MASI，一款用于提高南非感染艾滋病毒的青少年和年轻人治疗依从性的智能手机应用程序：一项试点随机对照试验方案

MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial.

作者信息

Mulawa Marta I, Hoare Jacqueline, Knippler Elizabeth T, Mtukushe Bulelwa, Matiwane Mluleki, Muessig Kathryn E, Al-Mujtaba Maryam, Wilkinson T Harper, Platt Alyssa, Egger Joseph R, Hightow-Weidman Lisa B

机构信息

School of Nursing, Duke University, Durham, NC, United States.

Duke Global Health Institute, Duke University, Durham, NC, United States.

出版信息

JMIR Res Protoc. 2023 Sep 19;12:e47137. doi: 10.2196/47137.

BACKGROUND

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.

OBJECTIVE

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04661878; https://clinicaltrials.gov/ct2/show/study/NCT04661878.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47137.

背景

感染艾滋病毒的青少年和青年反复表现出抗逆转录病毒疗法（ART）依从率低以及病毒抑制率低的情况。数字健康干预措施是促使感染艾滋病毒的青少年和青年支持ART依从性的一种有前景的方式。然而，在南非等国家，针对青少年和青年开发并测试的数字健康干预措施很少，而南非青少年和青年中的艾滋病毒负担最为沉重。Masakhane Siphucule Impilo Yethu（MASI；科萨语，意为“让我们相互赋能，改善我们的健康”）是一款面向南非感染艾滋病毒的青少年和青年的综合性ART依从性支持应用程序。它是使用HealthMpowerment平台进行文化调适的。

目的

本文旨在描述一项试点随机对照试验的方案，该试验旨在检验MASI对自我报告的ART依从性和社会支持的可行性、可接受性及初步疗效。

方法

我们将招募50名年龄在15至21岁之间感染艾滋病毒的青少年和青年。参与者将从与南非开普敦一家大型政府资助教学医院相关联的公共ART诊所招募。参与者将按1:1随机分为接受完整版MASI的干预组或接受仅提供信息版本应用程序的对照组（每组25人）。参与者将被要求每天使用MASI，为期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。