NCT03362476

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

Completed NA Results posted Last updated 9 January 2025

What this trial tests

NA trial testing Computer-based alcohol reduction intervention in Human Immunodeficiency Virus in 200 participants. Completed in 28 February 2022.

Timeline

3 January 2018

Primary endpoint
28 February 2022

28 February 2022

Quick facts

Lead sponsor	New York University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	200
Start date	3 January 2018
Primary completion	28 February 2022
Estimated completion	28 February 2022
Sites	2 locations across Russia, United States

Drugs / interventions tested

• Computer-based alcohol reduction intervention
• Brief clinician-delivered MET
• Standard of care

Conditions studied

• Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →
• Hepatitis C — all drugs for Hepatitis C →
• Alcohol Abuse — all drugs for Alcohol Abuse →

Sponsor

New York University

Who can join

Adults 21 to 45, female only, with Human Immunodeficiency Virus or Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative Primary · 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

Group	Value	95% CI
Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling	93
Clinican-delivered Brief MET Counseling	99

Percentage of Women Who Test Phosphatidylethanol (PEth) Negative (<= 8 ng/mL) Secondary · 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.

Group	Value	95% CI
Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling	44
Clinician-delivered Brief MET Counseling	43

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 Secondary · 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.

Group	Value	95% CI
Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling	16
Clinican-delivered Brief MET Counseling	26

CD4 Cell Count Secondary · 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.

Group	Value	95% CI
Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling	532.1	± 155.1
Clinician-delivered Brief MET Counseling	502.9	± 111.4

Count of Women With a Severe FibroTest Score (3-4) at 9-month Post Baseline Secondary · 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.

Group	Value	95% CI
Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling	24
Clinician-delivered Brief MET Counseling	22

Liver Stiffness Secondary · 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.

Group	Value	95% CI
Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling	84
Clinician-delivered Brief MET Counseling	90

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Computer-based alcohol reduction intervention for alcohol-using HIV/HCV co-infected Russian women in clinical care: study protocol for a randomized controlled trial.
   DiClemente RJ, Brown JL, Capasso A, Revzina N, et al · · 2021 · cited 5× · PMID 33596972 · DOI 10.1186/s13063-021-05079-x
2. Development and Cultural Adaptation of a Computer-Delivered and Multi-Component Alcohol Reduction Intervention for Russian Women Living with HIV and HCV.
   Brown JL, Anastasakis I, Revzina N, Capasso A, et al · · 2021 · cited 2× · PMID 34668412 · DOI 10.1177/23259582211044920
3. Computer-Based Alcohol Reduction Intervention for Alcohol-Using HIV/HCV Co-Infected Russian Women in Clinical Care: Study Protocol for a Randomized Controlled Trial
   DiClemente RJ, Brown JL, Capasso A, Revzina N, et al · · 2021 · DOI 10.21203/rs.3.rs-45325/v1