OBJECTIVES: To determine the impact of increased long-acting injectable antiretroviral therapy (Cabotegravir-rilpivirine [CAB/RPV]) use among persons with diagnosed HIV (PWDH) with viral suppression (VLS), per 2021 US Food and Drug Administration (FDA) guidelines, on HIV incidence and levels of VLS in the US. METHODS: We used the HOPE compartmental model to simulate CAB/RPV use during 2023-2035. We first simulated a baseline scenario (no CAB/RPV), in which 69% of PWDH had VLS. We then introduced CAB/RPV in 2023 under two scenarios: (1) where CAB/RPV improved the duration of VLS post-cessation of ART use compared to oral ART; (2) where CAB/RPV additionally improved adherence. We compared cumulative 2023-35 incidence and percentage of PWDH with VLS at year-end 2035 to baseline. RESULTS: When CAB/RPV increased the duration of VLS only, cumulative incidence was reduced up to 9%, and VLS increased up to 4%. When CAB/RPV also improved ART adherence, incidence was reduced up to 19.5%, and VLS increased up to 9%. CONCLUSIONS: CAB/RPV, even if only used among PWDH with VLS, may reduce HIV incidence and increase VLS, due to longer-lasting VLS post-cessation of usage. If CAB/RPV also improves ART adherence, incidence is further reduced. Improved clinical efficacy of CAB/RPV may translate to improved population-level outcomes, even in limited use cases.

BACKGROUND: In 2019, there were an estimated 1.2 million persons with HIV (PWH) and 35,100 new infections in the United States. The HIV care continuum has a large influence on transmission dynamics. METHODS: We updated Progression and Transmission of HIV 3.0, an agent-based simulation model, to estimate 2019 HIV transmission rates and distribution of transmissions by the HIV care continuum, race/ethnicity, transmission group, and age group. RESULTS: In 2019, the estimated transmission rate in the United States was 2.94 new infections per 100 person-years (inf /100p-y). Transmission rates decreased along the HIV care continuum; the highest transmission rate was associated with persons with acute HIV infection and unaware of their HIV status at 16.35 inf /100p-y, followed by persons with HIV (non-acute) and unaware of their HIV status (9.52), persons aware of their HIV status and not in care (5.96), persons receiving HIV care (on antiretroviral therapy) but not virally suppressed (4.53), and persons virally suppressed (0). The highest transmission rate by transmission group was among men who have sex with men at 3.68 inf /100p-y. Transmission rates decreased as age increased and are similar by race/ethnicity, after accounting for the HIV care continuum. CONCLUSION: Our results support a continued emphasis on helping PWH move along the care continuum through early diagnosis, linkage to care, and adherence to ART, resulting in viral suppression to reduce HIV transmissions. Further, efforts should focus on reducing disparities in the provision of HIV prevention and care services, particularly for populations disproportionally affected by HIV.

