Abstract
BackgroundMen who have sex with men (MSM) are disproportionally affected by HIV in China. ‘Treatment as Prevention’ is a promising strategy for HIV prevention but requires adequate adherence. Mobile health (mHealth) may be an acceptable and feasible approach for service delivery, but there is little evidence supporting mHealth intervention for improving antiretroviral treatment adherence among HIV-infected MSM in low- and middle-income countries, including China. This study will aim to develop a smartphone application-based case-management service and compare its efficacy to standard care with regards to adherence, CD4, HIV viral load and psychosocial outcomes among MSM patients in Guangzhou, China.MethodsA non-blinded 1:1 parallel-group randomised controlled trial will be conducted in Guangzhou Eighth People’s Hospital, with 300 MSM enrolled in each arm. Eligible MSM who are newly initiating ART will be randomly assigned to an intervention group (standard-of-care case management plus mHealth intervention) or a control group (standard-of-care case management). The development of the mHealth intervention will be based on the information–motivation–behavioural skills theory of ART adherence, and comprise four components: educational articles, one-to-one online communication with case managers, support-service information and hospital-visit reminders. Outcome measures will be collected at baseline and at months 1, 3, 6, and 12. The primary outcomes will be ART adherence and CD4 count at month 6. Secondary outcomes include HIV RNA, sexual behaviours, mental health status, illness perceptions, and quality of life. χ2 test and t-test will be used for between-group comparisons. Intervention effects will be evaluated using General estimating equation performed by SAS 9.0, on the principle of intention-to-treat. Structural equation modelling will be used to test potential mechanisms of intervention effect.DiscussionThis study is the first to explore the efficacy of mHealth intervention in the case management services targeted at HIV-infected MSM in low-and middle-income countries. Once proven effective, the innovative mHealth service could be integrated into the routine case management of PLWH. as well as be tailored to the patient management service for other chronic conditions.Trial registrationClinicalTrial.gov: NCT03860116; Registered on 1 March 2019.
Highlights
Men who have sex with men (MSM) are disproportionally affected by Human immunodeficiency virus (HIV) in China
This study is the first to explore the efficacy of Mobile health (mHealth) intervention in the case management services targeted at HIV-infected MSM in low-and middle-income countries
It was decided to send the educational material to participants at 10 p.m. to optimize subjects’ assimilation of the information. This timing was for three reasons: 1) a previous study had suggested that the rate of reading articles published on WeChat accounts peaked at 10.00 p.m. [43]; 2) individual MSM patients had suggested in interviews that educational articles should be delivered at night to avoid inadvertent sero-status disclosure to colleagues in the daytime or to friends during off hours. 3) case managers recommended 10:00 p.m. for article-delivery, as this would be close to most patients’ daily medication-taking schedule, i.e., half an hour before patients’ bedtime
Summary
Men who have sex with men (MSM) are disproportionally affected by HIV in China. ‘Treatment as Prevention’ is a promising strategy for HIV prevention but requires adequate adherence. This study will aim to develop a smartphone application-based case-management service and compare its efficacy to standard care with regards to adherence, CD4, HIV viral load and psychosocial outcomes among MSM patients in Guangzhou, China. The long-term success of such efforts to scale-up coverage of ART for PLWHA may be negatively affected by deficits in adherence to the spectrum of HIV care. ART requires adequate adherence (usually defined as intake of at least 95% of ART doses [7, 8]) to yield satisfactory clinical outcomes, e.g., suppressing HIV viral replication [9], improving quality of life [10], and preventing transmission [11]. The ART adherence of this group warrants more attention
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