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通过一项文化定制的健康促进干预措施预防老年 HIV 感染拉丁裔成年人认知能力下降:一项单臂试点试验方案。

Preventing Cognitive Decline in Older Latino Adults With HIV Through a Culturally Tailored Health Promotion Intervention: Protocol for a Single-Arm Pilot Trial.

机构信息

Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, United States.

Department of Surgery, University of Miami Miller School of Medicine, Miami, FL, United States.

出版信息

JMIR Res Protoc. 2024 Aug 12;13:e55507. doi: 10.2196/55507.

Abstract

BACKGROUND

Older Latino adults with HIV are at increased risk for mild cognitive impairment and earlier onset of aging-related cognitive decline. Improvements in cognitive functioning and cognitive outcomes are possible among people with HIV who adopt health promotion behaviors. However, health promotion interventions for older Latino adults with HIV have not been extensively used or widely recognized as viable treatment options. Happy Older Latinos are Active (HOLA) is a multicomponent, health promotion intervention that is uniquely tailored for older Latino adults with HIV.

OBJECTIVE

This study aims to (1) determine the feasibility and acceptability of an adapted version of HOLA aimed at improving cognitive functioning among older Latino adults with HIV; (2) explore whether HOLA will produce changes in cognitive functioning; (3) explore whether HOLA will produce changes in activity, psychosocial functioning, or biomarkers of cognition; and (4) explore whether changes in activity, psychosocial functioning or cognitive biomarkers correlate with changes in cognition, while accounting for genetic risk for dementia.

METHODS

A single-arm pilot trial with 30 Latino (aged 50 years and older) men and women with HIV was conducted to assess feasibility, acceptability, and preliminary effects on cognition. Participants were assessed at 2 time points (baseline and postintervention) on measures of neurocognitive and psychosocial functioning. In addition, blood samples were collected to determine biomarkers of cognition at baseline and postintervention. Successful recruitment was defined as meeting 100% of the targeted sample (N=30), with 20% (n=6) or less of eligible participants refusing to participate. Adequate retention was defined as 85% (n=25) or more of participants completing the postintervention assessment and acceptability was defined as 80% (n=38) or more of sessions attended by participants.

RESULTS

Participant recruitment began on February 22, 2022, and was completed on August 15, 2022. The last study visit took place on February 20, 2023. Data analysis is currently ongoing.

CONCLUSIONS

Encouraging findings from this exploratory study may provide a blueprint for scaling up the HOLA intervention to a larger cohort of older Latino adults with HIV who may be currently experiencing or are at risk for HIV-related cognitive challenges.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04791709; https://clinicaltrials.gov/study/NCT04791709.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55507.

摘要

背景

感染艾滋病毒的老年拉丁裔成年人认知障碍的风险增加,并且认知能力下降的起始年龄更早。对于采用健康促进行为的艾滋病毒感染者,认知功能和认知结果是可以改善的。然而,针对感染艾滋病毒的老年拉丁裔成年人的健康促进干预措施并未得到广泛使用或广泛认可为可行的治疗选择。快乐拉丁裔老年人是活跃的(HOLA)是一种多成分的健康促进干预措施,专为感染艾滋病毒的老年拉丁裔成年人量身定制。

目的

本研究旨在:(1)确定针对感染艾滋病毒的老年拉丁裔成年人的改良版 HOLA 是否可行和可接受,目的是改善他们的认知功能;(2)探索 HOLA 是否会导致认知功能的变化;(3)探索 HOLA 是否会导致活动、心理社会功能或认知生物标志物的变化;(4)探索活动、心理社会功能或认知生物标志物的变化是否与认知变化相关,同时考虑痴呆症的遗传风险。

方法

一项针对 30 名感染艾滋病毒的拉丁裔(年龄在 50 岁及以上)男性和女性的单臂试点试验,旨在评估可行性、可接受性和对认知的初步影响。参与者在 2 个时间点(基线和干预后)接受神经认知和心理社会功能的评估。此外,还采集了血液样本,以确定基线和干预后的认知生物标志物。成功招募的定义是达到 100%的目标样本(N=30),有 20%(n=6)或更少的合格参与者拒绝参与。足够的保留率定义为 85%(n=25)或更多的参与者完成了干预后评估,可接受性定义为 80%(n=38)或更多的参与者参加了课程。

结果

参与者招募于 2022 年 2 月 22 日开始,于 2022 年 8 月 15 日完成。最后一次研究访问于 2023 年 2 月 20 日进行。数据分析正在进行中。

结论

这项探索性研究的令人鼓舞的结果可能为扩大 HOLA 干预措施提供蓝图,以涵盖更多目前正在经历或面临艾滋病毒相关认知挑战的感染艾滋病毒的老年拉丁裔成年人。

试验注册

ClinicalTrials.gov NCT04791709;https://clinicaltrials.gov/study/NCT04791709。

国际注册报告标识符(IRRID):DERR1-10.2196/55507。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d36c/11347906/74e6983de915/resprot_v13i1e55507_fig1.jpg

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