Hepatitis C, HIV Infections, Opioid-use Disorder
Conditions
Keywords
Peer recovery coach (PRC), Pre-exposure prophylaxis (PrEP), HIV care, HCV care, Low-barrier-to-access (LBA)
Brief 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 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.
Interventions
OTHERPRC brief motivational interview intervention
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.
OTHERPhone contact
The PRC will remain in at least weekly contact by phone with each participant.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Boston University
Boston Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Individuals already linked to substance use care * Individuals co-infected with HIV and HCV and engaged in care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Linkage to HCV Care | 6 months | Participants will be interviewed and asked investigator developed questions about linkage to HCV care |
| Participant Linkage to Care for Opioid Use | 3 months and 6 months | Participants will be interviewed and asked investigator developed questions about their linkage to care for opioid use |
| Participant Linkage to HIV Care | 3 months and 6 months | Participants will be interviewed and asked investigator developed questions about linkage to HIV care |
| Number of Participants Who Received HCV Care | 6 months | Whether participants received HCV care will be abstracted from their electronic medical records (EMR) system. |
| Number of Participants Who Received Opioid Use Treatment | 6 months | Whether participants received opioid use treatment will be abstracted from their electronic medical records (EMR) system. |
| Number of Participants Who Received Pre-exposure Prophylaxis (PrEP) | 6 months | Whether participants received PrEp treatment will be abstracted from their electronic medical records (EMR) system. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group 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.
PRC brief motivational interview intervention: 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 contact: The PRC will remain in at least weekly contact by phone with each participant. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Intervention Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized How would you describe your racial/ethnic identity? (check all that apply) American Indian or Alaska Native | 2 Participants |
| Race/Ethnicity, Customized How would you describe your racial/ethnic identity? (check all that apply) Asian | 0 Participants |
| Race/Ethnicity, Customized How would you describe your racial/ethnic identity? (check all that apply) Black or African American | 3 Participants |
| Race/Ethnicity, Customized How would you describe your racial/ethnic identity? (check all that apply) Hispanic/Latinx | 8 Participants |
| Race/Ethnicity, Customized How would you describe your racial/ethnic identity? (check all that apply) Native Hawaiian or Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized How would you describe your racial/ethnic identity? (check all that apply) White | 17 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
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.
Time frame: 6 months
Population: 20 out of the 29 participants that were retained at 6 months, completed the 6 month satisfaction survey. 9 Participants were unreachable at 6 months.~Only 14 participants were asked about the cell phones as it was added later in the study.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention Group | Acceptability of Intervention | Intervention was helpful | Satisfied/Agreed | 3 Participants |
| Intervention Group | Acceptability of Intervention | Lived-Experience of Peer Recovery Had Positive Impact | Very Satisfied/Strongly Agreed | 15 Participants |
| Intervention Group | Acceptability of Intervention | Lived-Experience of Peer Recovery Had Positive Impact | Satisfied/Agreed | 4 Participants |
| Intervention Group | Acceptability of Intervention | Lived-Experience of Peer Recovery Had Positive Impact | Neither Satisfied nor Dissatisfied/NA | 0 Participants |
| Intervention Group | Acceptability of Intervention | Satisfaction working with Peer Recovery Coach | Very Satisfied/Strongly Agreed | 13 Participants |
| Intervention Group | Acceptability of Intervention | Satisfaction working with Peer Recovery Coach | Satisfied/Agreed | 6 Participants |
| Intervention Group | Acceptability of Intervention | Satisfaction working with Peer Recovery Coach | Neither Satisfied nor Dissatisfied/NA | 0 Participants |
| Intervention Group | Acceptability of Intervention | Satisfaction working with Peer Recovery Coach | Dissatisfied/Disagreed | 0 Participants |
| Intervention Group | Acceptability of Intervention | Satisfaction working with Peer Recovery Coach | Very Dissatisfied/Strongly Disagreed | 1 Participants |
| Intervention Group | Acceptability of Intervention | Intervention was helpful | Very Satisfied/Strongly Agreed | 16 Participants |
