UNASSIGNED: The US Centers for Disease Control and Prevention recommends HIV testing every 3 months in oral PrEP users. We performed a national assessment of HIV testing compliance among oral PrEP users.
UNASSIGNED: We analyzed 408 910 PrEP prescriptions issued to 39 809 PrEP users using a national insurance claims database that contained commercial and Medicaid claims. We identified PrEP use based on pharmacy claims and outpatient diagnostic coding. We evaluated the percentage of PrEP prescription refills without HIV testing (identified by CPT codes) within the prior 3, 6, and 12 months using time to event methods. We performed subgroup and multivariate analyses by age, gender, race, insurance type, and geography.
UNASSIGNED: Of 39 809 persons, 36 197 were commercially insured, 3612 were Medicaid-insured, and 96% identified as male; the median age (interquartile range) was 34 (29-44) years, and the Medicaid-insured PrEP users were 24% Black/African American, 44% White, and 9% Hispanic/Latinx. Within the prior 3, 6, and 12 months, respectively, the percentage of PrEP prescription fills in individuals without HIV Ag/Ab testing was 34.3% (95% CI, 34.2%-34.5%), 23.8% (95% CI, 23.7%-23.9%), and 16.6% (95% CI, 16.4%-16.7%), and the percentage without any type of HIV test was 25.8% (95% CI, 25.6%-25.9%), 14.6% (95% CI, 14.5%-14.7%), and 7.8% (95% CI, 7.7%-7.9%).
UNASSIGNED: Approximately 1 in 3 oral PrEP prescriptions were filled in persons who had not received an HIV Ag/Ab test within the prior 3 months, with evidence of health disparities. These findings inform clinical PrEP monitoring efforts and compliance with national HIV testing guidance to monitor PrEP users.

BACKGROUND: The syndemic nature of gonococcal infections and HIV provides an opportunity to develop a synergistic intervention tool that could address the need for adequate treatment for gonorrhea, screen for HIV infections, and offer pre-exposure prophylaxis (PrEP) for persons who meet the criteria. By leveraging information available on electronic health records, a clinical decision support (CDS) system tool could fulfill this need and improve adherence to Centers for Disease Control and Prevention (CDC) treatment and screening guidelines for gonorrhea, HIV, and PrEP.
OBJECTIVE: The goal of this study was to translate portions of CDC treatment guidelines for gonorrhea and relevant portions of HIV screening and prescribing PrEP that stem from a diagnosis of gonorrhea as an electronic health record-based CDS intervention. We also assessed whether this CDS solution worked in real-world clinic.
METHODS: We developed 4 tools for this CDS intervention: a form for capturing sexual history information (SmartForm), rule-based alerts (best practice advisory), an enhanced sexually transmitted infection (STI) order set (SmartSet), and a documentation template (SmartText). A mixed methods pre-post design was used to measure the feasibility, use, and usability of the CDS solution. The study period was 12 weeks with a baseline patient sample of 12 weeks immediately prior to the intervention period for comparison. While the entire clinic had access to the CDS solution, we focused on a subset of clinicians who frequently engage in the screening and treatment of STIs within the clinical site under the name \"X-Clinic.\" We measured the use of the CDS solution within the population of patients who had either a confirmed gonococcal infection or an STI-related chief complaint. We conducted 4 midpoint surveys and 3 key informant interviews to quantify perception and impact of the CDS solution and solicit suggestions for potential future enhancements. The findings from qualitative data were determined using a combination of explorative and comparative analysis. Statistical analysis was conducted to compare the differences between patient populations in the baseline and intervention periods.
RESULTS: Within the X-Clinic, the CDS alerted clinicians (as a best practice advisory) in one-tenth (348/3451, 10.08%) of clinical encounters. These 348 encounters represented 300 patients; SmartForms were opened for half of these patients (157/300, 52.33%) and was completed for most for them (147/300, 89.81%). STI test orders (SmartSet) were initiated by clinical providers in half of those patients (162/300, 54%). HIV screening was performed during about half of those patient encounters (191/348, 54.89%).
CONCLUSIONS: We successfully built and implemented multiple CDC treatment and screening guidelines into a single cohesive CDS solution. The CDS solution was integrated into the clinical workflow and had a high rate of use.

