N/A N=48 Randomized Double-blind Treatment

Women SHARE Study: Reducing Sexual Risk

Alcohol and Substance-Related Mental Disorders · Sexually Transmitted Diseases

Bottom Line

View on ClinicalTrials.gov: NCT03323086 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2020

Primary outcome: Primary: Feasibility of Providing Intervention — 25; 22 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Brief Intervention (BI) with Technology Extender (Behavioral); Brochure (Other)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: The Miriam Hospital
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility of Providing Intervention	25; 22	—
SECONDARY Session Evaluation Questionnaire	4.65; 3.98	—
SECONDARY Number of Sexual Partners	3.23; 4.00	—
SECONDARY Condomless Sex	3; 5	—
SECONDARY Alcohol Use Quantity	3.23; 4.00	—
SECONDARY Alcohol Use Binge Frequency	2.36; 2.00	—

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03323086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.