JAIDS Journal of Acquired Immune Deficiency Syndromes最新文献

{"title":"Resistance to Dolutegravir in Treatment-experienced Patients in South Africa: A Retrospective Cohort Study.","authors":"Ying Zhao, Melanie Holtman, Vanessa Mudaly, Gert van Zyl, Gary Maartens, Graeme Meintjes","doi":"10.1097/QAI.0000000000003657","DOIUrl":"10.1097/QAI.0000000000003657","url":null,"abstract":"<p><strong>Background: </strong>Dolutegravir resistance has been reported more frequently in patients with prior treatment experience compared to those on dolutegravir in first-line antiretroviral therapy (ART). The widespread use of dolutegravir in resource-limited programmatic settings might facilitate the emergence of resistance. Data on the prevalence of dolutegravir resistance from programmatic settings in Africa are scarce.</p><p><strong>Methods: </strong>This retrospective observational cohort study assessed dolutegravir resistance in routine care settings of the Western Cape provincial public healthcare sector program between February 2021 and June 2024. Treatment-experienced adults who developed virologic failure (two HIV-1 RNA ≥1000 copies/mL), who had received dolutegravir-based ART for >24 months, were eligible for genotypic antiretroviral resistance testing (GART). Drug resistance mutations (DRMs) and resistance levels were classified using the Stanford database.</p><p><strong>Results: </strong>Among 99 eligible patients, 76 had GART performed, and 68 had successful sequences. Among these 68, 43 (63%) had dolutegravir DRMs with: 1 potential low, 1 low, 15 intermediate, and 26 high resistance levels. The median time on dolutegravir-based ART was 24 months (IQR, 23-31). Of the 43 patients with dolutegravir DRMs, 21 (49%) were receiving zidovudine-lamivudine-dolutegravir and 19 (44%) were receiving tenofovir-lamivudine-dolutegravir; 42/43 had prior ART experience.</p><p><strong>Conclusions: </strong>Over 60% of patients with prior treatment experience who had been on dolutegravir-based ART for over two years and experienced virologic failure had intermediate or high level dolutegravir resistance. This suggests that criteria for GART used are too stringent, which has resource implications in programmatic settings where access to resistance testing for individual management is limited.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7617472/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143542028","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Cross-Biomeasure Study to Optimize Antiretroviral Adherence Estimation.","authors":"Aaron S Devanathan, Amanda J Poliseno, Nicole R White, Amanda P Schauer, Craig Sykes, Ann Marie K Weideman, Kayla W Kilpatrick, Michael G Hudgens, Cynthia L Gay, Elias P Rosen, Julie B Dumond, Angela D M Kashuba, Mackenzie L Cottrell","doi":"10.1097/QAI.0000000000003570","DOIUrl":"10.1097/QAI.0000000000003570","url":null,"abstract":"<p><strong>Background: </strong>Incomplete adherence to daily tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) reduces effectiveness. Adherence biomeasures (ie, drug concentrations in biological specimen) are more accurate than self-report. TDF/FTC's intracellular active metabolites (tenofovir-diphosphate; TFVdp and FTC-triphosphate; FTCtp) can be quantified in different types of blood samples to estimate adherence. To optimize adherence estimation, we investigated approaches to measure TFVdp and FTCtp in 4 blood matrices.</p><p><strong>Methods: </strong>Twelve HIV-negative, healthy volunteers were enrolled in a single-center, open-label, 3-phase, directly observed therapy study. LC-MS/MS methods quantified TFVdp/FTCtp in dried blood spots, volumetrically accurate microsampling, upper layer packed cells, and peripheral blood mononuclear cells (PBMCs). Noncompartmental analysis estimated half-lives and accumulation ratios. Correlations characterized relationships between clinical variables and exposure. Regression models were fit to determine concentrations associated with <4 and ≥4 doses/week; correct classification percentages were determined.