Journal of the International AIDS Society最新文献

{"title":"HIV post-exposure prophylaxis in community settings and by lay health workers or through task sharing: a systematic review of effectiveness, case studies, values and preferences, and costs","authors":"Caitlin E. Kennedy, Rahel Dawit, Ping Teresa Yeh, Michelle Rodolph, Nathan Ford, Heather-Marie A. Schmidt, Robin Schaefer, Rachel Baggaley, Virginia Macdonald","doi":"10.1002/jia2.26448","DOIUrl":"https://doi.org/10.1002/jia2.26448","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Post-exposure prophylaxis (PEP) for HIV prevention has been inadequately promoted, provided and used. Expanded access and task sharing could increase the HIV prevention impact of PEP, but scientific evidence to inform programmatic and policy decisions has not been synthesized.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>To inform World Health Organization guidelines, we conducted a systematic review of studies examining the provision of PEP in community settings, and by trained lay health workers or through task sharing. We searched CINAHL, PsycINFO, PubMed, EMBASE and scientific conferences for studies published between January 2012 and October 2023. We screened abstracts and extracted data in duplicate. The effectiveness review included randomized controlled trials and comparative observational studies; risk of bias was assessed using Cochrane Collaboration and Evidence Project tools, and the certainty of the evidence was assessed using GRADE. We also summarized implementation case studies, values and preferences studies, and cost and cost-effectiveness studies.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>For provision of PEP in community settings, we identified one effectiveness study, three case studies, one values and preferences study, and one cost study. Very low certainty evidence from one study in Kenya and Uganda suggested that PEP uptake, when offered as part of a dynamic prevention package, was highest in the community setting (vs. outpatient or antenatal care settings). For provision of PEP by trained lay health workers or task sharing, we identified three effectiveness studies, two case studies, four values and preferences studies, and one cost study. Very low certainty evidence from Kenya, Uganda and the United States suggested that engagement of lay providers or pharmacists increased PEP uptake and completion and decreased HIV acquisition. Studies from six countries found most health workers supported PEP provision by non-specialist providers. One modelling study suggested community-based provision may be cost-effective or cost-saving in Africa.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>Evidence on expanding PEP access through community delivery or task sharing is limited but generally suggests positive outcomes, feasibility, acceptability and cost-effectiveness of these approaches. Indirect evidence from HIV treatment and pre-exposure prophylaxis further supports these approaches.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 5","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26448","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144148622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The lavender purge","authors":"Kenneth H. Mayer","doi":"10.1002/jia2.26509","DOIUrl":"https://doi.org/10.1002/jia2.26509","url":null,"abstract":"<p>In May 1933, the Nazis looted Berlin's Institute for Sexual Science, founded by the highly regarded researcher, Dr. Magnus Hirschfeld, destroying his archives in a book burning. Hirschfeld recognized that although most humans are cisgender heterosexuals, sexual and gender minorities have existed throughout human history, and their behaviours and identities needed to be considered as part of the human continuum [<span>1</span>]. Sexual orientation, gender identity and sexual behaviours do not necessarily overlap in uniform and predictable ways; each domain may vary throughout the life course, and may be expressed in different ways in diverse cultures.