Computerized Brief Alcohol Intervention (BI) for Binge Drinking HIV At-Risk and Infected Women
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Purpose
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) 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hazardous Alcohol Use Binge Drinking High Risk Sexual Behaviors HIV Risk Reduction HIV Infection |
Behavioral: Computerized brief alcohol intervention with IVR booster calls Behavioral: Computer delivered brief alcohol intervention Behavioral: Attention Control |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Computerized BI for Binge Drinking HIV At-Risk and Infected African-American Women |
- Reduction in alcohol use [ Time Frame: 0, 3, 6, and 12 months ] [ Designated as safety issue: No ]change alcohol-related risk behaviors (number of binge drinking episodes, drinking days/week, and drinks per occasion)
- sexual risk behaviors [ Time Frame: 0, 3, 6, 12 months ] [ Designated as safety issue: No ]sexual risk behaviors (number of partners, episodes of unprotected vaginal/anal sex, episodes of sex while high), and occurrence of HIV/STI biomarkers
| Estimated Enrollment: | 450 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Computerized Brief alcohol intervention + IVR phone calls
Computer-delivered brief alcohol intervention with booster phone calls delivered by interactive voice response technology + text messages
|
Behavioral: Computerized brief alcohol intervention with IVR booster calls
1) Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages
|
|
Active Comparator: Computerized Brief Alcohol Intervention
Computerized Brief Alcohol Intervention without IVR booster calls
|
Behavioral: Computer delivered brief alcohol intervention
Clinic based computer delivered brief alcohol intervention delivered one time
|
|
Placebo Comparator: Attention Control
Attention control
|
Behavioral: Attention Control
20 minute attention control condition focused on dental hygiene delivered once
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Mary Yep, BA | 410-935-7698 | myep1@jhmi.edu |
| United States, Maryland | |
| Baltimore City Health Department STD Clinic | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Contact: Luke Johnson, DO 410-396-4398 | |
| Sub-Investigator: Emily Erbelding, MD | |
| Principal Investigator: | Geetanjali Chander, MD | Johns Hopkins University |
More Information
No publications provided
| Responsible Party: | Geetanjali Chander, MD MPH, Associate Professor of Medicine, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01125371 History of Changes |
| Other Study ID Numbers: | NIAAAGC018632, R01AA018632 |
| Study First Received: | May 17, 2010 |
| Last Updated: | February 20, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
Hazardous alcohol use Binge drinking High risk sexual behaviors HIV risk reduction |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Alcohol Drinking Binge-Eating Disorder Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Drinking Behavior Eating Disorders Mental Disorders Ethanol Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on March 14, 2013
