Trial Outcomes & Findings for Coaching for HCV and HIV (NCT NCT04314414)
NCT ID: NCT04314414
Last Updated: 2022-12-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
6 months
Results posted on
2022-12-19
Participant Flow
Participant milestones
| Measure |
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, hepatitis C (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.
|
|---|---|
|
3 Months
STARTED
|
31
|
|
3 Months
COMPLETED
|
31
|
|
3 Months
NOT COMPLETED
|
0
|
|
6 Months
STARTED
|
31
|
|
6 Months
COMPLETED
|
29
|
|
6 Months
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Coaching for HCV and HIV
Baseline characteristics by cohort
| Measure |
Intervention Group
n=31 Participants
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.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
How would you describe your racial/ethnic identity? (check all that apply) · American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
How would you describe your racial/ethnic identity? (check all that apply) · Asian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
How would you describe your racial/ethnic identity? (check all that apply) · Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
How would you describe your racial/ethnic identity? (check all that apply) · Native Hawaiian or Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
How would you describe your racial/ethnic identity? (check all that apply) · Hispanic/Latinx
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
How would you describe your racial/ethnic identity? (check all that apply) · White
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Intervention Group
n=29 Participants
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.
|
|---|---|
|
Acceptability of Intervention
Satisfaction working with Peer Recovery Coach · Very Satisfied/Strongly Agreed
|
13 Participants
|
|
Acceptability of Intervention
Satisfaction working with Peer Recovery Coach · Satisfied/Agreed
|
6 Participants
|
|
Acceptability of Intervention
Satisfaction working with Peer Recovery Coach · Neither Satisfied nor Dissatisfied/NA
|
0 Participants
|
|
Acceptability of Intervention
Satisfaction working with Peer Recovery Coach · Dissatisfied/Disagreed
|
0 Participants
|
|
Acceptability of Intervention
Satisfaction working with Peer Recovery Coach · Very Dissatisfied/Strongly Disagreed
|
1 Participants
|
|
Acceptability of Intervention
Intervention was helpful · Very Satisfied/Strongly Agreed
|
16 Participants
|
|
Acceptability of Intervention
Intervention was helpful · Satisfied/Agreed
|
3 Participants
|
|
Acceptability of Intervention
Intervention was helpful · Neither Satisfied nor Dissatisfied/NA
|
1 Participants
|
|
Acceptability of Intervention
Intervention was helpful · Dissatisfied/Disagreed
|
0 Participants
|
|
Acceptability of Intervention
Intervention was helpful · Very Dissatisfied/Strongly Disagreed
|
0 Participants
|
|
Acceptability of Intervention
Peer Recovery Coach Provided Navigation to Substance Use Programs/Resources · Very Satisfied/Strongly Agreed
|
15 Participants
|
|
Acceptability of Intervention
Peer Recovery Coach Provided Navigation to Substance Use Programs/Resources · Satisfied/Agreed
|
4 Participants
|
|
Acceptability of Intervention
Peer Recovery Coach Provided Navigation to Substance Use Programs/Resources · Neither Satisfied nor Dissatisfied/NA
|
0 Participants
|
|
Acceptability of Intervention
Peer Recovery Coach Provided Navigation to Substance Use Programs/Resources · Dissatisfied/Disagreed
|
0 Participants
|
|
Acceptability of Intervention
Peer Recovery Coach Provided Navigation to Substance Use Programs/Resources · Very Dissatisfied/Strongly Disagreed
|
1 Participants
|
|
Acceptability of Intervention
Peer Recovery Coach Provided Access to HIV Prevention and PrEP · Very Satisfied/Strongly Agreed
|
12 Participants
|
|
Acceptability of Intervention
Peer Recovery Coach Provided Access to HIV Prevention and PrEP · Satisfied/Agreed
|
7 Participants
|
|
Acceptability of Intervention
Peer Recovery Coach Provided Access to HIV Prevention and PrEP · Neither Satisfied nor Dissatisfied/NA
|
1 Participants
|
|
Acceptability of Intervention
Peer Recovery Coach Provided Access to HIV Prevention and PrEP · Dissatisfied/Disagreed
|
0 Participants
|
|
Acceptability of Intervention
Peer Recovery Coach Provided Access to HIV Prevention and PrEP · Very Dissatisfied/Strongly Disagreed
|
0 Participants
|
|
Acceptability of Intervention
Helpfulness of Phone · Very Satisfied/Strongly Agreed
|
12 Participants
|
|
Acceptability of Intervention
Helpfulness of Phone · Satisfied/Agreed
|
2 Participants
|
|
Acceptability of Intervention
Helpfulness of Phone · Neither Satisfied nor Dissatisfied/NA
|
0 Participants
|
|
Acceptability of Intervention
Helpfulness of Phone · Dissatisfied/Disagreed
|
0 Participants
|
|
Acceptability of Intervention
Helpfulness of Phone · Very Dissatisfied/Strongly Disagreed
|
0 Participants
|
|
Acceptability of Intervention
Lived-Experience of Peer Recovery Had Positive Impact · Very Satisfied/Strongly Agreed
|
15 Participants
|
|
Acceptability of Intervention
Lived-Experience of Peer Recovery Had Positive Impact · Satisfied/Agreed
|
4 Participants
|
|
Acceptability of Intervention
Lived-Experience of Peer Recovery Had Positive Impact · Neither Satisfied nor Dissatisfied/NA
|
0 Participants
|
|
Acceptability of Intervention
Lived-Experience of Peer Recovery Had Positive Impact · Dissatisfied/Disagreed
|
0 Participants
|
|
Acceptability of Intervention
Lived-Experience of Peer Recovery Had Positive Impact · Very Dissatisfied/Strongly Disagreed
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 months and 6 monthsPopulation: 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.
