Computerized BI for Binge Drinking HIV At-Risk and Infected African-American Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 439
- 试验地点
- 2
- 主要终点
- Change in Alcohol Use (Heavy Drinking Days)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older;
- •HIV infected or HIV negative and attending the Baltimore City Health Department sexually transmitted infection clinic for STI-related services
- •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
- •sexually active
- •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);
- •Able to speak and understand English
- •Able and willing to receive text messages
排除标准
- •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.
- •Currently enrolled in alcohol or drug treatment.
- •Non-English Speaking.
- •Actively Psychotic or have other severe mental health symptoms that would prevent appropriate participation in the brief intervention protocol.
- •Planning on moving out of the area within 12 months of study entry
结局指标
主要结局
Change in Alcohol Use (Heavy Drinking Days)
时间窗: 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)
时间窗: 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 Week)
时间窗: Baseline, 3, 6, and 12 months
Change in alcohol-related risk behavior as assessed by the standard drinks per week.
Change in Alcohol Use (Drinks Per Drinking Day)
时间窗: Baseline, 3, 6, and 12 months
Change in alcohol-related risk behavior as assessed by the standard drinks per drinking day.
次要结局
未报告次要终点
