Psychoeducation for HCV and Alcohol Behaviors

Study ID
STU 092010-003

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Dallas Veteran's Affairs Medical Center
  • Other Non-Affiliated Sites
  • Parkland Health & Hospital System

Contact
Dana Downs
214-648-5378
dana.downs@utsouthwestern.edu

Principal Investigator
Carol North

Summary

The study will consist of focus groups conducted to better understand the issues individuals with HCV and co-infected HCV/HiV face. The study will be a randomized controlled trail in which 400 consecutively invited study eligible HCV and co-infected HCV/HiV patients and their families (40 to be matriculated in each of ten quarters) will participate in random assignment PeRF or a control group intervention, regardless of their current condition during therapy. Both PeRF and control group intervention are six month multiple patient/family group programs. assessments which include personal interview and questionnaires will be collected at the start and end of the 6-month intervention and one year later. Those who do not wish to participate in the interventions will be invited to participate in brief baseline interviews only to compare characteristics of group participants with non-participants. Breathalyzer testing for alcohol and urine drug screening will be performed with every research interview, after immediate testing, samples are discarded. Study will enroll up to 75 patients co-infected with HCV/HiV in focus groups for the purpose of learning the issues the patients and their families face on a daily basis. in addition, the study is to design to enroll 100 HCV patients who are will to participate in the study but do not wish to participate in psychoeduation. These patients will be studied as nonmatriculators and compared to study patients who participate in psychoeducational groups. expected total enrollment from both uT Southwestern and VanTHCS(Veterans affairs north Texas Health Care System) is 275 (please refer to page 11 of the Protocol, table of enrollment). a final set of groups will be enrolled beginning august 2012. The modification for this final set of groups adds co-infection with HiV to the inclusion criteria. This will enable contrast and comparison of group participation and study outcomes between HCV patients with and without HiV.

Participant Eligibility

1) individuals who are seropositive for HCV as determined by ELISA test and confirmed by direct measure of viral load as part of their clinical care, 2) lack progressive or decompensated liver functions (manifest in jaundice, ascites, variceal bleeding, hepatic encephalopathy) 3) age at least 18 years, 4) identified family member(s)/ significant other(s) also willing to participate in the psychoeducation groups, and 5) ability to provide informed consent for research participation. 6) for the final set of groups participants will be co-infected with HIV.