Pilot optimization trial of a sexual and reproductive health program for Latina teens and their female caregivers: A study protocol
Background: Latina teens experience sexual and reproductive health disparities; however, few effective interventions designed for Latina teens and their families exist. Floreciendo is a sexual and reproductive health intervention for Latina teens (14–18 years) and their female caregivers (e.g., moth...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-08-01
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| Series: | Contemporary Clinical Trials Communications |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865425000869 |
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| author | Katherine G. Merrill Jacqueline Silva Wendy Chu Gisel Romero Vanessa Melgoza Blanca Gabino Corin Mora Sara Vargas Jacqueline Fuentes Caitlin Kelleher-Montero Nicholle Courrejolles Kate Guastaferro Felicia Scott-Wellington Susana Salgado Angela Sedeño |
| author_facet | Katherine G. Merrill Jacqueline Silva Wendy Chu Gisel Romero Vanessa Melgoza Blanca Gabino Corin Mora Sara Vargas Jacqueline Fuentes Caitlin Kelleher-Montero Nicholle Courrejolles Kate Guastaferro Felicia Scott-Wellington Susana Salgado Angela Sedeño |
| author_sort | Katherine G. Merrill |
| collection | DOAJ |
| description | Background: Latina teens experience sexual and reproductive health disparities; however, few effective interventions designed for Latina teens and their families exist. Floreciendo is a sexual and reproductive health intervention for Latina teens (14–18 years) and their female caregivers (e.g., mothers, sisters), delivered by trained staff at community partner organizations (CPOs). Methods: This protocol describes a hybrid type 2 mixed-methods study with a pilot 23 factorial experimental design which draws on the multiphase optimization strategy (MOST) framework. Small groups of teen-caregiver dyads (target n = 92 dyads/184 participants) will be randomized to 1 of 8 conditions across four CPOs. All will receive the Foundations in Sexual Risk Prevention (i.e., constant) component. Groups of dyads will be randomized to different combinations of three intervention components of Floreciendo, which are either “on” or “off”: 1) Condoms and Contraception, 2) Family Strengthening, and 3) Gender and Relationships. Our aim is to examine the feasibility of using a factorial design and the acceptability of the intervention components. We will also explore effectiveness outcomes—including risky sexual behavior (primary) and incidence of sexually transmitted infections and unplanned pregnancy (secondary)—and implementation outcomes, including appropriateness, feasibility, adoption, sustainability, cost, and fidelity. Qualitative data will build on quantitative data. We will conduct focus group discussions and key informant interviews with Latina teens, female caregivers, facilitators, CPO leadership, and collaborators. Discussion: Results will be used to guide intervention component and implementation refinement and will inform plans to conduct a fully powered optimization trial of Floreciendo. |
| format | Article |
| id | doaj-art-3d0d28ff7db449f0a44c7cc34a66e68e |
| institution | DOAJ |
| issn | 2451-8654 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj-art-3d0d28ff7db449f0a44c7cc34a66e68e2025-08-20T03:12:36ZengElsevierContemporary Clinical Trials Communications2451-86542025-08-014610151210.1016/j.conctc.2025.101512Pilot optimization trial of a sexual and reproductive health program for Latina teens and their female caregivers: A study protocolKatherine G. Merrill0Jacqueline Silva1Wendy Chu2Gisel Romero3Vanessa Melgoza4Blanca Gabino5Corin Mora6Sara Vargas7Jacqueline Fuentes8Caitlin Kelleher-Montero9Nicholle Courrejolles10Kate Guastaferro11Felicia Scott-Wellington12Susana Salgado13Angela Sedeño14Center for Dissemination and Implementation Science, University of Illinois Chicago, United States; Floreciendo Community Advisory Council, United States; Corresponding author. Center for Dissemination and Implementation Science, University of Illinois Chicago, United States.Center for Dissemination and Implementation Science, University of Illinois Chicago, United States; Floreciendo Community Advisory Council, United StatesDepartment of Psychiatry, University of Illinois Chicago, United States; Department of Psychology, University of