</p><p><strong>Results: </strong>Terminal half-life estimates of 3-4 vs 15-22 days distinguished between moderate-term (FTCtp in all samples; TFVdp in PBMCs) versus long-term (TFVdp in red blood cell-containing matrices) measures. Model-derived thresholds accurately categorized <4 and ≥4 doses/week when including both metabolites for 14- and 28-day dosing periods (81%-91% and 82%-85%, respectively). Within each classification and regression trees analyses containing both moderate- and long-term measures, dried blood spots exhibited highest accuracy to predict stable (74%-94%) and changing (42%-47%) adherence patterns.</p><p><strong>Conclusions: </strong>We demonstrate higher accuracy of moderate-term biomeasures to classify adherence over a 14-day period compared with long-term biomeasures to classify adherence over a 28-day period. Combined moderate- and long-term biomeasures predicted stable and changing adherence patterns, with dried blood spots exhibiting highest accuracy.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"291-299"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005226","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tenofovir Disoproxil Fumarate/Emtricitabine Prophylaxis Has No Effect on Bone Mineral Density and Bone Mineral Content in African Breastfeeding Women Receiving Pre-Exposure Prophylaxis for HIV.","authors":"Gaysheen Kistan, Motshedisi Sebitloane, Carl Lombard, Zukiswa Godlwana, Alicia C Desmond, Richard Clark, James F Rooney, Glenda Gray, Dhayendre Moodley","doi":"10.1097/QAI.0000000000003563","DOIUrl":"10.1097/QAI.0000000000003563","url":null,"abstract":"<p><strong>Background: </strong>Tenofovir disoproxil fumarate (TDF) when used as pre-exposure prophylaxis (PrEP) during pregnancy is considered safe overall, however, there is insufficient evidence of its effect on maternal bone. We compared bone mineral density (BMD) and bone mineral content (BMC) at the lumbar spine (LS) and hip of African breastfeeding women exposed and not exposed to TDF-containing PrEP in a randomized control trial (RCT).</p><p><strong>Methods: </strong>This is a secondary data analysis of an RCT where pregnant women were randomized to initiating PrEP during pregnancy or delayed initiation of PrEP until breastfeeding cessation. BMD and BMC at the LS and hip were measured using dual-energy x-ray absorptiometry (DXA) at 6, 26, 50, and 74 weeks postpartum. In an exploratory analysis, BMD at the hip and LS were evaluated against varying tenofovir levels during pregnancy.</p><p><strong>Results: </strong>Of 300 women in the RCT who had a DXA at 6 weeks postpartum, 102 (66%) women in the Immediate PrEP arm and 105 (72%) in the Delayed PrEP arm had a 74-week DXA scan. Adjusting for breastfeeding duration and body mass index, there were no significant differences in BMD or BMC at the hip and LS between treatment arms. There was no consistent dose-effect of tenofovir diphosphate detected during pregnancy on BMD at the hip ( P = 0.231) or the LS ( P = 0.277).</p><p><strong>Conclusions: </strong>After adjusting for breastfeeding and body mass index, tenofovir disoproxil fumarate when given as oral PrEP during pregnancy had no deleterious effect on BMD and BMC at the hip and LS of African breastfeeding women.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"98 3","pages":"265-273"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acceptability of Multilevel Sexual Health Interventions and Sexually Transmitted Infection Screening and Testing Among Persons With HIV Across Three Clinical Sites in Florida.","authors":"Preeti Manavalan, L Beth Gadkowski, Archie Sachdeva, Subharup Guha, Stacy Porvasnik, John A Nelson, Jennifer W Janelle","doi":"10.1097/QAI.0000000000003569","DOIUrl":"10.1097/QAI.0000000000003569","url":null,"abstract":"<p><strong>Introduction: </strong>The US state of Florida has the third highest rate of HIV and high rates of sexually transmitted infections (STIs) indicating critical HIV and STI prevention needs remain unmet. To address gaps in the STI care continuum in people with HIV (PWH), evidence-based interventions were implemented across 3 Ryan White HIV/AIDS Program (RWHAP)-funded clinics in Florida between August 2020 and August 2021. Interventions included comprehensive sexual health history (SHH) taking using audio computer-assisted self-interview (ACASI) software, self-collected extragenital gonorrhea and chlamydia testing, and the introduction of a lesbian, gay, bisexual, transgender, and queer (LGBTQ+) welcoming environment.