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Women living with HIV and breast cancer have poorer survival than HIV-negative women. Efavirenz-estrogen interactions are documented; however, the survival impact is unknown. Survival between women with estrogen-receptor positive breast cancer taking efavirenz (nâ=â38) and nonefavirenz regimens (nâ=â51) were compared. The 5-year overall-survival was 48.9% [95% confidence interval (CI) 33.0-72.2 and 51.1% (95% CI 34.0-76.8)] in the efavirenz and nonefavirenz groups, respectively suggesting efavirenz is unlikely driving poorer survival in women living with HIV and estrogen-receptor positive breast cancer.
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Alcinos , Fármacos Anti-HIV , Benzoxazinas , Neoplasias da Mama , Ciclopropanos , Infecções por HIV , Humanos , Benzoxazinas/uso terapêutico , Ciclopropanos/uso terapêutico , Feminino , Neoplasias da Mama/mortalidade , Neoplasias da Mama/tratamento farmacológico , Infecções por HIV/tratamento farmacológico , Infecções por HIV/mortalidade , Infecções por HIV/complicações , Pessoa de Meia-Idade , Adulto , Fármacos Anti-HIV/uso terapêutico , Análise de Sobrevida , IdosoRESUMO
Introduction: Young sexual minority men (SMM) bear the greatest burden of anal human papillomavirus (HPV) infections. We assessed anal HPV genotype discordance between the Linear Array (LA) and SPF10 PCR-DEIA-LiPA25 (LiPA25). Methods: Discordance was assessed between LA and LiPA25 using self-collected anal swabs from 120 SMM aged 18-29 who were recruited in 2014-2016. Multiple-type infection was explored as a potential confounder of testing agreement, along with clinical and behavioral factors such as HIV status, syphilis status, incarceration history, health insurance coverage, having 3 or more sex partners in the past 6 months, and co-infection with HPV-16. Results: Significant discordance was found for HPV-6, -11, -16, -31, -42, -54, and -59. Exploratory analyses suggest higher prevalence of genotype discordance in those living with HIV, those with 3 or more sex partners, and those who were positive for 4 or more HPV types. Conclusions: Our results highlight the importance of HPV detection methods which may inform different interpretations of research assessing anal HPV natural history among SMM at highest risk for HPV.
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BACKGROUND: Despite a higher risk of classical Hodgkin lymphoma (cHL) in people with HIV and the demonstrated safety and efficacy of PD-1 blockade in cHL, there are limited data on the use of these agents in HIV-associated cHL (HIV-cHL). PATIENTS/METHODS: We retrospectively identified patients with HIV-cHL from the "Cancer Therapy using Checkpoint inhibitors in People with HIV-International (CATCH-IT)" database who received nivolumab or pembrolizumab, alone or in combination with other agents, and reviewed records for demographics, disease characteristics, immune-mediated adverse events (imAEs), and treatment outcomes. Changes in CD4+ T-cell counts with treatment were measured via Wilcoxon signed-rank tests. Overall response rate (ORR) was defined as the proportion of patients with partial or complete response (PR/CR) per 2014 Lugano classification. RESULTS: We identified 23 patients with HIV-cHL who received a median of 6 cycles of PD-1 blockade: 1 as 1st-line, 6 as 2nd-line, and 16 as ≥3rd-line therapy. Seventeen (74%) patients received monotherapy, 5 (22%) received nivolumab plus brentuximab vedotin, and 1 received nivolumab plus ifosfamide, carboplatin, and etoposide. The median baseline CD4+ T-cell count was 155 cells/µL, which increased to 310 cells/µL at end-of-treatment (P = .009). Three patients had grade 3 imAEs; none required treatment discontinuation. The ORR was 83% with median duration of response of 19.7 months. The median progression-free survival was 21.2 months and did not differ between patients with <200 versus ≥200 CD4+ cells/µL (P = .95). CONCLUSION: Our findings support the use of PD-1 blockade in HIV-cHL for the same indications as the general population with cHL.
