Computer-based Intervention for Alcohol-using HIV/HCV+ Women
Study Details
Study Description
Brief Summary
The study will harness the multidisciplinary expertise of our research team to develop a brief, computer-based, alcohol reduction intervention tailored for HIV/HCV co-infected women and evaluate its efficacy. The intervention, if effective, may be an efficient and cost-effective alcohol reduction strategy, that is scalable and can be readily disseminated and integrated in clinical care at other AIDS Centres in Russia to enhance women's health and reduce HIV/HCV transmission risk.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Women co-infected with human immunodeficiency viruses (HIV) and Hepatitis C (HCV) are at elevated risk for adverse health outcomes associated with alcohol use. Evidence-based alcohol reduction interventions for this vulnerable population are limited. To address this gap, the proposed study will harness the multidisciplinary expertise and experience of collaborative Russian-U.S. research team to develop a brief, computer-based, alcohol reduction intervention tailored for HIV/HCV co-infected women and evaluate its efficacy. The proposed study will be conducted in three sequential stages: (1) Adaptation, (2) Implementation, and (3) Evaluation. Participants will be randomized to one of two conditions: (1) adapted computer-based alcohol reduction intervention, or (2) standard-of-care control condition. The proposed trial design and analysis provide an appropriate conceptual and methodological framework to assess the efficacy of the computer-based intervention. The intervention, if effective, may be an efficient and cost-effective alcohol reduction strategy that is scalable and can be readily disseminated and integrated in clinical care at other AIDS Centres in Russia to enhance women's health and reduce HIV/HCV transmission risk.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Computer-based alcohol reduction intervention. Brief, computer-based, alcohol reduction intervention based on cognitive behavioral therapy (CBT) tailored for HIV/HCV co-infected women in conjunction with standard clinical care for current substance users. |
Behavioral: Computer-based alcohol reduction intervention
Brief computer-based version of cognitive behavioral therapy (CBT) used in conjunction with standard clinical care for current substance users. Modules and follow up assignments focus on key concepts in substance use, including cravings, problem solving and decision making skills. The multimedia presentation, based on elementary level computer learning games, requires no previous experience with computers.The intervention was adapted to be linguistically, gender- and HIV/HCV-appropriate for Russian women living with HIV/HCV.
Behavioral: Standard-of-care
Routine counseling to avoid alcohol and drugs.
|
| Other: Standard-of-care. Routine counseling to avoid alcohol and drugs. |
Behavioral: Standard-of-care
Routine counseling to avoid alcohol and drugs.
|
Outcome Measures
Primary Outcome Measures
- Proportion of women who test ethyl glucuronide (EtG) negative [Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline]
Proportion of women who test ethyl glucuronide (EtG) negative will be estimated to evaluate the efficacy of the adapted computer-based alcohol reduction intervention condition, relative to standard of care condition.
Secondary Outcome Measures
- Proportion of women who test Phosphatidylethanol (PEth) negative (<= 8 ng/mL) [Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline]
Proportion of women who test PEth negative (<= 8 ng/mL) will be estimated to evaluate the efficacy of the adapted computer-based alcohol reduction intervention condition, relative to standard of care condition.
- Change in HIV viral load (VL) [Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline]
HIV viral load (VL) will be measured by testing blood to evaluate HIV disease progression.
- Change in CD4 cell count [Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline]
CD4 count will be measured by testing blood to evaluate HIV disease progression.
- Change in FibroTest score [Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline]
FibroTest, is a biomarker test that uses the results of six blood serum tests to generate a score that is correlated with the degree of liver damage. It combines α2-macroglobulin, haptoglobin, γ-glutamyl transpeptidatse, apolipoprotein A1, alanine transaminase, and total bilirubin.
- Change in liver stiffness [Baseline assessment and follow-up assessments at 3-, 6-, and 9-month post-baseline]
FibroScan - imaging modality - will be used to measure changes in liver stiffness.
Eligibility Criteria
Criteria
Inclusion Criteria:
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female;
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receiving HIV medical care at the AIDS Center;
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chart-documented HIV and chronic HCV infection;
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currently prescribed an antiretroviral (ARV) regimen;
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medically, cognitively, and psychologically capable of study participation;
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laboratory-confirmed recent alcohol use as detected by a EtG analysis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York University | New York | New York | United States | 10003 |
| 2 | North West District AIDS Center | Saint Petersburg | Russian Federation | 197376 |
Sponsors and Collaborators
- New York University
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
- Principal Investigator: Ralph J Diclemente, PhD, New York University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00094637
- R01AA025882-01