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Women SHARE Study: Reducing Sexual Risk (HIV)

Primary Purpose

Alcohol and Substance-Related Mental Disorders, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Intervention (BI) with Technology Extender
Brochure
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol and Substance-Related Mental Disorders

Eligibility Criteria

18 Years - 29 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Planned Parenthood of Southern New England

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Brief Intervention (BI) with Technology Extender

Brochure

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Feasibility of Providing Intervention
percentage of individuals who attended their intervention

Secondary Outcome Measures

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.
Number of Sexual Partners
The number of male partners that the participant reported having penetrative sex with.
Condomless Sex
The number of occasions of condomless sex
Alcohol Use Quantity
The average number of drinks in a week
Alcohol Use Binge Frequency
The number of drinking occasions (single day) when 4 or more drinks are consumed

Full Information

First Posted
October 18, 2017
Last Updated
January 2, 2020
Sponsor
The Miriam Hospital
Collaborators
Planned Parenthood of Southern New England, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03323086
Brief Title
Women SHARE Study: Reducing Sexual Risk
Acronym
HIV
Official Title
Reducing Alcohol-related HIV/STI Risk for Women in Reproductive Health Clinics
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 18, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
Collaborators
Planned Parenthood of Southern New England, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol and Substance-Related Mental Disorders, Sexually Transmitted Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Intervention (BI) with Technology Extender
Arm Type
Experimental
Arm Description
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.
Arm Title
Brochure
Arm Type
Other
Arm Description
Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention (BI) with Technology Extender
Intervention Description
One, 45-60 minute BI, followed by three months of access to technology extenders
Intervention Type
Other
Intervention Name(s)
Brochure
Intervention Description
Brochures provided one time
Primary Outcome Measure Information:
Title
Feasibility of Providing Intervention
Description
percentage of individuals who attended their intervention
Time Frame
Immediately following intervention session (post-intervention), up to 30 minutes
Secondary Outcome Measure Information:
Title
Session Evaluation Questionnaire
Description
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
Title
Number of Sexual Partners
Description
The number of male partners that the participant reported having penetrative sex with.
Time Frame
3-month Follow-up
Title
Condomless Sex
Description
The number of occasions of condomless sex
Time Frame
3-month Follow-up
Title
Alcohol Use Quantity
Description
The average number of drinks in a week
Time Frame
3-month Follow-up
Title
Alcohol Use Binge Frequency
Description
The number of drinking occasions (single day) when 4 or more drinks are consumed
Time Frame
3-month Follow-up

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
sex assigned at birth
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P Carey, PhD
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Planned Parenthood of Southern New England
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Women SHARE Study: Reducing Sexual Risk

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