| Intervention Group | Acceptability of Intervention | Intervention was helpful | Neither Satisfied nor Dissatisfied/NA | 1 Participants |
| Intervention Group | Acceptability of Intervention | Intervention was helpful | Dissatisfied/Disagreed | 0 Participants |
| Intervention Group | Acceptability of Intervention | Intervention was helpful | Very Dissatisfied/Strongly Disagreed | 0 Participants |
| Intervention Group | Acceptability of Intervention | Peer Recovery Coach Provided Navigation to Substance Use Programs/Resources | Very Satisfied/Strongly Agreed | 15 Participants |
| Intervention Group | Acceptability of Intervention | Peer Recovery Coach Provided Navigation to Substance Use Programs/Resources | Satisfied/Agreed | 4 Participants |
| Intervention Group | Acceptability of Intervention | Peer Recovery Coach Provided Navigation to Substance Use Programs/Resources | Neither Satisfied nor Dissatisfied/NA | 0 Participants |
| Intervention Group | Acceptability of Intervention | Peer Recovery Coach Provided Navigation to Substance Use Programs/Resources | Dissatisfied/Disagreed | 0 Participants |
| Intervention Group | Acceptability of Intervention | Peer Recovery Coach Provided Navigation to Substance Use Programs/Resources | Very Dissatisfied/Strongly Disagreed | 1 Participants |
| Intervention Group | Acceptability of Intervention | Peer Recovery Coach Provided Access to HIV Prevention and PrEP | Very Satisfied/Strongly Agreed | 12 Participants |
| Intervention Group | Acceptability of Intervention | Peer Recovery Coach Provided Access to HIV Prevention and PrEP | Satisfied/Agreed | 7 Participants |
| Intervention Group | Acceptability of Intervention | Peer Recovery Coach Provided Access to HIV Prevention and PrEP | Neither Satisfied nor Dissatisfied/NA | 1 Participants |
| Intervention Group | Acceptability of Intervention | Peer Recovery Coach Provided Access to HIV Prevention and PrEP | Dissatisfied/Disagreed | 0 Participants |
| Intervention Group | Acceptability of Intervention | Peer Recovery Coach Provided Access to HIV Prevention and PrEP | Very Dissatisfied/Strongly Disagreed | 0 Participants |
| Intervention Group | Acceptability of Intervention | Helpfulness of Phone | Very Satisfied/Strongly Agreed | 12 Participants |
| Intervention Group | Acceptability of Intervention | Helpfulness of Phone | Satisfied/Agreed | 2 Participants |
| Intervention Group | Acceptability of Intervention | Helpfulness of Phone | Neither Satisfied nor Dissatisfied/NA | 0 Participants |
| Intervention Group | Acceptability of Intervention | Helpfulness of Phone | Dissatisfied/Disagreed | 0 Participants |
| Intervention Group | Acceptability of Intervention | Helpfulness of Phone | Very Dissatisfied/Strongly Disagreed | 0 Participants |
| Intervention Group | Acceptability of Intervention | Lived-Experience of Peer Recovery Had Positive Impact | Dissatisfied/Disagreed | 0 Participants |
| Intervention Group | Acceptability of Intervention | Lived-Experience of Peer Recovery Had Positive Impact | Very Dissatisfied/Strongly Disagreed | 1 Participants |
Secondary
Number of Participants Who Received HCV Care
Whether participants received HCV care will be abstracted from their electronic medical records (EMR) system.
Time frame: 6 months
Population: Only 9 participants were eligible for HCV as they tested positive.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group | Number of Participants Who Received HCV Care | Number of participants engaged in HCV treatment at the time of enrollment | 0 Participants |
| Intervention Group | Number of Participants Who Received HCV Care | Number of participants receiving or had completed HCV treatment at 6 months. | 2 Participants |
Secondary
Number of Participants Who Received Opioid Use Treatment
Whether participants received opioid use treatment will be abstracted from their electronic medical records (EMR) system.
Time frame: 6 months
Population: 22 participants were already on a medications for opioid use disorder (MOUD) before enrollment. Of the total number of participants analyzed, 6 started a MOUD on the day of the enrollment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group | Number of Participants Who Received Opioid Use Treatment | Number of participants that started MOUD on the day of enrollment. | 6 Participants |
| Intervention Group | Number of Participants Who Received Opioid Use Treatment | Number of participants who were on MOUD at the time of enrollment. | 22 Participants |
| Intervention Group | Number of Participants Who Received Opioid Use Treatment | Number of participants on MOUD at 6 months after enrollment | 15 Participants |
| Intervention Group | Number of Participants Who Received Opioid Use Treatment | Number of participants on MOUD at enrollment and remained on through the end of the intervention | 13 Participants |
Secondary
Number of Participants Who Received Pre-exposure Prophylaxis (PrEP)
Whether participants received PrEp treatment will be abstracted from their electronic medical records (EMR) system.
