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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA018632 | 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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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computerized Brief Alcohol Intervention + IVR | Experimental | Computer-delivered brief alcohol intervention (CBI) with booster phone calls delivered by IVR+ text messages (TM) |
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| Computerized Brief Alcohol Intervention | Active Comparator | Computerized Brief Alcohol Intervention only (CBI) |
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| Attention Control | Placebo Comparator | Attention control |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized brief alcohol intervention + IVR booster calls | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alcohol Use (Heavy Drinking Days) | Change in alcohol-related risk behavior as assessed by the number of heavy drinking days. | 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. | 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. | 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. | Baseline, 3, 6, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geetanjali Chander, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore City Health Department STD Clinic | Baltimore | Maryland | 21205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jul 8, 2015 |
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| Computerized brief alcohol intervention | Behavioral | Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time |
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| Attention Control | Behavioral | Attention Control: 20 minute attention control condition focused on dental hygiene delivered once |
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| FG001 | 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 |
| FG002 | Attention Control | Attention control Attention Control: Attention Control: 20 minute attention control condition focused on dental hygiene delivered once |
| 3 Months Follow up |
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| 6 Months Follow up |
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| 12 Months Follow up |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Attention Control | Attention control Attention Control: Attention Control: 20 minute attention control condition focused on dental hygiene delivered once |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Level of Education | Count of Participants | Participants |
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| Income | Count of Participants | Participants |
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| HIV Positive Status | Count of Participants | Participants |
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| Illicit Drug Use | Count of Participants | Participants |
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| Marijuana Use | Count of Participants | Participants |
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| Cocaine Use | Count of Participants | Participants |
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| Heroin Use | Count of Participants | Participants |
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| Injection Drug Use | Count of Participants | Participants |
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| Non-medical Use of Prescription | Count of Participants | Participants |
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| PHQ Depressive Symptoms | Patient Health Questionnaire (PHQ) assesses for depressive symptoms: The score range is 0-27. Diagnosis Total Score For Score Action Minimal depression 0-4, Mild depression 5-9, Moderate depression 10-14, Moderately severe depression 15-19, Severe depression 20-27. | Median | Inter-Quartile Range | score on a scale |
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| PHQ Panic Symptoms | Participants with Panic Symptoms per the PHQ assessment. | Count of Participants | Participants |
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| Post-Traumatic Stress Disorder (PTSD) | Participants with Post-Traumatic Stress Disorder. | Count of Participants | Participants |
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| Generalized Anxiety Symptoms | Count of Participants | Participants |
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| MINI Assessment | The MINI Assessment is an assessment for alcohol abuse or dependence. It assesses for the Diagnostic and Statistical Manual of Mental Disorders (DSM) Alcohol use Disorder, categorized as "Neither", "Abuse" or "Dependence". | Count of Participants | Participants |
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| Audit Score | The Audit Score is an Alcohol use disorders identification test which assesses alcohol use. Scores range from 0-40. <7 = no hazardous alcohol use 7-12 = Hazardous alcohol use ≥13 = Alcohol use Disorder | Count of Participants | Participants |
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| 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 | Change in Alcohol Use (Heavy Drinking Days) | Change in alcohol-related risk behavior as assessed by the number of heavy drinking days. | Some participants in each of the arms did not complete assessments at 3, 6 and 12 months. | Posted | Median | Inter-Quartile Range | heavy drinking days | Baseline, 3, 6, and 12 months |
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| Primary | Change in Alcohol Use (Drinking Days) | Change in alcohol-related risk behavior as assessed by the number of drinking days. | Some participants in each of the arms did not complete assessments at 3, 6 and 12 months. | Posted | Median | Inter-Quartile Range | drinking days | Baseline, 3, 6, and 12 months |
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| Primary | Change in Alcohol Use (Drinks Per Drinking Day) | Change in alcohol-related risk behavior as assessed by the standard drinks per drinking day. | Some participants in each of the arms did not complete assessments at 3, 6 and 12 months. | Posted | Median | Inter-Quartile Range | drinks per drinking day | Baseline, 3, 6, and 12 months |
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| Primary | Change in Alcohol Use (Drinks Per Week) | Change in alcohol-related risk behavior as assessed by the standard drinks per week. | Some participants in each of the arms did not complete assessments at 3, 6 and 12 months. | Posted | Median | Inter-Quartile Range | drinks per week | Baseline, 3, 6, and 12 months |
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1 year
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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 | 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 | 1 | 146 | 0 | 146 | 0 | 146 |
| EG001 | 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 | 0 | 145 | 0 | 145 | 0 | 145 |
| EG002 | Attention Control | Attention control Attention Control: Attention Control: 20 minute attention control condition focused on dental hygiene delivered once | 1 | 148 | 0 | 148 | 0 | 148 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Geetanjali Chander | Johns Hopkins University | 443-287-2030 | gchande1@jhmi.edu |
| Apr 28, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D063425 | Binge Drinking |
| D012309 | Risk-Taking |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D000428 | Alcohol Drinking |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| 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 |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D008722 | Methods |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008919 | Investigative Techniques |
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| Male |
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| Other |
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| GED or Higher |
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| $5,001 - 10,000 |
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| $10,001 - 15,000 |
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| $15,001 or more |
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| Yes |
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| Unsure |
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| Mild |
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| Moderate |
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| Severe |
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| Missing |
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| Abuse |
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| Dependence |
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| 7-12 |
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| ≥13 |
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| 3 months |
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| 6 months |
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| 12 months |
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