Marlborough

Researchers are evaluating the effectiveness of Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adults who screen positive for risky alcohol or substance use behaviors while seeking care at sexual and reproductive health clinics. The study aims to understand if SBIRT impacts alcohol and substance use, sexual and reproductive health, mental and physical health, quality of life, and wellbeing, and whether its effectiveness varies by ethnicity, socioeconomic status, age, gender, urbanicity, or delivery mode (in-person vs. telemedicine). Participants will receive either in-person or telemedicine SBIRT or usual care. SBIRT involves validated screening tools to identify substance use risk, followed by a brief motivational interviewing-based intervention for those in the risky range. Individuals with severe substance use issues receive a brief intervention and a warm hand-off referral to specialty addiction treatment. The intervention procedures are adapted to fit telemedicine visits as well. Participants will complete surveys and interviews at the start of the study, after 30 days, and at 3 months. Researchers will monitor alcohol and drug use, sexual activity under the influence, mental health using the Patient Health Questionnaire, and the use of SBIRT by providers and clinics during implementation and sustainment phases lasting up to 12 months. The study also tracks the competency of providers delivering brief interventions and motivational style during these phases.

Researchers are investigating the safety, effectiveness, and immune response of an Acne mRNA vaccine in adults aged 18 to 45 years who have moderate to severe acne. This Phase I/II trial aims to find the best vaccine dose and regimen by studying up to three intramuscular injections at four different dose levels. Acne is a widespread inflammatory skin condition with significant global impact, and current treatments have changed little in the past 30 years, highlighting the need for new options. The study includes a Core Study and an optional Long-Term Extension (LTE). The Core Study has two groups testing two doses (Cohorts A) and two groups testing three doses (Cohorts B). Participants in Sentinel Cohorts A and B and Main Cohort A may join a 30-month follow-up after their last Core Study visit to evaluate long-term vaccine effects. Those in Main Cohort B can enter a separate LTE study. The vaccine and placebo are given as liquid injections into the muscle. Participants will be monitored closely through various safety assessments, including tracking adverse events shortly after each dose and for several months afterward. Researchers will measure changes in acne lesions at two months post-treatment and follow participants for up to 38 or 40 months in the LTE. Evaluations include medical exams, lab tests, and questionnaires to understand safety, immune response, and how well the vaccine works over time.