BACKGROUND: The OraQuick In-Home HIV self-test represents a fast, inexpensive, and convenient method for users to assess their HIV status. If integrated thoughtfully into existing testing practices, accompanied by efficient pathways to formal diagnosis, self-testing could enhance both HIV awareness and reduce HIV incidence. However, currently available self-tests are less sensitive, particularly for recent infection, when compared to gold-standard laboratory tests. It is important to understand the impact if some portion of standard testing is replaced by self-tests. We used a compartmental model to evaluate the effects of self-testing in diverse scenarios among gay, bisexual and other men who have sex with men (MSM) in the United States for the period 2020-2030, and to understand which scenarios maximize the advantages of self-testing. METHODS: We introduced a novel 4-compartment model for HIV self-testing. We employed the model under different screening rates, self-test proportions, and delays to diagnosis for those identified through self-tests to determine the potential effects of self-testing on HIV incidence and awareness of status when applied to the US MSM population. We studied scenarios in which self-tests supplement laboratory-based tests, with no replacement, and scenarios in which some replacement occurs. We also examined how future improvements in self-test sensitivity may affect our results. RESULTS: When HIV self-tests are supplemental rather than substitutes for laboratory-based testing, self-testing can decrease HIV incidence among MSM in the US by up to 10 % and increase awareness of status among MSM from 85 % to 91 % over a 10-year period, provided linkage to care and formal diagnosis occur promptly following a positive self-test (90 days or less). As self-tests replace a higher percentage laboratory-based testing algorithms, increases in overall testing rates were necessary to ensure reductions in HIV incidence. However, such needed increases were relatively small (under 10 % for prompt engagement in care and moderate levels of replacement). Improvements in self-test sensitivity and/or decreases in the detection period may further reduce any necessary increases in overall testing by up to 40 %. CONCLUSIONS: If properly utilized, self-testing can provide significant long-term reductions to HIV incidence and improve awareness of HIV status. Ensuring that self-testing increases overall testing and that formal diagnosis and engagement in care occur promptly following a positive self-test are necessary to maximize the benefits of self-testing. Future improvements in self-test sensitivity and reductions in the detection period would further reduce HIV incidence and the potential risks associated with replacing laboratory tests with self-tests.

OBJECTIVES: To identify studies promoting the use of artificial intelligence (AI) or automation with HIV pre-exposure prophylaxis (PrEP) care and explore ways for AI to be used in PrEP interventions. DESIGN: Systematic review. METHODS: We searched in the US Centers for Disease Control and Prevention Research Synthesis database through November 2023 PROSPERO (CRD42023458870). We included studies published in English that reported using AI or automation in PrEP interventions. Two reviewers independently reviewed the full text and extracted data by using standard forms. Risk of bias was assessed using either the revised Cochrane risk-of-bias tool for randomized trials for randomized controlled trials or an adapted Newcastle-Ottawa Quality Assessment Scale for non-randomized studies. RESULTS: Our search identified 12 intervention studies (i.e., interventions that used AI/automation to improve PrEP care). Currently available intervention studies showed AI/automation interventions were acceptable and feasible in PrEP care while improving PrEP-related outcomes (i.e., knowledge, uptake, adherence, discussion with care providers). These interventions have used AI/automation to reduce workload (e.g., directly observed therapy) and helped non-HIV specialists prescribe PrEP with AI-generated clinical decision-support. Automated tools can also be developed with limited budget and staff experience. CONCLUSIONS: AI and automation have high potential to improve PrEP care. Despite limitations of included studies (e.g., the small sample sizes and lack of rigorous study design), our review suggests that by using aspects of AI and automation appropriately and wisely, these technologies may accelerate PrEP use and reduce HIV infection.

BACKGROUND: The COVID-19 pandemic impacted sexual behaviors and the HIV continuum-of-care in the United States, reducing HIV testing and diagnosis, and use of pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART). We aim to understand the future implications of these effects through a modeling study. METHODS: We first ran our compartmental model of HIV transmission in the US accounting for pandemic-related short-term changes in transmission behavior and HIV prevention and care provision in 2020-2021 only. We then ran a comparison scenario that did not apply pandemic effects but assumed a continuation of past HIV prevention and care trends. We compared results from the two scenarios through 2024. RESULTS: HIV incidence was 4·4% lower in 2020-21 for the pandemic scenario compared with the no-pandemic scenario due to reduced levels of transmission behavior, despite reductions in HIV prevention and care caused by the pandemic. However, reduced care led to less viral load suppression among people with HIV (PWH) in 2020 and, in turn, our model resulted in a slightly greater incidence of 2·0% from 2022-24 in the COVID-19 scenario, as compared to the non-COVID scenario. DISCUSSION: Disruptions in HIV prevention and care services during COVID-19 may lead to somewhat higher post-pandemic HIV incidence, than assuming pre-pandemic trends in HIV care and prevention continued. These results underscore the importance of continuing to increase HIV prevention and care efforts in the coming years.