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Community-based organizations (CBOs) deliver services in culturally-responsive ways, and could effectively partner with health centers to deliver HIV pre-exposure prophylaxis (PrEP) to Latino men who have sex with men (LMSM). However, few such models exist. We conducted a planning study in collaboration with three CBOs serving LMSM to identify optimal PrEP delivery strategies for health centers and CBOs to implement jointly. We established a Community Expert Panel (CEP) of eight client-facing CBO and health center staff. Over 6 months, the panel met monthly to identify collaborative strategies for PrEP delivery, using a modified Delphi method consisting of the following steps: (1) brainstorming strategies; (2) rating strategies on acceptability, appropriateness and feasibility; (3) review of data from qualitative focus group discussions with CBO clients; and (4) final strategy selection. The panel initially identified 25 potential strategies spread across three categories: improving communication between health centers and CBOs; using low-barrier PrEP options (e.g. telemedicine), and developing locally-relevant, culturally-sensitive outreach materials. Focus groups with CBO clients highlighted a desire for flexible options for PrEP-related care and emphasized trust in CBOs. The final package of strategies consisted of: (1) a web-based referral tool; (2) telemedicine appointments; (3) geographically-convenient options for lab specimen collection; (4) tailored print and social media; and (5) regular coaching sessions with CBO staff. Through a community-engaged process, we identified a package of PrEP delivery strategies that CBOs and health centers can implement in partnership, which have the potential to overcome barriers to PrEP for LMSM.

Several countries in the European Union (EU) and European Economic Area (EEA) established and/or scaled up HIV pre-exposure prophylaxis (PrEP) programmes between 2016 and 2023. Data on PrEP programmes\' performance and effectiveness in reaching those most in need will be needed to assess regional progress in the roll-out of PrEP. However, there is a lack of commonly defined indicators for routine monitoring to allow for minimum comparability. We propose a harmonised PrEP monitoring approach for the EU/EEA, based on a systematic and evidence-informed consensus-building process involving a broad and multidisciplinary expert panel. We present a set of indicators, structured along relevant steps of an adapted PrEP care continuum, and offer a prioritisation based on the degree of consensus among the expert panel. We distinguish between \'core\' indicators deemed essential for any PrEP programme in the EU/EEA, vs \'supplementary\' and \'optional\' indicators that provide meaningful data, yet where experts evaluated their feasibility for data collection and reporting as very context-dependent. By combining a standardised approach with strategic opportunities for adaptation and complementary research, this monitoring framework will contribute to assess the impact of PrEP on the HIV epidemic in Europe.

Testing guidelines for initiation of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) have been developed to ensure appropriate use of PrEP, such as among those with renal dysfunction or at high risk of seroconversion. While many studies have looked at the trends of use of PrEP in the United States, little is known about compliance with these guidelines, the quality of care of PrEP at a national level, or what provider-level factors are associated with high-quality care. We conducted a retrospective claims analysis of providers of commercially insured new users of PrEP between January 1, 2011, and December 31, 2019. Of the 4200 providers, quality of care was low, with only 6.4% having claims for ≥60% of guideline-recommended testing for their patients in the testing window for all visits. More than half of the providers did not have claims for HIV testing at initiation of PrEP and ≥40% did not for sexually transmitted infections at both initiation and follow-up visits. Even when extending the testing window, quality of care remained low. Logistic regression models found no association between provider type and high quality of care, but did find that providers with one PrEP patient were more likely to have higher quality of care than those with multiple patients for all tests [adjusted odds ratio 0.47 (95% confidence interval: 0.33-0.67)]. The study findings suggest further training and interventions, such as integrated test ordering through electronic health records, are needed to increase quality of care for PrEP and ensure appropriate monitoring of patients.

