Women SHARE Study: Reducing Sexual Risk
- Conditions
- Sexually Transmitted DiseasesAlcohol and Substance-Related Mental Disorders
- Interventions
- Behavioral: Brief Intervention (BI) with Technology ExtenderOther: Brochure
- Registration Number
- NCT03323086
- Lead Sponsor
- The Miriam Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
- Female
- 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
- Male
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brief Intervention (BI) with Technology Extender 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. Brochure Brochure Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.
- Primary Outcome Measures
Name Time Method Feasibility of Providing Intervention Immediately following intervention session (post-intervention), up to 30 minutes percentage of individuals who attended their intervention
- Secondary Outcome Measures
Name Time Method Session Evaluation Questionnaire Immediately following intervention session (post-intervention), up to 30 minutes Measure Name: Session Evaluation Questionnaire; Construct Assessed: Treatment Satisfaction; Minimum total scale score = 1; Maximum total scale score = 5; Scoring: averaged ratings across 4 items; Interpretation: Higher scores represent a better outcome.
Number of Sexual Partners 3-month Follow-up The number of male partners that the participant reported having penetrative sex with.
Condomless Sex 3-month Follow-up The number of occasions of condomless sex
Alcohol Use Quantity 3-month Follow-up The average number of drinks in a week
Alcohol Use Binge Frequency 3-month Follow-up The number of drinking occasions (single day) when 4 or more drinks are consumed
Trial Locations
- Locations (1)
Planned Parenthood of Southern New England
🇺🇸Providence, Rhode Island, United States