Computer-based Intervention for Alcohol-using HIV/HCV+ Women

Computer-based Alcohol Reduction Intervention for Alcohol-using HIV/HCV+ Russian Women in Clinical Care

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03362476

Enrollment

200

Registered

2017-12-05

Start date

2018-01-03

Completion date

2022-02-28

Last updated

2025-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Abuse, Hepatitis C, Human Immunodeficiency Virus

Keywords

Human Immunodeficiency Virus, Hepatitis C, Computer Intervention, Alcoholism, Women, Russia

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.

Interventions

BEHAVIORALComputer-based alcohol reduction intervention

Brief computer-based version of motivation enhancement therapy (MET) used in conjunction with clinician-delivered MET and 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.

BEHAVIORALBrief clinician-delivered MET

Clinician-delivered MET used in conjunction with standard clinical care for current substance users. The brief intervention is focused on goals, cravings, problem-solving and decision-making. The intervention was adapted to be linguistically, gender- and HIV/HCV-appropriate for Russian women living with HIV/HCV.

BEHAVIORALStandard of care

Clinicians ask about substance use and provide evidence-based recommendations promoting abstinence.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative	3-, 6-, and 9-month post-baseline	Percentage 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. Ethyl glucuronide will be measured in urine, with a sample taken at point-of-care at baseline and follow-ups. The definition of EtG negative is \<500ng/mL. A dichotomous score will be created for times 3, 6, and 9-months post baseline, with participants testing EtG negative over the three time points assigned a 0 and participants testing EtG positive at any of the three follow-up points assigned a 1.

Secondary

Measure	Time frame	Description
Percentage of Women Who Test Phosphatidylethanol (PEth) Negative (<= 8 ng/mL)	9-month post-baseline	Percentage 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.
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	9-month post-baseline	HIV viral load (VL) will be measured by testing blood to evaluate HIV disease progression. The measure is the number of participants with an undetectable viral load (\<200 HIV copies per milliliter of blood.). A dichotomous measure is created by which any participant who has an undetectable viral load at 9-month post-baseline is assigned a 0 and any participant with a detectable viral load at that time point is assigned a 1.
CD4 Cell Count	9-month post-baseline	CD4 count will be measured at 9-months post-baseline and compared between intervention groups. CD4 is measured as the number of CD4 cells per cubic mm of blood.
Count of Women With a Severe FibroTest Score (3-4) at 9-month Post Baseline	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 transpeptidase, apolipoprotein A1, alanine transaminase, and total bilirubin. FibroTest is scored on a scale of 0-4 depending on severity: 0-1 being mild liver damage; 1-2 being moderate; and 3-4 being severe damage. This outcome presents the count of women with a severe FibroTest score (3-4) at 9-months post baseline.
Liver Stiffness	9-month post-baseline	FibroScan - imaging modality - will be used to measure liver stiffness at 9-months post-baseline and compared by intervention group. Liver stiffness is diagnosed by a medical specialist.

Countries

Russia, United States

Participant flow

Participants by arm

Arm	Count
Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling Brief, computer-based, alcohol reduction intervention based on motivational enhancement therapy (MET) tailored for HIV/HCV co-infected women who used alcohol. Clinician-based MET counseling plus standard-of-care (SOC) for current substance users. Computer-based alcohol reduction intervention: Brief computer-based version of motivation enhancement therapy (MET) used in conjunction with clinician-delivered MET and 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. Brief clinician-delivered MET: Clinician-delivered MET used in conjunction with standard clinical care for current substance users. The brief intervention is focused on goals, cravings, problem-solving and decision-making. The intervention was adapted to be linguistically, gender- and HIV/HCV-appropriate for Russian women living with HIV/HCV. Standard of care: Clinicians ask about substance use and provide evidence-based recommendations promoting abstinence.	98
Clinican-delivered Brief MET Counseling Clinician-based brief MET counseling plus standard-of-care (SOC) for current substance users. only Brief clinician-delivered MET: Clinician-delivered MET used in conjunction with standard clinical care for current substance users. The brief intervention is focused on goals, cravings, problem-solving and decision-making. The intervention was adapted to be linguistically, gender- and HIV/HCV-appropriate for Russian women living with HIV/HCV. Standard of care: Clinicians ask about substance use and provide evidence-based recommendations promoting abstinence.	102
Total	200

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling	Clinican-delivered Brief MET Counseling	Total
Age, Continuous	35 years STANDARD_DEVIATION 3.7	35 years STANDARD_DEVIATION 4	35 years STANDARD_DEVIATION 3.8
Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative	34 Participants	33 Participants	67 Participants
Race and Ethnicity Not Collected	—	—	0 Participants
Region of Enrollment Russia	98 participants	102 participants	200 participants
Sex: Female, Male Female	98 Participants	102 Participants	200 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 98	0 / 102
other Total, other adverse events	0 / 98	0 / 102
serious Total, serious adverse events	0 / 98	0 / 102

Outcome results

Primary

Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative

Percentage 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. Ethyl glucuronide will be measured in urine, with a sample taken at point-of-care at baseline and follow-ups. The definition of EtG negative is \<500ng/mL. A dichotomous score will be created for times 3, 6, and 9-months post baseline, with participants testing EtG negative over the three time points assigned a 0 and participants testing EtG positive at any of the three follow-up points assigned a 1.

Time frame: 3-, 6-, and 9-month post-baseline

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling	Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative	93 Participants
Clinican-delivered Brief MET Counseling	Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative	99 Participants

Secondary

CD4 Cell Count

CD4 count will be measured at 9-months post-baseline and compared between intervention groups. CD4 is measured as the number of CD4 cells per cubic mm of blood.