Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The New York Academy of Medicine | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Physician Management |
|
| 2 | Experimental | Physician Management and counseling (drug counseling and medication adherence) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physician Management | Other | Standard physician care |
| |
| Counseling |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment retention | 52 weeks | |
| Reductions in illicit opioid use | 52 weeks | |
| Adherence to antiretroviral medications | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| T-lymphocyte CD4 cell count | 52 weeks | |
| HIV-1 RNA levels | 52 weeks | |
| Reduction in HIV transmission risk behaviors |
Not provided
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher J Cutter, Ph.D. | Yale University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06519 | United States |
Not provided
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020399 | Practice Management |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D008605 | Mental Health Services |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Behavioral |
Physician Management and Counseling |
|
| 52 weeks |
| Improved health status | 52 weeks |
| Patient satisfaction | 52 weeks |
| Provider satisfaction | 52 weeks |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D000079524 | Narcotic-Related Disorders |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |