Targeting Effective Analgesia in Clinics for HIV - Patient Cohort

NCT02525731 | Completed

• 2 other identifiers: H-33343R01DA037768
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

HIV Infection; Pain; Drug Dependence

Keywords

HIV Infection; Pain; Chronic Opioid Therapy; Addiction; Analgesics, Opioid

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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

• 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

Study Arms (1)

Patient Cohort

The TEACH patient cohort component will establish an observational cohort of HIV-infected patients on chronic opioid therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected COT patients from the HIV clinics at Boston Medical Center and Grady Memorial Hospital

You may qualify if:

• Patient is HIV-infected
• Patient receives care in the HIV clinic at participating sites
• Patient is on chronic opioid therapy (e.g. 3 or more opioid prescriptions written at least 21 days apart in the prior 6 months)
• Patient is at least 18 years of age
• Patient can provide contact information for at least two contacts to assist with follow-up
• Patient has a home or mobile telephone
• Patient speaks English

You may not qualify if:

• Patient plans to move from area within 12 months
• Patient is unable to consent or understand interview (determined by trained research staff)

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Emory University: collaborator
• Grady Health System: collaborator

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

• 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.

  PMID: 33752634 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.

  PMID: 31303143 DERIVED

MeSH Terms

Conditions

HIV Infections; Pain; Substance-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Jeffrey Samet, MD, MA, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of General Internal Medicine

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 17, 2015
• Study Start: July 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)