OBJECTIVE: :COVID-19 and related disruptions led to a significant decline in HIV diagnoses in the US in 2020. A previous analysis estimated 18% fewer diagnoses than expected among persons with HIV (PWH) acquiring infection in 2019 or earlier, suggesting that the decline in overall diagnoses cannot be attributed solely to decreased transmission. This analysis evaluates the progress made towards closing the 2020 diagnosis deficit in 2021. METHODS: :We apply previously developed methods analyzing 2021 diagnosis data from the National HIV Surveillance System to determine whether 2021 diagnosis levels of PWH infected pre2020 are above or below the expected pre-COVID trends. Results are stratified by assigned sex at birth, transmission group, geographic region, and race/ethnicity. RESULTS: :In 2021, HIV diagnoses returned to pre-COVID levels among all PWH acquiring infection 2011-19. Among Hispanic/Latino PWH and males, diagnoses returned to pre-COVID levels. White PWH, men who have sex with men, and PWH living in the south and northeast showed higher-than-expected levels of diagnosis in 2021. For the remaining populations, there were fewer HIV diagnoses in 2021 than expected. CONCLUSIONS: :While overall diagnoses among persons acquiring HIV pre2020 returned to pre-COVID levels, the diagnosis gap observed in 2020 remained unclosed at the end of 2021. Fewer than expected diagnoses among certain populations indicate that COVID-19 related disruptions to HIV diagnosis trends remained in 2021. Although some groups showed higher-than-expected levels of diagnoses, such increases were smaller than corresponding 2020 decreases. Expanded testing programs designed to close these gaps are essential.

BACKGROUND: Whether the COVID-19 pandemic has had a disproportionate impact on mortality among persons with diagnosed HIV (PWDH) in United States is unclear. Through our macro-scale analysis, we seek to better understand how the COVID-19 pandemic affected mortality among PWDH. METHODS: We obtained mortality and population data for the years 2018-2020 from the National HIV Surveillance System (NHSS) for the U.S. PWDH population, and from publicly available data for the general population. We computed mortality rates and excess mortality for both the general and PWDH populations. Stratifications by age, race/ethnicity, and sex were considered. For each group, we determined whether the 2020 mortality rates and mortality risk ratio showed a statistically significant change from 2018-2019. RESULTS: Approximately 1550 excess deaths occurred among PWDH in 2020, with Black, Hispanic/Latino and PWDH 55 and older comprising the majority of excess deaths. Mortality rates increased in 2020 from 2018-2019 across the general population in all groups. Among PWDH, mortality rates either increased, or showed no statistically significant change. These increases were similar to, or smaller than, those observed in the general population, resulting in a 7.7% decrease in the mortality risk ratio between PWDH and the general population. CONCLUSIONS: While mortality rates among PWDH increased in 2020 relative to 2018-2019, the increases were smaller, or of similar magnitude, to those observed in the general population. We thus do not find evidence of elevated mortality risk from the COVID-19 pandemic among PWDH. These findings held across subpopulations stratified by age, sex, and racial/ethnic group.

Background: Whether COVID-19 has had a disproportionate impact on mortality among persons with diagnosed HIV (PWDH) in United States is unclear. Through our macro-scale analysis, we seek to better understand how COVID-19 and subsequent behavioral changes affected mortality among PWDH. Method(s): We obtained mortality and population size data for the years 2018-2020 from the National HIV Surveillance System (NHSS) for the PWDH population aged >=13 years in the United States, and from publicly available data for the general population. We computed mortality rates and excess mortality for both the general and PWDH populations. Stratifications by age, race/ethnicity, and sex-at birth were considered. For each group, we determined whether the 2020 mortality rates and mortality risk ratio showed a statistically significant change from 2018-2019. Result(s): Mortality rates increased in 2020 from 2018-2019 across the general population in all groups. Among PWDH, mortality rates either increased, or showed no statistically significant change. The mortality risk ratio between PWDH and the general population decreased 7.7% in 2020. Approximately 1550 excess deaths occurred among PWDH in 2020, with Black, Hispanic/Latino and PWDH above 55 and older representing the majority of excess deaths. Conclusion(s): While mortality rates among PWDH increased in 2020 relative to 2018-2019, the increases were smaller than those observed in the general population. This suggests that COVID-19 and resulting behavioral changes among PWDH did not result in disproportionate mortality among PWDH. These findings suggest that COVID-19, and any associated indirect effects, do not represent a proportionally greater risk for PWDH compared to the general population. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license.

