Evaluation of a Smart Phone App-based Case Management Model Among ART-naive HIV-infected MSM
Development and Evaluation of a Smart Phone App-based Case Management Model Among ART-naive HIV-infected MSM： A Randomized Controlled Trial
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2019
CompletedFirst Posted
Study publicly available on registry
March 1, 2019
CompletedStudy Start
First participant enrolled
March 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedOctober 15, 2019
October 1, 2019
1.2 years
February 14, 2019
October 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
self-reported ART medication adherence
Measured by visual analogue scale (VAS) ranging from 0 to 100%. The ART medication visual analogue scale is a instrument for patients to rate their dose taken percentages. 100% of doses taken will be regarded as good adherence.
month 6 after enrolment
CD4 count
measured by flow cytometer during visits to hospitals
month 6 after enrolment
Secondary Outcomes (7)
Anxiety
baseline and month 1/3/6/12 after enrolment
Depression
baseline and month 1/3/6/12 after enrolment
Quality of Life
baseline and month 3/6/12 after enrolment
ART-related perception
baseline and month 1/3/6/12 after enrolment
High risk sexual behavior
baseline and month 1/3/6/12 after enrolment
- +2 more secondary outcomes
Other Outcomes (6)
utilization of the case-management service in the intervention group
month 1/3/6/12 after enrolment
uptake of supportive service
month 1/3/6/12 after enrolment
intervention adherence of participants in the intervention group
month 1/3/6/12 after enrolment
- +3 more other outcomes
Study Arms (2)
Intervention group
EXPERIMENTALparticipants in this arm receive the APP-based case management service and standard-of-care followup service.
control group
ACTIVE COMPARATORparticipants in the control arm receive standard-of-care followup service
Interventions
The intervention consists of 4 parts, educational articles, online communication with case managers, supportive service information and visit reminder. Educational articles are both delivered automatically and retrieved by participants. Online communication can also be initiated by participants and case managers. Case managers are request to respond to questions from participants as well as care about medication taking behaviors of each patients during the first month. Supportive service information, which include time, location and charges of service providers will be retrieved by participants, with reminders of available service information scheduled at the beginning of every month. Visit reminders are scheduled at one week before due date.
When participants initiate HIV antiretroviral treatment (ART), they receive 20-minute ART-related education from the case managers, and have physical examination including blood test, CD4 count, hepatic and renal function tests. Subsequent visits are scheduled at month 1, 2, 3, 6 and 12. During each visit, pills enough to cover days until the next visit will be distributed. And patients will be asked about their medication adherence, high risk behavior and side effects experienced. Any relevant questions from patients will be answered. Physical tests are also included in the routine of each visits.
Eligibility Criteria
You may qualify if:
- \. diagnosed as HIV positive;
- \. initiate antiretroviral therapy on the day of recruitment;
- \. was infected through male same-sex behavior;
- \. has access to internet on a personal mobile phone;
- \. has a Wechat account and use it daily;
- \. willing to provide written informed consent;
You may not qualify if:
- \. under severe physical or mental condition which precludes study participation;
- \. being an inpatient of the hospital;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sun Yat-sen Universitylead
- Guangzhou Eighth People's Hospitalcollaborator
Study Sites (1)
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, 510080, China
Related Publications (2)
Fan X, Ning K, Liu C, Zhong H, Lau JTF, Hao C, Hao Y, Li J, Li L, Gu J. Uptake of an App-Based Case Management Service for HIV-Positive Men Who Have Sex With Men in China: Process Evaluation Study. J Med Internet Res. 2023 Apr 26;25:e40176. doi: 10.2196/40176.
PMID: 37099367DERIVEDFan 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.
PMID: 31959139DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jing Gu
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of School of Public Health
Study Record Dates
First Submitted
February 14, 2019
First Posted
March 1, 2019
Study Start
March 19, 2019
Primary Completion
June 1, 2020
Study Completion
December 1, 2020
Last Updated
October 15, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 6 months after data collection is over
- Access Criteria
- Researchers who provide a methodologically sound proposal.
De-identified individual participant data for all primary and secondary outcome measures will be made available from the principal investigator on reasonable request. Due to the highly sensitive nature of the data collected and the characteristics of this often stigmatized population, no client-level data will be shared until the entire cohort is accrued and completed, even that which is de-identified.