Alcohol; Harmful Use, Binge Drinking, HIV Infection, Risk Behavior
Conditions
Keywords
Hazardous alcohol use, Binge drinking, High risk sexual behaviors, HIV risk reduction
Brief summary
African American (AA) women are disproportionately affected by HIV/AIDs. The major risk factor for HIV acquisition among AA women is high-risk heterosexual sex, including unprotected vaginal and anal sex, and sex with a high-risk partner. Hazardous alcohol use has been associated with high risk sexual behaviors and prevalent gonorrhea among women attending an urban STI clinic, both of which increase a woman's vulnerability to HIV acquisition and transmission. This application proposes a randomized controlled trial (RCT) of a culturally tailored computer-directed brief alcohol intervention (CBI) enhanced with cell-phone booster calls using interactive voice response technology (IVR) and text messages among HIV-infected and at-risk AA women attending an urban STI Clinic. Hazardous drinking AA women (N=450) presenting with STI complaints will be randomized to one of three arms: 1) usual clinical care, 2) clinic-based, CBI, or 3) clinic-based, CBI + 3 booster calls using IVR and text messages. The CBI, an evidence-based based method for behavior change, will use principles of motivational interviewing, to counsel on: 1) alcohol use and 2) associated HIV/STI risk behaviors. Primary outcomes, measured at 3, 6, and 12 month intervals, include alcohol-related risk behaviors (number of binge drinking episodes, drinking days/week, and drinks per occasion), sexual risk behaviors (number of partners, episodes of unprotected vaginal/anal sex, episodes of sex while high), and occurrence of HIV/STI biomarkers. Prior to implementing the RCT, the CBI and IVR software messages will be revised to: 1) include the association between hazardous alcohol use and risky sexual behaviors, and 2) ensure their relevance and acceptability using quantitative/qualitative feedback from a sample of AA women attending a Baltimore City STI clinic. The proposed research focuses on a particularly vulnerable population of urban HIV at-risk and HIV-infected AA women seeking treatment in a public STI clinic and examines two novel BI intervention delivery strategies specifically tailored to be culturally/socially relevant to this minority population. If the intervention(s) prove to be effective, study findings will offer real life specialty care clinics a screening and intervention package that is practical, low cost, and easy to implement.
Interventions
BEHAVIORALComputerized brief alcohol intervention + IVR booster calls
1\) Computerized brief alcohol intervention + IVR booster calls: Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages
BEHAVIORALComputerized brief alcohol intervention
Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time
BEHAVIORALAttention Control
Attention Control: 20 minute attention control condition focused on dental hygiene delivered once
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18 years of age or older; 2. HIV infected or HIV negative and attending the Baltimore City Health Department sexually transmitted infection clinic for STI-related services 3. Consumes an average of 8 or more drinks per week OR has had two binge drinking episodes (4 drinks/occasion) in the last 3 months 4. sexually active 5. Cognitively able to understand proposed research design (10 min screening, followed by random assignment to one of three study groups (if individual fulfills criteria for RCT enrollment); 6. Able to speak and understand English 7. Able and willing to receive text messages
Exclusion criteria
1. Pregnant women will be excluded and referred directly to social work for referral to either alcohol or drug treatment due to ethical concerns of randomization to usual care. 2. Currently enrolled in alcohol or drug treatment. 3. Non-English Speaking. 4. Actively Psychotic or have other severe mental health symptoms that would prevent appropriate participation in the brief intervention protocol. 5. Planning on moving out of the area within 12 months of study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alcohol Use (Heavy Drinking Days) | Baseline, 3, 6, and 12 months | Change in alcohol-related risk behavior as assessed by the number of heavy drinking days. |
| Change in Alcohol Use (Drinking Days) | Baseline, 3, 6, and 12 months | Change in alcohol-related risk behavior as assessed by the number of drinking days. |
| Change in Alcohol Use (Drinks Per Drinking Day) | Baseline, 3, 6, and 12 months | Change in alcohol-related risk behavior as assessed by the standard drinks per drinking day. |
