PDF(Pubmed)
Abstract：
BACKGROUND: In 2020, Greater New Orleans, Louisiana, was home to 7048 people living with HIV-1083 per 100,000 residents, 2.85 times the US national rate. With Louisiana routinely ranked last in indexes of health equity, violent crime rates in Orleans Parish quintupling national averages, and in-care New Orleans people living with HIV surviving twice the US average of adverse childhood experiences, accessible, trauma-focused, evidence-based interventions (EBIs) for violence-affected people living with HIV are urgently needed.
OBJECTIVE: To meet this need, we adapted Living in the Face of Trauma, a well-established EBI tailored for people living with HIV, into NOLA GEM, a just-in-time adaptive mobile health (mHealth) intervention. This study aimed to culturally tailor and refine the NOLA GEM app and assess its acceptability; feasibility; and preliminary efficacy on care engagement, medication adherence, viral suppression, and mental well-being among in-care people living with HIV in Greater New Orleans.
METHODS: The development of NOLA GEM entailed identifying real-time tailoring variables via a geographic ecological momentary assessment (GEMA) study (n=49; aim 1) and place-based and user-centered tailoring, responsive to the unique cultural contexts of HIV survivorship in New Orleans, via formative interviews (n=12; aim 2). The iOS- and Android-enabled NOLA GEM app leverages twice-daily GEMA prompts to offer just-in-time, in-app recommendations for effective coping skills practice and app-delivered Living in the Face of Trauma session content. For aim 3, the pilot trial will enroll an analytic sample of 60 New Orleans people living with HIV individually randomized to parallel NOLA GEM (intervention) or GEMA-alone (control) arms at a 1:1 allocation for a 21-day period. Acceptability and feasibility will be assessed via enrollment, attrition, active daily use through paradata metrics, and prevalidated usability measures. At the postassessment time point, primary end points will be assessed via a range of well-validated, domain-specific scales. Care engagement and viral suppression will be assessed via past missed appointments and self-reported viral load at 30 and 90 days, respectively, and through well-demonstrated adherence self-efficacy measures.
RESULTS: Aims 1 and 2 have been achieved, NOLA GEM is in Beta, and all aim-3 methods have been reviewed and approved by the institutional review board of Tulane University. Recruitment was launched in July 2023, with a target date for follow-up assessment completion in December 2023.
CONCLUSIONS: By leveraging user-centered development and embracing principles that elevate the lived expertise of New Orleans people living with HIV, mHealth-adapted EBIs can reflect community wisdom on posttraumatic resilience. Sustainable adoption of the NOLA GEM app and a promising early efficacy profile will support the feasibility of a future fully powered clinical trial and potential translation to new underserved settings in service of holistic survivorship and well-being of people living with HIV.
BACKGROUND: ClinicalTrials.gov NCT05784714; https://clinicaltrials.gov/ct2/show/NCT05784714.
UNASSIGNED: PRR1-10.2196/47151.
OBJECTIVE: To meet this need, we adapted Living in the Face of Trauma, a well-established EBI tailored for people living with HIV, into NOLA GEM, a just-in-time adaptive mobile health (mHealth) intervention. This study aimed to culturally tailor and refine the NOLA GEM app and assess its acceptability; feasibility; and preliminary efficacy on care engagement, medication adherence, viral suppression, and mental well-being among in-care people living with HIV in Greater New Orleans.
METHODS: The development of NOLA GEM entailed identifying real-time tailoring variables via a geographic ecological momentary assessment (GEMA) study (n=49; aim 1) and place-based and user-centered tailoring, responsive to the unique cultural contexts of HIV survivorship in New Orleans, via formative interviews (n=12; aim 2). The iOS- and Android-enabled NOLA GEM app leverages twice-daily GEMA prompts to offer just-in-time, in-app recommendations for effective coping skills practice and app-delivered Living in the Face of Trauma session content. For aim 3, the pilot trial will enroll an analytic sample of 60 New Orleans people living with HIV individually randomized to parallel NOLA GEM (intervention) or GEMA-alone (control) arms at a 1:1 allocation for a 21-day period. Acceptability and feasibility will be assessed via enrollment, attrition, active daily use through paradata metrics, and prevalidated usability measures. At the postassessment time point, primary end points will be assessed via a range of well-validated, domain-specific scales. Care engagement and viral suppression will be assessed via past missed appointments and self-reported viral load at 30 and 90 days, respectively, and through well-demonstrated adherence self-efficacy measures.
RESULTS: Aims 1 and 2 have been achieved, NOLA GEM is in Beta, and all aim-3 methods have been reviewed and approved by the institutional review board of Tulane University. Recruitment was launched in July 2023, with a target date for follow-up assessment completion in December 2023.
CONCLUSIONS: By leveraging user-centered development and embracing principles that elevate the lived expertise of New Orleans people living with HIV, mHealth-adapted EBIs can reflect community wisdom on posttraumatic resilience. Sustainable adoption of the NOLA GEM app and a promising early efficacy profile will support the feasibility of a future fully powered clinical trial and potential translation to new underserved settings in service of holistic survivorship and well-being of people living with HIV.
BACKGROUND: ClinicalTrials.gov NCT05784714; https://clinicaltrials.gov/ct2/show/NCT05784714.