South Carolina, United StatesFloreciendo Community Advisory Council, United States; LoSAH Center of Hope, United StatesFloreciendo Community Advisory Council, United States; Corazón Community Services, United StatesFloreciendo Community Advisory Council, United States; Gads Hill Center, United StatesFloreciendo Community Advisory Council, United States; Centro Romero, United StatesFloreciendo Community Advisory Council, United States; The Center for Relational Wellness, United StatesFloreciendo Community Advisory Council, United States; Feinberg School of Medicine, Northwestern University, United StatesCenter for Dissemination and Implementation Science, University of Illinois Chicago, United StatesDepartment of Medicine, University of Illinois Chicago, United StatesSchool of Global Public Health, New York University, United StatesDepartment of Pediatrics, University of Illinois Chicago, United StatesFloreciendo Community Advisory Council, United States; Centro Romero, United StatesExpanded Mental Health Services of Chicago NFP, United StatesBackground: Latina teens experience sexual and reproductive health disparities; however, few effective interventions designed for Latina teens and their families exist. Floreciendo is a sexual and reproductive health intervention for Latina teens (14–18 years) and their female caregivers (e.g., mothers, sisters), delivered by trained staff at community partner organizations (CPOs). Methods: This protocol describes a hybrid type 2 mixed-methods study with a pilot 23 factorial experimental design which draws on the multiphase optimization strategy (MOST) framework. Small groups of teen-caregiver dyads (target n = 92 dyads/184 participants) will be randomized to 1 of 8 conditions across four CPOs. All will receive the Foundations in Sexual Risk Prevention (i.e., constant) component. Groups of dyads will be randomized to different combinations of three intervention components of Floreciendo, which are either “on” or “off”: 1) Condoms and Contraception, 2) Family Strengthening, and 3) Gender and Relationships. Our aim is to examine the feasibility of using a factorial design and the acceptability of the intervention components. We will also explore effectiveness outcomes—including risky sexual behavior (primary) and incidence of sexually transmitted infections and unplanned pregnancy (secondary)—and implementation outcomes, including appropriateness, feasibility, adoption, sustainability, cost, and fidelity. Qualitative data will build on quantitative data. We will conduct focus group discussions and key informant interviews with Latina teens, female caregivers, facilitators, CPO leadership, and collaborators. Discussion: Results will be used to guide intervention component and implementation refinement and will inform plans to conduct a fully powered optimization trial of Floreciendo.http://www.sciencedirect.com/science/article/pii/S2451865425000869 |
| spellingShingle | Katherine G. Merrill Jacqueline Silva Wendy Chu Gisel Romero Vanessa Melgoza Blanca Gabino Corin Mora Sara Vargas Jacqueline Fuentes Caitlin Kelleher-Montero Nicholle Courrejolles Kate Guastaferro Felicia Scott-Wellington Susana Salgado Angela Sedeño Pilot optimization trial of a sexual and reproductive health program for Latina teens and their female caregivers: A study protocol Contemporary Clinical Trials Communications |
| title | Pilot optimization trial of a sexual and reproductive health program for Latina teens and their female caregivers: A study protocol |
| title_full | Pilot optimization trial of a sexual and reproductive health program for Latina teens and their female caregivers: A study protocol |
| title_fullStr | Pilot optimization trial of a sexual and reproductive health program for Latina teens and their female caregivers: A study protocol |
| title_full_unstemmed | Pilot optimization trial of a sexual and reproductive health program for Latina teens and their female caregivers: A study protocol |
| title_short | Pilot optimization trial of a sexual and reproductive health program for Latina teens and their female caregivers: A study protocol |
| title_sort | pilot optimization trial of a sexual and reproductive health program for latina teens and their female caregivers a study protocol |
| url | http://www.sciencedirect.com/science/article/pii/S2451865425000869 |
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