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

Sexually Transmitted Infections Clinical Trial

Official title: Evidence-based Sexual and Reproductive Health Intervention Using a Multiphase Optimization Strategy

Status Recruiting

Clinical Trial Summary

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 and preliminary effectiveness of the intervention components of Floreciendo will be examined. This work will be conducted in partnership with community-based organizations in the Chicagoland area.

Clinical Trial Description

In the U.S., Latina teens face a disproportionate burden of HIV/AIDS/sexually-transmitted infections (STIs) and other adverse consequences of risky sexual behavior. Parents play a key role in shaping the sexual behavior of their teens as they transition into adulthood. Positive parenting practices-including monitoring, open parent-child communication, and parent-child bonding-have been shown to deter teens' engagement in high-risk behavior. Interventions which engage parents have shown positive effects on youths' sexual health, including among Latinos. Effective Latina mother-daughter sexual health programs are critically needed since Latina mothers are less likely to discuss sexual risk behaviors with their teens than White or Black mothers but are greatly respected as figures of authority in Latino tradition.

This study centers on Floreciendo, a sexual and reproductive health workshop for Latina teens and their female caregivers which was adapted from the evidence-based IMARA (Informed, Motivated, Aware, and Responsible Adolescents and Adults) intervention. Floreciendo is comprised of 4 two-hour sessions, during which teens and caregivers complete separate and joint activities. This study will draw on the multiphase optimization strategy (MOST) framework, an engineering-inspired methodological framework for optimizing an intervention by identifying an intervention package that produces the best expected outcome achievable within key constraints.

The goal of the study is to carry out a pilot optimization trial of Floreciendo using the MOST framework. In partnership with community-based organizations in the Chicagoland area, approximately 92 teen-caregiver dyads (184 participants) will be enrolled. All participants will receive the first workshop session (the constant). In a 2 x 2 x 2 factorial design, small groups of teen-caregiver dyads will be randomized to receive different combinations of the remaining three workshop sessions (the intervention components): 1) condoms & contraception; 2) family strengthening, and 3) gender and relationships. Primary outcomes are: 1) feasibility of using a factorial trial design, 2) acceptability of the intervention components, and 3) preliminary effectiveness of the intervention components on sexual risk behavior. Secondary outcomes are preliminary effectiveness of the intervention components on incidence of STIs (a biological measure of chlamydia, gonorrhea, and trichomonas) and unplanned pregnancy (self-reported) at 6 months. Primary and secondary effectiveness outcomes will be assessed among teens. ;

Related Conditions & MeSH terms

• Sexual Risk Behavior
• Sexually Transmitted Diseases
• Sexually Transmitted Infections
• Unplanned Pregnancy

• NCT number: NCT06223165
• Study type: Interventional
• Source: University of Illinois at Chicago
• Contact: Kate Merrill, PhD
• Phone: 312-413-0386
• Email: kgm@uic.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2024
• Completion date: August 2026