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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA020781 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This randomized clinical trial will examine the effectiveness of a strategy of HIV and Hepatitis Care Coordination (HCC) consisting of testing, education, counseling and vaccination for methadone maintenance patients compared with standard Testing, Education, and Counseling (TEC).
In the HCC model, HIV and hepatitis screening, and HAV and HBV vaccination will be done on site and participants receive on site theory-based HIV and hepatitis education, counseling, and case management to promote adherence to HIV and HCV evaluation; in TEC hepatitis screening is done on site, but vaccination and medical care will be provided by off site referral. Primary aims are to assess the impact of the HCC intervention on adherence to hepatitis A virus (HAV) and hepatitis B virus (HBV) vaccination and attendance at an initial appointment with an HIV and/or HCV care provider. Secondary aims include examining intervention effects on HIV and hepatitis knowledge, risky behaviors, alcohol use; follow-up with later stages of HIV and hepatitis C care; to identify psychological mediators of intervention outcomes; and to estimate the incremental cost of the HCC intervention to facilitate fuller economic evaluations of the intervention if proven effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testing, Education, & Counseling (TEC) | Active Comparator | HIV and hepatitis screening is done on-site, but vaccination and medical care will be provided by off-site referral. HIV and Hepatitis, Testing, Education, & Counseling (TEC) participants will receive standard HIV and hepatitis education & counseling. TEC participants will not receive case management services. |
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| Hepatitis Care Coordination (HCC) | Experimental | Participants will receive on-site HIV and viral hepatitis screening. Hepatitis A and B combination vaccination will be provided on-site. Participants will receive on-site theory-based HIV and hepatitis education, counseling, and 6 months of case management to promote adherence to HIV and HCV evaluation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testing, Education, & Counseling (TEC) | Behavioral | Trained research staff will provide a two-session HIV/hepatitis education class. Participants will also be offered serological testing for hepatitis A, B and C, and HIV (optional), and off-site referrals for vaccination and hepatitis care. The content of the TEC intervention is evidence based. The TEC condition is comparable to screening and education methods commonly used in many drug treatment settings. Those in the TEC intervention group who do not adhere to needed off site vaccinations will be offered on site vaccination 30 days after vaccination referral. |
| Measure | Description | Time Frame |
|---|---|---|
| Vaccination adherence visits | 30 days | |
| Health Care Utilization Survey | 12 months | |
| Intervention Costs & Hepatitis Care Utilization: DATCAP, public and private health care system administrative databases | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatitis A Knowledge Test | post-intervention & 90 days | |
| Hepatitis B Knowledge Test | post-intervention & 90 days | |
| Hepatitis C Knowledge Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen L Masson, Ph.D. | Univerisity of California, San Francisco, Dept. of Psychiatry | Principal Investigator |
| David Perlman, MD | Chemical Dependency Institute at Beth Israel Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital Opiate Treatment Outpatient Program | San Francisco | California | 94110 | United States | ||
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| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D007239 | Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| Hepatitis Care Coordination (HCC) | Behavioral | HCC Participants will be offered serological testing and counseling for hepatitis A, B and C, and HIV (optional). HCC participants will be offered on-site hepatitis A and B combination vaccination at the methadone clinic. They will also receive a two-session HIV/hepatitis education class with Motivational Interviewing. In addition, participants will receive 6 months of weekly case management to facilitate entry into hepatitis care. |
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| post-intervention & 90 days |
| HIV Knowledge Test | post-intervention & 90 days |
| Risk Behavior Survey | 3 months, 9 months, 12 months |
| Addiction Severity Index | 3 months, 9 months, 12 months |
| Beth Israel Medical Center Methadone Maintenance Program |
| New York |
| New York |
| 10003 |
| United States |
| D004066 |
| Digestive System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |