Pilot optimization trial of a sexual and reproductive health program for Latina teens and their female caregivers: A study protocol

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-06-23 DOI:10.1016/j.conctc.2025.101512

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

{"title":"Pilot optimization trial of a sexual and reproductive health program for Latina teens and their female caregivers: A study protocol","authors":"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","doi":"10.1016/j.conctc.2025.101512","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>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).</div></div><div><h3>Methods</h3><div>This protocol describes a hybrid type 2 mixed-methods study with a pilot 2<sup>3</sup> 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.</div></div><div><h3>Discussion</h3><div>Results will be used to guide intervention component and implementation refinement and will inform plans to conduct a fully powered optimization trial of Floreciendo.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101512"},"PeriodicalIF":1.4000,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2451865425000869","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

Abstract

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.

查看原文本刊更多论文

拉丁裔青少年及其女性照顾者性健康和生殖健康项目的试点优化试验：一项研究方案

拉丁裔青少年在性健康和生殖健康方面存在差距；然而，为拉丁裔青少年及其家庭设计的有效干预措施很少。Floreciendo是一项针对拉丁裔青少年（14-18岁）及其女性照顾者（如母亲、姐妹）的性健康和生殖健康干预措施，由社区伙伴组织训练有素的工作人员提供。方法采用多阶段优化策略（MOST）框架，采用2型混合方法进行23因子试验设计。小组青少年监护人（目标n = 92对/184名参与者）将被随机分配到四个cpo的8个条件中的1个。所有人都将获得预防性风险基础（即恒定）部分。二人组将被随机分配到Floreciendo的三种干预成分的不同组合中，这三种干预成分要么是“开”的，要么是“关”的：1)避孕套和避孕，2)加强家庭，3)性别和关系。我们的目的是检验使用因子设计的可行性和干预成分的可接受性。我们还将探讨有效性结果——包括危险的性行为（主要）、性传播感染和意外怀孕的发生率（次要）——以及实施结果，包括适当性、可行性、采用、可持续性、成本和保真度。定性数据将以定量数据为基础。我们将与拉丁裔青少年、女性看护人、辅导员、CPO领导和合作者进行焦点小组讨论和关键线人访谈。讨论结果将用于指导干预组件和实施改进，并将告知进行Floreciendo全动力优化试验的计划。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.