Impact of simplified HCV diagnostic strategies on the HCV epidemic among men who have sex with men in the era of HIV oral pre-exposure prophylaxis in Taiwan: a modelling study.

INTRODUCTION: Simplified hepatitis C virus (HCV) diagnostic strategies have the potential to improve HCV diagnoses and treatment. We aimed to investigate the impact of simplified HCV diagnostic strategies on HCV incidence and its effect on HCV diagnosis and treatment among men who have sex with men (MSM) regardless of HIV status and use of HIV pre-exposure prophylaxis (PrEP) in Taiwan. METHODS: A compartmental deterministic model was developed to describe the natural history of HCV disease progression, the HCV care cascade and the HIV status and PrEP using among MSM. The model was calibrated to available data for HCV and HIV epidemiology and population demographics in Taiwan. We simulated the epidemic from 2004 and projected the impact of simplified testing strategies on the HCV epidemic among MSM over 2022-2030. RESULTS: Under the current testing approach in Taiwan, total HCV incidence would increase to 12.6 per 1000 person-years among MSM by 2030. Single-visit point-of-care RNA testing had the largest impact on reducing the number of new HCV infections over 2022-2030, with a 31.1% reduction (interquartile range: 24.9%-32.8%). By 2030, single-visit point-of-care HCV testing improved HCV diagnosis to 90.9%, HCV treatment to 87.7% and HCV cure to 81.5% among MSM living with HCV. Compared to status quo, prioritized simplified HCV testing for PrEP users and MSM living with diagnosed HIV had considerable impact on the broader HCV epidemic among MSM. A sensitivity analysis suggests that reinfection risk would have a large impact on the effectiveness of each point-of-care testing scenario. CONCLUSIONS: Simplified HCV diagnostic strategies could control the ongoing HCV epidemic and improve HCV testing and treatment among Taiwanese MSM. Single-visit point-of-care RNA testing would result in large reductions in HCV incidence and prevalence among MSM. Efficient risk-reduction strategies will need to be implemented alongside point-of-care testing to achieve HCV elimination among MSM in Taiwan.

Preferences for long-acting pre-exposure prophylaxis among gay, bisexual and other men who have sex with men in Taiwan: findings from the 2021 HEART Survey.

INTRODUCTION: While various antiretrovirals have been studied as potential candidates for long-acting pre-exposure prophylaxis (PrEP), the bimonthly injectable cabotegravir-the first long-acting form of PrEP-was approved in 2021. Event-driven (ED) PrEP has been the most prevalent dosing regimen among gay, bisexual and other men who have sex with men (GBMSM) in Taiwan, providing a unique setting to observe the preferences for long-acting PrEP in a community where the daily regimen is not the mainstream method. This study aimed to determine the preferences for the different forms and dosing intervals of long-acting PrEP that are currently in the development pipeline. METHODS: We conducted a survey in 2021 by convenience sampling the users of social networking applications for GBMSM in Taiwan. Our survey included questions on sexual behaviours, current PrEP regimens and the preferences for potential candidates of long-acting PrEP, such as implants, intramuscular and subcutaneous injections. We compared the Likert-scale preference ratings for potential long-acting options, and conducted logistic regression analysis to examine the factors associated with a preference for bimonthly intramuscular injections (2M IM) over ED and daily PrEP regimens, respectively. RESULTS: A total of 1728 responses were eligible for analysis. Three percent of respondents (n = 52) were daily PrEP users; 11.5% (n = 198) were ED PrEP users. When not considering cost, current PrEP users-regardless of their original dosing regimen-were most likely to express preferences for monthly oral PrEP, followed by a 6-month subcutaneous injectable (6M SC) and 2M IM. However, among non-current PrEP users, monthly oral PrEP was the most preferred form, followed by ED, daily oral and 6M SC injectable. Multivariable logistic regression revealed that current daily users, those willing to take PrEP in the next 6 months and those with more sex partners in the last 12 months had a significant correlation with preferences for the 2M IM injectable over the ED PrEP. CONCLUSIONS: The monthly oral form was the most preferable long-acting PrEP among GBMSM in Taiwan. Current daily PrEP users preferred the 2M IM injectable over the ED PrEP, which made the 2M IM injectable a potential alternative. Further studies should focus on how the cost and delivery affect PrEP preferences and their actual uptake.

