Women SHARE Study: Reducing Sexual Risk

Not Applicable

Completed

• Conditions: Sexually Transmitted Diseases; Alcohol and Substance-Related Mental Disorders

• 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.

Study Timeline

• Study Start: 2017-10-18
• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-26
• Primary Completion: 2019-06-30
• Study Completion: 2019-11-01
• Results First Submitted: 2019-11-08
• Results First Submitted QC: 2019-12-27
• Status Verified: 2020-01
• Results First Posted: 2020-01-02
• Last Update Submitted: 2020-01-02
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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