An interventional study of Computerized brief alcohol intervention + IVR booster calls and Computerized brief alcohol intervention in Alcohol; Harmful Use, Binge Drinking and Risk Behavior, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to female participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-24.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.
This study's enrollment of 439 is above the median of 120 across 64 interventional studies indexed under Binge Drinking.
Browse Binge Drinking studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Computer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM)
Behavioral: Computerized brief alcohol intervention + IVR booster calls
Computerized Brief Alcohol Intervention only (CBI)
Behavioral: Computerized brief alcohol intervention
Attention control
Behavioral: Attention Control
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
Also known as: CBI+IVR+TM
Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time
Also known as: CBI
Attention Control: 20 minute attention control condition focused on dental hygiene delivered once
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
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
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
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
| Milestone | Computerized Brief Alcohol Intervention + IVR | Computerized Brief Alcohol Intervention | Attention Control |
|---|---|---|---|
| Started | 146 | 145 | 148 |
| 3 months follow up | 127 | 131 | 135 |
| 6 months follow up | 125 | 133 | 131 |
| 12 months follow up | 120 | 130 | 129 |
| Completed | 120 | 130 | 129 |
| Not completed | 26 | 15 | 19 |
Change in alcohol-related risk behavior as assessed by the number of heavy drinking days.
| heavy drinking days | Computerized Brief Alcohol Intervention + IVR | Computerized Brief Alcohol Intervention | Attention Control |
|---|---|---|---|
| Baseline | 6 (2 to 13) | 6 (3 to 11) | 6 (2 to 11) |
| 3 months | 3 (1 to 7) | 3 (1 to 8) | 3 (0 to 8) |
| 6 months | 3 (0 to 7) | 4 (1 to 8) | 2 (0 to 8) |
| 12 months | 2 (0 to 6) | 2 (0 to 6) | 3 (1 to 6) |
Change in alcohol-related risk behavior as assessed by the number of drinking days.
| drinking days | Computerized Brief Alcohol Intervention + IVR | Computerized Brief Alcohol Intervention | Attention Control |
|---|---|---|---|
| Baseline | 9 (5 to 15) | 9 (6 to 14) | 8.5 (5.8 to 15) |
| 3 months | 6.4 (3 to 10) | 7 (4 to 12) | 6 (2.1 to 11) |
| 6 months | 6 (2 to 11) | 7 (2 to 12) | 5 (2 to 11) |
| 12 months | 6 (2 to 11) | 6 (2 to 11) | 6 (2 to 10) |
Change in alcohol-related risk behavior as assessed by the standard drinks per drinking day.
| drinks per drinking day | Computerized Brief Alcohol Intervention + IVR | Computerized Brief Alcohol Intervention | Attention Control |
|---|---|---|---|
| Baseline | 5.6 (3.2 to 8.8) | 5.6 (3.3 to 9.3) | 6.1 (3.7 to 7.8) |
| 3 months | 3.7 (2.2 to 6.2) | 4.2 (2.3 to 6.4) | 4.1 (2.0 to 6.5) |
| 6 months | 3.8 (1.4 to 6.4) | 4.4 (2.1 to 6.8) | 3.8 (1.7 to 6.2) |
| 12 months | 3.0 (1.5 to 5.7) | 3.4 (1.4 to 5.6) | 3.8 (1.4 to 6.5) |
Change in alcohol-related risk behavior as assessed by the standard drinks per week.
| drinks per week | Computerized Brief Alcohol Intervention + IVR | Computerized Brief Alcohol Intervention | Attention Control |
|---|---|---|---|
| Baseline | 12.0 (4.7 to 28.7) | 12.4 (5.8 to 25.5) | 12.0 (5.3 to 25.3) |
| 3 months | 6.5 (2.1 to 13.6) | 7.0 (2.9 to 15.4) | 6.4 (1.6 to 16.1) |
| 6 months | 5.6 (1.1 to 13.1) | 6.8 (1.4 to 15.7) | 4.4 (0.9 to 15.7) |
| 12 months | 4.3 (1.0 to 11.5) | 5.3 (1.0 to 12.4) | 5.4 (1.4 to 11.2) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Computerized Brief Alcohol Intervention + IVR | 1/146 (0.7%) | 0/146 (0%) | 0/146 (0%) |
| Computerized Brief Alcohol Intervention | 0/145 (0%) | 0/145 (0%) | 0/145 (0%) |
| Attention Control | 1/148 (0.7%) | 0/148 (0%) | 0/148 (0%) |
| Age, Continuous(years) | Computerized Brief Alcohol Intervention + IVR | Computerized Brief Alcohol Intervention | Attention Control | Total |
|---|---|---|---|---|
| Median | 32 (25 to 43) | 31 (25 to 45) | 31 (24 to 45) | 31 (25 to 44) |
| Sex: Female, Male(Participants) | Computerized Brief Alcohol Intervention + IVR | Computerized Brief Alcohol Intervention | Attention Control | Total |
|---|---|---|---|---|
| Female | 146 | 145 | 148 | 439 |
| Male | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Computerized Brief Alcohol Intervention + IVR | Computerized Brief Alcohol Intervention | Attention Control | Total |
|---|---|---|---|---|
| African American | 131 | 125 | 132 | 388 |
| Other | 15 | 20 | 16 | 51 |
| Level of Education(Participants) | Computerized Brief Alcohol Intervention + IVR | Computerized Brief Alcohol Intervention | Attention Control | Total |
|---|---|---|---|---|
| < Grade 12 | 42 | 41 | 50 | 133 |
| GED or Higher | 104 | 104 | 98 | 306 |
| Income(Participants) | Computerized Brief Alcohol Intervention + IVR | Computerized Brief Alcohol Intervention | Attention Control | Total |
|---|---|---|---|---|
| $0 - 5,000 | 77 | 63 | 75 | 215 |
| $5,001 - 10,000 | 23 | 35 | 25 | 83 |
| $10,001 - 15,000 | 18 | 24 | 22 | 64 |
| $15,001 or more | 28 | 23 | 26 | 77 |
| HIV Positive Status(Participants) | Computerized Brief Alcohol Intervention + IVR | Computerized Brief Alcohol Intervention | Attention Control | Total |
|---|---|---|---|---|
| No | 132 | 129 | 140 | 401 |
| Yes | 8 | 10 | 4 | 22 |
| Unsure | 6 | 6 | 4 | 16 |
| Illicit Drug Use(Participants) | Computerized Brief Alcohol Intervention + IVR | Computerized Brief Alcohol Intervention | Attention Control | Total |
|---|---|---|---|---|
| Count of participants | 95 | 93 | 97 | 285 |
| Marijuana Use(Participants) | Computerized Brief Alcohol Intervention + IVR | Computerized Brief Alcohol Intervention | Attention Control | Total |
|---|---|---|---|---|
| Count of participants | 78 | 72 | 71 | 221 |
10 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of Oct 2011, a primary completion of Jun 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2022, 6 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.