HIV, chemsex, and the need for harm-reduction interventions to support gay, bisexual, and other men who have sex with men.

Numerous studies have identified an association between the use of drugs in sexual contexts (chemsex) and HIV among gay, bisexual, and other men who have sex with men (GBMSM), although whether a causal relationship exists is contentious. An intricate relationship exists between chemsex, HIV treatment and prevention, harm reduction, and the provision of community-grounded health services. Furthermore, potential harms exist beyond HIV, such as intoxication and overdose. Community-engaged responses to chemsex involve social and cultural strategies of harm reduction and sexual health promotion before, during, and after a chemsex session. Ultimately, this Review calls for actions and collaborations aimed at developing a greater understanding of chemsex as a practice within different GBMSM subpopulations and to develop tailored harm-reduction models that can accommodate GBMSM who engage in chemsex in various ways and with varied effects.

Usability and effectiveness of adherence monitoring of a mobile app designed to monitor and improve adherence to event-driven and daily HIV pre-exposure prophylaxis among men who have sex with men in Taiwan.

Objective: The UPrEPU mobile app is a self-monitoring system to enable men who have sex with men to optimize their pre-exposure prophylaxis adherence for HIV prevention. The app was designed to accommodate a rather complicated event-driven dosing schedule. We aim to evaluate the usability of the UPrEPU app and its effectiveness in improving adherence monitoring. Methods: From May to October 2020, 35 participants were enrolled for the usability study and followed up for 4 months. Blood samples for the drug concentration in the dried blood spots were obtained once during the second to fourth follow-up visits. The effectiveness of adherence monitoring was analyzed using Cohen's kappa statistic to calculate the concordance between the average number of pills taken and drug concentration in the dried blood spots. Results: Overall retention was 91.4% (32 participants) at the end of the study. Participants used the app for a mean of 29 days and made 2565 data entries in total, with an average of 76 data entries. The average systematic usability scale score for the app was 71.5, indicating acceptable usability. Slight agreement was reached between the dried blood spots measurement and the number of pills taken and recorded in the app (weighted kappa: 0.21). Conclusions: Our user-centered UPrEPU app demonstrated that it could accommodate both daily and event-driven dosing schedules for men who have sex with men clients with acceptable usability scores. We confirmed that complex behaviors such as different drug-dosing regimens that are contingent on sexual behaviors could be incorporated into the design of a mobile app.

Condomless Anal Sex Associated With Heterogeneous Profiles Of HIV Pre-Exposure Prophylaxis Use and Sexual Activities Among Men Who Have Sex With Men: A Latent Class Analysis Using Sex Diary Data on a Mobile App.

