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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03323086
Other study ID # 775844-4
Secondary ID R34AA023158
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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