehensive HCV, HIV and Opioid Use Disorder Treatment: A Pilot Study
- ClinicalTrials.gov ID
- NCT04314414
- Acronym / sponsor ID
- H-39712
- Conditions
- Hepatitis C, HIV Infections, Opioid-use Disorder
- Keywords
- Peer recovery coach (PRC), Pre-exposure prophylaxis (PrEP), HIV care, HCV care, Low-barrier-to-access (LBA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Boston University
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Posted 19 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the feasibility and acceptability of a peer recovery coach (PRC) intervention to improve linkage to hepatitis C (HCV) and/or human immunodeficiency virus (HIV) care, treatment initiation, and evaluation for HIV pre-exposure prophylaxis (PrEP) (when applicable) among individuals with a history of opioid use disorder accessing a substance use low-barrier-to-access (LBA) walk-in clinic.
In-depth interviews will be administered to participants at baseline, three- and six-months for study participants (40 total participants). The investigator will also follow-up with the per recovery coach and administer surveys to assess the feasibility of a peer recovery coaching intervention in improving HCV/HIV related linkage to care and management. Patient medical records and peer recovery coach monthly reports will be accessed and reviewed to determine fidelity to research protocols.
Detailed description
*NOTE* Due to the COVID-19 pandemic, surveys were conducted via telephone and not all participants could be contacted. Therefore, the number of results from participants at three months and six months vary. The data gathered are from participants that were reachable and completed the surveys.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: PRC brief motivational interview intervention, Other: Phone contactParticipants in the intervention group will receive a semi-scripted brief motivational interview from the peer recovery coach (PRC) in addition to the standard of care at Boston Medical Center (BMC) for HIV, HCV, and opioid use disorder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals with opioid use disorder, non-reactive HIV antibody test and reactive HCV antibody testing at the BMC LBA walk-in clinic
- Able to speak English
- Individuals providing contact information of two family members or friends
- Individuals signing a medical records release form
Key exclusion criteria (2 listed)
- Individuals already linked to substance use care
- Individuals co-infected with HIV and HCV and engaged in care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRC brief motivational interview interventionThe intervention will involve the following elements: establishing rapport, asking permission to discuss drugs, discussing the pros and cons associated with drug use, uncovering the gaps between current and desired quality of life and determining readiness to change. The intervention will last approximately 20 minutes and take place at the time of the clinical visit while participants are waiting to be seen by a clinician or are awaiting laboratory testing. | Other | Intervention group |
| Phone contactThe PRC will remain in at least weekly contact by phone with each participant. | Other | Intervention group |
Primary outcome
Acceptability of Intervention
Time frame: 6 months
As part of an investigator developed survey a 5-point LIkert scale question will be asked on how acceptable the intervention/care was where 1 is not acceptable and 5 is very acceptable.
6 secondary outcomes
Participant Linkage to HIV Care
Time frame: 3 months and 6 months
Participant Linkage to HCV Care
Time frame: 6 months
Participant Linkage to Care for Opioid Use
Time frame: 3 months and 6 months
Number of Participants Who Received Pre-exposure Prophylaxis (PrEP)
Time frame: 6 months
Number of Participants Who Received HCV Care
Time frame: 6 months
Number of Participants Who Received Opioid Use Treatment
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabrina A Assoumou, MD MPH principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRC brief motivational interview intervention and Phone contact in people with Hepatitis C and HIV Infections, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.