Pregnant and lactating people (PLP) experience heightened risk of acquiring HIV, which adversely impacts their health and increases the risk for vertical HIV transmission. Preexposure prophylaxis (PrEP), as part of a combination prevention package, including condoms, sexually transmitted infection prevention, and regular HIV testing, is a safe, efficacious method to prevent HIV infections among PLP and their infants. This article examines the evolution of strategies and guidance on PrEP services for PLP from 18 countries supported by the U.S. President\'s Emergency Plan for AIDS Relief (PEPFAR).
The 18 countries implement PEPFAR-supported prevention of vertical transmission of HIV and PrEP programs. We reviewed a total of 18 national HIV strategic plans, 28 national HIV guidelines, and 54 PEPFAR country operational plans (COPs) published in 2013-2020. We compared documents from 2013 to 2017 to those from 2017 to 2020 to assess for differences after the release of the 2017 World Health Organization recommendations supporting the use of PrEP by PLP at substantial risk of acquiring HIV.
National HIV guidelines and PEPFAR COPs that endorsed PrEP for PLP through any categorization increased from 41% to 73% and 11% to 83%, respectively, in the pre-2017 and post-2017 periods. While many documents approved PrEP but not specifically for PLP (10 national strategic plans, 6 national guidelines, and 28 COPs), none of the documents explicitly prohibited PrEP for PLP.
National HIV guidelines and PEPFAR COPs expanded inclusion of PLP in PrEP eligibility when comparing the pre-2017 and the post-2017 groups. However, policy gaps remain as only 36% (4/11) of the post-2017 national HIV guidelines included PLP as a specific priority population for PrEP. Inclusive national HIV strategic plans and guidelines on PrEP for PLP, together with effective program implementation, remain critical for reducing new infections in PLP and eliminating vertical transmission of HIV.

Standard-of-care HIV pre-exposure prophylaxis (PrEP) is highly efficacious, but uptake of and persistence on a daily oral pill is low in many settings. Evaluation of alternate PrEP products will require innovation to avoid the unpractically large sample sizes in noninferiority trials. We propose estimating HIV incidence in people not on PrEP as an external counterfactual to which on-PrEP incidence in trial subjects can be compared. HIV recent infection testing algorithms (RITAs), such as the limiting antigen avidity assay plus viral load used on specimens from untreated HIV positive people identified during screening, is one possible approach. Its feasibility is partly dependent on the sample size needed to ensure adequate power, which is impacted by RITA performance, the number of recent infections identified, the expected efficacy of the intervention, and other factors. Screening sample sizes to support detection of an 80% reduction in incidence for 3 key populations are more modest, and comparable to the number of participants in recent phase III PrEP trials. Sample sizes would be significantly larger in populations with lower incidence, where the false recency rate is higher or if PrEP efficacy is expected to be lower. Our proposed counterfactual approach appears to be feasible, offers high statistical power, and is nearly contemporaneous with the on-PrEP population. It will be important to monitor the performance of this approach during new product development for HIV prevention. If successful, it could be a model for preventive HIV vaccines and prevention of other infectious diseases.

Transgender and nonbinary (TG/NB) persons are listed as one of the key populations in the context of HIV, due to increased risk of HIV infection in this group. HIV prevention, which includes a variety of available methods, should therefore be included in the comprehensive health care for TG/NB persons. One such method is the pre-exposure prophylaxis (PrEP), whose high effectiveness in preventing HIV transmission has already been demonstrated in numerous studies conducted in the cisgender population. However, the available empirical data on its use in TG/NB persons are limited in many respects. This issue is also practically absent in the Polish literature; as a consequence, there are significant gaps in recommendations for professionals involved i n the prevention of HIV among TG/NB persons and professionals involved in the comprehensive health care for TG/NB persons. This article 1) outlines the issue of the use of PrEP among TG/NB persons, including the associated challenges for professionals (specialising in physical, as well as mental health); 2) demonstrates the possible applicability of PrEP in TG/NB populations based on available research findings; 3) summarises good practices in counselling and PrEP-related psychoeducational activities, as part of the comprehensive health care for TG/NB individuals.