Journal of the International AIDS Society最新文献

{"title":"HIV pre-exposure prophylaxis initiation in community safe spaces increases PrEP access among key populations in Zambia","authors":"Linah K. Mwango, Caitlin Baumhart, Brianna Lindsay, Pawel Olowski, Henry Sakala, Chimika Phiri, Cassidy W. Claassen, Marie-Claude C. Lavoie","doi":"10.1002/jia2.26487","DOIUrl":"https://doi.org/10.1002/jia2.26487","url":null,"abstract":"<p>Comprehensive HIV prevention initiatives in Zambia are significantly blunting the epidemic spread. Between 2010 and 2021, new HIV acquisitions decreased by >50% [<span>1</span>], 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 [<span>2</span>].</p><p>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% [<span>3-5</span>], poses few safety risks, and unlike barrier methods, can be taken discreetly and independently [<span>6</span>]. As of 2023, over four million people initiated PrEP globally [<span>4, 7</span>]. 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% [<span>1, 7, 8</span>].</p><p>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.</p><p>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.</p><p>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%).</p><p>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}

{"title":"Evaluation of point-of-care diagnostics for sexually transmitted infection on oral PrEP initiation and persistence among young people in South Africa: a randomized controlled study","authors":"Dvora Joseph Davey,&nbsp;Lauren Fynn,&nbsp;Elzette Rousseau,&nbsp;Pippa Macdonald,&nbsp;Bryan Leonard,&nbsp;Keitumese Lebelo,&nbsp;Ande Kolisa,&nbsp;Francesca Little,&nbsp;Linda-Gail Bekker","doi":"10.1002/jia2.26488","DOIUrl":"https://doi.org/10.1002/jia2.26488","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Introduction&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Pre-exposure prophylaxis (PrEP) services are linked to increased sexually transmitted infection (STI) diagnoses, which may facilitate PrEP uptake. We hypothesized that point-of-care (POC) STI testing and treatment would improve PrEP initiation and persistence.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Methods&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Between September 2023 and November 2024, we conducted a single-centre, open-label, unblinded, randomized controlled trial among adolescent girls and young women (15−29 years old) or male partners (any age). Participants were randomized 1:1 to standard syndromic STI management (SOC) or POC testing for &lt;i&gt;C. trachomatis&lt;/i&gt;, &lt;i&gt;N. gonorrhoeae&lt;/i&gt;, syphilis and &lt;i&gt;T. vaginalis&lt;/i&gt; (women only). All participants received standard HIV prevention counselling, including the offer of oral PrEP. The primary outcome was effect of POC STI testing versus syndromic management on PrEP initiation; secondary outcomes included persistence at 1 and 4 months (PrEP prescription), verified in the secondary analysis of tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) in a random subset. TFV-DP in DBS was analysed in a subset. Analysis was intention-to-treat, adjusted for age and sex.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Results&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;We enrolled and randomized 900 participants (452 in intervention; 448 in SOC). The mean age was 20.4 years (SD = 4.2); 48% were female. In the intervention arm, 435 received POC STI testing (96%); 25% (110 of 435 tested) were diagnosed with =&gt;1 STIs; 84% were treated. In SOC, 7% of participants reported symptoms of STIs (31); 88% were treated (27). Overall, 64% of participants in SOC versus 62% in intervention-initiated PrEP (RR = 0.98, 95% CI = 0.88ng women and partners1.08). In the intervention, 41% persisted on PrEP at 1 month and 25% through 4 months, compared to 46% and 19%, respectively, in SOC (aRR intervention = 1.39; 95% CI = 0.93−2.09; &lt;i&gt;p&lt;/i&gt; = 0.08). In participants treated for STIs or syndromically, 77% initiated PrEP versus 60% untreated/diagnosed (aRR = 1.14; 95% CI = 1.02−1.27); 19% versus 14% persisted on PrEP at 4 months (aRR STI/syndrome treated = 1.41; 95% CI = 0.79−2.51). Overall, 30% of 64 DBS had any TFV-DP levels present with no difference by study arm (RR = 0.74; 95% CI: 0.38−1.41).