Women SHARE Study: Reducing Sexual Risk (HIV)

Lifespan

Status: Completed

Conditions: Sexually Transmitted Diseases; Alcohol and Substance-Related Mental Disorders

Treatments: Other: Brochure; Behavioral: Brief Intervention (BI) with Technology Extender

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03323086

775844-4

R34AA023158 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will investigate whether BI and technology extenders are feasible and acceptable for female patients at a reproductive health center (ages 18-29).

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 29 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups

Brief Intervention (BI) with Technology Extender

Experimental group

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.

Treatment:

Behavioral: Brief Intervention (BI) with Technology Extender

Brochure

Other group

Description:

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

Treatment:

Other: Brochure