Women SHARE Study: Reducing Sexual Risk

The Miriam Hospital50 enrolled

Overview

This study will investigate whether BI and technology extenders are feasible and acceptable for female patients at a reproductive health center (ages 18-29).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alcohol and Substance-Related Mental Disorders Sexually Transmitted Diseases

Interventions

Brief Intervention (BI) with Technology ExtenderBEHAVIORAL

One, 45-60 minute BI, followed by three months of access to technology extenders

BrochureOTHER

Brochures provided one time

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 29 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Planned Parenthood of Southern New England

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

Feasibility of Providing Intervention

percentage of individuals who attended their intervention

Time frame: Immediately following intervention session (post-intervention), up to 30 minutes

Secondary Outcomes

Session Evaluation Questionnaire

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.

Time frame: Immediately following intervention session (post-intervention), up to 30 minutes

Number of Sexual Partners

The number of male partners that the participant reported having penetrative sex with.

Time frame: 3-month Follow-up

Condomless Sex

The number of occasions of condomless sex

Time frame: 3-month Follow-up

Alcohol Use Quantity

The average number of drinks in a week

Time frame: 3-month Follow-up

Alcohol Use Binge Frequency

The number of drinking occasions (single day) when 4 or more drinks are consumed

Time frame: 3-month Follow-up

Data from ClinicalTrials.gov

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