Project title
愛滋病防治整合型研究計畫 (VIII)
Internal ID
MOHW115-CDC-C-104-000109
Principal Investigator
Start Date
January 1, 2026
End Date
December 31, 2026
Organizations
Partner Organizations
Ministry of Health and Welfare
HIV/AIDS Control and Study Center (VIII) = 愛滋病防治整合型研究計畫 (VIII)
Keywords
sexually transmitted infection；
rapid diagnostic tests；
self-testing
HIV
viral hepatitis
syphilis
gonorrhea
Description
Subproject 1: Effectiveness Analysis of Novel HIV and Sexually Transmitted Infections Screening Tools Sexually transmitted infections (STIs) such as HIV, chlamydia, gonorrhea, syphilis, and viral hepatitis cause significant disease burden globally. Many STIs are asymptomatic in early stages, and if not diagnosed and treated promptly, may lead to serious complications. Traditional testing relies on laboratory serological or nucleic acid amplification tests, requiring professional sampling with long waiting times, preventing high-risk populations from timely diagnosis and treatment. Healthcare providers lack immediate testing tools and can only provide empirical treatment based on symptoms, easily missing asymptomatic infections and leading to antibiotic overuse that causes drug resistance. Recent years have seen rapid development of rapid diagnostic tests (RDTs) and self-testing technologies that provide immediate or short-term test results, including pathogen antigen detection, host antibody detection, and pathogen nucleic acid detection techniques. These technologies improve testing accessibility in resource-limited areas, community outreach programs, and high-risk populations, shortening the interval between diagnosis and treatment, promoting early diagnosis, immediate treatment, and partner notification, helping to reduce transmission chains. This subproject adopts a prospective observational design, recruiting approximately 50-100 cases of people with HIV, HIV Pre-exposure prophylaxis (PrEP) users, or STI consultees at multiple medical institutions including National Taiwan University Hospital. This subproject will evaluate various novel rapid test reagents, including simultaneous antigen-antibody testing for HIV, syphilis, and viral hepatitis; nucleic acid testing for chlamydia, gonorrhea, and trichomonas; HPV antigen testing; and HIV viral load rapid testing. By comparing rapid test reagents with existing clinical testing in terms of patient acceptance, time interval from testing to treatment, cost-effectiveness, and combining questionnaire surveys to understand user needs and satisfaction, we aim to provide evidence-based support for future STI screening strategies and policy planning, achieving WHO's 2030 STI control goals. Subproject 2: Mpox and Sexual Transmitted Infections Epidemiological Trend Monitoring Since the 1990s, global STI incidence has continued to rise, primarily attributed to changes in high-risk sexual behavior patterns, including finding sexual partners through mobile dating apps, chemsex, and group sex. Among gay, bisexual, and other men who have sex with men (GBMSM), STI infection risk is particularly significant. Although HIV infection rates have shown a declining trend with advances in anti-HIV drugs and widespread use of HIV PrEP, other bacterial STIs, such as syphilis, gonorrhea, and chlamydia, continue to rise. Additionally, the global Mpox outbreak since 2022 has accumulated over 150,000 confirmed cases as of August 2025, with transmission highly correlated with high-risk sexual networks. Taiwan's current STI surveillance system relies mainly on post-diagnosis reporting by medical institutions; however, this passive surveillance approach may not fully reflect actual community prevalence. Many infected individuals are reluctant to seek medical screening due to asymptomatic infections or social stigma, and some STIs are not yet included in mandatory reporting categories, resulting in insufficient data support for true community STI prevalence and antimicrobial resistance patterns. This subproject uses a cross-sectional study design, collaborating with non-profit organizations such as the Red Ribbon Foundation and Taiwan Tongzhi Hotline to provide anonymous screening services for Mpox and STIs to individuals seeking HIV or syphilis screening services. Through advanced multiplex PCR technology, the research team will simultaneously detect multiple pathogens in a single specimen, including Chlamydia, Gonorrhea, and Mycoplasma genitalium, and conduct antimicrobial resistance gene analysis. Specimens will be collected from participants' oral, urethral, and anal sites, with questionnaires collecting clinical symptoms, demographic data, risk behaviors, and antimicrobial exposure history. This subproject focuses not only on epidemiological data collection but also on establishing horizontal cooperation models with community organizations. The research team will establish real-time data feedback systems, share prevalence data with non-profit organizations, and provide medical referral recommendations for screening-positive cases. Through understanding community-level infection transmission patterns, this project aims to provide more precise risk assessment information, thereby strengthening community-level STI prevention and response capabilities, establishing a more comprehensive monitoring and prevention system for Taiwan's sexual health promotion work. Subproject 3: Utilizing Digital Tools and Medical Monitoring to Establish PrEP Case Management Models for Improving Adherence and Prevention Effectiveness This project addresses adherence issues among HIV PrEP users by developing innovative monitoring and support models. Although PrEP is an effective biomedical intervention for preventing HIV infection in high-risk populations, in real-world applications, users often discontinue medication due to personal barriers (such as low risk perception, forgetting to take medication, drug side effects), social barriers (discrimination and stigma), and structural barriers (lack of correct information channels), affecting prevention effectiveness. This subproject adopts a dual-track strategy to address these issues. First, establishing a digital case management model using LINE chatbots combined with bidirectional feedback mechanisms, COM-B behavioral theory framework, and motivational interviewing techniques to provide personalized medication reminders and psychological support. This system will provide daily or event-driven medication reminders for 150-200 PrEP users, monitor adherence through weekly self-assessment