</p><p>Over the past few months, the Trump Administration has issued Executive Orders from the President that have promulgated policies that are detrimental to the lives of sexual, gender, racial and ethnic minorities, as well as people living in low- and middle-income countries who have been affected by HIV and other major public health challenges. One manifestation of these orders has been that hundreds of researchers have received notices from several United States government agencies, including the National Institutes of Health (NIH, the major funder of health research in the United States), as well as the Centers for Disease Control and Prevention (the major funder of public health programmes in the United States), that stated: “This award no longer effectuates agency priorities. Research programs based primarily on artificial and nonscientific categories, including amorphous equity objectives, are antithetical to the scientific inquiry, do nothing to expand our knowledge of living systems, provide low returns on investment, and ultimately do not enhance health, lengthen life, or reduce illness.” The Trump Administration terminated studies that it deemed to be too focused on “gender ideology” and “diversity, equity and inclusion.” The spate of NIH grant terminations for research studies that addressed sexual behaviour, gender identity, discrimination and health equity among other proscribed topics (e.g. climate change) is reminiscent of earlier regressive periods.</p><p>The studies that were terminated had undergone the rigorous process of peer review, wherein applications were examined by external experts, scored and discussed with NIH project officers who then determined which projects were fundable after discussions with their institutes’ leadership. The process is rigorous and highly competitive. Only 10–20% of applications that are submitted for consideration ultimately get funded, so the terminations eliminated research that was deemed to be highly promising after careful assessment. The same rigor applied to the programmes funded by the CDC, USAID and PEPFAR, resulting in the abrupt elimination of needed services for millions.</p><p>The recent NIH, PEPFAR and USAID terminations have not been based on objective evidence. A prime example of how the Trump Administration actions have been p","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 5","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26509","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144131550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility and acceptability of peer-delivered HIV and syphilis self-test kits and assisted partner notification services for gay, bisexual and other men who have sex with men: a qualitative study in Uganda","authors":"Stephen Okoboi,&nbsp;Andrew Mujugira,&nbsp;Deborah Ekusai-Sebatta,&nbsp;Adeline Twimukye,&nbsp;Peninah Tumuhimbise,&nbsp;Brian Aliganyira,&nbsp;Barbara Castelnuovo,&nbsp;Rachel King","doi":"10.1002/jia2.26456","DOIUrl":"https://doi.org/10.1002/jia2.26456","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>There is a need to combine different approaches to tackle the HIV epidemic, particularly in high-incidence populations. We explored the feasibility and acceptability of using peer-delivered HIV self-testing (HIVST), syphilis self-testing (SST) and assisted partner notification (APN) services among gay, bisexual and other men who have sex with men (GBMSM) in Uganda.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>From November 2023 to March 2024, we conducted in-depth interviews with 20 purposively selected GBMSM peers and 10 healthcare workers (HCWs). The GBMSM and HCWs interviews explored their perspectives on (1) the feasibility, acceptability and preferences for peer-delivered interventions (HIVST, SST and APN) and (2) strategies and methods of reaching individuals who had not been tested or tested more than 6 months before the interview. We used a content analysis approach to define and organize codes deductively and inductively to identify themes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The median age of the 20 GBMSM peers was 27 years (interquartile range [IQR], 22–35 years), and 37 years (IQR, 25–52) for the 10 HCWs, of whom seven were female. We identified four emerging categories: (1) <i>Trust</i>: GBMSM peers and HCWs expressed trust in the peer delivery of self-test kits (HIVST and SST) to obtain same-day results effectively. HCWs were preferred over peers for APN services in reaching sexual contacts of index clients for testing; (2) <i>Intimate partner violence (IPV)</i>: Although initial concerns about IPV were raised concerning both HIVST programmes and peer APN strategies, such incidents were rarely reported in practice; (3) <i>Entry point</i>: Similar to HIVST, SST was a self-administered activity that served as an entry point for HIV testing discussions among GBMSM who had either never undergone or had postponed testing. Self-test kits could also facilitate pre-sexual testing among GBMSM; (4) <i>Social media</i>: Campaigns on social media dedicated to promoting self-testing could expand testing coverage services to GBMSM vulnerable to HIV and syphilis acquisition.