BACKGROUND: New innovative technologies, such as mobile apps, have been developed to increase pre-exposure prophylaxis (PrEP) adherence and the use of log sex diaries. The contiguity of mobile apps reduces the recall bias that generally affects reported condom and PrEP use. However, none of the currently used mobile apps were designed for event-driven PrEP users, and few studies have demonstrated the potential usage of sex diary data to facilitate the understanding of the different HIV risks among heterogeneous profiles of sex diaries and PrEP use. OBJECTIVE: We aim to discriminate the heterogeneous profiles of sex events and PrEP use and examine the risk of condomless anal sex among different types of sex events. METHODS: We recruited 35 adult men who have sex with men from two medical centers in Taiwan since May 2020 and followed up for four months. Participants were on PrEP or willing to take PrEP. They were asked to log their sex events, PrEP use, and dosing regimens on a mobile app to improve their PrEP adherence. Latent class analysis was used to distinguish profiles of sex events and PrEP use. Indicators included correct intake of PrEP for each sex event, participants' sexual positioning, partner's HIV status, and age. RESULTS: A total of 551 sex events were classified into three classes by latent class analysis: PrEP nonadherent flip-flopping (234/551, 42%), PrEP imperfect-adherent power bottoming (284/551, 52%), and PrEP adherent serodiscordant topping (33/551, 6%). "PrEP nonadherent flip-flopping" sex events were more likely to involve condomless anal sex than "PrEP imperfect-adherent power bottoming" (OR 1.83, 95% CI 1.03-3.25) after considering random intercepts for individuals, and this class needed to increase their PrEP adherence and use of condoms. "PrEP imperfect-adherent power bottoming" realized their own risk and packaged PrEP with condoms to protect themselves. Up to 99% (32/33) of sex events in "PrEP adherent serodiscordant topping" were protected by PrEP, but all of the sex events in this group were condomless. CONCLUSIONS: Using the sex diary data could advance the capacity to identify high-risk groups. HIV prevention strategy should be more flexible and combine PrEP with condom use for future HIV prevention.

Imperfect adherence in real life: a prevention-effective perspective on adherence to daily and event-driven HIV pre-exposure prophylaxis among men who have sex with men - a prospective cohort study in 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.

Factors Associated with Preferred Pre-Exposure Prophylaxis Dosing Regimen Among Men Who Have Sex with Men in Real-World Settings: A Mixed-Effect Model Analysis.

When provided with both choices of pre-exposure prophylaxis (PrEP) in MSM, men may choose to use either method based on their sexual practice. The study objective was to describe the switches between dosing regimens and identify factors that predict choice of a dosing regimen among MSM. We performed a multi-center, observational, prospective PrEP cohort study conducted at three study sites in Taiwan between January 2018 and March 2019. A total of 215 participants made 469 visits. In half of the visits (49.7%), participants reported using on-demand PrEP. There were 36 regimen switches: 20 from daily to on-demand and 16 from on-demand to daily. Among 28 participants who switched regimens, 22 switched regimens once and 6 switched more than once. The frequency of condomless anal sex and a history of post-exposure prophylaxis use were associated with taking PrEP on-demand (p < 0.05). PrEP adherence intervention should be tailored specifically to sexual behavior to increase adherence to PrEP.

RESUMEN: Cuando se les proporcionan ambas opciones de la profilaxis pre-exposición (PrEP) en HSH, los hombres pueden elegir usar cualquiera de los métodos según su práctica sexual. El objetivo del estudio fue describir los cambios entre los regímenes de dosificación e identificar los factores que predicen la elección del régimen de dosificación entre los HSH. Realizamos un estudio de cohorte prospectivo, observacional y multicéntrico de la PrEP realizado en tres sitios de estudio en Taiwán entre enero de 2018 y marzo de 2019. Un total de 215 participantes contribuyeron con 469 visitas. En la mitad de las visitas (49.7%), los participantes informaron haber usado PrEP a pedido. Hubo 36 cambios de régimen: 20 de diario a pedido y 16 de pedido a diario. Entre los 28 participantes que cambiaron de régimen, 22 cambiaron de régimen una vez y 6 cambiaron más de una vez. La frecuencia del sexo anal sin condón y cualquier uso previo de la PEP fueron asociados con la toma de la PrEP a pedido (p < .05). La intervención de adherencia a la PrEP debe adaptarse específicamente al comportamiento sexual para aumentar la adherencia a la PrEP.

Mobile App (UPrEPU) to Monitor Adherence to Pre-exposure Prophylaxis in Men Who Have Sex With Men: Protocol for a User-Centered Approach to Mobile App Design and Development.

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.

Taiwan guideline on oral pre-exposure prophylaxis for HIV prevention - 2018 update.

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.

Differences in awareness of and willingness to use pre-exposure prophylaxis and anticipated condom use among serodiscordant couples in Taiwan.

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.