Women SHARE Study: Reducing Sexual Risk

Sexually Transmitted Diseases Clinical Trial

— HIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03323086
• Other study ID #: 775844-4
• Secondary ID: R34AA023158
• Status: Completed
• Phase: N/A
• Start date: October 18, 2017
• Est. completion date: November 1, 2019

Study information

• Verified date: January 2020
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 1, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol and Substance-Related Mental Disorders
• Mental Disorders
• Sexually Transmitted Diseases

Intervention

Behavioral:
• Brief Intervention (BI) with Technology Extender
One, 45-60 minute BI, followed by three months of access to technology extenders

Other:
• Brochure
Brochures provided one time

Locations

Country	Name	City	State
United States	Planned Parenthood of Southern New England	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
The Miriam Hospital	National Institute on Alcohol Abuse and Alcoholism (NIAAA), Planned Parenthood of Southern New England

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Providing Intervention	percentage of individuals who attended their intervention	Immediately following intervention session (post-intervention), up to 30 minutes
Secondary	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
Secondary	Number of Sexual Partners	The number of male partners that the participant reported having penetrative sex with.	3-month Follow-up
Secondary	Condomless Sex	The number of occasions of condomless sex	3-month Follow-up
Secondary	Alcohol Use Quantity	The average number of drinks in a week	3-month Follow-up
Secondary	Alcohol Use Binge Frequency	The number of drinking occasions (single day) when 4 or more drinks are consumed	3-month Follow-up