NCT01539525

Screening to Augment Referral to Treatment- Project START

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 439 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose to use obstetric-gynecological clinics to conduct a randomized clinical trial that would compare two SBIRTS (Screening, Brief Intervention, Referral and Treatment), delivered either by a trained nurse or by computer, to usual care (a control condition). As part of this trial, the investigators will include outcomes that allow us to assess the cost effectiveness of these three conditions.

Detailed description

Aim 1: To assess whether SBIRT, based upon motivational interviewing and delivered either by computer or a trained nurse, leads to decreased use of a subject's primary drug of abuse. Hypothesis #1a: Referrals based upon motivational principles and delivered by computer, as compared to usual care (health brochure with treatment resources), will lead to greater reductions in a woman's primary substance of abuse. Hypothesis #1b: Referrals based upon motivational principles and delivered by nurse, as compared to usual care (health brochure with treatment resources), will lead to greater reductions in a woman's primary substance of abuse. Aim 2: To determine whether SBIRT based upon motivational interviewing and delivered either by computer or by a nurse will promote substance abuse treatment utilization for the primary drug of abuse. Hypothesis #2a: Treatment utilization (eg. treatment initiation, attendance, use of quit-line or medication) will be higher if a woman receives the computer delivered brief intervention than if she receives usual care only. Hypothesis #2b: Treatment utilization (eg. treatment initiation, attendance, use of quit-line or medication) will be higher if a woman receives the nurse delivered brief intervention than if she receives usual care only. Secondary Aim 3: To evaluate whether SBI leads to a decrease in HIV/AIDS risk Hypothesis #3: Rates of sexually transmitted diseases, injection drug use and risky sexual behavior will be lower at follow up for subjects who receive either computer or a nurse delivered brief intervention than usual care subjects. Secondary Aim 4: To compare the relative cost-effectiveness of the three interventions. Hypothesis #4a: Screening and usual care will be the most cost-effective intervention method when the value of an additional unit of effect for the given individual's outcome is relatively low. Hypotheses #4b: Screening, and a brief intervention delivered by computer, will be the most cost-effective treatment method when the value of an additional unit of effect is relatively high. Hypotheses #4c: Screening, and a brief intervention delivered by a nurse, will be less cost-effective than a brief intervention delivered by computer.

Conditions

• Alcohol Abuse
• Tobacco Use Disorder
• Marijuana Abuse
• Substance-Related Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Motivational Interview	Motivational Interview provided by either a Nurse or Computer
OTHER	Treatment as Usual	Subjects given a brochure listing relevant recovery resources in the local area.

Timeline

• Start date: 2011-09-05
• Primary completion: 2015-01-28
• Completion: 2015-01-28
• First posted: 2012-02-27
• Last updated: 2017-04-14
• Results posted: 2017-04-14

Locations

2 sites across 1 country: United States