Clinical trial NCT03362476: Computer-based Intervention for Alcohol-using HIV/HCV+ Women
Official title: Computer-based Alcohol Reduction Intervention for Alcohol-using HIV/HCV+ Russian Women in Clinical Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Hepatitis C
Alcohol Abuse
Keywords: Human Immunodeficiency Virus
Hepatitis C
Computer Intervention
Alcoholism
Women
Russia
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2017-12-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study harnessed 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.

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 study harnessed 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 study was 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 PLUS PLUS provider-delivered brief motivational counseling, or (2) provider-delivered brief motivational counseling. The 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.

Eligibility criteria: Inclusion Criteria:

* female;
* receiving HIV medical care at the AIDS Center;
* chart-documented HIV and chronic HCV infection;
* currently prescribed an antiretroviral (ARV) regimen;
* medically, cognitively, and psychologically capable of study participation;
* laboratory-confirmed recent alcohol use as detected by a Ethylglucuronide (EtG) analysis or self-reported alcohol use

Exclusion Criteria:

* not identifying as biological female
* not HIV and HCV positive
* no laboratory-confirmed or self-reported
* not willing to participate in the trial
* not able to participate in the trial due to medical, cognitive, or psychological issues

Primary outcomes:
measure: Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative
timeFrame: 3-, 6-, and 9-month post-baseline
Secondary outcomes:
measure: Percentage of Women Who Test Phosphatidylethanol (PEth) Negative (<= 8 ng/mL)
timeFrame: 9-month post-baseline
measure: Percentage of Participants in the Intervention Group With an Undetectable HIV Viral Load Compared to the Percentage of Women in the Control Group With an Undetectable Viral Load
timeFrame: 9-month post-baseline
measure: CD4 Cell Count
timeFrame: 9-month post-baseline
measure: Count of Women With a Severe FibroTest Score (3-4) at 9-month Post Baseline
timeFrame: 9-month post-baseline
measure: Liver Stiffness
timeFrame: 9-month post-baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
city: Saint Petersburg
country: Russian Federation
facility: North West District AIDS Center
Study officials:
affiliation: New York University
name: Ralph J Diclemente, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: DiClemente RJ, Brown JL, Capasso A, Revzina N, Sales JM, Boeva E, Gutova LV, Khalezova NB, Belyakov N, Rassokhin V. Computer-based alcohol reduction intervention for alcohol-using HIV/HCV co-infected Russian women in clinical care: study protocol for a randomized controlled trial. Trials. 2021 Feb 17;22(1):147. doi: 10.1186/s13063-021-05079-x.
citation: Khalezova NB, Capasso A, Boeva EV, Gutova LV, Rassokhin VV, Neznanov NG, Belyakov NA, Brown JL, DiClemente RJ. Situational and motivational factors associated with unhealthy alcohol use among Russian women with HIV and hepatitis C Virus co-infection. Drug Alcohol Depend Rep. 2022 Jun;3:100053. doi: 10.1016/j.dadr.2022.100053. Epub 2022 Apr 14.
citation: Brown JL, Anastasakis I, Revzina N, Capasso A, Boeva E, Rassokhin V, Crusey A, Sales JM, Hitch A, Renfro T, DiClemente RJ. Development and Cultural Adaptation of a Computer-Delivered and Multi-Component Alcohol Reduction Intervention for Russian Women Living with HIV and HCV. J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:23259582211044920. doi: 10.1177/23259582211044920.