Kathrine Meyers

Aim Long-acting injectable cabotegravir (CAB-LA) is used for HIV treatment and pre-exposure prophylaxis (PrEP), but substantial inter-individual pharmacokinetic variability, drug-drug interactions, and a prolonged post-discontinuation pharmacokinetic “tail” complicates patient management. No FDA-cleared cabotegravir assay exists. We aimed to develop, validate, and clinically implement an LC-MS/MS assay for therapeutic drug monitoring (TDM) of cabotegravir. Methods We developed and validated an LC-MS/MS assay for cabotegravir in EDTA plasma. Method performance was compared against a reference research assay (Johns Hopkins University Clinical Pharmacology Analytical Laboratory) and between paired plasma specimens collected by venipuncture and a self-collected capillary blood lancet device (Tasso+) in 30 adults receiving cabotegravir-containing injectable therapy. Results The assay was linear from 10 to 10,000 ng/mL, with intra- and inter-day precision (CV%) ≤6.1%. Method comparison against JHU-CPAL (n=48) gave a Deming regression slope of 1.048 (R2=0.99); venipuncture versus Tasso+ comparison (n=40) gave a Deming regression slope of 1.002 (R2=0.99). Cabotegravir was stable in whole blood for ≥7 days at room temperature and ≥1 day at 40°C. Conclusion This LC-MS/MS assay provides accurate, reproducible cabotegravir quantification from venipuncture or self-collected capillary plasma and is in routine clinical use. It enables individualized assessment of cabotegravir exposure, including subtherapeutic concentrations for tail-phase HIV infection risk assessment after CAB-LA PrEP discontinuation as well as trough-level monitoring during active therapy for HIV.

Stigma toward anal sex impedes engagement in health services that are vital to Ending the HIV Epidemic. We evaluated a stigma-reduction training to build HIV worker capacity to address anal pleasure and health during HIV service encounters in China. In a sequential explanatory mixed-methods design, we assessed the training’s preliminary impact on anal health promotion activities and, based on the Theoretical Domains Framework , mechanisms of action among 51 health workers. We conducted descriptive statistics, bivariate comparisons, and thematic analyses based on pre/post-training online surveys and post-training in-depth interviews. The frequency of anal health promotion activities among the 38 participants who completed pre/post-training surveys increased by 7–8% of the scale range, but not significantly ( p -values between 0.06 and 0.08). Mechanisms for discussing anal sex ( knowledge , skills , role responsibility , self-efficacy , organizational acceptability , and positive emotions ) shifted from baseline (5%-36% range), primarily due to boosts in knowledge and skills (28% and 36%, all p < .05). Additional mechanisms of comfort addressing sexual orientation , anal health , and sex-related concerns also increased (4–14% range, all p < .05). Qualitative analysis revealed mechanistic themes of heightened empathy, weakened stereotypes, and a shift toward accepting role responsibility to discuss anal sex. Gay and bisexual workers reported notable personal growth to optimize their own anal health. Although knowledge and communication skills increased provider confidence, some participants remained hesitant to initiate discussion during HIV service encounters. For most participants the theoretically-informed training activities operated as hypothesized, to enhance mechanisms that could increase provider-initiated discussion of anal pleasure and health.

We iteratively designed a novel patient decision aid (PDA) to improve patient-provider communication regarding the benefits, risks, and proper usage of doxycycline as post-exposure prophylaxis (Doxy-PEP). We tested the feasibility, acceptability, and appropriateness of counseling using this PDA among a pilot group in two academic, urban sexual health clinics. Using a pretest-posttest model we assessed the extent to which this intervention impacted participants’ knowledge of and attitudes towards Doxy-PEP. Participants (N = 30) were all assigned male at birth and had at least one sexually transmitted infection in the past year; 30% were living with HIV. We found that counseling using this PDA increased participants’ familiarity with, comfort with, and knowledge of Doxy-PEP. Participants found this intervention to be acceptable, appropriate, and feasible. This model of employing formally evaluated PDAs to enhance patient-provider communication may be adaptable for other public health interventions.