&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Conclusions&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;POC STI testing did not increase PrEP initiation or 1-month persistence but showed a moderate association with 4-month persistence. STI treatment (syndromic or confirmed) was linked to higher PrEP uptake and persistence. Integrating STI ","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 5","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26488","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143938854","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":"Low-level viraemia as a risk factor for virologic failure in children and adolescents living with HIV on antiretroviral therapy in Tanzania: a multicentre, retrospective cohort study","authors":"Kevin P. McKenzie,&nbsp;Duc T. Nguyen,&nbsp;Lilian B. Komba,&nbsp;Eunice W. Ketang'enyi,&nbsp;Neema E. Kipiki,&nbsp;Evance N. Mgeyi,&nbsp;Lumumba F. Mwita","doi":"10.1002/jia2.26474","DOIUrl":"https://doi.org/10.1002/jia2.26474","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Viral load (VL) of 1000 copies/ml or greater is commonly used to define virologic failure (VF) in children and adolescents living with HIV (CALHIV) in low- and middle-income countries (LMICs). However, evidence in adults suggests that low-level viraemia (LLV) (VL 50–999 copies/ml) increases the risk of subsequent VF. There is limited research on LLV in CALHIV.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This study retrospectively reviewed VL data from Baylor College of Medicine Children's Foundation—Tanzania (sites in Mbeya and Mwanza) collected between January 2015 and December 2022. CALHIV (0−19 years) on antiretroviral therapy for ≥6 months with at least one VL &lt;50 copies/ml plus ≥2 subsequent VLs were included. VF was defined as both VL ≥1000 and ≥200 copies/ml. Multivariable Cox regression models were used to assess the association between LLV and VF, reporting adjusted hazard ratios (aHR) with 95% confidence intervals (CI).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Among 2618 CALHIV included in the outcome analysis (median age 13.2 years, 52.5% female), 81.9% were on first-line dolutegravir-based regimens and LLV was found in 40.5%. CALHIV with LLV had an increased risk of VF with aHRs of 1.63 (CI 1.38−1.91) (VL ≥1000 copies/ml) and 3.85 (3.33, 4.46) (VL ≥200 copies/ml). When stratifying by LLV (50−199, 200–399 and 400–999 copies/ml), all levels were associated with increased risk for VF (VL ≥1000 copies/ml) with aHRs of 1.39 (1.13, 1.69), 1.69 (1.33, 2.16) and 2.03 (1.63, 2.53). When VF was defined as VL ≥200 copies/ml, the corresponding aHRs were 1.41 (1.15, 1.72), 7.99 (6.68, 9.57) and 9.37 (7.85, 11.18).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>LLV is associated with a greater risk of VF in CALHIV. The risk of VF increases with higher levels of LLV. This study provides further evidence for revising guidelines in LMICs that define VF as VL ≥1000 copies/ml.</p>\u0000 </section>\u0000 </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 5","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26474","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143938855","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":"ART to prevent vertical transmission in Latin America: where are we in the “Treat-All” era?","authors":"Gabriel Castillo-Rozas,&nbsp;Fernanda F. Fonseca,&nbsp;Jessica Castilho,&nbsp;Peter F. Rebeiro,&nbsp;Daisy M. Machado,&nbsp;Marco Tulio Luque,&nbsp;Emilia M. Jalil,&nbsp;Fernando Mejia,&nbsp;Ahra Kim,&nbsp;Bryan E. Shepherd,&nbsp;Claudia P. Cortes","doi":"10.1002/jia2.26411","DOIUrl":"https://doi.org/10.1002/jia2.26411","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Antiretroviral therapy (ART) during pregnancy and at delivery has nearly eliminated vertical transmission (VT) in some settings but previously reported VT prevalence has been as high as 15% in Latin America and the Caribbean (LAC). We evaluated VT in the Caribbean, Central and South America network for HIV epidemiology to further study the benefit of ART on VT in our region.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We retrospectively collected data on cis-gender women ≥15 years of age enrolled in HIV clinics in Brazil, Chile, Honduras and Peru from 2003 to 2018 with ≥1 pregnancy resulting in a live birth after clinic entry to examine the association of ART use at the time of delivery and VT. We used propensity-score-matched logistic regression to examine the odds of VT by ART use. Matching weights incorporated site, HIV RNA, CD4 cell count, maternal age, year and HIV diagnosis before or during pregnancy. We also examined the proportion of women who received ART during pregnancy before and after the treat-all era, as defined within each country.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 623 pregnant women with HIV contributed 727 live births. Of all births, 613 (84.3%) infants had known HIV status and there were 22 (3.6%) VT events. Four of the 22 (18%) were born to women on ART at delivery, compared to 403 of 591 (68%) infants negative for HIV. In the propensity-score-matched model, ART use at delivery was associated with 85% decreased odds of VT (odds ratio = 0.15, 95% confidence interval 0.04−0.58). In the pre-treat-all era, 37% (181/485) of women received ART within 30 days of pregnancy diagnosis, compared to 59% (75/128) during the treat-all era (<i>p</i>&lt;0.001). In the pre-treat-all era, 4.3% (21/485) of infants were born HIV positive, compared to 0.8% (1/128) in the treat-all era (<i>p</i> = 0.055).