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>HCWs and GBMSM peers preferred delivery of self-test kits through peers over facility-based approaches; however, they favoured HCWs for providing APN services. Integrating peer-delivered self-testing programmes into differentiated testing models and leveraging social media influencers could expand testing coverage among GBMSM.</p>\u0000 </section>\u0000 </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 5","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26456","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144091810","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dosing forgiveness of oral PrEP for cisgender women remains uncertain","authors":"Mia Moore,&nbsp;David Glidden,&nbsp;Peter Anderson,&nbsp;Craig Hendrix,&nbsp;Dobromir Dimitrov","doi":"10.1002/jia2.26496","DOIUrl":"https://doi.org/10.1002/jia2.26496","url":null,"abstract":"&lt;p&gt;Pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) has been proven safe and effective for preventing HIV acquisition, when taken daily, in men and transgender women who have sex with men (MSM/TGW) and cisgender women (hereafter, women). Based on existing evidence, we can have high confidence that as few as 4 pills per week reduce HIV incidence by at least 90% in MSM/TGW. In addition, a “2-1-1” regimen in which two pills are taken prior to a potential HIV exposure followed by one pill in each of the two following days has been clinically proven to substantially reduce HIV incidence in MSM/TGW. However, the same level of support is not yet available for either dosing forgiveness or the efficacy of “2-1-1” event-driven PrEP in women.&lt;/p&gt;&lt;p&gt;One of the most controversial notions in HIV therapeutics is whether women require different adherence or dosing strategies compared with MSM/TGW by virtue of differences in drug distribution between the female genital tract and rectal tissue [&lt;span&gt;1, 2&lt;/span&gt;]. The TDF/FTC adherence-efficacy curve has previously been established in MSM/TGW using levels of intraerythrocytic tenofovir-diphosphate (TFV-DP) in incident cases of HIV and matched controls from iPrEx, iPrEx OLE and recently reinforced with HPTN 083 [&lt;span&gt;3-5&lt;/span&gt;].&lt;/p&gt;&lt;p&gt;Four secondary analyses have assessed the relationship between TDF/FTC adherence and HIV incidence in women [&lt;span&gt;5-8&lt;/span&gt;]. These analyses have prompted renewed discussion on the dosing forgiveness in this population and their potential to benefit from on-demand PrEP [&lt;span&gt;2, 9, 10&lt;/span&gt;]. Here, we outline the methodological differences in the latest studies and discuss potential implications for clinical practice guidelines.&lt;/p&gt;&lt;p&gt;Of the four analyses, three concluded that women need to adhere to daily dosing to achieve a 90% reduction in HIV incidence (Figure 1). Two subgroup analyses of non-randomized cohorts of PrEP users compared HIV incidence in those with high adherence to low adherence [&lt;span&gt;5, 8&lt;/span&gt;]. First, women enrolled in HPTN 084 and MSM/TGW enrolled in HPTN 083 had their adherence assessed with intraerythrocytic TFV-DP, which quantifies adherence over the prior 1–2 months. HIV incidence in those assessed to take &lt;2, 2–3, 4–6 or 7 pills per week was compared to HIV incidence in those with no quantifiable TFV-DP [&lt;span&gt;5&lt;/span&gt;]. Although the confidence intervals were wide, this analysis suggested that women need to adhere to daily pills to gain the same benefit from PrEP as MSM/TGW taking 2–3 pills per week. Second, a meta-analysis analysed the adherence of 6296 women enrolled in 11 demonstration projects over 8 years [&lt;span&gt;8&lt;/span&gt;]. HIV incidence was calculated in four sub-populations based on adherence which was assessed by various methods including self-report and drug concentrations. The reduction in HIV incidence among those taking 4–6 and 7 pills per week compared to those taking &lt;2 was comparable to","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 5","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26496","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"HIV pre-exposure prophylaxis initiation in community safe spaces increases PrEP access among key populations in Zambia","authors":"Linah K. Mwango,&nbsp;Caitlin Baumhart,&nbsp;Brianna Lindsay,&nbsp;Pawel Olowski,&nbsp;Henry Sakala,&nbsp;Chimika Phiri,&nbsp;Cassidy W. Claassen,&nbsp;Marie-Claude C. Lavoie","doi":"10.1002/jia2.26487","DOIUrl":"https://doi.org/10.1002/jia2.26487","url":null,"abstract":"&lt;p&gt;Comprehensive HIV prevention initiatives in Zambia are significantly blunting the epidemic spread. Between 2010 and 2021, new HIV acquisitions decreased by &gt;50% [&lt;span&gt;1&lt;/span&gt;], due to increased access to antiretroviral therapy (ART), comprehensive prevention and scale-up of pre-exposure prophylaxis (PrEP) since 2018. With these advancements, Zambia is nearing HIV epidemic control, with 88.7% of people living with HIV aware of their status; 98.0% of those are on ART, 96.3% of whom are virally suppressed [&lt;span&gt;2&lt;/span&gt;].