</p><p><strong>Methods: </strong>We (1) assessed the acceptability of these interventions and examined if acceptability differed among youth and sexual, racial, and ethnic minorities; (2) determined the proportion of appropriate STI testing completed based on the SHH assessment; (3) examined whether STI at-risk individuals underwent STI screening 3-6 months after initial evaluation; and (4) determined the proportion of positive STI test results among priority intervention groups in Florida.</p><p><strong>Results: </strong>Acceptability of all interventions was high. Youth, lesbian, gay, and bisexual, and Hispanic individuals were significantly more likely to notice and like LGTBQ+ welcoming measures. The proportion of recommended tests completed was high, although only a subset of at-risk individuals completed rescreening. About 11.9% of rectal samples were positive for chlamydia, and 6.5% of pharyngeal samples were positive for gonorrhea.</p><p><strong>Conclusions: </strong>Our study highlights the importance of incorporating comprehensive sexual health care protocols, including extragenital STI testing, into the overall care of PWH.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"282-290"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11801437/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Economic Evaluation of Delivering an Evidence-Based Online HIV Prevention Program to MSM via Direct-To-Consumer Marketing Versus Community-Based Organization Recruitment.","authors":"Sarah Munroe, Bruce R Schackman, Krystal Madkins, Rana Saber, Kathryn Macapagal, Jocelyn Vititow, Nicholas Sweeney, Noah M Feder, Nanette Benbow, Brian Mustanski, Benjamin P Linas","doi":"10.1097/QAI.0000000000003572","DOIUrl":"10.1097/QAI.0000000000003572","url":null,"abstract":"<p><strong>Purpose: </strong>This study, conducted as part of the Keep It Up! (KIU!) 3.0 trial, compares the implementation costs of 2 strategies-centralized direct-to-consumer (DTC) marketing and decentralized distribution through community-based organizations (CBO)-in delivering an evidence-based online HIV prevention program.</p><p><strong>Methods: </strong>We conducted interviews and collected data to identify and quantify all costs for both delivery strategies. Costs were then categorized into start-up and ongoing (time-dependent and variable) costs and assigned dollar values based on established microcosting protocols.</p><p><strong>Results: </strong>In the DTC arm (1468 enrollees), the program was implemented from October 2019 through August 2022. Total ongoing costs including overhead and excluding start-up costs were $735,953, averaging $501 per participant. Start-up costs were $398,384 ($376,393 for content design and development and $21,991 for other costs), time-dependent costs were $219,177 ($149 per participant), and variable costs were $491,658 ($335 per participant). In the CBO arm (656 enrollees across 22 sites), KIU! was implemented for a 2-year period between October 2019 and December 2022. Total ongoing costs including overhead and excluding start-up costs were $2,780,682 ($4239 per participant). Start-up costs were $511,528 ($401,141 for content design and development and $110,386 for other costs), time-dependent costs were $1,926,958 ($2937 per participant), and variable costs were $256,543 ($391 per participant).</p><p><strong>Conclusions: </strong>The DTC arm demonstrated a lower overall cost and a lower cost per participant than distribution by the CBO arm. Understanding these cost dynamics is pivotal for guiding decisions on program sustainability and determining funding requirements for future large-scale implementation.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"257-264"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11866060/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142768937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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 Prescription Initiation and Maintenance Among Homeless-Experienced People Who Use Drugs.","authors":"William H Eger, Leah C Shaw, Katie B Biello, Claudia Lopez, Jennifer K Brody, Angela R Bazzi","doi":"10.1097/QAI.0000000000003568","DOIUrl":"10.1097/QAI.0000000000003568","url":null,"abstract":"<p><strong>Background: </strong>HIV pre-exposure prophylaxis (PrEP) remains particularly underused among homeless-experienced people who use drugs (PWUD).