An interventional study of Computer-based alcohol reduction intervention and Brief clinician-delivered MET in Human Immunodeficiency Virus, Hepatitis C and Alcohol Abuse, sponsored by New York University. Completed at 2 sites in 2 countries. Open to female participants aged 21 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-01-09.
Sponsored by New York University · Not applicable, Interventional, and Health services research
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Among 725 studies in Hepatitis C with a site in United States — 29 open to participants now, 37 under way, 1 of them phase 3. Hepatitis C · United States.
Among the 725 studies in Hepatitis C with a site in United States, this one is the 162nd largest by enrollment of the 594 interventional ones that give a count, is one of 28 that started in 2018, is one of 140 with no phase, and was the 603rd registered.
1,744 studies on the registry are indexed under Hepatitis C; 98 are open to participants now.
Browse Hepatitis C studies →29 of the 725 studies in Hepatitis C with a site in United States are open now. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 16–45 · Women only
University of Washington · Sites in United States
Ages 18+
West Virginia University · Sites in United States
Ages 18+ · Healthy volunteers
University of California, Los Angeles · Sites in United States
Ages 18–59 · Men only · Healthy volunteers
University of Southern California · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 56 Hepatitis C studies recruiting now, 43 (77%) set no upper age limit and 6 (11%) stop at 75 or younger; 10 take children under 18; 26 take healthy volunteers.
This study: 21 Years to 45 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
725 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 115 · Phase 2 186 · Phase 3 100 · Phase 4 85
First in 1981; this study’s year is marked. 28 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 200 is above the median of 73 across 1,224 interventional studies indexed under Hepatitis C.
Median enrollment 60 across the 594 interventional studies, 113 across the 127 observational. Of the 633 that completed or were terminated, 286 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
286 of 725 have an industry lead sponsor. The 10 most frequent:
New York University is the lead sponsor of 123 studies on the registry; 32 are open to participants now.
New York University has 2 studies filed under Hepatitis C — fewer than ten, so there is no comparison to draw.
13 of the studies in Hepatitis C with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06367465Washington University School of MedicineFeasibility and Acceptability of HCV Treatment in Pregnancy | 2026-12-28 |
| NCT06870019University of Southern CaliforniaHepatitis C Tracker Study | 2026-12-31 |
| NCT06953479LifespanImplementing Low-Barrier HCV Treatment in a Jail Setting | 2027-01 |
| NCT07631559University of California, San FranciscoPilot Study of an Adapted Partner Navigation Intervention Booster Session for Sustained Healthcare Engagement Among People Who Inject Drugs | 2027-03-01 |
| NCT06179498University of California, San FranciscoPartner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs | 2027-03-01 |
Add all 13 to your calendar (.ics) → With an account.
Among the 725 studies in Hepatitis C with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
1,744 studies on the registry are indexed under Hepatitis C; 98 are open to participants now.
This study's enrollment of 200 is above the median of 73 across 1,224 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →New York University is the lead sponsor of 123 studies on the registry; 32 are open to participants now.
Compared within Hepatitis C, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Computer-based alcohol reduction intervention · Behavioral: Brief clinician-delivered MET · Behavioral: Standard of care
Clinician-based brief MET counseling plus standard-of-care (SOC) for current substance users. only
Behavioral: Brief clinician-delivered MET · Behavioral: Standard of care
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.
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.
Clinicians ask about substance use and provide evidence-based recommendations promoting abstinence.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 9-month post-baseline
| Milestone | Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling | Clinican-delivered Brief MET Counseling |
|---|---|---|
| Started | 98 | 102 |
| Completed | 98 | 101 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| Participants | Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling | Clinican-delivered Brief MET Counseling |
|---|---|---|
| Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative | 93 | 99 |
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.
| participants | Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling | Clinician-delivered Brief MET Counseling |
|---|---|---|
| Percentage of Women Who Test Phosphatidylethanol (PEth) Negative (<= 8 ng/mL) | 44 | 43 |
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.
| Participants | Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling | Clinican-delivered Brief MET Counseling |
|---|---|---|
| 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 | 16 | 26 |
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.
| CD4 cells/mm | Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling | Clinician-delivered Brief MET Counseling |
|---|---|---|
| CD4 Cell Count | 532.1 ± 155.1 | 502.9 ± 111.4 |
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.
| Participants | Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling | Clinician-delivered Brief MET Counseling |
|---|---|---|
| Count of Women With a Severe FibroTest Score (3-4) at 9-month Post Baseline | 24 | 22 |
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.
| Participants | Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling | Clinician-delivered Brief MET Counseling |
|---|---|---|
| Liver Stiffness | 84 | 90 |
Collected over 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling | 0/98 (0%) | 0/98 (0%) | 0/98 (0%) |
| Clinican-delivered Brief MET Counseling | 0/102 (0%) | 0/102 (0%) | 0/102 (0%) |
| Age, Continuous(years) | Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling | Clinican-delivered Brief MET Counseling | Total |
|---|---|---|---|
| Mean | 35 ± 3.7 | 35 ± 4.0 | 35 ± 3.8 |
| Sex: Female, Male(Participants) | Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling | Clinican-delivered Brief MET Counseling | Total |
|---|---|---|---|
| Female | 98 | 102 | 200 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling | Clinican-delivered Brief MET Counseling | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling | Clinican-delivered Brief MET Counseling | Total |
|---|---|---|---|
| Russia | 98 | 102 | 200 |
| Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative(Participants) | Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling | Clinican-delivered Brief MET Counseling | Total |
|---|---|---|---|
| Count of participants | 34 | 33 | 67 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Deidentified (IPD) collected in this study will be made available to other researchers.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Will be shared upon request by investigators
Access criteria: Request from researcher to the PIs for use explaining nature of use; use must be for research purposes; willingness to share eventual abstracts and/or publications with the PIs
Ran from Jan 2018 to primary completion in Feb 2022, 49 months.
Results were first posted in Jan 2025, 2 years 10 months after primary completion.
Of 150 non-industry interventional studies with no phase under Hepatitis C, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 42. This study's 49 months is above that.
Counting every sponsor, half of 153 studies reached it within 25 months; a quarter within 14 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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