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Infecções por HIV , Doença de Hodgkin , Inibidores de Checkpoint Imunológico , Humanos , Masculino , Doença de Hodgkin/tratamento farmacológico , Feminino , Pessoa de Meia-Idade , Adulto , Estudos Retrospectivos , Estados Unidos , Infecções por HIV/tratamento farmacológico , Infecções por HIV/complicações , Inibidores de Checkpoint Imunológico/uso terapêutico , Inibidores de Checkpoint Imunológico/efeitos adversos , Inibidores de Checkpoint Imunológico/farmacologia , Nivolumabe/uso terapêutico , Nivolumabe/efeitos adversos , Receptor de Morte Celular Programada 1/antagonistas & inibidores , Idoso , Resultado do Tratamento , Anticorpos Monoclonais HumanizadosRESUMO
Objectives: Annual screening with a provider has been recommended for groups at highest risk for anal cancer. Anal self-sampling could help address screening barriers, yet no studies have examined annual engagement with this method. Methods: The Prevent Anal Cancer Self-Swab Study recruited sexual and gender minority individuals 25 years and over who have sex with men in Milwaukee, Wisconsin to participate in an anal cancer screening study. Participants were randomized to a home or clinic arm. Home-based participants were mailed an anal human papillomavirus self-sampling kit at baseline and 12 months, while clinic-based participants were asked to schedule and attend one of five participating clinics at baseline and 12 months. Using Poisson regression, we conducted an intention-to-treat analysis of 240 randomized participants who were invited to screen at both timepoints. Results: 58.8% of participants completed annual (median=370 days) anal screening. When stratified by HIV status, persons living with HIV had a higher proportion of home (71.1%) versus clinic (22.2%) annual screening ( p <0.001). Non-Hispanic Black participants had a higher proportion of home-based annual anal screening engagement (73.1%) compared to annual clinic screening engagement (31.6%) ( p =0.01). Overall, annual screening engagement was significantly higher among participants who had heard of anal cancer from an LGBTQ organization, reported "some" prior anal cancer knowledge, preferred an insertive anal sex position, and reported a prior cancer diagnosis. Annual screening engagement was significantly lower for participants reporting a medical condition. Conclusions: Annual screening engagement among those at disproportionate anal cancer risk was higher in the home arm.
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BACKGROUND: Differentiated service delivery (DSD) for children and adolescents living with HIV can improve targeted resource use. We derived a mortality prediction score to guide clinical decision making for children and adolescents living with HIV. METHODS: Data for this retrospective observational cohort study were evaluated for all children and adolescents living with HIV and initiating antiretroviral therapy (ART); aged 0-19 years; and enrolled at Baylor clinics in Eswatini, Malawi, Lesotho, Tanzania, and Uganda between 2005 and 2020. Data for clinical prediction, including anthropometric values, physical examination, ART, WHO stage, and laboratory tests were captured at ART initiation. Backward stepwise variable selection and logistic regression were performed to develop predictive models for mortality within 1 year of ART initiation. Probabilities of mortality were generated, compared with true outcomes, internally validated, and evaluated against WHO advanced HIV criteria. FINDINGS: The study population included 16â958 children and adolescents living with HIV and initiated on ART between May 18, 2005, and Dec 18, 2020. Predictive variables for the most accurate model included: age, CD4 percentage, white blood cell count, haemoglobin concentration, platelet count, and BMI Z score as continuous variables, and WHO clinical stage and oedema, abnormal muscle tone and respiratory distress on examination as categorical variables. The area under the curve (AUC) of the predictive model was 0·851 (95% CI 0·839-0·863) in the training set and 0·822 (0·800-0·845) in the test set, compared with 0·606 (0·595-0·617) for the WHO advanced HIV criteria (p<0·0001). INTERPRETATION: This study evaluated a large, multinational population to derive a mortality prediction tool for children and adolescents living with HIV. The model more accurately predicted clinical outcomes than the WHO advanced HIV criteria and has the potential to improve DSD for children and adolescents living with HIV in high-burden settings. FUNDING: National Institute of Health Fogarty International Center.
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Infecções por HIV , Humanos , Adolescente , Infecções por HIV/tratamento farmacológico , Infecções por HIV/mortalidade , Criança , Estudos Retrospectivos , Feminino , Masculino , Pré-Escolar , África Subsaariana/epidemiologia , Lactente , Adulto Jovem , Recém-Nascido , Fármacos Anti-HIV/uso terapêuticoRESUMO
Background Anal cancer disproportionately affects sexual and gender minority individuals living with HIV. High-resolution anoscopy (HRA) is an in-clinic procedure to detect precancerous anal lesions and cancer, yet prospective data on factors associated with HRA attendance are lacking. We examined whether anal HPV sampling at home versus in a clinic impacts HRA uptake and assessed HRA acceptability. Methods Sexual and gender minority individuals were randomised to home-based self-sampling or clinical sampling. All were asked to attend in-clinic HRA 1year later. We regressed HRA attendance on study arm using multivariable Poisson regression and assessed HRA acceptability using χ 2 tests. Results A total of 62.8% of 196 participants who engaged in screening attended HRA. Although not significant (P =0.13), a higher proportion of participants who engaged in clinic-based screening attended HRA (68.5%) compared to home-based participants (57.9%). Overall, HRA uptake was higher among participants with anal cytology history (aRR 1.40, 95% CI 1.07-1.82), and lower among participants preferring a versatile anal sex position versus insertive (aRR 0.70, 95% CI 0.53-0.91), but did not differ by race or HIV serostatus. In the clinic arm, persons living with HIV had lower HRA attendance (42.9%) versus HIV-negative participants (73.3%) (P =0.02) and Black non-Hispanic participants had lower HRA attendance (41.7%) than White non-Hispanic participants (73.1%), (P =0.04). No differences in attendance by race or HIV status were observed in the home arm. Conclusions HRA uptake differed significantly by race and HIV status in the clinic arm but not the home arm.
