Screening to Augment Referral to Treatment- Project START
Trial Purpose and Description
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.
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.
- 18 Years - 60 Years
In order to participate, women must meet the following criteria:
1. Are non-pregnant and meet ASSIST criteria for at least moderate risk for alcohol
(=11) or drug (=4) abuse or dependence (tobacco or illicit drugs, including cocaine,
opiates, methamphetamine, marijuana or a prescription drug used in a medically
2. Are pregnant and meet ASSIST criteria for at least mild to moderate risk for alcohol
(=6) or drug (=4) abuse or dependence (alcohol, tobacco, an illicit drug, or a
prescription drug in a medically inappropriate manner). We define pregnant women who
use alcohol or drugs at least monthly in the last 90 days as eligible because alcohol
and many of the other substances (eg. tobacco) are teratogens and use in pregnancy
would be consistent with a diagnosis of abuse ("recurrent use in situations in which
it is physically hazardous"). This level of use in pregnancy also indicates a greater
likelihood of problematic substance use.
3. Have used their primary substance at least once within the prior 28 days.
4. Are aged 18 or more. We include participants who are aged 18 or older because
parents may not be available at screening to provide consent for non-pregnant
participants and subjects may not wish to disclose drug or alcohol abuse to a parent.
Women are ineligible if they have any of the following criteria:
1. Are unable to speak English.
2. Are incarcerated or at risk of incarceration. The YNHH Women's Center provides care
to incarcerated women. These individuals as well as those at risk of incarceration
are excluded because incarceration precludes their ability to seek specialty drug or
alcohol abuse treatment (a dependent measure).
3. Have a cognitive disorder that would impair their ability to provide informed consent
or provide accurate information.
4. Require immediate hospitalization because of general medical needs or due to active
suicidal or homicidal ideation or other behavioral health problems. We exclude
individuals who are in need of immediate hospitalization because hospitalization will
render it more difficult for them to immediately follow-up on a referral and because
providers, rather than subjects, may be making the decision to initiate treatment.
Hospitalization would also potentially force women who smoke to initiate treatment
for tobacco addiction.
5. Are currently participating or have participated in drug abuse treatment, including
self-help interventions (eg. 12 step facilitation, smoking cessation interventions),
within the last 3 months prior to screening.
6. Are planning to relocate out of the area in the following 6 months. Women who
relocate out of the area would be difficult to see for follow up assessments and it
would be difficult to confirm treatment attendance in local treatment centers.
7. Have previously participated in this protocol or
8. Are unwilling to participate or accept randomization.
- National Institute on Drug Abuse (NIDA)
- Yale University
- September 2010
- Last Updated:
- May 21, 2013
- Study HIC#:
Clinicaltrials.gov ID: NCT01539525