| Change in Alcohol Use (Drinks Per Week) | Baseline, 3, 6, and 12 months | Change in alcohol-related risk behavior as assessed by the standard drinks per week. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Computerized Brief Alcohol Intervention + IVR Computer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM)
Computerized brief alcohol intervention + IVR booster calls: 1) Computerized brief alcohol intervention + IVR booster calls: Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages | 146 |
| Computerized Brief Alcohol Intervention Computerized Brief Alcohol Intervention only (CBI)
Computerized brief alcohol intervention: Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time | 145 |
| Attention Control Attention control
Attention Control: Attention Control: 20 minute attention control condition focused on dental hygiene delivered once | 148 |
| Total | 439 |
Baseline characteristics
| Characteristic | Attention Control | Computerized Brief Alcohol Intervention | Computerized Brief Alcohol Intervention + IVR | Total |
|---|---|---|---|---|
| Age, Continuous | 31 years | 31 years | 32 years | 31 years |
| Audit Score ≥13 | 58 Participants | 63 Participants | 72 Participants | 193 Participants |
| Audit Score <7 | 43 Participants | 35 Participants | 40 Participants | 118 Participants |
| Audit Score 7-12 | 47 Participants | 47 Participants | 34 Participants | 128 Participants |
| Cocaine Use | 20 Participants | 21 Participants | 21 Participants | 62 Participants |
| Generalized Anxiety Symptoms Mild | 43 Participants | 45 Participants | 39 Participants | 127 Participants |
| Generalized Anxiety Symptoms Missing | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Generalized Anxiety Symptoms Moderate | 20 Participants | 20 Participants | 15 Participants | 55 Participants |
| Generalized Anxiety Symptoms None | 72 Participants | 63 Participants | 81 Participants | 216 Participants |
| Generalized Anxiety Symptoms Severe | 13 Participants | 17 Participants | 10 Participants | 40 Participants |
| Heroin Use | 7 Participants | 9 Participants | 16 Participants | 32 Participants |
| HIV Positive Status No | 140 Participants | 129 Participants | 132 Participants | 401 Participants |
| HIV Positive Status Unsure | 4 Participants | 6 Participants | 6 Participants | 16 Participants |
| HIV Positive Status Yes | 4 Participants | 10 Participants | 8 Participants | 22 Participants |
| Illicit Drug Use | 97 Participants | 93 Participants | 95 Participants | 285 Participants |
| Income $0 - 5,000 | 75 Participants | 63 Participants | 77 Participants | 215 Participants |
| Income $10,001 - 15,000 | 22 Participants | 24 Participants | 18 Participants | 64 Participants |
| Income $15,001 or more | 26 Participants | 23 Participants | 28 Participants | 77 Participants |
| Income $5,001 - 10,000 | 25 Participants | 35 Participants | 23 Participants | 83 Participants |
| Injection Drug Use | 1 Participants | 2 Participants | 3 Participants | 6 Participants |
| Level of Education GED or Higher | 98 Participants | 104 Participants | 104 Participants | 306 Participants |
| Level of Education < Grade 12 | 50 Participants | 41 Participants | 42 Participants | 133 Participants |
| Marijuana Use | 71 Participants | 72 Participants | 78 Participants | 221 Participants |
| MINI Assessment Abuse | 26 Participants | 32 Participants | 23 Participants | 81 Participants |
| MINI Assessment Dependence | 77 Participants | 71 Participants | 69 Participants | 217 Participants |
| MINI Assessment Neither | 45 Participants | 42 Participants | 54 Participants | 141 Participants |
| Non-medical Use of Prescription | 12 Participants | 16 Participants | 9 Participants | 37 Participants |
| PHQ Depressive Symptoms | 7.5 score on a scale | 7 score on a scale | 6 score on a scale | 7 score on a scale |
| PHQ Panic Symptoms | 43 Participants | 52 Participants | 35 Participants | 130 Participants |
| Post-Traumatic Stress Disorder (PTSD) | 54 Participants | 51 Participants | 46 Participants | 151 Participants |
| Race/Ethnicity, Customized African American | 132 Participants | 125 Participants | 131 Participants | 388 Participants |
| Race/Ethnicity, Customized Other | 16 Participants | 20 Participants | 15 Participants | 51 Participants |
| Sex: Female, Male Female | 148 Participants | 145 Participants | 146 Participants | 439 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 146 | 0 / 145 | 1 / 148 |
| other Total, other adverse events | 0 / 146 | 0 / 145 | 0 / 148 |
| serious Total, serious adverse events | 0 / 146 | 0 / 145 | 0 / 148 |
Outcome results
Primary
Change in Alcohol Use (Drinking Days)
Change in alcohol-related risk behavior as assessed by the number of drinking days.