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Neoplasias do Ânus , Infecções por Papillomavirus , Humanos , Masculino , Neoplasias do Ânus/prevenção & controle , Neoplasias do Ânus/diagnóstico , Neoplasias do Ânus/virologia , Feminino , Infecções por Papillomavirus/prevenção & controle , Infecções por Papillomavirus/diagnóstico , Adulto , Pessoa de Meia-Idade , Manejo de Espécimes/métodos , Minorias Sexuais e de Gênero/estatística & dados numéricos , Canal Anal/virologia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Proctoscopia , Detecção Precoce de Câncer , Infecções por HIV/prevenção & controle , Infecções por HIV/epidemiologia , Autocuidado , Papillomavirus HumanoRESUMO
OBJECTIVES: People with HIV (PWH) may have an increased burden of penile cancer. We aimed to evaluate the risk of penile cancer in PWH compared with that of the general population. DESIGN: We conducted a nationwide retrospective matched cohort study of penile cancer incidence among veterans with HIV (VWH) compared with veterans without HIV. METHODS: We compared penile cancer incidence rates in 44â173 VWH to those of veterans without HIV ( N â=â159â443; 4â:â1 matched in age). We used Cox regression models to estimate hazard ratios and 95% confidence intervals (CIs) for associations with HIV infection and for penile cancer risk factors. RESULTS: HIV positivity was associated with an increased risk of penile cancer, with adjusted hazard ratios of 2.63 (95% CI 1.64-4.23) when adjusting for age, race/ethnicity, baseline BMI, smoking and alcohol use, economic means test, and history of condyloma. The risk increased to hazard ratioâ=â4.25 (95% CI 2.75-6.57) when adjusting for all factors except history of condyloma. Risk factors for penile cancer in VWH included lower nadir CD4 + count, less than 50% of follow-up time with undetectable HIV viral load, and history of condyloma. CONCLUSION: VWH - particularly those with low CD4 + counts, detectable HIV viral loads, or history of condyloma - are at increased risk of penile cancer, suggesting the penile cancer prevention activities are needed in this population.
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Infecções por HIV , Neoplasias Penianas , Veteranos , Humanos , Masculino , Neoplasias Penianas/epidemiologia , Neoplasias Penianas/virologia , Veteranos/estatística & dados numéricos , Estudos Retrospectivos , Infecções por HIV/complicações , Infecções por HIV/epidemiologia , Pessoa de Meia-Idade , Estados Unidos/epidemiologia , Incidência , Adulto , Fatores de Risco , Medição de Risco , IdosoRESUMO
OBJECTIVE: The objective is to determine cervical cancer screening rates and factors associated with decreased cervical cancer screening in women with systemic lupus erythematosus (SLE). METHODS: We conducted a cross-sectional study that enrolled consecutive women (age 21-64 years) with SLE. We collected demographics, clinical characteristics, constructs of the Health Beliefs Model (HBM) (ie, susceptibility, severity, barriers, benefits, cues to action, and self-efficacy), and self-reported cervical cancer screening (confirmed with the electronic medical record). The primary outcome was adherence to cervical cancer screening according to current guidelines. Multivariable logistic regression models were used to examine the association between SLE disease activity and cervical cancer screening and explore mediation effects from HBM constructs. RESULTS: We enrolled 130 women with SLE. The median age was 42 years (interquartile range 32-52 years). The cervical cancer screening adherence rate was 61.5%. Women with high SLE disease activity were less likely to have cervical cancer screening versus those with low disease activity (odds ratio 0.59, 95% confidence interval [CI] 0.39-0.89; P = 0.01), which remained statistically significant after adjusting for baseline demographics and drug therapy in a multivariable model (odds ratio 0.25, 95% CI 0.08-0.79; P = 0.02). Regarding the HBM constructs, increased perceived barriers to cervical cancer screening (r = -0.30, P < 0.01) and decreased self-efficacy (r = -0.21, P = 0.02) correlated with decreased cervical cancer screening. CONCLUSION: Patients with SLE with high disease activity undergo cervical cancer screening less frequently than those with low disease activity. Perceived barriers to cervical cancer screening are moderately correlated with decreased screening. These data highlight the need to develop strategies to increase cervical cancer screening in this high-risk patient population.
