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临床试验/NCT04718974
NCT04718974已完成不适用

Acceptability, Effect and Cost of Mobile-health on ART Adherence Among Youths: A Mixed Methods Sequential Study in Kiryandongo

Makerere University2 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2020年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
206
试验地点
2
主要终点
• Viral Load Suppression

研究概览

简要总结

Study purpose: To assess effect of mHealth Call for life Uganda tool (CFLU) on ART adherence among youth measured by interactive voice response to daily adherence calls mapped in the database and proportion with viral suppression of copies below 1000 copies/mL.

The intervention call for life Uganda (CFLU) uses IVR calls or text messages delivered via MOTECH™ based Connect for Life technology™. The calls are delivered in 4 languages (Luganda, English, Luo and Runyakitara) and the participant has to make a choice of the preferred language during registration to the system. The system offers adherence pill reminders, health message tips, visit appointment reminders and receipt of self-reported symptoms.

详细描述

The intervention is mobile phone based IVR. However, the CLFU trial found that, it was observed that a good number of participants (50 of 256) at the urban site were not enrolled due to absence of a basic mobile phone, or had malfunctioning phone keyboards (for Poster Exhibition at the 20th International Conference on AIDS and STIs in Africa (ICASA 2019). Therefore, we shall provide a basic mobile phone to everyone in the study (SoC and intervention arm). To avoid stigma associated with a particular phone, we shall get 4 or more types of basic phones. Issues regarding simcard registration will be dealt with by the individuals.

Four study questionnaires will be administered at baseline and 6-monthly until the 12-month exit visit.

The questionnaires will capture:

  • Sociodemographic and medical history
  • Stigma scores
  • Knowledge assessment
  • Sexual behavior assessment
  • Knowledge of COVID-19 ( only at baseline) The data will be entered using REDCap. Blood for viral load will be collected at baseline and at the 6 and 12-month visit.

Intervention: mHealth CFLU tool The tool capitalises on a basic mobile phone's core utilities of voice and short messaging services. The system design, development, testing and evaluation was done by Janssen and the Grameen Foundation (http://motechsuite.org/index.php/implementations). In 2015, Janssen Global Public Health Research and Development, in close collaboration with the Infectious Diseases Institute Kampala (IDI), developed Call for Life Uganda (CFLU) tailored to the needs of PLHIV in Uganda. The CFLU system follows the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security rules. While the Privacy rules deals with electronic Protected Health Information, the security rule covers administrative, physical and technical safeguards to ensure confidentiality, integrity and security of electronic protected health information. Data transaction between patient and system is encrypted when it comes to human subjects. The system is password protected, and interaction of system and patient is personalised with a secret code. The system interacts with the patient through a basic mobile phone via a keypad and with the health worker through a web-based interface. The system has options to either use interactive voice response or short message service and the user has to make a choice, get a secret pin code which ensures privacy to enduser.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
15 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Youth living with HIV
  • Documented HIV test result
  • ART naïve or on ART since Jun 2019

排除标准

  • Youth with Hearing loss,
  • Youth with severe illness likely to shorten life span,
  • Youth in boarding schools
  • Inability to use a basic mobile phone

结局指标

主要结局

• Viral Load Suppression

时间窗: • Viral load suppression at 12 months

Viral load suppression as per Blood draws at 12 months for those on intervention and those on standard of care arm will be used to measure viral load status at these time points

Proportions Retained in Care

时间窗: 12 months

Proportions of youth retained in care at 12 months for those on intervention in comparison to those on standard of care arm

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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