Women SHARE Study: Reducing Sexual Risk (HIV)

Reducing Alcohol-related HIV/STI Risk for Women in Reproductive Health Clinics

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

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Diseases; Alcohol and Substance-Related Mental Disorders
• Intervention / Treatment: Behavioral: Brief Intervention (BI) with Technology Extender; Other: Brochure

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Planned Parenthood of Southern New England

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: Brief Intervention (BI) with Technology Extender; One, 45-60 minute BI, followed by three months of access to technology extenders
OTHER: Brochure; Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.	Other: Brochure; Brochures provided one time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Providing Intervention	percentage of individuals who attended their intervention	Immediately following intervention session (post-intervention), up to 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3-month Follow-up
Condomless Sex	The number of occasions of condomless sex	3-month Follow-up
Alcohol Use Quantity	The average number of drinks in a week	3-month Follow-up
Alcohol Use Binge Frequency	The number of drinking occasions (single day) when 4 or more drinks are consumed	3-month Follow-up

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); Planned Parenthood of Southern New England
• Investigators: Principal Investigator: Michael P Carey, PhD, The Miriam Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 18, 2017
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (ACTUAL): October 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Mental Disorders; Sexually Transmitted Diseases
• Other Study ID Numbers: 775844-4; R34AA023158 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No