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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA037768 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Emory University | OTHER |
| Grady Health System | OTHER |
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The TEACH patient cohort will characterize a clinic sample of HIV-infected patients on chronic opioid therapy (COT) by describing basic demographics and health status, including characteristics of pain (severity and interference), aberrant behaviors/misuse of COT, substance use and trust/satisfaction with providers. In addition, data on a subset of participants will be used to supplement analysis of secondary outcomes for the TEACH randomized controlled trial (RCT), an intervention study directed at COT providers (outlined in a separate Clinical Trials Protocol Registration and Results (PRS) summary).
The TEACH patient cohort study is multi-site and will be conducted at Boston Medical Center and Grady Memorial Hospital. It will involve recruiting and consenting HIV-infected patients on chronic opioid therapy (COT) to be participants in an observational study. The patient cohort will characterize a clinic sample of HIV-infected patients on COT by describing basic demographics and health status, including characteristics of pain (severity and interference), aberrant behaviors/misuse of COT, substance use and trust/satisfaction with providers. Participation in the study will involve completing one baseline and one follow-up assessment. The follow-up assessment will take place approximately 12 months after the baseline assessment. Both the baseline and follow-up assessments will be conducted at the clinical site, and a single signed consent form will be obtained for both visits. A similar assessment instrument will be used at baseline and follow-up. Additional health information will be collected from the medical record.
There are two distinct components to the TEACH study. The patient cohort component, which is outlined in this Clinical Trials PRS summary, will involve recruiting and consenting patients in the HIV clinic on COT to be participants in an observational study. The intervention, outlined in a separate Clinical Trials PRS summary, will involve consenting physicians as participants in a randomized controlled trial of an intervention and, via a waiver of informed consent, extracting patient level data on the physicians' patients from the electronic medical record. Data on a subset of observational cohort participants will be used to supplement analysis of secondary outcomes for the intervention (i.e. those patients whose providers were enrolled).
The TEACH patient cohort component seeks to inform physicians and other providers about patients who use chronic opioid therapy, including valuable information on the effect of the COT prescriber-directed intervention on patients. This knowledge will guide both prescribers and patients in improving care and reducing risks associated with chronic opioid therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Cohort | The TEACH patient cohort component will establish an observational cohort of HIV-infected patients on chronic opioid therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain severity in the past week (Brief Pain Inventory) | Participants will be followed up to one year | |
| Opioid misuse (Current Opioid Misuse Measure) | Participants will be followed up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Pain interference in the past week (Brief Pain Inventory) | Participants will be followed up to one year | |
| Any emergency department visit to seek opioids (medical chart review and interview) | Participants will be followed up to one year |
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Inclusion Criteria:
Exclusion Criteria:
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HIV-infected COT patients from the HIV clinics at Boston Medical Center and Grady Memorial Hospital
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Samet, MD, MA, MPH | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| Boston Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33752634 | Derived | Ngo B, Liebschutz JM, Cheng DM, Colasanti JA, Merlin JS, Armstrong WS, Forman LS, Lira MC, Samet JH, Del Rio C, Tsui JI. Hazardous alcohol use is associated with greater pain interference and prescription opioid misuse among persons living with HIV and chronic pain. BMC Public Health. 2021 Mar 22;21(1):564. doi: 10.1186/s12889-021-10566-6. | |
| 31303143 | Derived | Lira MC, Tsui JI, Liebschutz JM, Colasanti J, Root C, Cheng DM, Walley AY, Sullivan M, Shanahan C, O'Connor K, Abrams C, Forman LS, Chaisson C, Bridden C, Podolsky MC, Outlaw K, Harris CE, Armstrong WS, Del Rio C, Samet JH. Study protocol for the targeting effective analgesia in clinics for HIV (TEACH) study - a cluster randomized controlled trial and parallel cohort to increase guideline concordant care for long-term opioid therapy among people living with HIV. HIV Res Clin Pract. 2019 Apr;20(2):48-63. doi: 10.1080/15284336.2019.1627509. |
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There is no plan to make individual participant data available.
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D010146 | Pain |
| D019966 | Substance-Related Disorders |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Number of days of drug use in the past 30 days (Addiction Severity Index) | Participants will be followed up to one year |
| Trust in provider (Physician Trust Scale) | Participants will be followed up to one year |
| Satisfaction with COT (questions created) | Participants will be followed up to one year |
| Boston |
| Massachusetts |
| 02118 |
| United States |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |