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BACKGROUND The use of mobile health (mHealth), including smartphone apps, can improve the HIV prevention cascade for key populations such as men who have sex with men (MSM). In Malaysia, where stigma and discrimination toward MSM are high, the mHealth platform has the potential to open new frontiers for HIV prevention efforts. However, little guidance is available to inform researchers about privacy and confidentiality concerns unique to the development and implementation of app-based HIV prevention programs. OBJECTIVE Given the lack of empirical data in this area, we aim to understand the privacy and confidentiality concerns associated with participation in a hypothetical app-based research study for HIV prevention efforts. METHODS A cross-sectional, web-based survey was conducted between June and July 2020 among 355 Malaysian MSM. The survey included demographic and sexual health questions and a series of short videos describing a hypothetical app-based HIV prevention program, followed by questions related to privacy and confidentiality concerns in each step of the app-based program (ie, recruitment, clinical interaction, risk assessment, and weekly reminder). Multivariable logistic regression models were used to identify the correlates of willingness to use such an app-based program. RESULTS Most of the participants (266/355, 74.9%) indicated their willingness to participate in a hypothetical mHealth app–based HIV prevention program. Participants expressed concerns about privacy, confidentiality, data security, and risks and benefits of participating in all stages of the app-based HIV research process. Multivariate analyses indicated that participants who had a higher degree of perceived participation benefits (adjusted odds ratio [aOR] 1.873; 95% CI 1.274-2.755; P=.001) were more willing to participate. In contrast, participants who had increased concerns about app-based clinical interaction and e-prescription (aOR 0.610; 95% CI 0.445-0.838; P=.002) and those who had a higher degree of perceived risks of participating (aOR 0.731; 95% CI 0.594-0.899; P=.003) were less willing to participate. CONCLUSIONS Overall, our results indicate that mHealth app–based HIV prevention programs are acceptable for future research on Malaysian MSM. The findings further highlighted the role of privacy and confidentiality, as well as the associated risks and benefits associated with participation in such a program. Given the ever-evolving nature of such technological platforms and the complex ethical–legal landscape, such platforms must be safe and secure to ensure widespread public trust and uptake. |