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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA014500 | U.S. NIH Grant/Contract | View source | |
| K23AA015313 | 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 purpose of this study is to determine whether two brief counseling sessions reduce drinking and improve health outcomes in HIV-positive women who drink at heavy/hazardous levels. Also, the study seeks to compare hazardous drinking versus nonhazardous drinking women on a variety of alcohol, HIV and life quality outcome measures.
Heavy alcohol use negatively impacts HIV/AIDS in several important ways. It increases HIV-risk behaviors, impairs the immune system and accelerates HIV disease progression. Heavy alcohol use also interferes with HIV care compliance, including appointment attendance and medication adherence.
Women are particularly important targets for alcohol use interventions. The threshold for harmful alcohol effects is strikingly low in women, with two drinks per day placing women at risk for negative health consequences. Heavy/hazardous alcohol use is less likely to be detected in women receiving health services. Women may be less likely to seek and or engage in alcohol treatment services, making nontraditional care settings particularly important for reaching this population.
This proposal tests the utility of a brief alcohol intervention for HIV+ women delivered in a medical setting. Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content. In addition, a comparison group of nonhazardous drinking, HIV+ women will be recruited. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
The investigators hypothesize that women who receive the brief intervention will report lower mean weekly alcohol consumption and fewer heavy drinking episodes than women in standard care. The investigators also predict that women who receive brief intervention will adhere to their HIV medications and keep their health care appointments more consistently, and have improved HIV-related health outcomes. Finally, the investigators hypothesize that nonhazardous drinkers will have fewer psychiatric symptoms and better quality of life than hazardous drinking women.
Comparison(s): Standard HIV care
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Brief Intervention | Experimental | The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content. |
|
| 2 Standard Care Arm | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief alcohol intervention based on Project Treat | Behavioral | The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Drinking Days Out of the Past 90 Days | Baseline through 1 year follow-up | |
| Number of Binge Drinking Days Out of the Past 90 Days | Number of days during the past 90 days on which women drank more than 3 standard drinks | Baseline through 12 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Clinic Appointment Adherence (Kept/Scheduled Appointments) | the % of kept appointments out of scheduled appointments was determined for each participant, and then averaged for the set of participants at each time point | baseline through 1 year follow-up |
| % of Patients Currently on Antiretroviral Therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary E. McCaul, Ph.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Brief Intervention | The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content. Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content. |
| FG001 | 2 Standard Care Arm | Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Brief Intervention | The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content. Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at baseline assessment (Years) |
| 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 | Number of Drinking Days Out of the Past 90 Days | All randomized participants were included in analyses although 6 participants from each arm did not complete the study due to loss to follow up | Posted | Mean | Standard Deviation | days | Baseline through 1 year follow-up |
|
Baseline to 12 month follow-up
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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 | 1 Brief Intervention | The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content. Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary E McCaul | Johns Hopkins University School of Medicine | 410-955-9526 | mmccaul1@jhmi.edu |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000437 | Alcoholism |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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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 |
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| Standard care | Behavioral | Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms. |
|
number of participants who are currently receiving antiretroviral therapy/total number of participants |
| baseline through 1 year follow-up |
| Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex | Number of days in the past 90 days on which participants reported having unprotected vaginal sex | Baseline to 12 month follow-up |
| BG001 | 2 Standard Care Arm | Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex at baseline assessment | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race at baseline assessment | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Employment % | Current employment status at baseline assessment | Count of Participants | Participants |
|
| Income, Continuous | Annual income at baseline assessment (US dollars) | Mean | Standard Deviation | dollars |
|
| Undetectable HIV-1 RNA % | Count of Participants | Participants |
|
| CD4 count, Continuous | Mean | Standard Deviation | cells/mm3 |
|
| AUDIT score, continuous | Score on the Alcohol Use Disorders Identification Test (AUDIT) at baseline assessment. The AUDIT ranges from 0 (minimum) to 40 (maximum). The higher the score, the more likely it is that the individual has an alcohol use disorder. | Mean | Standard Deviation | units on a scale |
|
| Total number of drinking days out of the past 90 days | Mean | Standard Deviation | days |
|
| Number of standard drinks per episode, continuous | A standard drink is any drink that contains about 14 grams of pure alcohol. One standard drink is typically considered to be 12 fluid ounces of beer, 4 - 5 fluid ounces of wine, or 1.5 fluid ounces of 80 proof liquor. | Mean | Standard Deviation | standard drinks |
|
| Number of participants with illicit drug use in past 6 months | Count of Participants | Participants |
|
Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
|
|
|
| Primary | Number of Binge Drinking Days Out of the Past 90 Days | Number of days during the past 90 days on which women drank more than 3 standard drinks | Not all subjects participated in every follow-up interview. | Posted | Mean | Standard Deviation | days out of past 90 days | Baseline through 12 month follow-up |
|
|
|
| Secondary | HIV Clinic Appointment Adherence (Kept/Scheduled Appointments) | the % of kept appointments out of scheduled appointments was determined for each participant, and then averaged for the set of participants at each time point | Posted | Mean | Standard Deviation | percentage of kept/scheduled appointment | baseline through 1 year follow-up |
|
|
|
| Secondary | % of Patients Currently on Antiretroviral Therapy | number of participants who are currently receiving antiretroviral therapy/total number of participants | Posted | Number | percentage of participants | baseline through 1 year follow-up |
|
|
|
| Secondary | Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex | Number of days in the past 90 days on which participants reported having unprotected vaginal sex | Not all subjects participated in every follow-up interview. | Posted | Mean | Standard Deviation | days | Baseline to 12 month follow-up |
|
|
|
| 0 |
| 74 |
| 0 |
| 74 |
| 0 |
| 74 |
| EG001 | 2 Standard Care Arm | Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms. | 0 | 74 | 0 | 74 | 0 | 74 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D006298 |
| Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| 3-month follow-up |
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| 6-month follow-up |
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| 12 month follow-up |
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| 6-month follow-up |
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| 12-month follow-up |
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| 6-month follow-up |
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| 12-month follow-up |
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| 3-month follow-up |
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| 6-month follow-up |
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| 12-month follow-up |
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