Alcoholism, HIV Infections
Conditions
Keywords
Controlled Clinical Trials, Randomized, Alcohol Consumption, Behavioral Research, HIV, Alcohol Abuse
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALBrief 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.
BEHAVIORALStandard 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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Heavy/hazardous drinking levels (i.e., consuming 8 or more drinks per week, or have reported at least two heavy drinking occasions \[4 or more drinks/drinking episode\] in the last six months, or score positively on the CAGE or T-ACE). * HIV-positive * Receiving HIV care in Johns Hopkins Hospital (JHH) Moore Clinic
Exclusion criteria
* Actively psychotic and other severe mental health symptoms * Current enrollment in alcohol or drug treatment * Current enrollment in Hopkins psychiatric services * Pregnancy (because of the ethical concern of randomization to standard care)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline through 12 month follow-up | Number of days during the past 90 days on which women drank more than 3 standard drinks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV Clinic Appointment Adherence (Kept/Scheduled Appointments) | baseline through 1 year follow-up | 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 |
| % of Patients Currently on Antiretroviral Therapy | baseline through 1 year follow-up | number of participants who are currently receiving antiretroviral therapy/total number of participants |
| Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex | Baseline to 12 month follow-up | Number of days in the past 90 days on which participants reported having unprotected vaginal sex |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 74 |
| 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. | 74 |
| Total | 148 |
Baseline characteristics
| Characteristic | 2 Standard Care Arm | 1 Brief Intervention | Total |
|---|---|---|---|
| Age, Continuous | 44.86 years STANDARD_DEVIATION 9.1 | 46.27 years STANDARD_DEVIATION 7.07 | 45.56 years STANDARD_DEVIATION 8.08 |
| AUDIT score, continuous | 12.3 units on a scale STANDARD_DEVIATION 8.9 | 11.9 units on a scale STANDARD_DEVIATION 8.7 | 12.1 units on a scale STANDARD_DEVIATION 8.8 |
| CD4 count, Continuous | 393.24 cells/mm3 STANDARD_DEVIATION 236.78 | 398.11 cells/mm3 STANDARD_DEVIATION 269.02 | 395.68 cells/mm3 STANDARD_DEVIATION 252.9 |
| Employment % Unemployed | 46 Participants | 53 Participants | 99 Participants |
| Employment % Working part-time or full-time | 28 Participants | 21 Participants | 49 Participants |
| Income, Continuous | 8189.19 dollars STANDARD_DEVIATION 7239.17 | 8497.38 dollars STANDARD_DEVIATION 7166.03 | 8343.28 dollars STANDARD_DEVIATION 7202.6 |
| Number of participants with illicit drug use in past 6 months | 52 Participants | 50 Participants | 102 Participants |
| Number of standard drinks per episode, continuous | 9.55 standard drinks STANDARD_DEVIATION 6.42 | 9.69 standard drinks STANDARD_DEVIATION 9.13 | 9.62 standard drinks STANDARD_DEVIATION 7.78 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 60 Participants | 67 Participants | 127 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 7 Participants | 19 Participants |
| Region of Enrollment United States | 74 participants | 74 participants | 148 participants |
| Sex: Female, Male Female | 74 Participants | 74 Participants | 148 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Total number of drinking days out of the past 90 days | 30.45 days STANDARD_DEVIATION 27.57 | 34.03 days STANDARD_DEVIATION 29.47 | 32.24 days STANDARD_DEVIATION 28.52 |
| Undetectable HIV-1 RNA % Detectable HIV-1 RNA | 43 Participants | 45 Participants | 88 Participants |
| Undetectable HIV-1 RNA % Undetectable HIV-1 RNA (<50 copies) | 31 Participants | 29 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 74 |
| other Total, other adverse events | 0 / 74 | 0 / 74 |
| serious Total, serious adverse events | 0 / 74 | 0 / 74 |
Outcome results
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
Time frame: Baseline through 12 month follow-up
Population: Not all subjects participated in every follow-up interview.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 Brief Intervention | Number of Binge Drinking Days Out of the Past 90 Days | 6-month follow-up | 12.07 days out of past 90 days | Standard Deviation 21.61 |
| 1 Brief Intervention | Number of Binge Drinking Days Out of the Past 90 Days | Baseline | 24.91 days out of past 90 days | Standard Deviation 26.99 |
| 1 Brief Intervention | Number of Binge Drinking Days Out of the Past 90 Days | 12 month follow-up | 12.76 days out of past 90 days | Standard Deviation 23.42 |
| 1 Brief Intervention | Number of Binge Drinking Days Out of the Past 90 Days | 3-month follow-up | 7.68 days out of past 90 days | Standard Deviation 13.75 |
| 2 Standard Care Arm | Number of Binge Drinking Days Out of the Past 90 Days | 12 month follow-up | 13.23 days out of past 90 days | Standard Deviation 20.4 |
| 2 Standard Care Arm | Number of Binge Drinking Days Out of the Past 90 Days | Baseline | 26.71 days out of past 90 days | Standard Deviation 28.55 |
| 2 Standard Care Arm | Number of Binge Drinking Days Out of the Past 90 Days | 6-month follow-up | 16.14 days out of past 90 days | Standard Deviation 23.63 |
| 2 Standard Care Arm | Number of Binge Drinking Days Out of the Past 90 Days | 3-month follow-up | 13.95 days out of past 90 days | Standard Deviation 22.11 |
Primary
Number of Drinking Days Out of the Past 90 Days
Time frame: Baseline through 1 year follow-up
