MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial.
MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial.
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DOI：
10.2196/47137
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发表时间：
2023-09-19
影响因子：
1.7
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感染艾滋病毒的青少年和年轻人反复表现出抗逆转录病毒治疗（ART）依从率低以及病毒抑制率低。数字健康干预措施是一种很有前途的方式，可以让青少年和年轻人感染艾滋病毒，以支持抗逆转录病毒疗法的坚持。然而，在南非等青少年和年轻人中艾滋病毒负担最大的国家，很少有数字健康干预措施得到开发和测试。Masakhane Siphucule Impilo Yethu（马西;科萨语：“让我们彼此赋权，改善我们的健康”）是一个针对南非艾滋病毒感染者的综合性抗逆转录病毒疗法支持应用程序。它利用健康赋权平台进行文化调整。本文的目的是描述一个试点随机对照试验的可行性，可接受性和马西自我报告的ART依从性和社会支持的初步疗效的协议。我们将招募50名年龄在15-21岁之间的青少年和年轻成人艾滋病毒感染者。参与者将从与南非开普敦一家大型政府资助的教学医院有联系的公共ART诊所招募。受试者将以1：1的比例随机分配至接受完整版马西的干预组或接受仅含信息版本应用程序的对照组（每组n=25）。参与者将被要求每天参与马西，持续6个月。所有参与者将在3个月和6个月时完成基线和随访评估。研究筛选于2022年5月开始，第一名参与者于2022年6月21日入组。截至2023年6月12日，81名受试者完成了筛选，36名合格受试者已入组试点随机对照试验。招募预计持续到2023年8月31日，研究活动预计到2024年2月29日。迫切需要创新的干预措施，以提高南非等地青少年和年轻人的抗逆转录病毒治疗依从性。如果被认为是可行和可接受的，马西可以在该国其他地区对感染艾滋病毒的青少年和年轻人实施。ClinicalTrials.gov NCT 04661878; https://clinicaltrials.gov/ct2/show/study/NCT04661878 DERR 1 -10.2196/47137
Adolescents and young adults with HIV repeatedly demonstrate low rates of antiretroviral therapy (ART) adherence as well as low rates of viral suppression. Digital health interventions are a promising way to engage adolescents and young adults with HIV to support ART adherence. However, few digital health interventions have been developed and tested with adolescents and young adults in countries like South Africa, where the HIV burden among adolescents and young adults is greatest. Masakhane Siphucule Impilo Yethu (MASI; Xhosa for “Let's empower each other and improve our health”) is a comprehensive ART adherence-supporting app for South African adolescents and young adults with HIV. It was culturally adapted using the HealthMpowerment platform. The aim of this paper is to describe the protocol for a pilot randomized controlled trial examining the feasibility, acceptability, and preliminary efficacy of MASI on self-reported ART adherence and social support. We will enroll 50 adolescents and young adults with HIV ages 15-21 years. Participants will be recruited from public ART clinics linked to a large government-funded teaching hospital in Cape Town, South Africa. Participants will be randomized 1:1 into either the intervention arm receiving a full version of MASI or the control arm receiving an information-only version of the app (n=25 per arm). Participants will be asked to engage with MASI daily for 6 months. All participants will complete baseline and follow-up assessments at 3 and 6 months. Study screening began in May 2022 and the first participant was enrolled on June 21, 2022. As of June 12, 2023, 81 participants have completed screeners, and 36 eligible participants have been enrolled in the pilot randomized controlled trial. Recruitment is anticipated to last through August 31, 2023, with study activities anticipated through February 29, 2024. There is an urgent need for innovative interventions to improve ART adherence among adolescents and young adults in settings like South Africa. If found to be feasible and acceptable, MASI could be implemented with adolescents and young adults with HIV in other parts of the country. ClinicalTrials.gov NCT04661878; https://clinicaltrials.gov/ct2/show/study/NCT04661878 DERR1-10.2196/47137