</p><p><strong>Setting: </strong>Boston Health Care for the Homeless Program, a Federally Qualified Health Center serving homeless-experienced individuals in Boston, Massachusetts.</p><p><strong>Methods: </strong>To identify determinants of PrEP prescription initiation and continuation, we analyzed electronic medical records and pharmacy data between April 2018 and March 2022. Participants were HIV-negative and reported sexual, drug, or community-related HIV exposures. Adjusted multinomial logistic regression explored associations between sociodemographics, social vulnerabilities, behavioral factors (eg, injection drug use), and mental health and substance use disorder diagnoses with filling of 1 and more than 1 PrEP prescription.</p><p><strong>Results: </strong>Among 509 participants, mean age was 38 years, 28% were women, 19% were Black, and 24% were Hispanic/Latino. At program enrollment, most were experiencing homelessness (92%), injecting drugs (78%), and living with a mental health disorder (71%). In multivariable-adjusted models, injection drug use was positively associated with filling 1 and more than 1 PrEP prescription (adjusted odds ratio [AOR]: 2.88, 95% confidence interval [CI]: 1.33 to 6.26; and AOR: 3.60, 95% CI: 2.02 to 6.42, respectively). Participants with opioid use disorder and generalized anxiety disorder were more likely to fill 1 and more than 1 prescription, whereas those with bipolar disorder were less likely to fill 1 prescription. No sociodemographic characteristics, sexual behaviors, or other mental health or substance use disorders were associated with study outcomes.</p><p><strong>Conclusions: </strong>A low-threshold, harm reduction-oriented PrEP program supported prescription initiation and continuation for homeless-experienced PWUD. Implementation research is needed to facilitate scale-up of this approach.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"234-241"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11854316/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005289","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Brief Report: Effect of Improved Provider Communication and Adherence to Guidelines on PrEP Initiation in Kisumu Kenya.","authors":"Melissa Vera, Joseph Sila, Barbra A Richardson, Felix Otieno, George Owiti, Valarie Kemunto, John Kinuthia, Kristin Beima-Sofie, Anna Larsen, Julia C Dettinger, Jillian Pintye, Grace John-Stewart, Pamela Kohler","doi":"10.1097/QAI.0000000000003567","DOIUrl":"10.1097/QAI.0000000000003567","url":null,"abstract":"<p><strong>Introduction: </strong>Adolescent girls and young women (AGYW) in Kenya have low pre-exposure prophylaxis (PrEP) initiation rates in part because of stigmatizing interactions with health care providers. Our recent randomized clinical trial of a standardized patient actor (SP) training intervention for providers found higher quality PrEP delivery at intervention sites; however, it was unclear whether improved service quality improved PrEP initiation.</p><p><strong>Methods: </strong>This analysis used routine records from facilities participating in the randomized trial that aimed to improve provider communication and adherence to Kenyan guidelines when offering PrEP to AGYW. We used facility-level PrEP registers from May to December 2019 as the baseline period and December 2020 to June 2021 as the postintervention period. We used linear regression with percentage initiating as the outcome, intervention and baseline initiation levels as covariates, and the number eligible postintervention at each facility as frequency weights.</p><p><strong>Results: </strong>Overall, 1375 AGYW presented to study sites, were eligible for PrEP, and were included in analyses (baseline: n = 706, postintervention: n = 669). Among 669 PrEP-eligible AGYW in the postintervention period (intervention: n = 360, control: n = 309), 591 (88.3%) initiated PrEP (intervention: n = 335, control: n = 256). PrEP initiation was 93.1% at intervention sites (range: 0%-100%) and 82.8% at control sites (range: 0%-100%). Adjusted for baseline initiation rates, initiation was 12.1% higher at intervention sites than at control sites ( P < 0.001, [95% CI: 0.09 to 0.15]).