&lt;/p&gt;&lt;p&gt;Yet, 1.5 million Zambians remain at high risk of acquiring HIV, with about 810,000 ever-initiating PrEP. Oral PrEP decreases the risk of HIV acquisition by more than 90% [&lt;span&gt;3-5&lt;/span&gt;], poses few safety risks, and unlike barrier methods, can be taken discreetly and independently [&lt;span&gt;6&lt;/span&gt;]. As of 2023, over four million people initiated PrEP globally [&lt;span&gt;4, 7&lt;/span&gt;]. While sub-Saharan Africa represents over 70% of the global HIV burden, the region only accounts for 44% of global PrEP initiations, with Zambia contributing just 9% [&lt;span&gt;1, 7, 8&lt;/span&gt;].&lt;/p&gt;&lt;p&gt;The CIRKUITS community PrEP programme expanded from four safe spaces in two districts to 13 safe spaces in 12 districts between October 2020 and September 2022. The programme now has 194 staff members, including 154 KP-CHWs, 13 community liaison officers and 27 nurses, in addition to 140 gatekeepers. CHW retention increased from 57% in year 1 to 82% in year 2 after implementing measures like standardized stipends and transport reimbursement.&lt;/p&gt;&lt;p&gt;From 1st October 2021 to 1st March 2023, among 6,583 individuals eligible for and willing to start PrEP, 6,567 (99.8%) initiated PrEP at prevention posts. Among KPs, TG had the highest PrEP uptake, with all 241 (100%) initiating PrEP. PrEP uptake was also high among FSW (3,254/3,262; 99.8%); MSM (2,674/2,681; 99.7%); and PWID (398/399; 99.7%) (Figure 1). PrEP initiation rates were consistently high across all KPs, age groups and provinces, with near 100% uptake. By region, the highest PrEP uptake was in Western Province; by age, PrEP uptake was the highest among persons aged 45 years and above.&lt;/p&gt;&lt;p&gt;For PrEP perseverance at month 1, 67.8% of initiated clients continued PrEP; this decreased to 36.2% at 3 months. Among KPs, TG had the highest PrEP continuation at 1 month (75.9%), while MSM had the highest continuation at month 3 (37.7%). PWID had the lowest PrEP continuation rates, at both 1 month (63.6%) and 3 months (26.6%).&lt;/p&gt;&lt;p&gt;We found community PrEP initiation through community prevention health posts to be an effective strategy for reaching underserved KPs in Zambia with biomedical HIV prevention interventions. However, PrEP persistence remained overall low, despite the implementation of multiple supportive strategies, including motivational interviewing regarding stigma and pill fatigue, peer support groups, flexible service delivery models like community-based refills and phone consultations, and ","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 5","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26487","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144091930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"No significant drug−drug interaction between oral TAF-based PrEP and feminizing hormone therapy among transgender women in Thailand: the iFACT-3 study","authors":"Akarin Hiransuthikul,&nbsp;Narukjaporn Thammajaruk,&nbsp;Stephen Kerr,&nbsp;Rena Janamnuaysook,&nbsp;Siriporn Nonenoy,&nbsp;Piranun Hongchookiat,&nbsp;Rapee Trichavaroj,&nbsp;Yardpiroon Tawon,&nbsp;Jakkrapatara Boonruang,&nbsp;Nipat Teeratakulpisarn,&nbsp;Tim R. Cressey,&nbsp;Peter L. Anderson,&nbsp;Nittaya Phanuphak,&nbsp;the iFACT3 study team","doi":"10.1002/jia2.26502","DOIUrl":"https://doi.org/10.1002/jia2.26502","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Concerns regarding potential drug−drug interaction (DDI) between feminizing hormone therapy (FHT) and HIV pre-exposure prophylaxis (PrEP) may hinder PrEP use among transgender women. We assessed the potential DDI between FHT and emtricitabine-tenofovir alafenamide (F/TAF)-based PrEP among transgender women.