Time frame: Baseline, 3, 6, and 12 months
Population: Some participants in each of the arms did not complete assessments at 3, 6 and 12 months.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Computerized Brief Alcohol Intervention + IVR | Change in Alcohol Use (Drinking Days) | Baseline | 9 drinking days |
| Computerized Brief Alcohol Intervention + IVR | Change in Alcohol Use (Drinking Days) | 3 months | 6.4 drinking days |
| Computerized Brief Alcohol Intervention + IVR | Change in Alcohol Use (Drinking Days) | 6 months | 6 drinking days |
| Computerized Brief Alcohol Intervention + IVR | Change in Alcohol Use (Drinking Days) | 12 months | 6 drinking days |
| Computerized Brief Alcohol Intervention | Change in Alcohol Use (Drinking Days) | 12 months | 6 drinking days |
| Computerized Brief Alcohol Intervention | Change in Alcohol Use (Drinking Days) | Baseline | 9 drinking days |
| Computerized Brief Alcohol Intervention | Change in Alcohol Use (Drinking Days) | 6 months | 7 drinking days |
| Computerized Brief Alcohol Intervention | Change in Alcohol Use (Drinking Days) | 3 months | 7 drinking days |
| Attention Control | Change in Alcohol Use (Drinking Days) | 12 months | 6 drinking days |
| Attention Control | Change in Alcohol Use (Drinking Days) | 3 months | 6 drinking days |
| Attention Control | Change in Alcohol Use (Drinking Days) | 6 months | 5 drinking days |
| Attention Control | Change in Alcohol Use (Drinking Days) | Baseline | 8.5 drinking days |
Primary
Change in Alcohol Use (Drinks Per Drinking Day)
Change in alcohol-related risk behavior as assessed by the standard drinks per drinking day.
Time frame: Baseline, 3, 6, and 12 months
Population: Some participants in each of the arms did not complete assessments at 3, 6 and 12 months.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Computerized Brief Alcohol Intervention + IVR | Change in Alcohol Use (Drinks Per Drinking Day) | Baseline | 5.6 drinks per drinking day |
| Computerized Brief Alcohol Intervention + IVR | Change in Alcohol Use (Drinks Per Drinking Day) | 3 months | 3.7 drinks per drinking day |
| Computerized Brief Alcohol Intervention + IVR | Change in Alcohol Use (Drinks Per Drinking Day) | 6 months | 3.8 drinks per drinking day |
| Computerized Brief Alcohol Intervention + IVR | Change in Alcohol Use (Drinks Per Drinking Day) | 12 months | 3.0 drinks per drinking day |
| Computerized Brief Alcohol Intervention | Change in Alcohol Use (Drinks Per Drinking Day) | 12 months | 3.4 drinks per drinking day |
| Computerized Brief Alcohol Intervention | Change in Alcohol Use (Drinks Per Drinking Day) | Baseline | 5.6 drinks per drinking day |
| Computerized Brief Alcohol Intervention | Change in Alcohol Use (Drinks Per Drinking Day) | 6 months | 4.4 drinks per drinking day |
| Computerized Brief Alcohol Intervention | Change in Alcohol Use (Drinks Per Drinking Day) | 3 months | 4.2 drinks per drinking day |
| Attention Control | Change in Alcohol Use (Drinks Per Drinking Day) | 12 months | 3.8 drinks per drinking day |
| Attention Control | Change in Alcohol Use (Drinks Per Drinking Day) | 3 months | 4.1 drinks per drinking day |
| Attention Control | Change in Alcohol Use (Drinks Per Drinking Day) | 6 months | 3.8 drinks per drinking day |
| Attention Control | Change in Alcohol Use (Drinks Per Drinking Day) | Baseline | 6.1 drinks per drinking day |
Primary
Change in Alcohol Use (Drinks Per Week)
Change in alcohol-related risk behavior as assessed by the standard drinks per week.