Background: Diagnoses of HIV in the US decreased by 17% in 2020 due to COVID-related disruptions. The extent to which this decrease is attributable to changes in HIV testing versus HIV transmission is unclear. We seek to better understand this issue by analyzing the discrepancy in expected versus observed HIV diagnoses in 2020 among persons who acquired HIV between 2010-2019, as changes in diagnosis patterns in this cohort cannot be attributed to changes in transmission. Method(s): We developed three methods based on the CD4-depletion model to estimate excess missed diagnoses in 2020 among persons with HIV (PWH) infected from 2010-2019. We stratified the results by transmission group, sex assigned at birth, race/ethnicity, and region to examine differences by group and confirm the reliability of our estimates. We performed similar analyses projecting diagnoses in 2019 among PWH infected from 2010-2018 to evaluate the accuracy of our methods against surveillance data. Result(s): There were approximately 3100-3300 (approximately 18%) fewer diagnoses than expected in 2020 among PWH infected from 2010-2019. Females (at birth), heterosexuals, persons who inject drugs, and Hispanic/Latino PWH missed diagnoses at higher levels than the overall population. Validation and stratification analyses confirmed the accuracy and reliability of our estimates. Conclusion(s): The substantial drop in number of previously infected PWH diagnosed in 2020, suggests that changes in testing played a substantial role in the observed decrease. Levels of missed diagnoses differed substantially across population subgroups. Increasing testing efforts and innovative strategies to reach undiagnosed PWH are needed to offset this diagnosis gap. These analyses may be used to inform future estimates of HIV transmission during the COVID-19 pandemic. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license.

BACKGROUND: Diagnoses of HIV in the United States decreased by 17% in 2020 due to COVID-related disruptions. The extent to which this decrease is attributable to changes in HIV testing versus HIV transmission is unclear. We seek to better understand this issue by analyzing the discrepancy in expected versus observed HIV diagnoses in 2020 among persons who acquired HIV between 2010 and 2019 because changes in diagnosis patterns in this cohort cannot be attributed to changes in transmission. METHODS: We developed 3 methods based on the CD4-depletion model to estimate excess missed diagnoses in 2020 among persons with HIV (PWH) infected from 2010 to 2019. We stratified the results by transmission group, sex assigned at birth, race/ethnicity, and region to examine differences by group and confirm the reliability of our estimates. We performed similar analyses projecting diagnoses in 2019 among PWH infected from 2010 to 2018 to evaluate the accuracy of our methods against surveillance data. RESULTS: There were approximately 3100-3300 (approximately 18%) fewer diagnoses than expected in 2020 among PWH infected from 2010 to 2019. Females (at birth), heterosexuals, persons who inject drugs, and Hispanic/Latino PWH missed diagnoses at higher levels than the overall population. Validation and stratification analyses confirmed the accuracy and reliability of our estimates. CONCLUSIONS: The substantial drop in number of previously infected PWH diagnosed in 2020 suggests that changes in testing played a substantial role in the observed decrease. Levels of missed diagnoses differed substantially across population subgroups. Increasing testing efforts and innovative strategies to reach undiagnosed PWH are needed to offset this diagnosis gap. These analyses may be used to inform future estimates of HIV transmission during the COVID-19 pandemic.