HIV/AIDS Clinical Trial
Official title:
Development and Evaluation of a Smart Phone App-based Case Management Model Among ART-naive HIV-infected MSM： A Randomized Controlled Trial
This is a randomized controlled trial about an app-based case management intervention. The intervention is a comprehensive case management approach consisting of the following aspects: articles delivery, online communication with case managers, supportive service information and hospital visits reminders. The aim of this study is to evaluate the efficacy of the intervention among HIV-positive men who have sex with men compared to standard-of-care service.
Men who have sex with men (MSM) are one of the key populations in HIV epidemic. They are
characterized by multiple risky sexual behaviors: unprotected anal/oral sex, commercial sex,
sex during drug use and multiple partners sexual behavior. In the conservative context of
Chinese culture, MSM face a wide variety of psychosocial barriers including: stigma, poor
mental health and lack of social support. HIV-positive MSM, not only do they have to deal
with external stress about their sexual preference, but they also face the pressure to hide
their infection status to avoid discrimination. The aforementioned factors limit their
adherence to antiretroviral treatment (ART), and lead to suboptimal treatment outcome.
Besides, due to the ART scale-up strategy in China, the existing health system is burdened
with increasing numbers of patients, which calls for innovative patient management approach
using mobile technology. Moreover, the needs of HIV/AIDS patients are growing complex. So,
case management, a comprehensive service model, is adopted to meet the needs of patients with
chronic illness, combined with smart phone application (APP) to improve adherence of
HIV-positive Chinese men who have sex with men.
This study aims to evaluate the efficacy of an APP-based case management approach on ART
adherence. 600 participants will be recruited and randomized into intervention group or
control group. The app is called "Trusted Doctor". It allows communication between doctor and
patient as well as online patient management including: sharing disease related knowledge,
scheduling follow up questionnaire to collect patients' information, visits reminder, free
phone calls with phone numbers encrypted. In this study, doctors download the APP, and
participants in the intervention group will use Wechat to follow the platform which is
connected to Trusted Doctor. Inc server and receive intervention. Wechat is a popular social
media that not only allows instant messaging between users, but also provides individuals or
groups the function of delivering articles or messages on their own Wechat platform to
subscribers. By establishing a unique Wechat platform and link it with the APP, service and
relative information can be provided on the daily communication tool. After being screened
and informed consent, eligible participants will administer a baseline questionnaire on a
tablet and then be randomized into intervention or control group. An identification number
will be generated for each participant in this study. Then the intervention group will use
Wechat to follow the platform and add contact of case managers. Tutoring about the function
of the platform will be provided by investigators. Intervention in this study includes:
articles delivery, online communication with case managers, supportive service information
and hospital visits reminders. Both the intervention and control group will receive
standard-of-care service in the hospital, including medication education after treatment
initiation, physical examination and brief counselling scheduled at each hospital visits.
Hospital visits are scheduled at month 1/2/3/6/12. Questionnaires are scheduled at baseline,
month 1, 3, 6, and 12. Follow-up questionnaires will be delivered through Wechat. The primary
outcome is ART adherence and CD4+ T cell count.
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