Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1UL1TR001430 | U.S. NIH Grant/Contract | View source | |
| 5P30AI042853 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Boston University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
*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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRC brief motivational interview intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Linkage to HIV Care | Participants will be interviewed and asked investigator developed questions about linkage to HIV care | 3 months and 6 months |
| Participant Linkage to HCV Care | Participants will be interviewed and asked investigator developed questions about linkage to HCV care |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sabrina A Assoumou, MD MPH | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center - Low-Barrier-Access (LBA) walk-in clinic | Boston | Massachusetts | 02118 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3 Months |
| |||||||||||||
| 6 Months |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 6 months |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sabrina A Assoumou, MD MPH | Boston Medical Center | (617) 414-5282 | sabrina.assoumou@bmc.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2020 | Nov 9, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 25, 2020 | Feb 12, 2022 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D015658 | HIV Infections |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Phone contact | Other | The PRC will remain in at least weekly contact by phone with each participant. |
|
| 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 | 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. | 6 months |
| Number of Participants Who Received HCV Care | Whether participants received HCV care will be abstracted from their electronic medical records (EMR) system. | 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. | 6 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Participant Linkage to HIV Care | Participants will be interviewed and asked investigator developed questions about linkage to HIV care | 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. | Posted | Count of Participants | Participants | 3 months and 6 months |
|
|
|
| Secondary | Participant Linkage to HCV Care | Participants will be interviewed and asked investigator developed questions about linkage to HCV care | Only 9 participants were eligible for HCV treatment as they tested positive for HCV. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 3 months and 6 months |
|
|
|
| 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. | Of all 29 participants at 6 months, only 14 were eligible to initiate PrEP. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Number of Participants Who Received HCV Care | Whether participants received HCV care will be abstracted from their electronic medical records (EMR) system. | Only 9 participants were eligible for HCV as they tested positive. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
|
| Dissatisfied/Disagreed |
|
| Very Dissatisfied/Strongly Disagreed |
|
|
| Dissatisfied/Disagreed |
|
| Very Dissatisfied/Strongly Disagreed |
|
|
| Dissatisfied/Disagreed |
|
| Very Dissatisfied/Strongly Disagreed |
|
|
| Dissatisfied/Disagreed |
|
| Very Dissatisfied/Strongly Disagreed |
|
|
| Dissatisfied/Disagreed |
|
| Very Dissatisfied/Strongly Disagreed |
|
| Neither/Na |
|
| Disagree |
|
| Strongly |
|
| 6 Months: PRC provided access to HIV prevention and PrEP. |
|
|
|
| Neither or N/A |
|
| Disagree |
|
| Strongly Disagree |
|
| 6 Months: The PRC provided adequate navigation to substance use programs and/or resources. |
|
|
|
|
| Number of participants on MOUD at 6 months after enrollment |
|
|
| Number of participants on MOUD at enrollment and remained on through the end of the intervention |
|
|