American Foundation for AIDS Research

HIV testing is required before pre-exposure prophylaxis (PrEP) initiation and recommended before an oral PrEP prescription refill or at the time of a cabotegravir long acting (CAB LA) PrEP injection per the CDC PrEP guidelines. Regular screening for syphilis, gonorrhea, and chlamydia are also recommended, with frequency based on risk characteristics. We describe HIV and sexually transmitted infection (STI) testing practices during CAB LA or oral PrEP use in the OPERA cohort. Adults without HIV who received ≥ 1 CAB LA injection and/or an oral PrEP prescription in the OPERA cohort (21DEC2021-30JUN2023) were followed through 30JUN2024. Individuals could contribute to multiple PrEP episodes, defined as continuous use of a specific PrEP type (CAB LA, oral). Incidence rates (IR) of HIV and STI testing (univariate Poisson regression) and proportions of individuals receiving HIV or STI testing at relevant intervals were estimated from 14 days before, up to 12 months after, PrEP episode start. A total of 1,025 CAB LA PrEP episodes and 22,776 oral PrEP episodes were included. HIV testing occurred twice as frequently on CAB LA PrEP (IR: 5.93; 95% confidence interval [CI]: 5.76, 6.10) than oral PrEP (IR: 2.92; 95% CI: 2.90, 2.95) (Fig 1). Similarly, STI testing occurred 1.5 times more frequently on CAB LA PrEP (IR: 5.18; 95% CI: 5.02, 5.35) than oral PrEP (IR: 3.42; 95% CI: 3.39, 3.44) (Fig 2). Both HIV and STI testing were more likely to occur at the predefined intervals during CAB LA PrEP than oral PrEP episodes (Fig 3). The difference was most pronounced for HIV testing (55% vs 14%) and STI testing every 3 months (37% vs 15%). The 12-month HIV incidence rates per 100 person-years were 0.18 (95% CI: 0.03, 1.26) for CAB LA and 0.59 (95% CI: 0.50, 0.71) for oral PrEP. HIV PrEP clinical care represents an opportunity to provide sexual health-related services. In this large, real-world US cohort of PrEP users, HIV acquisition rates were low. However, HIV testing was suboptimal, raising concerns for delayed HIV diagnosis and treatment. Rates of both HIV and STI testing were significantly higher during CAB LA PrEP use than oral PrEP use. These results suggest that increased clinical contact from regular CAB LA PrEP injection visits may encourage more frequent HIV and STI testing among PrEP users. Laurence Brunet, PhD, Gilead Sciences: Grant/Research Support|Merck & Co.: Grant/Research Support|Theratechnologies Inc.: Grant/Research Support|ViiV Healthcare: Grant/Research Support Jennifer S. Fusco, BS, Gilead Sciences: Grant/Research Support|Merck & Co.: Grant/Research Support|Theratechnologies Inc: Grant/Research Support|ViiV Healthcare: Grant/Research Support Karam Mounzer, MD, Aspire Scientific: Medical writing support|Gilead Sciences: Advisor/Consultant|Gilead Sciences: Grant/Research Support|Gilead Sciences: Honoraria|Gilead Sciences: Medical writing support Supriya Sarkar, PhD, MPH, ViiV Healthcare: Stocks/Bonds (Public Company) Kimberley Brown, PharmD, ViiV Healthcare: Employee|ViiV Healthcare: Stocks/Bonds (Public Company) Harmony Garges, MD, GSK: I am an employee of ViiV Healthcare|GSK: Stocks/Bonds (Public Company) Vani Vannappagari, MBBS, MPH, PhD, ViiV Healthcare: Full time Employee of ViiV Healthcare and owns GSK stock|ViiV Healthcare: Stocks/Bonds (Public Company) Gregory P Fusco, MD, MPH, Gilead: Grant/Research Support|Merck: Grant/Research Support|Theratechnologies: Grant/Research Support|Viiv: Grant/Research Support

