Trial Outcomes & Findings for Computer-based Intervention for Alcohol-using HIV/HCV+ Women (NCT NCT03362476)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

200 participants

Primary outcome timeframe

3-, 6-, and 9-month post-baseline

Results posted on

2025-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	98	102
Overall Study COMPLETED	98	101
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Computer-based Alcohol Reduction Intervention + Clinician-delivered Brief MET Counseling n=98 Participants 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.	Clinican-delivered Brief MET Counseling n=102 Participants 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.	Total n=200 Participants Total of all reporting groups
Age, Continuous	35 years STANDARD_DEVIATION 3.7 • n=98 Participants	35 years STANDARD_DEVIATION 4.0 • n=102 Participants	35 years STANDARD_DEVIATION 3.8 • n=200 Participants
Sex: Female, Male Female	98 Participants n=98 Participants	102 Participants n=102 Participants	200 Participants n=200 Participants
Sex: Female, Male Male	0 Participants n=98 Participants	0 Participants n=102 Participants	0 Participants n=200 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Russia	98 participants n=98 Participants	102 participants n=102 Participants	200 participants n=200 Participants
Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative	34 Participants n=98 Participants	33 Participants n=102 Participants	67 Participants n=200 Participants

PRIMARY outcome

Timeframe: 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.