针对感染艾滋病毒或性传播感染以及患有物质使用障碍的青少年的数字健康预防干预措施的效果:一项随机对照试验方案

Efficacy of a Digital Health Preventive Intervention for Adolescents With HIV or Sexually Transmitted Infections and Substance Use Disorder: Protocol for a Randomized Controlled Trial.

作者信息

Cordova David, Bauermeister José A, Warner Sydni, Wells Patricia, MacLeod Jennifer, Neilands Torsten B, Mendoza Lua Frania, Delva Jorge, Fessler Kathryn Bondy, Smith Versell, Khreizat Sarah, Boyer Cherrie

机构信息

School of Social Work, University of Michigan, Ann Arbor, MI, United States.

School of Nursing, University of Pennsylvania, Philadelphia, PA, United States.

出版信息

JMIR Res Protoc. 2024 Feb 19;13:e47216. doi: 10.2196/47216.

Abstract

BACKGROUND

HIV or sexually transmitted infections remain a significant public health concern in the United States, with adolescents affected disproportionately. Adolescents engage in HIV/STI risk behaviors, including drug use and condomless sex, which increase the risk for HIV/STIs. At-risk adolescents, many of whom are racial minorities, experience HIV/STI disparities. Although at-risk adolescents are disproportionately affected by HIV/STI risk behaviors and infections and although the Centers for Disease Control and Prevention recommends routine HIV/STI testing for adolescents, relatively few adolescents report having ever been tested for HIV/STI. With expected increases in health clinic visits as a result of the Affordable Care Act combined with technological advances, health clinics and mobile health (mHealth), including apps, provide innovative contexts and tools to engage at-risk adolescents in HIV/STI prevention programs. Yet, there is a dearth of efficacious mHealth interventions in health clinics to prevent and reduce both condomless sex and drug use and increase HIV/STI testing for at-risk adolescents.

OBJECTIVE

To address this gap in knowledge, we developed a theory-driven, culturally congruent mHealth intervention (hereon referred to as S4E [Storytelling 4 Empowerment]) that has demonstrated feasibility and acceptability in a clinical setting. The next step is to examine the preliminary efficacy of S4E on adolescent HIV/STI testing and risk behaviors. This goal will be accomplished by 2 aims: the first aim is to develop a cross-platform and universal version of S4E. The cross-platform and universal version of S4E will be compatible with both iOS and Android operating systems and multiple mobile devices, aimed at providing adolescents with ongoing access to the intervention once they leave the clinic, and the second aim is to evaluate the preliminary efficacy of S4E, relative to usual care control condition, in preventing or reducing drug use and condomless sex and increasing HIV/STI testing in a clinical sample of at-risk adolescents aged 14-21 years living in Southeast Michigan.

METHODS

In this study, 100 adolescents recruited from a youth-centered community health clinic will be randomized via blocked randomization with random sequences of block sizes to one of the 2 conditions: S4E mHealth intervention or usual care. Theory-driven and culturally congruent, S4E is an mHealth adaptation of face-to-face storytelling for empowerment, which is registered with the Substance Abuse and Mental Health Services Administration's National Registry of Evidence-Based Programs and Practices.

RESULTS

This paper describes the protocol of our study. The recruitment began on May 1, 2018. This study was registered on December 11, 2017, in ClinicalTrials.gov. All participants have been recruited. Data analysis will be complete by the end of March 2024, with study findings available by December 2024.

CONCLUSIONS

This study has the potential to improve public health by preventing HIV/STI and substance use disorders.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03368456; https://clinicaltrials.gov/study/NCT03368456.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47216.

摘要

背景

在美国,艾滋病毒或性传播感染仍是重大的公共卫生问题,青少年受影响的比例尤其高。青少年会参与艾滋病毒/性传播感染的风险行为,包括吸毒和无保护性行为,这增加了感染艾滋病毒/性传播感染的风险。高危青少年(其中许多是少数族裔)面临艾滋病毒/性传播感染方面的差异。尽管高危青少年受艾滋病毒/性传播感染风险行为和感染的影响不成比例,且疾病控制与预防中心建议对青少年进行常规艾滋病毒/性传播感染检测,但相对较少的青少年报告曾接受过艾滋病毒/性传播感染检测。由于《平价医疗法案》导致预计健康诊所就诊人数增加,再加上技术进步,健康诊所和移动健康(mHealth),包括应用程序,为让高危青少年参与艾滋病毒/性传播感染预防项目提供了创新的环境和工具。然而,健康诊所中缺乏有效的移动健康干预措施来预防和减少无保护性行为及吸毒行为,并增加高危青少年的艾滋病毒/性传播感染检测。

目的

为填补这一知识空白,我们开发了一种理论驱动、文化适配的移动健康干预措施(以下简称S4E [赋权故事讲述]),该措施已在临床环境中证明了其可行性和可接受性。下一步是检验S4E对青少年艾滋病毒/性传播感染检测及风险行为的初步疗效。这一目标将通过两个目标来实现:第一个目标是开发S4E的跨平台通用版本。S4E的跨平台通用版本将与iOS和安卓操作系统以及多种移动设备兼容,旨在让青少年在离开诊所后仍能持续获得该干预措施,第二个目标是评估S4E相对于常规护理对照条件在预防或减少吸毒和无保护性行为以及增加居住在密歇根州东南部的14至21岁高危青少年临床样本中的艾滋病毒/性传播感染检测方面的初步疗效。

方法

在本研究中,从以青少年为中心的社区健康诊所招募的100名青少年将通过区组随机化(区组大小为随机序列)随机分为以下两种情况之一:S4E移动健康干预或常规护理。S4E是一种理论驱动、文化适配的移动健康干预措施,它是对面对面赋权故事讲述的改编,已在物质滥用和精神健康服务管理局的基于证据的项目和实践国家登记处注册。

结果

本文描述了我们研究的方案。招募工作于2018年5月1日开始。本研究于2017年12月11日在ClinicalTrials.gov上注册。所有参与者均已招募完成。数据分析将于2024年3月底完成,研究结果将于2024年12月公布。

结论

本研究有可能通过预防艾滋病毒/性传播感染和物质使用障碍来改善公共卫生。

试验注册

ClinicalTrials.gov NCT03368456;https://clinicaltrials.gov/study/NCT03368456。

国际注册报告识别码(IRRID):DERR1-10.2196/47216。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/452d/10912993/a5c92ee7db41/resprot_v13i1e47216_fig1.jpg

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