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Transgender women without HIV who never underwent orchiectomy were enrolled between January and February 2022. Oral FHT (oestradiol valerate 2 mg and cyproterone acetate 25 mg) was initiated at baseline and continued until week 9, while oral PrEP (F/TAF 200/25 mg) was initiated at week 3 and continued until week 12. Intensive blood sampling was performed at weeks 3 and 9 to assess the impact of PrEP on FHT; and weeks 9 and 12 to assess the impact of FHT on PrEP. Pharmacokinetics (PKs) of plasma oestradiol (E2), TAF, tenofovir (TFV) and emtricitabine (FTC); urine TFV and FTC; and tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) in peripheral blood mononuclear cells (PBMCs) and rectal tissues were assessed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Eighteen participants completed all PK visits. No significant differences in PK parameters for plasma E2, TAF and TFV were observed with FHT and F/TAF administration. The geometric mean of FTC AUC₀₋₂₄ at week 9 was 9% lower than at week 12, but the 90% CI (0.88−0.95) remained within the 80–125% range. There were no significant differences in PBMCs and rectal tissues TFV-DP and FTC-TP concentrations when F/TAF was administered with FHT.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>No bidirectional clinically significant DDI between FHT and F/TAF-based PrEP was observed across systemic and local tissue anatomical compartments, supporting the use of oral F/TAF-based PrEP among transgender women.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Clinical Trial Number</h3>\u0000 \u0000 <p>NCT04590417</p>\u0000 </section>\u0000 </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 5","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26502","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144091811","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Status of HIV vaccine development: progress and promise","authors":"Barton F. Haynes,&nbsp;Kevin O. Saunders,&nbsp;Beatrice H. Hahn,&nbsp;Kevin Wiehe,&nbsp;Lindsey R. Baden,&nbsp;George M. Shaw","doi":"10.1002/jia2.26489","DOIUrl":"https://doi.org/10.1002/jia2.26489","url":null,"abstract":"&lt;p&gt;HIV Vaccine Awareness Day (HVAD) each year commemorates President Bill Clinton's 1997 declaration that “only a truly effective preventive HIV vaccine can limit and eventually eliminate the threat of AIDS.” Here, we review recent progress that the HIV vaccine field has made in inducing protective broadly neutralizing antibodies (bnAbs) that can prevent HIV acquisition. Several papers provide further review and discussion of the concepts discussed in this Viewpoint [&lt;span&gt;1-3&lt;/span&gt;].&lt;/p&gt;&lt;p&gt;An HIV bnAb-based vaccine has been difficult to develop because of the extensive genetic variability of HIV, its heavily glycosylated and conformationally masked envelope (Env) surface protein and the need to induce durable high levels of multiple bnAb specificities to achieve protection [&lt;span&gt;4&lt;/span&gt;]. In addition, because HIV mutates so rapidly, it will be necessary to induce multiple types of bnAbs to fully cover the broad range of variants.&lt;/p&gt;&lt;p&gt;One solution to inducing naturally disfavoured bnAbs is to design immunogens that target naïve bnAb B cell precursors, expand them and select for improbable mutations that are roadblocks for bnAb affinity maturation [&lt;span&gt;5, 6&lt;/span&gt;]. Following naïve B cell priming, sequential immunization with Env immunogens with increasing affinities will be needed to mature bnAb lineages along desired pathways [&lt;span&gt;5, 7&lt;/span&gt;]. Thus, iterative vaccine design in animal models and in small Phase I clinical trials is required to assess the many steps in such a complex vaccine strategy. Such trials in the HIV Vaccine Trials Network (HVTN) are called Discovery Medicine trials [&lt;span&gt;8&lt;/span&gt;]. Figure 1 shows the bnAb target epitopes on the HIV envelope for which a degree of success in inducing B cell lineages has been achieved by vaccination in immunoglobulin humanized mice, non-human primates or humans. What follows here are brief updates on trials that have initiated immunization with bnAb B cell lineages primarily in either non-human primates or in humans by vaccination.&lt;/p&gt;&lt;p&gt;Gp41 membrane proximal external region (MPER) bnAbs are among the most broadly reactive HIV antibodies. An MPER peptide-liposome priming immunogen designed to mimic gp41 bnAb binding sites and bind to a prototype bnAb naïve B cell receptor was used in the HVTN 133 clinical trial. B cells were induced that bound to the proximal MPER bnAb epitope—the most potent of these antibodies neutralized 35% of heterologous clade B and 17% of global HIV isolates [&lt;span&gt;9&lt;/span&gt;]. The HVTN 133 trial demonstrated that antibody mutations that take years to develop in people living with HIV (PLWH) can be induced by vaccination in months. Work is ongoing to expand the breadth and potency of induced bnabs by the design of boosting immunogens to target MPER sequences of contemporary global HIV strains.