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Women SHARE Study: Reducing Sexual Risk

Not Applicable
Completed
Conditions
Sexually Transmitted Diseases
Alcohol and Substance-Related Mental Disorders
Interventions
Behavioral: Brief Intervention (BI) with Technology Extender
Other: 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
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
Arm && Interventions
GroupInterventionDescription
Brief Intervention (BI) with Technology ExtenderBrief Intervention (BI) with Technology ExtenderParticipants 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.
BrochureBrochureParticipants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.
Primary Outcome Measures
NameTimeMethod
Feasibility of Providing InterventionImmediately following intervention session (post-intervention), up to 30 minutes

percentage of individuals who attended their intervention

Secondary Outcome Measures
NameTimeMethod
Session Evaluation QuestionnaireImmediately 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 Partners3-month Follow-up

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

Condomless Sex3-month Follow-up

The number of occasions of condomless sex

Alcohol Use Quantity3-month Follow-up

The average number of drinks in a week

Alcohol Use Binge Frequency3-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

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