Reducing Alcohol-related HIV/STI Risk for Women in Reproductive Health Clinics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Miriam Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Feasibility of Providing Intervention
Study Overview
Brief Summary
This study will investigate whether BI and technology extenders are feasible and acceptable for female patients at a reproductive health center (ages 18-29).
Detailed Description
This study will assess the feasibility and acceptability, and obtain initial evidence of the efficacy, of the BI and technology extenders. At-risk women drinkers (N = 50) recruited from a reproductive health care clinic will be assessed, randomly assigned to the integrated BI or control (a Centers for Disease Control and Prevention-produced brochure with information about alcohol and women's health), and reassessed at 3 months to determine impact on alcohol use, condom use, and number of partners as well as hypothesized mediators.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 29 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 18-29 years
- •Meeting NIAAA definition of "at-risk" drinking (>3 drinks on any day in the last 3 months18 and/or >7 drinks per week)
- •Sexual risk behavior (i.e., last 3 months: vaginal/anal intercourse with >1 partner; vaginal/anal intercourse with a partner who has other partners; inconsistent condom use; new relationship (under 3 months))
- •English speaking
- •Absence of acute intoxication, depression, or suicidal ideation
- •No plans for relocation
Exclusion Criteria
- •Under 18 years old or older than 29 years old
- •Non-English speaking
- •Suicidal Ideation
- •Relocating
- •Clinic provider advising against recruitment in the study
- •Unwilling or unable to provide consent
Arms & Interventions
Brief Intervention (BI) with Technology Extender
Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics.
Intervention: Brief Intervention (BI) with Technology Extender (Behavioral)
Brochure
Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.
Intervention: Brochure (Other)
Outcomes
Primary Outcomes
Feasibility of Providing Intervention
Time Frame: Immediately following intervention session (post-intervention), up to 30 minutes
percentage of individuals who attended their intervention
Secondary Outcomes
- Session Evaluation Questionnaire(Immediately following intervention session (post-intervention), up to 30 minutes)
- Number of Sexual Partners(3-month Follow-up)
- Condomless Sex(3-month Follow-up)
- Alcohol Use Quantity(3-month Follow-up)
- Alcohol Use Binge Frequency(3-month Follow-up)
Investigators
Michael P. Carey
Professor and Director, Centers for Behavioral and Preventive Medicine, The Miriam Hospital
The Miriam Hospital