Women SHARE Study: Reducing Sexual Risk

Study Overview
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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.

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

Conditions
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Alcohol and Substance-Related Mental Disorders, Sexually Transmitted Diseases

Intervention / Treatment
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* Behavioral: Brief Intervention (BI) with Technology Extender
* Other: Brochure


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |