Clinical trial NCT03860116: Evaluation of a Smart Phone App-based Case Management Model Among ART-naive HIV-infected MSM
Official title: Development and Evaluation of a Smart Phone App-based Case Management Model Among ART-naive HIV-infected MSM： A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV/AIDS
Keywords: case management
men who have sex with men
mhealth
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Guangzhou Eighth People's Hospital
First posted: 2019-03-01
Enrollment: 600
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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;

Primary outcomes:
measure: self-reported ART medication adherence
timeFrame: month 6 after enrolment
measure: CD4 count
timeFrame: month 6 after enrolment
Secondary outcomes:
measure: Anxiety
timeFrame: baseline and month 1/3/6/12 after enrolment
measure: Depression
timeFrame: baseline and month 1/3/6/12 after enrolment
measure: Quality of Life
timeFrame: baseline and month 3/6/12 after enrolment
measure: ART-related perception
timeFrame: baseline and month 1/3/6/12 after enrolment
measure: High risk sexual behavior
timeFrame: baseline and month 1/3/6/12 after enrolment
measure: Retention in ART
timeFrame: month 1/3/6/12 after enrolment
measure: HIV RNA viral load
timeFrame: baseline and month 12 after enrolment
Other outcomes:
measure: utilization of the case-management service in the intervention group
timeFrame: month 1/3/6/12 after enrolment
measure: uptake of supportive service
timeFrame: month 1/3/6/12 after enrolment
measure: intervention adherence of participants in the intervention group
timeFrame: month 1/3/6/12 after enrolment
measure: sexually transmitted infection
timeFrame: month 1/3/6/12 after enrolment
measure: sexual orientation disclosure
timeFrame: month 1/3/6/12 after enrolment
measure: HIV infection status disclosure
timeFrame: month 1/3/6/12 after enrolment
Locations:
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hospital
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Jing Gu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fan X, She R, Liu C, Zhong H, Lau JTF, Hao C, Li J, Hao Y, Li L, Gu J. Evaluation of smartphone APP-based case-management services among antiretroviral treatment-naive HIV-positive men who have sex with men: a randomized controlled trial protocol. BMC Public Health. 2020 Jan 20;20(1):85. doi: 10.1186/s12889-020-8171-5.