Buprenorphine and Integrated HIV Care

Phase 4

Completed

• Conditions: AIDS; HIV Infections; Drug Addiction; Substance-related Disorders; Human Immunodeficiency Virus
• Interventions: Behavioral: Counseling; Other: Physician Management

• Registration Number: NCT00317460
• Lead Sponsor: Yale University

Brief Summary

The purpose of this study is to examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting.

Detailed Description

The purpose of this study is to examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting. The proposed study will compare Physician Management (PM), a manual-guided brief intervention that approximates the usual counseling provided by primary care practitioners to patients with chronic medical conditions vs. an enhanced strategy of PM with the addition of a combined drug counseling and adherence management strategy (PM+DC/AM). DC is designed to educate the patient about the recovery process and provide additional advice about lifestyle changes including HIV transmission risk reduction and 12-step participation. Adherence Management (AM) is a counseling strategy focusing on HIV medication adherence, adapted from Sorensen et al1. This research will build on pilot work that is being completed in order to further develop and refine these counseling interventions, determine what other psychosocial interventions might be required, and to evaluate this model of integrated care in terms of its effects on opioid agonist therapy retention, decreasing illicit drug use, and increasing adherence to highly active antiretroviral therapy (HAART). Finally, it will provide data that will aid in the formulation of guidelines and the creation of practical manuals for optimizing the provision of this novel therapy to individuals with HIV disease and opioid dependence, as well as provide data for future funded randomized clinical trials.

From September 2005 (start date) to December 1, 2007, the study was conducted as part of a multi-site project that was overseen by the New York Academy of Medicine (NYAM), which is in charge of data analysis. Following December 1, 2007, the study will continue as a local, single-site project without further collaboration from NYAM.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-04-20
• Study First Submitted QC: 2006-04-21
• Study First Posted: 2006-04-24
• Primary Completion: 2009-10
• Study Completion: 2012-10
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• HIV disease
• DSM-IV criteria for opioid dependence, as assessed by SCID
• Documented opioid positive urine toxicology testing

Exclusion criteria:

• Desire to remain enrolled in opioid agonist treatment at an opioid treatment program
• Current dependence on alcohol, benzodiazepines or sedatives (patients who are receiving benzodiazepines under the care of a psychiatrist for the treatment of an anxiety disorder will not be excluded)
• Current suicide or homicide risk
• Current psychotic disorder or major depression
• Inability to read or understand English
• Dementia
• Life-threatening or unstable medical problems requiring inpatient medical care or nursing home placement
• Currently enrolled in other studies involving the provision of psychosocial treatment.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Counseling	Physician Management and counseling (drug counseling and medication adherence)
1	Physician Management	Physician Management

Primary Outcome Measures

Name	Time	Method
Treatment retention	52 weeks
Reductions in illicit opioid use	52 weeks
Adherence to antiretroviral medications	52 weeks

Secondary Outcome Measures

Name	Time	Method
HIV-1 RNA levels	52 weeks
T-lymphocyte CD4 cell count	52 weeks
Improved health status	52 weeks
Provider satisfaction	52 weeks
Reduction in HIV transmission risk behaviors	52 weeks
Patient satisfaction	52 weeks

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States