Fan 2020.

Study name	Evaluation of smartphone APP‐based case‐ management services amongst antiretroviral treatment‐naïve HIV‐positive men who have sex with men
Methods	Study design: RCT Country: China
Participants	Men who have sex with men (MSM) patients Inclusion criteria:  a. aged 18 years or older; b. HIV‐positive; c. ART‐naïve, and planning to initiate ART on the day of recruitment; d. self‐reported to be HIV‐infected through homosexual transmission; e. access to the internet on a smartphone; f. having a WeChat account and using it in daily communication; g. willing to provide written informed consent. Exclusion criteria: a. hospitalized due to severe opportunistic infections Stated purpose: to design and evaluate the efficacy of an APP‐based case‐management intervention amongst men who have sex with men who are newly initiating ART, using the IMB model as the theoretical framework
Interventions	Intervention: APP‐based case‐management intervention The Self‐Help Plus intervention consists of a pre‐recorded audio course, delivered by trained facilitators in a group setting and complemented with an illustrated self‐help book adapted for the target cultural group. The intervention is based on acceptance and commitment therapy, a form of cognitive‐behavioural therapy. It is delivered across five 2‐hour sessions. The audio material imparts key information about stress management and guides participants through individual exercises and small group discussions. The self‐help book reviews all essential content and concepts. In this study, a version of the intervention previously adapted for Syrian populations was used. Control: The control group receives SOC service at the hospital, which commences with a 20‐min ART education session for MSM patients newly initiating ART.
Outcomes	Participants'outcomes of interest for this review Mental health symptoms/anxiety – Generalized Anxiety Disorder‐7 (GAD‐7) Mental health symptoms/depression – Patient Health Questionnaire‐9 (PHQ‐9) Quality of life – World Health Organization Quality‐of‐Life Scale ‐ HIV (WHOQOL‐HIV BREF) Economic outcomes Nil Time points: baseline, post‐intervention (months 3, 6, and 12)
Starting date	NA
Contact information	Xiaoyang Fan, Jing Gu, gujing5@mail.sysu.edu.cn
Notes	Source of funding: National Natural Science Foundation of China (Grant #71774178); Science and Technology Planning Project of Guangdong (Grant #2017A020212006); the Guangzhou Science and Technology Project (Grant #201607010368); and National Major Science and Technology Projects of China: Infectious Disease Prevention and Control (Grant #2018ZX10715004) Prospective trial registration number: NCT03860116