N/A
Completed N=200
Computer-based Intervention for Alcohol-using HIV/HCV+ Women
Human Immunodeficiency Virus Infection · Hepatitis C · Alcohol Abuse
Source: ClinicalTrials.gov NCT03362476 ↗
Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative — 93; 99 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative |
93; 99 | — |
| SECONDARY Percentage of Women Who Test Phosphatidylethanol (PEth) Negative (<= 8 ng/mL) |
44; 43 | — |
| SECONDARY 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 | — |
| SECONDARY CD4 Cell Count |
532.1; 502.9 | — |
| SECONDARY Count of Women With a Severe FibroTest Score (3-4) at 9-month Post Baseline |
24; 22 | — |
| SECONDARY Liver Stiffness |
84; 90 | — |
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
Data sourced from ClinicalTrials.gov (NCT03362476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.