&lt;/p&gt;&lt;p&gt;CD4 binding site (CD4bs) bnAbs are both potent and broad and thus represent key vaccine targets. There are two types of CD4bs bnAbs, which include those that mimic","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 5","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26489","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144074456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The changing cost-effectiveness of primary HIV prevention: simple calculations of direct effects","authors":"Geoff P. Garnett,&nbsp;Joshua T. Herbeck,&nbsp;Adam Akullian","doi":"10.1002/jia2.26494","DOIUrl":"https://doi.org/10.1002/jia2.26494","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Over the course of the HIV pandemic, prevention and treatment interventions have reduced HIV incidence, but there is still scope for new prevention tools to further control HIV. Studies of the cost-effectiveness of HIV prevention tools are often done using detailed, “transmission-aware” models, but there is a role for simpler analyses.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>We present equations to calculate the cost-effectiveness, budget impact and epidemiological impact of HIV prevention interventions including equations allowing for multiple interventions and heterogeneity in risk across populations. As HIV incidence declines, the number needed to cover to prevent one HIV acquisition increases. Along with the benefits of averting HIV acquisitions, the cost-effectiveness of HIV prevention interventions is driven by incidence, along with efficacy, duration and costs of the intervention. The budget impact is driven by cost, size of the population and coverage achieved, and impact is determined by the effective coverage of interventions. HIV incidence has declined in sub-Saharan Africa, making primary HIV prevention less cost-effective and decreasing the price at which new prevention products provide value. Heterogeneity in risk could in theory allow for focusing HIV prevention, but current screening tools do not appear to sufficiently differentiate risk in populations where they have been applied. The simple calculations shown here provide rough initial estimates that can be compared with more sophisticated transmission dynamic and health economic models.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Simple equations show how the observed declines in HIV incidence in sub-Saharan Africa make primary prevention tools less cost-effective. If we require prevention to be more cost-effective, either we need primary prevention tools to be used disproportionately by those most at risk of acquiring HIV, or they need to be less expensive.</p>\u0000 </section>\u0000 </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 5","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26494","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144074454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A severe dismantling of LGBTQI+ health equity and equality: impact of new U.S. policies on the global response to HIV","authors":"Sean Robert Cahill","doi":"10.1002/jia2.26485","DOIUrl":"https://doi.org/10.1002/jia2.26485","url":null,"abstract":"&lt;p&gt;Since 20 January 2025, the new U.S. administration has deployed what is likely to be an illegal and unconstitutional “shock and awe” strategy to effectively dismantle entire government agencies that fund healthcare and humanitarian aid around the world, and to repeal policies and programmes supporting LGBTQI+ health equity and equality both in domestic and global policies. Although several executive orders target the so-called promotion of “gender ideology,” and transgender people in particular, U.S. agencies and private entities are overcomplying, even in the absence of rules and regulations requiring them to do so, ending programmes supporting LGBQTI+ individuals. This includes research on health disparities affecting LGBTQI+ people in the United States and around the world. Global programmes supporting LGBTQI+ communities, a key foreign policy goal of previous U.S. administrations, have been abruptly ended, leaving sexual and gender minority people even more vulnerable than they already were.&lt;/p&gt;&lt;p&gt;Specifically, on his first day in office, President Trump issued three executive orders that affect health equity in the United States. The first opposed alleged “gender ideology extremism” [&lt;span&gt;1&lt;/span&gt;]. It defined sex as referring to “an individual's immutable biological classification as exclusively male and female,” and stated that “[a]gencies shall take all necessary steps, as permitted by law, to end the Federal funding of gender ideology.” This has led to the defunding of hundreds of existing U.S. National Institutes of Health (NIH) research grants that included LGBTQI+ participants and HIV prevention and care research studies, and to new applications being abruptly removed from NIH consideration. It could also eventually restrict healthcare entities’ ability to provide gender-affirming care.