questionnaires, and automatically trigger human care when continuous low adherence is detected. Clinical services are simultaneously integrated, including regular STI screening (Gonorrhea, Chlamydia, Mycoplasma genitalium) and prevention education. Second, developing objective drug concentration monitoring methods to assess medication adherence. Traditional self-report or questionnaire-based assessment methods lack objectivity. This subproject will detect tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) concentrations using dried blood spots for 40-50 PrEP users and develop more convenient volumetric absorptive microsampling (VAMS) home collection technology. VAMS uses specially designed absorptive cotton tips that can precisely collect fixed volumes of blood samples, allowing users to self-collect at home and mail to testing facilities, greatly improving convenience and reducing bias from sampling time differences. Through combining digital management with objective monitoring technology, this project aims to establish more precise and feasible PrEP adherence support models, not only reducing user discontinuation due to various barriers but also providing reliable monitoring tools for clinical care and public health policy, ultimately improving HIV prevention effectiveness and promoting healthcare accessibility and equity for high-risk populations. Subproject 4: HIV Drug Resistance Monitoring and Clinical Impact Analysis of Adherence and Resistance in Treatment-Difficult Cases Following the Joint United Nations Programme on HIV/AIDS' promotion of the 95-95-95 strategy, aimed at reducing HIV transmission through widespread diagnosis and immediate treatment to achieve the goal of ending AIDS infections by 2030, antiretroviral therapy (ART) has proven effective in reducing viral load. When people with HIV (PWH)' viral loads are reduced to undetectable levels, they cannot transmit to sexual partners (U=U). Taiwan has seen continued decline in newly diagnosed infections since 2017 with the promotion of antiviral drug treatment, demonstrating the importance of current first-line treatment. However, HIV drug resistance mutations remain a major treatment challenge. Resistance may result from poor medication adherence, insufficient drug concentrations, or direct infection with resistant viral strains. According to previous studies, resistance prevalence among treatment-naive infected individuals in Taiwan from 2016-2022 has not changed despite shifts in treatment drugs. NNRTI drugs maintain high resistance rates, and with increased integrase strand transfer inhibitor (INSTI) use, first-generation INSTI resistance shows slight upward trends, with second-generation INSTI resistance rates exceeding 1% for the first time in 2022, requiring continued monitoring. This subproject conducts resistance testing on three populations, including lenacapavir resistance: (1) newly diagnosed PWH not yet receiving antiviral treatment, for analyzing pre-treatment resistance prevalence; (2) PWH experiencing viral rebound or treatment failure during treatment, analyzing associations between treatment resistance and adherence; (3) PWH who discontinued medication for more than three months before restarting treatment, understanding viral changes and resistance after treatment interruption. The subproject will collect blood specimens from November 2024 to October 2025, perform resistance gene testing, and combine retrospective analysis data from previous projects to provide important references for clinicians' drug selection. This research not only monitors HIV resistance prevalence trends in Taiwan but also evaluates resistance impact on newly diagnosed infected individuals' treatment outcomes, providing scientific evidence for personalized treatment strategies for infected individuals, with important significance for achieving 95-95-95 strategy goals. Subproject 5: Long-term Care Service Needs Assessment and Integrated Medical Care Service Model for Middle-aged and Elderly People with HIV With advances in ART, HIV infection has transformed from a fatal disease to a controllable chronic condition, but has brought new challenges, particularly aging-related care needs. Taiwan's HIV-infected population structure is rapidly aging, with individuals over 50 accounting for 23% of all PWH in 2024, reaching 35.8% at National Taiwan University Hospital. It is estimated that by 2036, approximately 27,000 PWH will be over 50, accounting for 52% of all infected individuals. This trend makes long-term care needs for middle-aged and elderly PWH an important public health issue. Existing research shows HIV-infected individuals face serious care discrimination problems, with rejection rates as high as 57.6% among those actually needing care services. This predicament stems from complex factors including medical discrimination and care difficulties, mental health and internal stigma, and support systems and economic conditions. Additionally, metabolic syndrome prevalence among HIV-infected individuals reaches 25.3%, with those receiving antiretroviral therapy at 25.6%, significantly increasing diabetes and cardiovascular disease risks. This subproject adopts a three-pronged strategy to explore these issues. First, using the Kihon Checklist (basic health and life function assessment scale) for PWH over 55 to understand aging conditions in elderly infected individuals compared with non-infected individuals. This scale covers six major areas including motor function, nutritional status, oral function, cognitive function, depression risk, and social participation, and is an effective screening tool developed in Japan that has been widely applied in Taiwan's elderly care. Second, through qualitative research design, deeply exploring long-term care service workers' feelings and experiences in caring for PWH. This part will recruit 20 experienced care workers for in-depth interviews, using thematic analysis to analyze their care willingness, difficulties and challenges, and needed support to understand the real attitudes and needs of care providers. Third, providing innovative digital health intervention programs (such as mobile dietary applications or continuous glucose monitoring) for HIV-infected individuals with metabolic syndrome. This subproject aims to deeply understand the current care needs of elderly PWH through comprehensive research design and provide innovative health management solutions, laying an important foundation for building a friendly and effective HIV long-term care system.