This prospective cohort study evaluated the real-world effectiveness of doxycycline postexposure prophylaxis use in reducing bacterial sexually transmitted infections (STIs) within a diverse urban sexual health program. Propensity-matched analyses showed significant STI reductions, particularly in rectal Chlamydia trachomatis infections, among early adopters. Uptake was disproportionately higher in non-Hispanic White individuals and those more engaged in care. Findings emphasize the need for targeted outreach to improve care engagement and equitable access to this STI prevention strategy. ( Am J Public Health. Published online ahead of print August 14, 2025:e1–e5. https://doi.org/10.2105/AJPH.2025.308209 )

Background: Clients seeking sexual health care often need concurrent mental healthcare services, which were disrupted during the COVID-19 pandemic. Using data from two studies conducted before and after the onset of COVID-19, we examined changes in self-reported depression and anxiety scores among clients in a sexual health clinic in New York City (NYC). Methods: We enrolled 144 participants pre-COVID-19 and 319 post-COVID-19 pandemic onset. Participants completed questionnaires assessing demographics, sexual behaviors, and mental health status. Primary mental outcomes included depression (Patient Health Questionnaire [PHQ-9]) and anxiety (Generalized Anxiety Disorder Scale [GAD-7]). We conducted descriptive analyses and used generalized linear mixed models (GLMM) to estimate predictors of mental health changes. Results: Cohorts were comparable by age, self-identified gender, race/ethnicity, income, HIV, and sexually transmitted infection assessment scores. Post-COVID-19 participants reported significantly higher mean PHQ-9 and GAD-7 scores compared with pre-COVID-19 participants (3.6 ± 4.2 vs 5.7 ± 5.3, P < .001; 3.9 ± 4.3 vs 5.1 ± 5.0; P = .019). Post-COVID-19 participants were also more likely to be uninsured or on Medicaid (2.7% vs 20%, 18% vs 30%, P < .001), and to report intimate partner violence victimization (24% vs 45%, P = .003). Adjusted GLMM showed post-COVID-19 was associated with a 1.55 (95% CI: .07, 3.03, P < .04) mean increase in PHQ-9 scores, but not GAD-7. Conclusions: Depression and anxiety scores increased after the onset of the COVID-19 pandemic in this NYC sexual health clinic sample. The sustained impact of the COVID-19 pandemic on depression calls for integrated, accessible mental health services within sexual health care settings.

Pre-exposure prophylaxis (PrEP) is an effective biomedical intervention to prevent HIV, however uptake of PrEP across the United States has been slow and uneven. Understanding “what it takes” to implement PrEP so that it reaches those groups with the highest rates of new diagnoses is a critically important and understudied question. This descriptive case study details the development of an implementation science tool to guide the introduction of PrEP into new settings. The Universal Stages of Implementation Completion (U-SIC) was customized for the provision of PrEP services (PrEP-SIC) by using subject matter expert recommendations to operationalize PrEP implementation processes into discreet activities. Six clinical sites used the PrEP-SIC retrospectively and prospectively to assess the extent to which the PrEP-SIC activities mapped onto their experience of introducing oral daily, event-driven, and injectable PrEP into their clinical settings. Interviews with site champions and PrEP-SIC data, including proportion of activities completed, were analyzed to refine the PrEP-SIC and identify patterns of implementation behavior. Five themes emerged about the accuracy of the PrEP-SIC to capture real world implementation processes: (1) Some PrEP-SIC activities, such as generating a costing plan, are not reflected in real-world implementation; (2) Sites do not define sustainment as achieving a set of quantitative program goals, but rather as being able to continue a program through staffing turnovers and shortages; (3) Written protocols and reviewing clinic data for program improvement were identified as two key factors that differentiate sites that reached sustainment from sites that did not; (4) The PrEP-SIC is assessed as somewhat useful to guide introduction of PrEP, but pairing the tool with technical assistance or coaching would optimize its utility; (5) Implementation is cyclical and recursive and pre-implementation activities may need to be revisited over time to ensure sustainment. The case study has resulted in a PrEP-SIC that accurately captures an idealized implementation process. Using a well-defined set of implementation activities as a roadmap with supportive services to clinics, like technical assistance or implementation coaching, could direct implementation efforts and facilitate the integration of PrEP into new clinical settings that reach the people who need PrEP the most.