</p><p><strong>Conclusions: </strong>Our study found significant improvement in PrEP initiation among AGYW who presented to intervention facilities. SP training interventions that improve quality of service delivery for AGYW could lead to higher population-level PrEP coverage.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"252-256"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005257","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing Whether Providing Regular, Free HIV Self-Testing Kits Reduces the Time to HIV Diagnosis: An Internet-Based, Randomized Controlled Trial in Men Who Have Sex With Men.","authors":"David T Dunn, Leanne McCabe, Denise Ward, Andrew N Phillips, Fiona C Lampe, Fiona Burns, Valerie Delpech, Peter Weatherburn, T Charles Witzel, Roger Pebody, Peter Kirwan, Jameel Khawam, Sara Croxford, Michael Brady, Kevin A Fenton, Roy Trevelion, Yolanda Collaco-Moraes, Sheena McCormack, Alison J Rodger","doi":"10.1097/QAI.0000000000003564","DOIUrl":"10.1097/QAI.0000000000003564","url":null,"abstract":"<p><strong>Background: </strong>The risk of onward HIV transmission is strongly influenced by the interval between HIV infection and its diagnosis. The SELPHI trial examined whether this interval could be reduced by offering free HIV self-testing kits to men who have sex with men (MSM).</p><p><strong>Setting: </strong>Internet-based RCT of MSM aged ≥16 years, resident in England/Wales, recruited through sexual and social networking sites.</p><p><strong>Methods: </strong>The second-stage randomization of SELPHI was open to participants who used an initial free HIV self-test kit, were HIV seronegative, and reported recent condomless anal sex. They were randomized to receive a free HIV self-test kit every 3 months (repeat testing [RT] group) versus no such offer (nRT group). The primary outcome was time from randomization to a confirmed HIV diagnosis, determined from linkage to national HIV surveillance databases. The key secondary outcome was the frequency of HIV testing regardless of test modality.</p><p><strong>Results: </strong>In total, 2308 eligible participants (1161 RT, 1147 nRT) were randomized between April 2017 and June 2018, and followed for 15-27 months. The proportion of participants reporting an HIV test in the previous 3 months was much higher in the RT group (86%) than in the nRT group (39%). Overall, 16 (9 RT, 7 nRT) confirmed HIV diagnoses were observed (0.35/100 person-years), with no difference between the groups (hazard ratio = 1.27 [95% CI: 0.47 to 3.41], P = 0.63).</p><p><strong>Conclusions: </strong>Providing regular free self-testing kits to sexually active MSM was highly acceptable and markedly increased HIV testing. However, in this low incidence cohort, it did not result in a demonstrably more rapid diagnosis of incident infections.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"274-281"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11801452/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Incognito Standardized Patient Approach for Measuring and Reducing Intersectional Healthcare Stigma: A Pilot Cluster Randomized Control Trial.","authors":"M Kumi Smith, Danyang Luo, Siyan Meng, Yunqing Fei, Wei Zhang, Joseph Tucker, Chongyi Wei, Weiming Tang, Ligang Yang, Benny L Joyner, Shujie Huang, Cheng Wang, Bin Yang, Sean Y Sylvia","doi":"10.1097/QAI.0000000000003565","DOIUrl":"10.1097/QAI.0000000000003565","url":null,"abstract":"<p><strong>Background: </strong>Consistent evidence shows stigma impedes healthcare access in people living with HIV (PLWH) and men who have sex with men (MSM). We evaluated the impact of stigma reduction training for providers whose design was informed by direct observation of their clinical behaviors obtained through visits by incognito standardized patients (SPs).</p><p><strong>Setting: </strong>We conducted this study in sexually transmitted disease clinics in Guangzhou, China.