Women SHARE Study: Reducing Sexual Risk

NCT ID: NCT03323086

Last Updated: 2020-01-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-18

Study Completion Date

2019-11-01

Brief Summary

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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

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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.

Conditions

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Alcohol and Substance-Related Mental Disorders Sexually Transmitted Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Brief Intervention (BI) with Technology Extender

Intervention Type BEHAVIORAL

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

Brochure

Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.

Group Type OTHER

Brochure

Intervention Type OTHER

Brochures provided one time

Interventions

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Brief Intervention (BI) with Technology Extender

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

Intervention Type BEHAVIORAL

Brochure

Brochures provided one time

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Planned Parenthood of Southern New England

OTHER

Sponsor Role collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michael P. Carey

Professor and Director, Centers for Behavioral and Preventive Medicine, The Miriam Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael P Carey, PhD

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Locations

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Planned Parenthood of Southern New England

Providence, Rhode Island, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R34AA023158

Identifier Type: NIH

Identifier Source: secondary_id

View Link

775844-4

Identifier Type: -

Identifier Source: org_study_id

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