Time frame: 6 months
Population: Of all 29 participants at 6 months, only 14 were eligible to initiate PrEP.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group | Number of Participants Who Received Pre-exposure Prophylaxis (PrEP) | Number of participants that started PrEP during the intervention | 5 Participants |
| Intervention Group | Number of Participants Who Received Pre-exposure Prophylaxis (PrEP) | Number of participants on PrEP at 6 months | 6 Participants |
Secondary
Participant Linkage to Care for Opioid Use
Participants will be interviewed and asked investigator developed questions about their linkage to care for opioid use
Time frame: 3 months and 6 months
Population: At 3 months, not all participants were contactable. 16 participants out of 31 completed the satisfaction survey.~At 6 months, not all participants were contactable. 20 participants out of 29 completed the satisfaction survey.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention Group | Participant Linkage to Care for Opioid Use | 3 Months: The PRC provided adequate navigation to substance use programs and/or resources. | Strongly Agree | 10 Participants |
| Intervention Group | Participant Linkage to Care for Opioid Use | 3 Months: The PRC provided adequate navigation to substance use programs and/or resources. | Agree | 6 Participants |
| Intervention Group | Participant Linkage to Care for Opioid Use | 3 Months: The PRC provided adequate navigation to substance use programs and/or resources. | Neither or N/A | 0 Participants |
| Intervention Group | Participant Linkage to Care for Opioid Use | 3 Months: The PRC provided adequate navigation to substance use programs and/or resources. | Disagree | 0 Participants |
| Intervention Group | Participant Linkage to Care for Opioid Use | 3 Months: The PRC provided adequate navigation to substance use programs and/or resources. | Strongly Disagree | 0 Participants |
| Intervention Group | Participant Linkage to Care for Opioid Use | 6 Months: The PRC provided adequate navigation to substance use programs and/or resources. | Strongly Agree | 15 Participants |
| Intervention Group | Participant Linkage to Care for Opioid Use | 6 Months: The PRC provided adequate navigation to substance use programs and/or resources. | Agree | 4 Participants |
| Intervention Group | Participant Linkage to Care for Opioid Use | 6 Months: The PRC provided adequate navigation to substance use programs and/or resources. | Neither or N/A | 0 Participants |
| Intervention Group | Participant Linkage to Care for Opioid Use | 6 Months: The PRC provided adequate navigation to substance use programs and/or resources. | Disagree | 1 Participants |
| Intervention Group | Participant Linkage to Care for Opioid Use | 6 Months: The PRC provided adequate navigation to substance use programs and/or resources. | Strongly Disagree | 0 Participants |
Secondary
Participant Linkage to HCV Care
Participants will be interviewed and asked investigator developed questions about linkage to HCV care
Time frame: 6 months
Population: Only 9 participants were eligible for HCV treatment as they tested positive for HCV.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group | Participant Linkage to HCV Care | Participants engaged in HCV treatment at time of enrollment. | 0 Participants |
| Intervention Group | Participant Linkage to HCV Care | Participants receiving or had completed HCV treatment at 6 months. | 2 Participants |
Secondary
Participant Linkage to HIV Care
Participants will be interviewed and asked investigator developed questions about linkage to HIV care
Time frame: 3 months and 6 months
Population: At 3 months 31 participants retained in the study, but only 16 participants completed the 3 month satisfaction survey due to unable to contact all participants.~At 6 months 29 participants retained in the study but only 20 completed the 6 month satisfaction survey due to unable to contact all participants.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention Group | Participant Linkage to HIV Care | 3 Months: PRC provided access to HIV prevention and PrEP. | Strongly Agree | 9 Participants |
| Intervention Group | Participant Linkage to HIV Care | 3 Months: PRC provided access to HIV prevention and PrEP. | Agree | 5 Participants |
| Intervention Group | Participant Linkage to HIV Care | 3 Months: PRC provided access to HIV prevention and PrEP. | Neither/Na | 2 Participants |
| Intervention Group | Participant Linkage to HIV Care | 3 Months: PRC provided access to HIV prevention and PrEP. | Disagree | 0 Participants |
| Intervention Group | Participant Linkage to HIV Care | 3 Months: PRC provided access to HIV prevention and PrEP. | Strongly | 0 Participants |
| Intervention Group | Participant Linkage to HIV Care | 6 Months: PRC provided access to HIV prevention and PrEP. | Strongly Agree | 12 Participants |
| Intervention Group | Participant Linkage to HIV Care | 6 Months: PRC provided access to HIV prevention and PrEP. | Agree | 7 Participants |
| Intervention Group | Participant Linkage to HIV Care | 6 Months: PRC provided access to HIV prevention and PrEP. | Neither/Na | 1 Participants |
| Intervention Group | Participant Linkage to HIV Care | 6 Months: PRC provided access to HIV prevention and PrEP. | Disagree | 0 Participants |
| Intervention Group | Participant Linkage to HIV Care | 6 Months: PRC provided access to HIV prevention and PrEP. | Strongly | 0 Participants |