Time frame: Baseline, 3, 6, and 12 months
Population: Some participants in each of the arms did not complete assessments at 3, 6 and 12 months.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Computerized Brief Alcohol Intervention + IVR | Change in Alcohol Use (Drinks Per Week) | Baseline | 12.0 drinks per week |
| Computerized Brief Alcohol Intervention + IVR | Change in Alcohol Use (Drinks Per Week) | 3 months | 6.5 drinks per week |
| Computerized Brief Alcohol Intervention + IVR | Change in Alcohol Use (Drinks Per Week) | 6 months | 5.6 drinks per week |
| Computerized Brief Alcohol Intervention + IVR | Change in Alcohol Use (Drinks Per Week) | 12 months | 4.3 drinks per week |
| Computerized Brief Alcohol Intervention | Change in Alcohol Use (Drinks Per Week) | 12 months | 5.3 drinks per week |
| Computerized Brief Alcohol Intervention | Change in Alcohol Use (Drinks Per Week) | Baseline | 12.4 drinks per week |
| Computerized Brief Alcohol Intervention | Change in Alcohol Use (Drinks Per Week) | 6 months | 6.8 drinks per week |
| Computerized Brief Alcohol Intervention | Change in Alcohol Use (Drinks Per Week) | 3 months | 7.0 drinks per week |
| Attention Control | Change in Alcohol Use (Drinks Per Week) | 12 months | 5.4 drinks per week |
| Attention Control | Change in Alcohol Use (Drinks Per Week) | 3 months | 6.4 drinks per week |
| Attention Control | Change in Alcohol Use (Drinks Per Week) | 6 months | 4.4 drinks per week |
| Attention Control | Change in Alcohol Use (Drinks Per Week) | Baseline | 12.0 drinks per week |
Primary
Change in Alcohol Use (Heavy Drinking Days)
Change in alcohol-related risk behavior as assessed by the number of heavy drinking days.
Time frame: Baseline, 3, 6, and 12 months
Population: Some participants in each of the arms did not complete assessments at 3, 6 and 12 months.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Computerized Brief Alcohol Intervention + IVR | Change in Alcohol Use (Heavy Drinking Days) | Baseline | 6 heavy drinking days |
| Computerized Brief Alcohol Intervention + IVR | Change in Alcohol Use (Heavy Drinking Days) | 3 months | 3 heavy drinking days |
| Computerized Brief Alcohol Intervention + IVR | Change in Alcohol Use (Heavy Drinking Days) | 6 months | 3 heavy drinking days |
| Computerized Brief Alcohol Intervention + IVR | Change in Alcohol Use (Heavy Drinking Days) | 12 months | 2 heavy drinking days |
| Computerized Brief Alcohol Intervention | Change in Alcohol Use (Heavy Drinking Days) | 12 months | 2 heavy drinking days |
| Computerized Brief Alcohol Intervention | Change in Alcohol Use (Heavy Drinking Days) | Baseline | 6 heavy drinking days |
| Computerized Brief Alcohol Intervention | Change in Alcohol Use (Heavy Drinking Days) | 6 months | 4 heavy drinking days |
| Computerized Brief Alcohol Intervention | Change in Alcohol Use (Heavy Drinking Days) | 3 months | 3 heavy drinking days |
| Attention Control | Change in Alcohol Use (Heavy Drinking Days) | 12 months | 3 heavy drinking days |
| Attention Control | Change in Alcohol Use (Heavy Drinking Days) | 3 months | 3 heavy drinking days |
| Attention Control | Change in Alcohol Use (Heavy Drinking Days) | 6 months | 2 heavy drinking days |
| Attention Control | Change in Alcohol Use (Heavy Drinking Days) | Baseline | 6 heavy drinking days |