Evaluation of a Smart Phone App-based Case Management Model Among ART-naive HIV-infected MSM

Sun Yat-sen University

Status: Unknown

Conditions: HIV/AIDS

Treatments: Behavioral: APP-based case management service; Behavioral: Standard-of-care followup service

Study type: Interventional

Funder types: Other

Identifiers

NCT03860116

2017A020212006

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. diagnosed as HIV positive;
• 2. initiate antiretroviral therapy on the day of recruitment;
• 3. was infected through male same-sex behavior;
• 4. has access to internet on a personal mobile phone;
• 5. has a Wechat account and use it daily;
• 6. willing to provide written informed consent;

Exclusion criteria

• 1. under severe physical or mental condition which precludes study participation;
• 2. being an inpatient of the hospital;

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Intervention group

Experimental group

Description:

participants in this arm receive the APP-based case management service and standard-of-care followup service.

Treatment:

Behavioral: APP-based case management service

Behavioral: Standard-of-care followup service

control group

Active Comparator group

Description:

participants in the control arm receive standard-of-care followup service

Treatment:

Behavioral: Standard-of-care followup service