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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA025882-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Clinician-delivered brief MET counseling | Active Comparator | Clinician-based brief MET counseling plus standard-of-care (SOC) for current substance users. only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer-based alcohol reduction intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-, 6-, and 9-month post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9-month post-baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralph J Diclemente, PhD | New York University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University | New York | New York | 10003 | United States | ||
| North West District AIDS Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33596972 | Background | 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. | |
| 35783993 | Background | Khalezova 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. |
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Deidentified (IPD) collected in this study will be made available to other researchers.
Will be shared upon request by investigators
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 3-, 6-, and 9-month post-baseline |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ralph J DiClemente | New York University | +1 (212) 992-3709 | rjd438@nyu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2021 | Nov 19, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 5, 2019 | Nov 22, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D006526 | Hepatitis C |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Brief clinician-delivered MET | Behavioral | 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 | Behavioral | Clinicians ask about substance use and provide evidence-based recommendations promoting abstinence. |
|
| 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. |
| 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. | 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. | 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. | 9-month post-baseline |
| Saint Petersburg |
| 197376 |
| Russia |
| 34668412 | Background | Brown 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative | Percentage of women who test ethyl glucuronide (EtG) negative at baseline before randomization. Ethyl glucuronide will be measured in urine, with a sample taken at point-of-care at baseline. The definition of EtG negative is <500ng/mL. A dichotomous score will be created with participants testing EtG negative at baseline assigned a 0 and participants testing EtG positive at baseline assigned a 1. | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Secondary | 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. | Number of participants who had PEth<8ng/mL at 9-months post-baseline | Posted | Number | participants | 9-month post-baseline |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 9-month post-baseline |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | CD4 cells/mm | 9-month post-baseline |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 9-month post-baseline |
|
|
|
| Secondary | 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. | Liver stiffness at to 9-month post-baseline (Yes) | Posted | Count of Participants | Participants | 9-month post-baseline |
|
|
|
| 0 |
| 98 |
| 0 |
| 98 |
| 0 |
| 98 |
| EG001 | 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. | 0 | 102 | 0 | 102 | 0 | 102 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D006298 |
| Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |