Hepatitis, Viral, Human, HIV Infections
Conditions
Keywords
HIV, viral hepatitis, methadone maintenance, case management, costs, vaccination, risk reduction education
Brief summary
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
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.
Interventions
BEHAVIORALTesting, Education, & Counseling (TEC)
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.
BEHAVIORALHepatitis Care Coordination (HCC)
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.
Sponsors
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| HIV Knowledge Test | post-intervention & 90 days |
| Hepatitis A Knowledge Test | post-intervention & 90 days |
| Addiction Severity Index | 3 months, 9 months, 12 months |
| Risk Behavior Survey | 3 months, 9 months, 12 months |
| Hepatitis B Knowledge Test | post-intervention & 90 days |
| Hepatitis C Knowledge Test | post-intervention & 90 days |
Countries
United States
Outcome results
None listed