HIV and Hepatitis Care Coordination in Methadone Treatment

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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HIV and Hepatitis Care Coordination in Methadone Treatment

Conditions
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Hepatitis, Viral, Human, HIV Infections

Intervention / Treatment
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* Behavioral: Testing, Education, & Counseling (TEC)
* Behavioral: Hepatitis Care Coordination (HCC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >=18 years of age be able to provide informed consent agree to participate in hepatitis/HIV intervention expect to be available to participate in the study for the entire duration of the study HCV negative, of unknown HCV status, or have not received any previous medical care for HCV Exclusion Criteria: have already had a formal hepatitis C evaluation are obtaining medical care for hepatitis C not interested in obtaining medical care for hepatitis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Testing, Education, & Counseling (TEC)<br>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. | Behavioral: Testing, Education, & Counseling (TEC)<br>* 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.<br>|
| Experimental: Hepatitis Care Coordination (HCC)<br>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. | Behavioral: Hepatitis Care Coordination (HCC)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis A Knowledge Test |  | post-intervention & 90 days | 
| Hepatitis B Knowledge Test |  | post-intervention & 90 days | 
| Hepatitis C Knowledge Test |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, viral hepatitis, methadone maintenance, case management, costs, vaccination, risk reduction education