Introduction:Viral load (VL) testing is the recommended approach for monitoring antiretroviral therapy (ART) effectiveness, while guidelines recommend targeted CD4 testing after ART initiation. This study examined trends in VL and CD4 testing frequencies, as well as the relationship with AIDS diagnosis and mortality among people with HIV in the Asia-Pacific region. Methods:We included adults enrolled in the Treat Asia HIV Observational Database (TAHOD) between 2003-2018 who had been on ART for ≥1 year. VL and CD4 testing rates were analysed using Poisson regression models. Associations between testing frequency and AIDS diagnosis or mortality were evaluated using Fine and Gray competing risk regression. Results:Among 8,446 patients, VL testing rates remained steady at 1 per person-year (PYS) between 2003-2018. Increased VL testing was associated with more frequent CD4 testing (>2 tests in the previous year; IRR=1.57, 95%CI 1.53-1.60), later follow-up years (2008-2012: IRR=1.15, 95%CI 1.12-1.18; 2013-2015: IRR=1.07, 95%CI 1.04-1.10), older age (31-40 years: IRR=1.06, 95%CI 1.03-1.08; 41-50 years: IRR=1.08, 95%CI 1.05-1.11; >50 years: IRR=1.07, 95%CI 1.03-1.11), higher current VL (401-1000 copies/mL: IRR=1.16, 95%CI 1.09-1.24; >1000 copies/mL: IRR=1.07, 95%CI 1.04-1.11), initial ART regimen (NRTI+PI: IRR=1.07, 95%CI 1.04-1.10; other combinations: IRR=1.11, 95%CI 1.05-1.17), and higher country income levels (upper-middle: IRR=2.17, 95%CI 2.11-2.23; high: IRR=3.14, 95%CI 3.03-3.26). CD4 testing rates decreased from 2.04 to 1.06/PYS over the same period. Lower CD4 testing frequency was associated with HIV exposure mode (MSM: IRR=0.94, 95%CI 0.92-0.96; IDU: IRR=0.93, 95%CI 0.90-0.97; other/unknown: IRR=0.90, 95%CI 0.87-0.93), higher current CD4 (201-350 cells/μL: IRR=0.95, 95%CI 0.93-0.97; 351-500 cells/μL: IRR=0.89, 95%CI 0.87-0.91; >500 cells/μL: IRR=0.85, 95%CI 0.83-0.87) and receiving an NRTI+PI first-line combination (IRR=0.96, 95% CI 0.94-0.98). VL and CD4 testing frequencies were not significantly associated with AIDS diagnosis. However, having > 2 CD4 tests in the previous year was associated with higher mortality risk. Conclusion:The trends in the rates for CD4 and VL testing in the region between 2003-2018 were significantly affected by demographic, clinical and socio-economic factors. Recognizing these factors is critical to optimizing differentiated monitoring strategies and improving outcomes for PWH in the region.

Introduction: HIV care and treatment programs around the world continue to evolve in response to changes in clinical guidelines, evidence-based practices, domestic and donor funding for the HIV response, new technological developments, and changing weather patterns. Since 2009, the International epidemiology Databases to Evaluate AIDS (IeDEA) research consortium has conducted periodic surveys to document the characteristics of participating clinics and the availability of HIV-related services across diverse settings -- information that provides important context for understanding variations and trends in HIV care outcomes. This paper describes the protocol for IeDEA's 2026 site assessment survey, launched in August 2026. Methods and analysis: This cross-sectional descriptive study aims to document HIV-related services and practices among clinics in 42 countries. The survey explores the characteristics and services provided at HIV care and treatment sites participating in IeDEA in 2026, along with real-world adoption and implementation of evidence-based service delivery strategies for people living with or at risk of HIV. Designed for self-administration, the survey questionnaire was developed through two complementary processes: a review of questions and data collected through IeDEA' prior consortium-wide surveys and an open call to IeDEA investigators for new survey content to advance a timely implementation science agenda relevant to the global HIV community. Survey materials and links to an online REDCap questionnaire will be distributed to 232 eligible clinics across IeDEA in September 2026, with a deadline of November 30, 2026, for completion. Planned analyses will examine the following topics: HIV care amidst funding constraints; the roll-out of differentiated service delivery models; pre-exposure HIV prophylaxis; long-acting injectable antiretroviral therapy (ART); prevention, screening and/or treatment services for viral hepatitis, mental health and substance use disorders, cardiovascular disease, and cancers among PLHIV; the integration of HIV care with other health services; and clinic vulnerability to extreme weather events. Ethics and dissemination: A "non-human subjects" research designation was determined by the Vanderbilt University Medical Center Human Research Protections Program. Survey findings will be shared with local partners and stakeholders across IeDEA, disseminated at regional and global conferences, and published in peer-reviewed journals. ### Competing Interest Statement The authors have declared no competing interest. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study will be available upon reasonable request to the authors National Institutes of Health's National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Cancer Institute, the National Institute of Mental Health, the National Institute on Drug Abuse, the National Heart, Lung, and Blood Institute, the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Diabetes and Digestive and Kidney Diseases, and the Fogarty International Center