Marlborough

This research aims to evaluate the effectiveness of an evidence-based approach called Screening, Brief Intervention, and Referral to Treatment SBIRT among adult patients who screen positive for risky alcohol or substance use behaviors while seeking care at sexual and reproductive health clinics. The study focuses on whether SBIRT can improve patients alcohol and substance use, sexual and reproductive health, mental and physical health, quality of life, and wellbeing. It also explores if SBIRTs impact varies by ethnicity, socioeconomic status, age, gender, urbanicity, and delivery mode in-person vs. telemedicine. Participants are randomly assigned to receive either the SBIRT intervention delivered both in-person and via telemedicine or usual care, which lacks a standardized screening or treatment approach. The SBIRT intervention includes validated screening tools, brief motivational interviewing-based interventions lasting 5 to 10 minutes, and referrals to specialty addiction treatment for severe cases. The study is conducted within a large family planning clinic network serving a diverse population of reproductive-aged individuals. During the study, participants complete surveys and interviews at baseline, 30 days, and 3 months to assess various outcomes such as alcohol and drug use frequency, sexual behaviors under influence, mental health status, and wellbeing. Researchers also monitor the implementation and use of SBIRT by clinics and providers over a 12-month period. The trial aims to provide guidance on scaling integrated alcohol and substance use services in sexual and reproductive health settings, promoting health equity among reproductive-aged populations.

Researchers are evaluating a new digital avatar-guided support program designed to help emerging adults aged 18 to 29 who visit the emergency department with suicidal thoughts and alcohol misuse. The study aims to understand if participants use and find the program helpful, whether they can complete daily surveys for 28 days and follow-up surveys over 12 weeks, and if the program shows early signs of reducing alcohol use and suicidal thoughts. The study compares this new program to a freely available suicide safety planning app. Participants will be randomly assigned to one of two groups. One group will use the avatar-guided digital intervention with text message reminders, which includes monitoring alcohol use and suicidal triggers, skills training, resources for outpatient care and crisis hotlines, and milestone achievements. The other group will use a free suicide safety planning app that helps create a personalized safety plan. All participants receive standard emergency department care and any follow-up or referral services needed. During the study, participants will complete surveys at the start and at 4, 8, and 12 weeks, along with daily short surveys for 28 days. Researchers will assess alcohol use, suicidal thoughts, and related experiences, as well as participant satisfaction and safety through adverse event monitoring. The total participation lasts 12 weeks, focusing on acceptability, feasibility, and early signals of the programs effects.

Researchers are studying an Acne mRNA vaccine candidate to evaluate its safety, effectiveness, and immune response in adults aged 18 to 45 years with moderate to severe acne. This first-in-human Phase III trial aims to find the best vaccine dose and regimen by testing four different doses and comparing two versus three injections. Acne is a common inflammatory skin disease, and current treatments have not changed much in 30 years, so new options are needed. The trial includes a Core Study with four cohorts two cohorts receive two doses Sentinel Cohort A and Main Cohort A and two cohorts receive three doses Sentinel Cohort B and Main Cohort B. The vaccine or placebo is given by intramuscular injection. After completing the Core Study, some participants will join a Long-Term Extension LTE follow-up lasting up to 30 months to assess lasting effects. Participants in the Main Cohort B may join a separate LTE study. During the study, participants will have medical exams, blood tests, and acne lesion counts. Researchers will monitor adverse events shortly after each injection and for up to 6 or 9 months after. They will measure changes in inflammatory and non-inflammatory acne lesions and antibody levels. Safety assessments include monitoring serious and unexpected reactions. Follow-up visits will continue for months after the last dose to observe long-term safety and immune response.