Human Immunodeficiency VirusNCT03362476
Computer-based Intervention for Alcohol-using HIV/HCV+ Women
A study testing Computer-based alcohol reduction intervention and Brief clinician-delivered MET in people with Human Immunodeficiency Virus and Hepatitis C, run by New York University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Human Immunodeficiency Virus, Hepatitis C, Alcohol Abuse
- What is being tested?
- Computer-based alcohol reduction intervention and Brief clinician-delivered MET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Jan 2018to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Computer-based Alcohol Reduction Intervention for Alcohol-using HIV/HCV+ Russian Women in Clinical Care
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus, Hepatitis C, Alcohol Abuse
- Being tested
- Computer-based alcohol reduction intervention, Brief clinician-delivered MET, Standard of care
- Keywords
- Human Immunodeficiency Virus, Hepatitis C, Computer Intervention, Alcoholism, Women, Russia
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hepatitis C, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based alcohol reduction interventionBehavioural
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 METBehavioural
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 careBehavioural
Clinicians ask about substance use and provide evidence-based recommendations promoting abstinence.
| Study group | Role | What they receive |
|---|---|---|
| Computer-based alcohol reduction intervention + Clinician-delivered brief MET counseling | Experimental | 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. Receives: Behavioral: Computer-based alcohol reduction intervention; Behavioral: Brief clinician-delivered MET; Behavioral: Standard of care |
| Clinician-delivered brief MET counseling | Active comparator | Clinician-based brief MET counseling plus standard-of-care (SOC) for current substance users. only Receives: Behavioral: Brief clinician-delivered MET; Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-, 6-, and 9-month post-baseline
Secondary outcomes (5)
Percentage of Women Who Test Phosphatidylethanol (PEth) Negative (<= 8 ng/mL)
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.
Measured: 9-month post-baseline
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
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.
Measured: 9-month post-baseline
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.
Measured: 9-month post-baseline
Count of Women With a Severe FibroTest Score (3-4) at 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.
Measured: 9-month post-baseline
Liver Stiffness
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.
Measured: 9-month post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start3 Jan 2018
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Ralph J Diclemente, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362476
- Sponsor's protocol ID
- IRB00094637
- Other IDs
- R01AA025882-01
- Status last verified
- Sep 2022
- First submitted
- 30 Nov 2017
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified (IPD) collected in this study will be made available to other researchers.
Publications
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.
PubMed 33596972Khalezova 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.
PubMed 35783993Brown 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.
PubMed 34668412
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-based Alcohol Reduction Intervention for Alcohol-using HIV/HCV+ Russian Women in Clinical Care
- ClinicalTrials.gov ID
- NCT03362476
- Acronym / sponsor ID
- IRB00094637
- Conditions
- Human Immunodeficiency Virus, Hepatitis C, Alcohol Abuse
- Keywords
- Human Immunodeficiency Virus, Hepatitis C, Computer Intervention, Alcoholism, Women, Russia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Posted 9 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-based alcohol reduction intervention + Clinician-delivered brief MET counseling | Experimental | Behavioral: Computer-based alcohol reduction intervention, Behavioral: Brief clinician-delivered MET, Behavioral: Standard of careBrief, 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. |
| Clinician-delivered brief MET counseling | Active comparator | Behavioral: Brief clinician-delivered MET, Behavioral: Standard of careClinician-based brief MET counseling plus standard-of-care (SOC) for current substance users. only |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-based alcohol reduction interventionBrief 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. | Behavioural | Computer-based alcohol reduction intervention + Clinician-delivered brief MET counseling |
| Brief clinician-delivered METClinician-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. | Behavioural | Clinician-delivered brief MET counseling, Computer-based alcohol reduction intervention + Clinician-delivered brief MET counseling |
| Standard of careClinicians ask about substance use and provide evidence-based recommendations promoting abstinence. | Behavioural | Clinician-delivered brief MET counseling, Computer-based alcohol reduction intervention + Clinician-delivered brief MET counseling |
Primary outcome
Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative
Time frame: 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.
5 secondary outcomes
Percentage of Women Who Test Phosphatidylethanol (PEth) Negative (<= 8 ng/mL)
Time frame: 9-month post-baseline
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
Time frame: 9-month post-baseline
CD4 Cell Count
Time frame: 9-month post-baseline
Count of Women With a Severe FibroTest Score (3-4) at 9-month Post Baseline
Time frame: 9-month post-baseline
Liver Stiffness
Time frame: 9-month post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33596972DiClemente 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.
- Background: PubMed 35783993Khalezova 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.
- Background: PubMed 34668412Brown 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.
- Individual participant dataSharing planned: Yes. Deidentified (IPD) collected in this study will be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph J Diclemente, PhD principal investigator
New York University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-based alcohol reduction intervention and Brief clinician-delivered MET in people with Human Immunodeficiency Virus and Hepatitis C, run by New York University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative (time frame: 3-, 6-, and 9-month post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03362476, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.