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Pre-exposure prophylaxis (PrEP) for prevention of human immunodeficiency virus infection is proved to be effective and has been implemented worldwide. This article introduces the guideline development and revised recommendations and guidance on PrEP provision in the updated Taiwan PrEP guideline. The Taiwan PrEP guideline writing group searched randomized controlled trials and guidelines published before October 2017 through Medline/PubMed, Cochrane Database, Embase and ClinicalTrials.gov database. Keywords included pre(-)exposure prophylaxis, PrEP, Truvada, tenofovir, HIV, and AIDS. Each selected article was assessed by two authors using the Grading of Recommendations Assessment, Development and Evaluation. External reviewers were invited to independently evaluate the revised manuscript per the Appraisal of Guidelines for Research and Evaluation II. Before publication, a public consultation was held to reach consensus on the updated guideline among providers, civil society, and Taiwan Centers for Disease Control. Four systematic reviews and 28 original articles were reviewed by Taiwan PrEP writing group. The second version of the Taiwan PrEP guideline was released in March 2018. We recommended daily PrEP use for the following populations: strong recommendation and high quality of evidence for men who have sex with men (MSM) and transgender women (TGW), as well as heterosexual serodiscordant couples; weak recommendation and high quality of evidence for people who inject drugs, while weak recommendation and moderate quality of evidence for at-risk heterosexual men and women. There is high-quality evidence for event-driven PrEP in MSM and likely TGW, and we additionally recognized these key populations could benefit from such dosing regimen. Keywords: Human immunodeficiency virus, Pre-exposure prophylaxis, PrEP, Taiwan

Introduction Both daily and event‐driven (ED) pre‐exposure prophylaxis (PrEP) have been demonstrated to be highly effective among men who have sex with men (MSM). Prevention‐effective adherence proposes that PrEP adherence should be aligned with the risk of HIV, which could be applied to both daily and ED PrEP adherence measurement. The objective of this study was to describe the relationship between the use of PrEP and sex events among the MSM PrEP users and identify factors associated with adherence among daily and ED MSM PrEP users. Methods A multicentre, observational, prospective cohort study was conducted at three hospital‐based clinics in three urban cities of Taiwan from January 2018 to December 2019. MSM ages 18 years or older – at high risk of HIV acquisition and taking PrEP during the study period – were included in the analysis. MSM PrEP users were allowed to choose between daily and ED PrEP based on their preference. Data on sociodemographic characteristics, mental health, sexual behaviours, substance use and PrEP‐taking behaviours were collected at each visit. Results A total of 374 MSM were included in the analysis with 1,054 visits. More than half (56%) of the PrEP users chose ED at the baseline and 150 regimen switches were reported by 21% of the participants. There was only one seroconversion documented during the study period. Most (84.2%) of the MSM PrEP users were able to adhere to PrEP during the most recent anal intercourse in the past one month. Among ED PrEP users with suboptimal adherence, the majority (81.9%) missed the pre‐coital dose. In the multivariable analysis, we found that participants who switched from daily to an ED dosing regimen were associated with poorer adherence to PrEP. Conclusions A high level of PrEP adherence was observed among the majority of MSM in a real‐world setting. On the other hand, Taiwanese MSM switching from daily to ED dosing regimens were less likely to adhere to PrEP, suggesting that novel approaches focusing on a dosing switch would be necessary for MSM to improve their adherence to PrEP.

Background Daily and on-demand pre-exposure prophylaxis (PrEP) has been well demonstrated to effectively prevent HIV acquisition for men who have sex with men (MSM). More than half of the MSM PrEP users in Taiwan prefer on-demand PrEP; however, on-demand PrEP involves a complicated dosing regimen because it requires precoital and postcoital dosing and sex events are hard to anticipate. Although there are a growing number of mobile apps designed to improve access to HIV prevention services and HIV medication adherence, few mobile apps focus on adherence to PrEP or are designed to accommodate a complicated, on-demand PrEP dosing schedule. Objective The aim of this project is to evaluate the usability of a newly developed mobile app (UPrEPU) to assist MSM PrEP users to self-monitor their adherence to either daily or on-demand PrEP using a user-centered scheme. Methods This research will be conducted in 2 phases: app development and usability study. In the app development phase, we will first conduct formative research with end users and stakeholders through in-depth interviews; the results will provide PrEP users’ and PrEP navigators’ personas as material used in the app conceptualization stage. PrEP navigators are individuals in the health care system that help HIV-negative individuals who need assistance in accessing PrEP care. A low-fidelity prototype of the app feature will be formatted by applying a participatory design approach to engage PrEP users, designers, and app developers in the design process of the app. Then, a high-fidelity prototype of the app will be developed for the usability study and refined iteratively by the multidisciplinary team and new internal testers. Internal testers include the research team consisting of experts in public health, infectious disease, and industrial design and a close network of the research team that is taking PrEP. In the usability study phase, we will enroll 70 MSM PrEP users and follow them up for 4 months. Usability, feasibility, and effectiveness of adherence monitoring will be evaluated. Results Refinement of the UPrEPU app is currently ongoing. The usability study commenced in May 2020. Conclusions The UPrEPU app is one of the first apps designed to help MSM PrEP users to self-manage their PrEP schedule better regardless of dosing modes. With a design-thinking approach and adapting to the cultural context in Taiwan’s MSM population, this novel app will have substantial potential to be acceptable and feasible and contribute to the reduction of new HIV infections. Trial Registration ClinicalTrials.gov NCT04248790; https://clinicaltrials.gov/ct2/show/NCT04248790 International Registered Report Identifier (IRRID) PRR1-10.2196/20360

Pre-exposure prophylaxis (PrEP) has proven to be effective in reducing the risk of HIV transmission in uninfected individuals who engaged in sexual activity with HIV-infected partners. Serodiscordant couples are the key targets of PrEP implementation. The study aimed to compare awareness of and willingness to use PrEP and anticipated condom use among 112 HIV-serodiscordant couples: 32 heterosexuals couples, 70 men who have sex with men (MSM) couples, and 10 people who inject drugs (PWID) couples. A cross-sectional study was conducted in an AIDS designated hospital in Taiwan. The PrEP survey for discordant couples included questions on awareness of non-occupational post-exposure prophylaxis (nPEP) and PrEP, attitudes toward PrEP, anticipated condom use if using PrEP, and sexual behaviors. Overall, 46.2% were aware of PrEP, only 33% were willing to take PrEP, and 44.6% would continue condom use if they were taking PrEP. Among the three key populations, MSM couples had the highest awareness of and willingness to use PrEP. Awareness of and willingness to use PrEP did not differ by HIV status, with moderate agreement (Cohen's Kappa coefficient: 0.56) between HIV-serodiscordant partners. Both HIV-serodiscordant partners' willingness to use PrEP was significantly associated with being MSM (adjusted odds ratio (AOR), 4.28 [1.28-14.30], p = 0.018), previous receipt of nPEP (AOR, 6.98 [1.23-39.65], p = 0.028), anticipated condom use (AOR, 0.14 [0.05-0.41], p 0.001), and income ≥ NT$30,000 per month (AOR, 2.25 (0.99-5.04), p = 0.05). Policy makers need to consider the differences among key populations to scale up PrEP implementation. More efforts should be focused on improving awareness of and willingness to use PrEP among heterosexual and PWID serodiscordant couples to scale up PrEP implementation in Taiwan.