&lt;/p&gt;&lt;p&gt;Executive orders related to “gender ideology extremism” [&lt;span&gt;2&lt;/span&gt;] repealed a January 2021 executive order that prohibited discrimination by the federal government on the basis of sexual orientation and gender identity (SOGI) [&lt;span&gt;3&lt;/span&gt;]. The rescinding of SOGI non-discrimination under U.S. law could have a grave impact on the ability of LGBTQI+ people to find employment, earn an income, and access housing, healthcare and other public services. While the 2020 U.S. Supreme Court ruling in &lt;i&gt;Bostock v. Clayton County, Georgia&lt;/i&gt;, prohibits anti-gay and anti-transgender discrimination in employment nationwide [&lt;span&gt;4&lt;/span&gt;], LGBTQI+ Americans continue to experience routine discrimination in many settings. A 2022 survey found that more than one-third of LGBTQI+ Americans reported experiencing discrimination in the past year. More than one in five respondents said that they delayed or avoided medical care due to experiences of discrimination [&lt;span&gt;5&lt;/span&gt;].&lt;/p&gt;&lt;p&gt;A third executive order targeted Diversity, Equity and Inclusion (DEI) initiatives [&lt;span&gt;6&lt;/span&gt;]. As a result of this EO, U.S. government agencies have removed informa","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 5","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26485","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144074455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Inequities in PrEP annualized pill-day coverage, United States, 2018–2022: a cross-sectional pharmacoequity analysis","authors":"Patrick S. Sullivan,&nbsp;Eric Hall,&nbsp;Heather Bradley,&nbsp;Elizabeth S. Russell,&nbsp;Cory R. Woodyatt","doi":"10.1002/jia2.26459","DOIUrl":"https://doi.org/10.1002/jia2.26459","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Pre-exposure prophylaxis (PrEP) is highly effective in reducing the risk of HIV acquisition, but the population-level impact of PrEP depends on the proportion of people with PrEP indications who use it (coverage) and how long they stay on it while at risk (persistence). We aimed to assess the extent to which PrEP persistence varied by race/ethnicity, sex and age.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Previously reported methods and US commercial pharmacy data identified PrEP users and days covered. We calculated PrEP Days Covered (PDC) as the annual number of pills dispensed (i.e., pill-days) overall and by sex, race/ethnicity and age group. Statistical differences by demographic characteristics were calculated. To assess the potential impact of 2-1-1 PrEP dosing on median days of PrEP use, we compared 2018 and 2022 (pre- and post-US Public Health Service guideline for 2-1-1 dosing).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>There were 225,180 PrEP users in 2018, and 459,984 in 2022. In 2022, the median PDC was 167 (IQR: 67, 308). There were 90 versus 180 median PDC for female and male users, respectively (difference of 90 PDC, 95% CI, 89.6−90.4). Among PrEP users with race/ethnicity data, the median PDC was higher for White non-Hispanic (NH) (290 days) than Hispanic (268 days) or Black NH (251 days) users. Older users had significantly more PDC than younger users (&lt;16 years: 60 days; 16–29 years: 120 days; 30–64 years: 191 days). Residents of states with PrEP-Drug Assistance Programs (PrEP-DAP) or Medicaid expansion had higher median PrEP duration than states without programmes. Median days covered for 2018 (154 days) and 2022 (167 days) did not suggest that the addition of the 2-1-1 PrEP guideline was associated with fewer covered days.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>PrEP programmes are often evaluated by enumerating people who used PrEP at any time during a year; our data indicate that significant differences in days of PrEP covered among users might mask further inequities in PrEP protection among women, and Black, Hispanic and younger people. Evaluations of PrEP equity should include a pharmacoequity component by assessing days covered as an additional indicator of PrEP equity.</p>\u0000 </section>\u0000 </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 5","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26459","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143944835","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}