Improving alcohol and substance use care during the reproductive years
Improving Alcohol and Substance Use Care Access, Outcomes, and Equity During the Reproductive Years: A Type 1 Hybrid Trial in Family Planning Clinics
This project will test whether offering SBIRT (screening, brief intervention, and referral to treatment) in sexual and reproductive health clinics helps adults who screen positive for risky alcohol or drug use reduce substance use and improve mental, reproductive, and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 4 sites (Boston, Massachusetts and 3 other locations) |
| Trial ID | NCT05910580 on ClinicalTrials.gov |
What this trial studies
This project compares SBIRT delivered in-person or by telemedicine to usual care for adults who screen positive for risky alcohol or substance use at sexual and reproductive health clinics. Participants are recruited at three Planned Parenthood–affiliated centers in Massachusetts, complete baseline, 30-day, and 3-month surveys, and receive either SBIRT (in-person or telehealth) or usual care. Outcomes include substance use, sexual and reproductive health, mental and physical health, quality of life, and wellbeing, with subgroup analyses by age, gender, ethnicity, socioeconomic status, and urbanicity. The trial also examines differences in outcomes by delivery mode and evaluates implementation in community-based family planning settings.
Who should consider this trial
Good fit: Adults 18 or older who live in the U.S., can read English or Spanish, have internet access, are receiving care at participating sexual and reproductive health clinics in Massachusetts, and screen positive for risky alcohol or substance use are ideal candidates.
Not a fit: People without risky substance use, those needing more intensive addiction treatment than SBIRT provides, those who cannot read English or Spanish, lack internet access, or cannot attend participating clinics are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could expand access to brief substance-use care in family planning clinics and reduce substance use and related reproductive and mental health harms among reproductive-aged adults.
How similar studies have performed: SBIRT has shown benefit for reducing risky alcohol use in some primary care and emergency settings, but evidence for drug use outcomes and for implementation in sexual and reproductive health clinics is limited, making this application relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over the age of 18 years * U.S. residing * Have internet access (own a computer or smart phone) * Screen positive to one or more risky alcohol and substance use behaviors as determined by our standardized abbreviated instruments Exclusion Criteria: * Not capable of communicating (reading, speaking, writing) in English or Spanish
Where this trial is running
Boston, Massachusetts and 3 other locations
- Greater Boston Health Center — Boston, Massachusetts, United States (Recruiting)
- Metro West Health Center — Marlborough, Massachusetts, United States (Recruiting)
- Western Massachusetts Health Center — Springfield, Massachusetts, United States (Recruiting)
- Central Massachusetts Health Center — Worcester, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Kelli S Hall, MD — Columbia University
- Study coordinator: Kelli S Hall, PhD MS
- Email: ksh2110@cumc.columbia.edu
- Phone: 212-305-4805
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.