Participants will be interviewed and asked investigator developed questions about linkage to HIV care
Outcome measures
| Measure |
Intervention Group
n=31 Participants
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.
|
|---|---|
|
Participant Linkage to HIV Care
3 Months: PRC provided access to HIV prevention and PrEP. · Strongly Agree
|
9 Participants
|
|
Participant Linkage to HIV Care
3 Months: PRC provided access to HIV prevention and PrEP. · Agree
|
5 Participants
|
|
Participant Linkage to HIV Care
3 Months: PRC provided access to HIV prevention and PrEP. · Neither/Na
|
2 Participants
|
|
Participant Linkage to HIV Care
3 Months: PRC provided access to HIV prevention and PrEP. · Disagree
|
0 Participants
|
|
Participant Linkage to HIV Care
3 Months: PRC provided access to HIV prevention and PrEP. · Strongly
|
0 Participants
|
|
Participant Linkage to HIV Care
6 Months: PRC provided access to HIV prevention and PrEP. · Strongly Agree
|
12 Participants
|
|
Participant Linkage to HIV Care
6 Months: PRC provided access to HIV prevention and PrEP. · Agree
|
7 Participants
|
|
Participant Linkage to HIV Care
6 Months: PRC provided access to HIV prevention and PrEP. · Neither/Na
|
1 Participants
|
|
Participant Linkage to HIV Care
6 Months: PRC provided access to HIV prevention and PrEP. · Disagree
|
0 Participants
|
|
Participant Linkage to HIV Care
6 Months: PRC provided access to HIV prevention and PrEP. · Strongly
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only 9 participants were eligible for HCV treatment as they tested positive for HCV.
Participants will be interviewed and asked investigator developed questions about linkage to HCV care
Outcome measures
| Measure |
Intervention Group
n=31 Participants
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.
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|---|---|
|
Participant Linkage to HCV Care
Participants engaged in HCV treatment at time of enrollment.
|
0 Participants
|
|
Participant Linkage to HCV Care
Participants receiving or had completed HCV treatment at 6 months.
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 months and 6 monthsPopulation: 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.
Participants will be interviewed and asked investigator developed questions about their linkage to care for opioid use
Outcome measures
| Measure |
Intervention Group
n=31 Participants
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.
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|---|---|
|
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
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0 Participants
|
|
Participant Linkage to Care for Opioid Use
6 Months: The PRC provided adequate navigation to substance use programs and/or resources. · Disagree
|
1 Participants
|
|
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
|
|
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
|
|
Participant Linkage to Care for Opioid Use
3 Months: The PRC provided adequate navigation to substance use programs and/or resources. · Agree
|
6 Participants
|
|
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
|
|
Participant Linkage to Care for Opioid Use
3 Months: The PRC provided adequate navigation to substance use programs and/or resources. · Disagree
|
0 Participants
|
|
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
|
|
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
|
|
Participant Linkage to Care for Opioid Use
6 Months: The PRC provided adequate navigation to substance use programs and/or resources. · Agree
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Of all 29 participants at 6 months, only 14 were eligible to initiate PrEP.
Whether participants received PrEp treatment will be abstracted from their electronic medical records (EMR) system.
Outcome measures
| Measure |
Intervention Group
n=29 Participants
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.
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|---|---|
|
Number of Participants Who Received Pre-exposure Prophylaxis (PrEP)
Number of participants that started PrEP during the intervention
|
5 Participants
|
|
Number of Participants Who Received Pre-exposure Prophylaxis (PrEP)
Number of participants on PrEP at 6 months
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only 9 participants were eligible for HCV as they tested positive.
Whether participants received HCV care will be abstracted from their electronic medical records (EMR) system.
Outcome measures
| Measure |
Intervention Group
n=9 Participants
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.
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|---|---|
|
Number of Participants Who Received HCV Care
Number of participants engaged in HCV treatment at the time of enrollment
|
0 Participants
|
|
Number of Participants Who Received HCV Care
Number of participants receiving or had completed HCV treatment at 6 months.
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
Whether participants received opioid use treatment will be abstracted from their electronic medical records (EMR) system.
Outcome measures
| Measure |
Intervention Group
n=31 Participants
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.
|
|---|---|
|
Number of Participants Who Received Opioid Use Treatment
Number of participants who were on MOUD at the time of enrollment.
|
22 Participants
|
|
Number of Participants Who Received Opioid Use Treatment
Number of participants that started MOUD on the day of enrollment.
|
6 Participants
|
|
Number of Participants Who Received Opioid Use Treatment
Number of participants on MOUD at 6 months after enrollment
|
15 Participants
|
|
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
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place