Clinical Research Directory

Evaluation of an Adolescent Pregnancy Prevention Program; Relationship Smarts+ With Lessons From Mind Matters

The goal of this randomized control trial (RCT) is to assess an innovative adolescent pregnancy prevention program among youth that are at the highest risk of adolescent pregnancy, to prevent pregnancy and Sexually Transmitted Infections (STIs), including HIV/AIDS in the greater Miami area in Florida. The primary research question it aims to answer is: (RQ1a): What is the effect of adding 4.5 hours of Mind Matters trauma-coping skills curriculum to the Relationship Smarts Plus curriculum, on rates of unprotected sex among 9th and 10th graders compared to the students receiving only the 14-hour-long Relationship Smarts Plus curriculum? (RQ1b): What is the effect of the 14-hour-long Relationship Smarts Plus curriculum on rates of unprotected sex among 9th and 10th graders compared to the control group receiving only financial literacy? Participants will complete program lessons and complete surveys for data collection. The RCT will assess behavioral health outcomes and other psychological outcomes at four-time points (baseline, post-program, 3 months, and 12 months)

WORTH Paths Intervention

Women in the criminal legal system are more likely to experience substance use disorders and unintended pregnancy than women in the general public. However, they often face barriers to accessing substance use treatment and sexual and reproductive health services. This study tests the feasibility and acceptability of Women on the Road to Health (WORTH) Promoting Access to Treatment, Health, and Support (Paths), a digital intervention adapted from the evidence-based CDC Best Practice HIV prevention intervention, Women on the Road to Health (WORTH), originally developed at Columbia University School of Social Work. WORTH Paths is designed to help reproductive-aged women in the criminal legal system with substance use disorders and unmet need for contraception reduce drug use and improve contraceptive use. Participants (N=50) will be randomly assigned to one of two groups: WORTH Paths Intervention Group - Participants will attend three virtual group sessions with facilitated videoconference sessions and self-paced digital activities focused on reducing drug use and increasing contraceptive use. They will also receive guidance on how to access and navigate health services. Control Group - Participants will receive a virtual general wellness program that includes education on substance use and sexual and reproductive health but does not include skills-based training related to these topics. The focus will be on general wellness and stress reduction. Both groups will receive resources for substance use treatment and sexual and reproductive health services. Researchers will track changes in drug use and contraceptive use over three months. Participants will complete surveys and provide urine samples to confirm changes in drug use. Primary aims: Feasibility: Measured by session attendance, treatment completion, dropouts, and reasons for termination. Acceptability: Measured by participant ease of use, helpfulness, and satisfaction. Primary behavioral outcomes: Self-reported drug use confirmed by urine drug tests. Contraceptive use, including initiation and consistent use. Secondary behavioral outcome: Linkage to substance use disorder treatment (measured by appointments made and sessions attended).

Optimizing the Floreciendo Sexual and Reproductive Health Workshop for Latina Teens and Female Caregivers: A Pilot

Floreciendo is a sexual and reproductive health workshop for Latina teens (ages 14-18 years) and their female caregivers (e.g., mothers, sisters, grandmothers). This study involves conducting a pilot optimization trial of Floreciendo using the multiphase optimization strategy (MOST) framework. The feasibility of using a 2 x 2 x 2 factorial trial design and the acceptability of the intervention components of Floreciendo will be examined. Effectiveness and implementation outcomes will be explored. This work will be conducted in partnership with community-based organizations in the Chicagoland area.