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| ID | Type | Description | Link |
|---|---|---|---|
| 1 H97HA03792-01-00 |
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We hypothesize that integrating drug treatment into HIV treatment will improve HIV outcomes as well as drug treatment outcomes in heroin users. This study will test this hypothesis by randomizing patients to two groups. The first group will receive HIV treatment and buprenorphine treatment contemporaneously at their HIV clinic. The second group will receive HIV treatment at their HIV clinic, and go to another facility to receive buprenorphine treatment services.
We will look at HIV outcomes such as CD4 counts, HIV viral loads, and attendance at appointments and drug treatment outcomes such as receipt of buprenorphine and urine toxicology testing.
This study will test the hypothesis that integrating buprenorphine within the context of primary care HIV treatment will improve outcomes for HIV-infected heroin users vs providing buprenorphine services at a separate, off-site facility. As a means of engagement, we will offer the OASIS education group each week at each facility. For those randomized to integrated care, subjects will attend one education session weekly at the time of their HIV clinic. During these sessions, subjects will receive contemporaneous HIV clinic appointments (monthly), case management (monthly), drug counseling (twice monthly), and buprenorphine (which will be dispensed weekly.) For those randomized to separate care, subjects will attend HIV clinic appointments monthly, and will attend weekly education sessions at the OASIS facility. During these sessions, subjects will receive weekly buprenorphine, twice monthly drug counseling, and monthly case management.
We will measure outcomes by reporting attendance, CD4 counts, HIV viral loads, urine toxicology testing on at least a quarterly basis. We will also measure patient satisfaction, knowledge, quality of life, and a number of other outcomes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrating drug treatment into HIV services | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| 1.Impact of integrated care vs nonintegrated care on: | ||
| a. Substance use and high-risk transmission behaviors | ||
| b. Medical engagement and outcomes | ||
| c. Psychosocial indices, such as criminal justice, employment, housing, and education |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Acceptability of HIV treatment-based buprenorphine therapy | ||
| 2. Health services utilization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana L Sylvestre, MD | Contact | 510-834-5442 | dsylves@itsa.ucsf.edu | |
| Laphyne Barrett | Contact | 510-834-5442 | oasisclinic@sbcglobal.net |
| Name | Affiliation | Role |
|---|---|---|
| Diana L Sylvestre, MD | Organization to Achieve Solutions in Substance Abuse (OASIS) | Principal Investigator |
| Ruth Finkelstein, ScD | New York Academy of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alameda County Medical Center HIV Clinic | Recruiting | Oakland | California | 94602 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| OASIS | Recruiting | Oakland | California | 94612 | United States |
|
| Fairmont Hospital HIV Clinic | Recruiting | San Leandro | California | 94578 | United States |
|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| 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 |