Population: All randomized participants were included in analyses although 6 participants from each arm did not complete the study due to loss to follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 Brief Intervention | Number of Drinking Days Out of the Past 90 Days | 6-month follow-up | 14.42 days | Standard Deviation 22.2 |
| 1 Brief Intervention | Number of Drinking Days Out of the Past 90 Days | 12-month follow-up | 15.96 days | Standard Deviation 24.07 |
| 1 Brief Intervention | Number of Drinking Days Out of the Past 90 Days | Baseline | 34.03 days | Standard Deviation 29.47 |
| 1 Brief Intervention | Number of Drinking Days Out of the Past 90 Days | 3-month follow-up | 13.58 days | Standard Deviation 19.89 |
| 2 Standard Care Arm | Number of Drinking Days Out of the Past 90 Days | 3-month follow-up | 20.22 days | Standard Deviation 25.27 |
| 2 Standard Care Arm | Number of Drinking Days Out of the Past 90 Days | Baseline | 30.45 days | Standard Deviation 27.57 |
| 2 Standard Care Arm | Number of Drinking Days Out of the Past 90 Days | 12-month follow-up | 20.83 days | Standard Deviation 27.53 |
| 2 Standard Care Arm | Number of Drinking Days Out of the Past 90 Days | 6-month follow-up | 24.48 days | Standard Deviation 26.78 |
Comparison: Drinking frequency was analyzed using a generalized binomial mixed-effects model with the logit link function and a random intercept. The use of a binomial distribution was indicated for this analysis because the outcome was assessed using a 90-day TLFB interview, which has a cap at 90 days.p-value: <0.00595% CI: [0.23, 0.75]Mixed Models Analysis
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
Time frame: baseline through 1 year follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 Brief Intervention | HIV Clinic Appointment Adherence (Kept/Scheduled Appointments) | Baseline | 63.40 percentage of kept/scheduled appointment | Standard Deviation 23.47 |
| 1 Brief Intervention | HIV Clinic Appointment Adherence (Kept/Scheduled Appointments) | 3-month follow-up | 70.11 percentage of kept/scheduled appointment | Standard Deviation 25.15 |
| 1 Brief Intervention | HIV Clinic Appointment Adherence (Kept/Scheduled Appointments) | 6-month follow-up | 67.87 percentage of kept/scheduled appointment | Standard Deviation 28.57 |
| 1 Brief Intervention | HIV Clinic Appointment Adherence (Kept/Scheduled Appointments) | 12-month follow-up | 63.33 percentage of kept/scheduled appointment | Standard Deviation 23.82 |
| 2 Standard Care Arm | HIV Clinic Appointment Adherence (Kept/Scheduled Appointments) | 12-month follow-up | 56.63 percentage of kept/scheduled appointment | Standard Deviation 27.91 |
| 2 Standard Care Arm | HIV Clinic Appointment Adherence (Kept/Scheduled Appointments) | Baseline | 58.59 percentage of kept/scheduled appointment | Standard Deviation 23.66 |
| 2 Standard Care Arm | HIV Clinic Appointment Adherence (Kept/Scheduled Appointments) | 6-month follow-up | 62.22 percentage of kept/scheduled appointment | Standard Deviation 33.98 |
| 2 Standard Care Arm | HIV Clinic Appointment Adherence (Kept/Scheduled Appointments) | 3-month follow-up | 60.57 percentage of kept/scheduled appointment | Standard Deviation 33.69 |
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
Time frame: Baseline to 12 month follow-up
Population: Not all subjects participated in every follow-up interview.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 Brief Intervention | Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex | Baseline | 2.68 days | Standard Deviation 8.61 |
| 1 Brief Intervention | Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex | 3-month follow-up | 2.56 days | Standard Deviation 12.15 |
| 1 Brief Intervention | Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex | 6-month follow-up | 2.31 days | Standard Deviation 7.83 |
| 1 Brief Intervention | Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex | 12-month follow-up | 1.59 days | Standard Deviation 5.11 |
| 2 Standard Care Arm | Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex | 12-month follow-up | 4.74 days | Standard Deviation 13.78 |
| 2 Standard Care Arm | Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex | Baseline | 3.31 days | Standard Deviation 9.21 |
| 2 Standard Care Arm | Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex | 6-month follow-up | 1.35 days | Standard Deviation 4.54 |
| 2 Standard Care Arm | Number of Days in Past 90 Days on Which Participants Reported Having Unprotected Vaginal Sex | 3-month follow-up | 3.06 days | Standard Deviation 10.31 |
Secondary
% of Patients Currently on Antiretroviral Therapy
number of participants who are currently receiving antiretroviral therapy/total number of participants
Time frame: baseline through 1 year follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 Brief Intervention | % of Patients Currently on Antiretroviral Therapy | Baseline | 72.97 percentage of participants |
| 1 Brief Intervention | % of Patients Currently on Antiretroviral Therapy | 3-month follow-up | 78.18 percentage of participants |
| 1 Brief Intervention | % of Patients Currently on Antiretroviral Therapy | 6-month follow-up | 75.81 percentage of participants |
| 1 Brief Intervention | % of Patients Currently on Antiretroviral Therapy | 12-month follow-up | 84.38 percentage of participants |
| 2 Standard Care Arm | % of Patients Currently on Antiretroviral Therapy | 12-month follow-up | 76.56 percentage of participants |
| 2 Standard Care Arm | % of Patients Currently on Antiretroviral Therapy | Baseline | 67.57 percentage of participants |
| 2 Standard Care Arm | % of Patients Currently on Antiretroviral Therapy | 6-month follow-up | 70.97 percentage of participants |
| 2 Standard Care Arm | % of Patients Currently on Antiretroviral Therapy | 3-month follow-up | 68.42 percentage of participants |