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>We found a low prevalence of VT in our cohort, especially in the treat-all era. ART use at delivery was strongly associated with a lower odd of VT. Despite improvements, access to ART during pregnancy remained far from universal. Therefore, new strategies to ensure its effective implementation in LAC are still warranted.</p>\u0000 </section>\u0000 </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 5","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26411","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143880010","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":"Incorporating acute HIV infection screening, same-day diagnosis and antiretroviral treatment into routine services for key populations at sexual health clinics in Indonesia: a baseline analysis of the INTERACT prospective study","authors":"Irwanto Irwanto,&nbsp;Nurhayati H. Kawi,&nbsp;Hendry Luis,&nbsp;Dwi P. Rahmawati,&nbsp;Erik P. Sihotang,&nbsp;Pande Putu Januraga,&nbsp;Margareta Oktaviani,&nbsp;Suwarti Suwarti,&nbsp;Gilbert Lazarus,&nbsp;Evi Sukmaningrum,&nbsp;Evy Yunihastuti,&nbsp;Maartje Dijkstra,&nbsp;Eduard J. Sanders,&nbsp;F. Stephen Wignall,&nbsp;Keerti Gedela,&nbsp;Raph L. Hamers,&nbsp;the INTERACT Study Group","doi":"10.1002/jia2.26463","DOIUrl":"https://doi.org/10.1002/jia2.26463","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Introduction&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Indonesia has an escalated HIV epidemic concentrated among key populations. To strengthen the care cascade, we implemented a care pathway for the screening of individuals for acute HIV infection (AHI), to achieve prompt diagnosis and antiretroviral treatment (ART) initiation, at three non-governmental sexual health clinics in Jakarta and Bali. We assessed the AHI testing uptake, yield and prevalence, and the care cascade.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Methods&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;This is a cross-sectional baseline analysis of individuals (≥16 years) who presented for HIV testing and were consecutively enrolled (May 2023−November 2024). We used an AHI risk-score self-assessment and test algorithm comprising a fourth-generation antibody/p24 antigen rapid diagnostic test (4gRDT; Abbott Determine HIV Early Detect) and, if negative/discordant, followed by HIV-PCR (Cepheid Xpert) (either individual or pooled-sample testing). AHI was pragmatically defined as having negative/discordant RDT results with positive HIV-PCR (ISRCTN41396071).&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Results&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Three thousand seven hundred and ninety-seven (44.0%) of 8665 individuals were screened for study eligibility, and 3689 (97.2%) were enrolled. Median age was 28 years, and 78.2% were male. Men who have sex with men (MSM) accounted for 53.3%, clients of sex workers 19.2%, persons having a sex partner living with HIV 8.9% and sex workers 4.1%. We diagnosed 229 (6.3%; 229/3662) persons with RDT-positive (chronic) HIV, and we additionally identified 13 persons with AHI—that is a diagnostic yield of 5.6% (95% CI 3.1−9.5; 13/229) overall, and 6.1% (95% CI 3.2−10.3; 12/198) among MSM. AHI prevalence was 0.38% (95% CI 0.20−0.65; 13/3429) overall, and 0.72% (95% CI 0.37−1.2; 12/1677) among MSM. The number of persons needed to test to identify one person with AHI was 264 (3429/13) overall and 140 (1677/12) among MSM. The 4gRDT's performance to detect AHI was poor (2/13). Most participants received their HIV-PCR results on the same day (84.8%, 2907/3429) or within 24 hours (92.8%, 3182/3429). Of the 242 newly HIV-diagnosed individuals, 236 (97.5%) started ART, of whom 158 (67.0%) on the same day and 215 (91.1%) within 1 week.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Conclusions&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;We successfully implemented prompt AHI diagnosis and treatment, and identified a high AHI prevalence among Indonesian MSM. Prioritizing access to AHI testing can create opportunities for enhanced interventions to curb the HIV epidemic among key populations.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 ","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 5","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26463","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143880011","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}