UNASSIGNED: PRR1-10.2196/47151.
摘要：
背景：2020年，大新奥尔良，路易斯安那州,是7048名艾滋病毒感染者的家园-每10万居民1083人，2.85倍美国国家利率。路易斯安那州通常在健康公平指数中排名最后，新奥尔良教区的暴力犯罪率是全国平均水平的五倍，新奥尔良的艾滋病毒携带者在不良童年经历中的存活率是美国平均水平的两倍，可访问,以创伤为中心，迫切需要针对受暴力影响的艾滋病毒感染者的循证干预措施（EBIs）。
目标：为了满足这一需求，我们改编了《面对创伤的生活》，为艾滋病毒感染者量身定制的完善的EBI，进入NOLAGEM，及时的自适应移动健康(mHealth)干预。这项研究旨在从文化上定制和完善NOLAGEM应用程序，并评估其可接受性;可行性;和护理参与的初步功效，药物依从性,病毒抑制，以及在大新奥尔良的艾滋病毒感染者中的心理健康。
方法：NOLAGEM的开发需要通过地理生态瞬时评估（GEMA）研究（n=49；目标1）和基于地点和以用户为中心的剪裁来识别实时剪裁变量，响应新奥尔良艾滋病毒幸存者的独特文化背景，通过形成性访谈(n=12；目标2)。支持iOS和Android的NOLAGEM应用程序利用每天两次的GEMA提示提供即时，应用程序内建议有效的应对技能实践和应用程序交付的生活在创伤的会议内容。对于目标3，试点试验将招募60名新奥尔良艾滋病毒感染者的分析样本，分别随机分配到平行的NOLAGEM（干预）或GEMA单独（控制）臂，以1：1分配21天。可接受性和可行性将通过注册进行评估，自然减员,通过paradata指标活跃的日常使用，和预先验证的可用性措施。在评估后时间点，主要终点将通过一系列经过充分验证的,特定领域的尺度。护理参与和病毒抑制将通过过去错过的预约和自我报告的病毒载量在30和90天进行评估，分别,并通过良好的依从性自我效能感措施。
结果：目标1和2已经实现，NOLAGEM处于测试阶段，并且所有的目标-3方法已经由杜兰大学的机构审查委员会审查和批准。招聘于2023年7月启动，后续评估完成的目标日期为2023年12月。
结论：通过利用以用户为中心的发展和接受原则，提升新奥尔良艾滋病毒感染者的生活专业知识，适应mHealth的EBI可以反映社区对创伤后复原力的智慧。NOLAGEM应用程序的可持续采用和有希望的早期疗效概况将支持未来完全有力的临床试验的可行性，并可能转化为新的服务不足的环境，以服务于艾滋病毒感染者的整体生存和福祉。
背景：ClinicalTrials.govNCT05784714;https://clinicaltrials.gov/ct2/show/NCT05784714。
■PRR1-10.2196/47151。
目标：为了满足这一需求，我们改编了《面对创伤的生活》，为艾滋病毒感染者量身定制的完善的EBI，进入NOLAGEM，及时的自适应移动健康(mHealth)干预。这项研究旨在从文化上定制和完善NOLAGEM应用程序，并评估其可接受性;可行性;和护理参与的初步功效，药物依从性,病毒抑制，以及在大新奥尔良的艾滋病毒感染者中的心理健康。
方法：NOLAGEM的开发需要通过地理生态瞬时评估（GEMA）研究（n=49；目标1）和基于地点和以用户为中心的剪裁来识别实时剪裁变量，响应新奥尔良艾滋病毒幸存者的独特文化背景，通过形成性访谈(n=12；目标2)。支持iOS和Android的NOLAGEM应用程序利用每天两次的GEMA提示提供即时，应用程序内建议有效的应对技能实践和应用程序交付的生活在创伤的会议内容。对于目标3，试点试验将招募60名新奥尔良艾滋病毒感染者的分析样本，分别随机分配到平行的NOLAGEM（干预）或GEMA单独（控制）臂，以1：1分配21天。可接受性和可行性将通过注册进行评估，自然减员,通过paradata指标活跃的日常使用，和预先验证的可用性措施。在评估后时间点，主要终点将通过一系列经过充分验证的,特定领域的尺度。护理参与和病毒抑制将通过过去错过的预约和自我报告的病毒载量在30和90天进行评估，分别,并通过良好的依从性自我效能感措施。
结果：目标1和2已经实现，NOLAGEM处于测试阶段，并且所有的目标-3方法已经由杜兰大学的机构审查委员会审查和批准。招聘于2023年7月启动，后续评估完成的目标日期为2023年12月。
结论：通过利用以用户为中心的发展和接受原则，提升新奥尔良艾滋病毒感染者的生活专业知识，适应mHealth的EBI可以反映社区对创伤后复原力的智慧。NOLAGEM应用程序的可持续采用和有希望的早期疗效概况将支持未来完全有力的临床试验的可行性，并可能转化为新的服务不足的环境，以服务于艾滋病毒感染者的整体生存和福祉。
背景：ClinicalTrials.govNCT05784714;https://clinicaltrials.gov/ct2/show/NCT05784714。
■PRR1-10.2196/47151。