Background: Effective implementation of evidence-based HIV prevention interventions continues to be a challenge in the United States, and the field is increasingly turning to implementation science for solutions. As such, it is critical to expand the current implementation science vocabulary—and its taxonomy of implementation strategies—to increase its relevance and utility for front-line implementers. Setting: Community-based health centers providing HIV prevention services in the southeastern United States. Methods: We conducted a collective case-study analysis, combining document review and qualitative interviews with program directors, clinicians, and other providers (N = 30) at 5 sites. We used an inductive and iterative analytic approach to specify and categorize strategies, and then conducted in-depth cross-case analysis to derive a practice-driven taxonomy of HIV prevention implementation strategies. Results: From an initial matrix of 264 activities, we identified 50 strategies common across sites. In contrast to existing implementation science frameworks, most (68%, n = 34) strategies were designed to affect implementation outcomes (eg, acceptability, adoption, feasibility) for patients. We present a practice-driven taxonomy of these strategies, operationalized according to implementation science literature, but with terminology that more directly relates to implementers. Conclusions: Findings demonstrate the feasibility and utility of this method for developing a practice-driven implementation science vocabulary for HIV prevention. Our evidence-based taxonomy provides a framework for implementers seeking data about the universe of strategies they might consider for their own programs, and increases researchers' ability to measure and evaluate the effectiveness of implementation strategies being enacted in practice settings.

Introduction: Approval of the first long‐acting injectable antiretroviral therapy (LAI ART) medication heralded a new era of HIV treatment. However, the years since approval have been marked by implementation challenges. The “Accelerating Implementation of Multilevel Strategies to Advance Long‐Acting Injectable for Underserved Populations (ALAI UP Project)” aims to accelerate the systematic and equitable delivery of LAI ART.Methods: We coded and analysed implementation barriers according to the Consolidated Framework for Implementation Research (CFIR) domains, desired resources and programme goals from questionnaire short‐answer responses by clinics across the United States responding to ALAI UP's solicitation to participate in the project between November 2022 and January 2023.Results: Thirty‐eight clinics responded to ALAI UP's solicitation. The characteristics of LAI ART as an innovation (cost, complexity of procurement, dosing interval, limited eligibility) precipitated and interacted with barriers in other CFIR domains. Barriers included obtaining coverage for the cost of medication (27/38 clinics) (outer setting); need for new workflows and staffing (12/38) and/or systems to support injection scheduling/coordination (16/38), transportation and expanded clinic hours (13/38) (inner setting); and patient (10/38) and provider (7/38) education (individuals). To support implementation, applicants sought: technical assistance to develop protocols and workflows (18/38), specifically strategies to address payor challenges (8/38); additional staff for care coordination and benefits navigation (17/38); opportunities to share experiences with other implementing clinics (12/38); patient‐facing materials to educate and increase demand (7/38); and support engaging communities (6/38). Clinics’ LAI ART programme goals varied. Most prioritized delivering LAI ART to their most marginalized patients struggling to achieve viral suppression on oral therapy, despite awareness that current US Food and Drug Administration approval is only for virally suppressed patients. The goal for LAI ART reach after 1 year of implementation ranged from ≤10% of patients with HIV on LAI ART (17/38) to ≥50% of patients (2/38).Conclusions: Diverse clinic types are interested in offering LAI ART and most aspire to use LAI ART to support their most vulnerable patients sustain viral suppression. Dedicated resources centred on equity and relevant to context and population are needed to support implementation. Otherwise, the introduction of LAI ART risks exacerbating, not ameliorating, health disparities.

With the rise of new and emerging Pre-Exposure Prophylaxis (PrEP) modalities, greater attention is needed to better understand how people who could benefit from PrEP make decisions to initiate, stop, pause, or switch PrEP regimens. In this study we borrow from the field of consumer research to create a consumer-derived PrEP Consumer Journey Model that describes key decision-making touchpoints a PrEP consumer moves through within and outside of a clinical context. Using in-depth interviews (n = 29) with gay and bisexual men who have sex with men, we evaluate which system 1 (emotional) and system 2 (cognitive) attributes are used for decision-making at different touchpoints along the PrEP Consumer Journey. Our results suggest system 1 attributes, such as feeling protected, reducing anxiety, enhancing pleasure, social norms, and taking ownership over health were more salient when consumers moved from pre-contemplation to information gathering, as well as evaluating post-uptake experience. System 2 attributes, including cost, side effects, dosing schedule, and sexual frequency, were present throughout the PrEP Consumer Journey, but particularly influential in the information gathering stage and when pausing, switching, or opting out of PrEP. We contend the PrEP Consumer Journey, and our findings related to decision-making, can help orient medical providers to anticipated patient concerns around PrEP use and ultimately provide more supportive and engaging PrEP counseling and services.