Baltimore City Health Department STD Clinic
Baltimore, Maryland, 21205, United States
NCT Number: NCT01125371
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.
Looking for future studies?
Notify Me18 year–90 year
Female
Interventional
Not applicable
Baltimore, Maryland, 21205, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: CBI+IVR+TM
Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time
Other names: CBI
Attention Control: 20 minute attention control condition focused on dental hygiene delivered once
Time frame: Baseline, 3, 6, and 12 months
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-related risk behavior as assessed by the number of drinking days.
Time frame: Baseline, 3, 6, and 12 months
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-related risk behavior as assessed by the standard drinks per week.
Johns Hopkins University
Other
Computerized BI for Binge Drinking HIV At-Risk and Infected African-American Women
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03449095
Alcohol Drinking, Alcohol Intoxication
Champaign, Illinois, United States
View Trial DetailsNCT06687525
Alcohol Drinking, Alcohol Intoxication
Champaign, Illinois, United States
View Trial DetailsNCT07125534
Alcohol Drinking, Alcohol Intoxication
Champaign, Illinois, United States
View Trial DetailsNCT03467191
Alcohol Drinking, Alcohol Intoxication
Pittsburgh, Pennsylvania, United States
View Trial Details