</p><p><strong>Methods: </strong>This pilot cluster randomized control trial assessed the feasibility, acceptability, and preliminary efficacy of an intervention whose design was informed by a baseline round of incognito visits in which SPs presented standardized cases to consenting doctors. By randomly varying the HIV status and sexual orientation of each case, we could quantify stigma as differences in care quality across scenarios. We then conducted a follow-up round of SP visits and assessed the impact using linear fixed effects regression.</p><p><strong>Results: </strong>Feasibility and acceptability among the 55 provider participants were high, with no adverse visit events. The provider training improved the offering of testing to HIV-negative MSM (0.05 percentage points, 95% confidence interval, -0.24 to 0.33) and diagnostic effort for HIV-positive MSM (0.23 SD improvement, 95% CI: -0.92 to 1.37). Patient-centered care only improved for HIV-positive straight cases (SD, 0.57; 95% CI: -0.39 to 1.53). All estimates lacked statistical precision, an expected outcome of a pilot randomized control trial.</p><p><strong>Conclusions: </strong>Our training reduced stigma in several domains of care, but least of all for PLWH, suggesting that future trainings should include more clinical content to strengthen clinical skills in PLWH management.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":"98 3","pages":"224-233"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11801425/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacokinetics and Safety of Bictegravir in Pregnant and Postpartum Persons With HIV and Their Infants.","authors":"Kathleen M Powis, Mauricio Pinilla, Flynn McMorrow, Alice Stek, Kristina M Brooks, David E Shapiro, Kevin Knowles, Ahizechukwu C Eke, Elizabeth Greene, Allison Agwu, Lourdes Topete, Renee Browning, Nahida Chakhtoura, Priyanka Arora, Xiaoying Huang, Brookie M Best, Mark Mirochnick, Jeremiah D Momper","doi":"10.1097/QAI.0000000000003571","DOIUrl":"10.1097/QAI.0000000000003571","url":null,"abstract":"<p><strong>Background: </strong>Limited data exist on bictegravir pharmacokinetics in pregnancy among persons with HIV (PWH) and infant washout.</p><p><strong>Setting: </strong>Nonrandomized, open-label, multicenter phase-IV prospective study of bictegravir pharmacokinetics and safety in pregnant PWH and their infants.</p><p><strong>Methods: </strong>Steady-state 24-hour pharmacokinetic sampling of oral bictegravir 50 mg once daily (a component of fixed-dose combination bictegravir/emtricitabine/tenofovir alafenamide) during the second and third trimesters and postpartum was performed. Cord blood and infant washout samples were collected. Total and free bictegravir concentrations were measured by validated liquid chromatography with tandem mass spectrometry methods. Within-participant geometric mean ratios (GMR) with 90% confidence intervals (CI) were calculated to compare pharmacokinetics between second and third trimester versus postpartum. Infant HIV testing results were obtained.</p><p><strong>Results: </strong>Twenty-seven maternal-infant pairs were enrolled. Bictegravir area under the concentration-time curve from time 0 through 24 hours post-dose was 46% lower in the second trimester (n = 12; P = 0.002; GMR 0.54; 90% CI: 0.43 to 0.69) and 52% lower in the third trimester (n = 24; P < 0.0001; GMR 0.48; 90% CI: 0.43 to 0.55), compared with postpartum. C 24 concentrations were above the estimated bictegravir protein-adjusted 95% effective concentration of 0.162 μg/mL. The median ratio of cord-to-maternal blood concentration was 1.38 (n = 17; quartiles: 1.17-1.63). Median T 1/2 for infant bictegravir washout was 33.2 hours (quartiles: 25.7-45.9) with a C max of 2.06 μg/mL (quartiles: 1.37-2.72). Overall, 88%-92% of participants maintained suppression <40 copies/mL throughout pregnancy and postpartum. All available infant HIV testing results were negative. The safety profile for pregnant PWH and infants was acceptable.</p><p><strong>Conclusions: </strong>Bictegravir exposure was lower during pregnancy compared with postpartum, yet C 24 concentrations were greater than the bictegravir protein-adjusted 95% effective concentration.</p>","PeriodicalId":14588,"journal":{"name":"JAIDS Journal of Acquired Immune Deficiency Syndromes","volume":" ","pages":"300-307"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11798693/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}