Background Men who have sex with men (MSM) in China are disproportionately affected by the HIV epidemic, and medication adherence to antiretroviral treatment in this vulnerable population is suboptimal. To address this issue, we developed an app-based case management service with multiple components, informed by the Information Motivation Behavioral skills model. Objective We aimed to conduct a process evaluation for the implementation of an innovative app-based intervention guided by the Linnan and Steckler framework. Methods Process evaluation was performed alongside a randomized controlled trial in the largest HIV clinic in Guangzhou, China. Eligible participants were HIV-positive MSM aged ≥18 years planning to initiate treatment on the day of recruitment. The app-based intervention had 4 components: web-based communication with case managers, educational articles, supportive service information (eg, information on mental health care and rehabilitation service), and hospital visit reminders. Process evaluation indicators of the intervention include dose delivered, dose received, fidelity, and satisfaction. The behavioral outcome was adherence to antiretroviral treatment at month 1, and Information Motivation Behavioral skills model scores were the intermediate outcome. Logistic and linear regression was used to investigate the association between intervention uptake and outcomes, controlling for potential confounders. Results A total of 344 MSM were recruited from March 19, 2019, to January 13, 2020, and 172 were randomized to the intervention group. At month 1 follow-up, there was no significant difference in the proportion of adherent participants between the intervention and control groups (66/144, 45.8% vs 57/134, 42.5%; P=.28). In the intervention group, 120 participants engaged in web-based communication with case managers and 158 accessed at least 1 of the delivered articles. The primary concern captured in the web-based conversation was the side effects of the medication (114/374, 30.5%), which was also one of the most popular educational articles topics. The majority (124/144, 86.1%) of participants that completed the month 1 survey rated the intervention as “very helpful” or “helpful.” The number of educational articles accessed was associated with adequate adherence in the intervention group (odds ratio 1.08, 95% CI 1.02-1.15; P=.009). The intervention also improved the motivation score after adjusting for baseline values (β=2.34, 95% CI 0.77-3.91; P=.004). However, the number of web-based conversations, regardless of conversation features, was associated with lower motivation scores in the intervention group. Conclusions The intervention was well-received. Delivering educational resources of interest may enhance medication adherence. The uptake of the web-based communication component could serve as an indicator of real-life difficulties and could be used by case managers to identify potential inadequate adherence. Trial Registration Clinicaltrial.gov NCT03860116; https://clinicaltrials.gov/ct2/show/NCT03860116 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-020-8171-5

BACKGROUND Men who have sex with men (MSM) were disproportionately affected by the HIV epidemic and reported to have lower medication adherence for antiretroviral treatment (ART). Our research team developed an app-based case management service with multiple components to improve medication adherence among MSM initiating ART. OBJECTIVE The aim of this study is to conduct a process evaluation for the implementation of innovative app-based intervention guided by Linnan and Steckler’s framework. METHODS The study was carried out alongside a randomized controlled trial. Eligible participants were HIV-positive MSM aged 18 or above planning to initiate treatment on the day of recruitment. The app-based intervention had four components: online communication with case managers, educational articles delivery, supportive service information retrieval, and hospital visit reminders. Process evaluation indicators, including dose delivered, dose received, and fidelity were reported for each intervention component. Logistic regression was used to investigate the association between intervention uptake and ART medication adherence among the intervention group. RESULTS A total of 344 MSM were recruited from March 19th, 2019, to January 13th, 2020, and 172 were randomized to the intervention group. In month-one follow-up, 45% of the participants in the intervention group had adequate ART adherence compared with 42.3% in the control group. In the intervention group, 124 engaged in online communication with case managers, and 158 participants read at least one of the delivered articles. The primary concern captured in the online conversation was the side effects of the medication (30.6%). Participants ever expressing negative emotions (OR=0.01, 95% Confidence Interval (CI) 0.00–0.39) and ever having conversations about HIV and ART-related knowledge (OR=0.01, 95% CI 0.00–0.60) were less likely to have adequate adherence. Participants displaying excessive reading behavior (OR=5.77, 95% CI 1.09–30.63) and reading more articles about general introduction to the disease and treatment (OR=2.13, 95% CI 1.02–4.45) were more likely to have adequate adherence. CONCLUSIONS The intervention was well-received. Delivering educational resources of interest may enhance medication adherence by increasing patients’ knowledge about the disease. The online communication component could serve as an instant information exchange channel between healthcare providers and patients facilitating medical decision making. CLINICALTRIAL Clinicaltrial.gov: NCT03860116; Registered on Mar 1, 2019. INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12889-020-8171-5