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Importance: Federally qualified health centers (FQHCs) deliver health care to nearly 30 million underserved persons across the US, yet nationwide and state-level breast, cervical, and colorectal cancer screening use in FQHCs is not described. Furthermore, it is unknown how the underscreened FQHC population contributes to the total underscreened population at national and state levels. Objective: To describe national- and state-level breast, cervical, and colorectal cancer screening use among individuals served by FQHCs in the US and to estimate the percentage of underscreened individuals in the general population served by FQHCs. Design, Setting, and Participants: This cross-sectional analysis of cancer screening used data from January 1 through December 31, 2020, from the FQHC Uniform Data System, reported by 1364 FQHCs across the US, and self-reported estimates from the Behavioral Risk Factor Surveillance System. Participants were 16 696 692 US adults served by FQHCs who were eligible for breast (age, 50-74 years), cervical (age, 21-64 years), and colorectal (age, 50-75 years) cancer screening. Analyses were conducted between January 1 and June 30, 2023. Exposures: Breast, cervical, and colorectal cancer screening. Main Outcomes and Measures: Percentages of breast, cervical, and colorectal cancer screening-eligible individuals up to date on screening. Results: A total of 3â¯162â¯882 breast, 7â¯444â¯465 cervical, and 6â¯089â¯345 colorectal screening-eligible individuals were served by FQHCs in 2020. Nationally, screening use in FQHCs was 45.4% (95% CI, 45.4%-45.5%) for breast cancer, 51.0% (95% CI, 51.0%-51.1%) for cervical cancer, and 40.2% (95% CI, 40.1%-40.2%) for colorectal cancer. Screening use among the US general population was 78.2% (95% CI, 77.6%-78.9%) for breast cancer, 82.9% (95% CI, 82.3%-83.4%) for cervical cancer, and 72.3% (95% CI, 71.7%-72.8%) for colorectal cancer. The contribution of the underscreened population served by FQHCs to the national underscreened general population was 16.9% (95% uncertainty interval [UI], 16.4%-17.4%) for breast cancer, 29.7% (95% UI, 28.8%-30.7%) for cervical cancer, and 14.7% (95% UI, 14.4%-15.0%) for colorectal cancer. Conclusions and Relevance: Findings from this national cross-sectional study indicated major gaps in cancer screening use in FQHCs in the US. Improved prevention is urgently needed to address screening disparities.
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Neoplasias da Mama , Neoplasias Colorretais , Detecção Precoce de Câncer , Neoplasias do Colo do Útero , Adulto , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/epidemiologia , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/epidemiologia , Estudos Transversais , Detecção Precoce de Câncer/estatística & dados numéricos , Detecção Precoce de Câncer/métodos , Programas de Rastreamento/métodos , Programas de Rastreamento/estatística & dados numéricos , Estados Unidos/epidemiologia , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/epidemiologiaRESUMO
Providing safe and informed healthcare for sexual and gender minority (SGM) individuals with cancer is stymied by the lack of sexual orientation and gender identity (SOGI) data reliably available in health records and by insufficient training for staff. Approaches that support institutional learning, especially around sensitive topics, are essential for hospitals seeking to improve practices impacting patient safety and research. We engineered annual institutional retreats to identify and unify stakeholders, promote awareness of gaps and needs, identify initiatives, minimize redundant projects, and coordinate efforts that promote improvements in SGM cancer care, education, and research. The 2022 and 2023 retreats employed a 4-h hybrid format allowing virtual and in-person engagement. Retreat organizers facilitated small-group discussions for brainstorming among participants. We performed descriptive statistics from retreat evaluations. The retreats engaged 104 attendees from distinct departments and roles. Participants expressed robust satisfaction, commending the retreat organization and content quality. Notably, the first retreat yielded leadership endorsement and funding for a Quality Improvement pilot to standardize SOGI data collection and clinical staff training. The second retreat provided a platform for updates on focused efforts across the institution and for receiving direction regarding national best practices for SGM care and research. We report the processes and outcomes of institution-wide retreats, which served as a platform for identifying gaps in organizational healthcare practices and research for SGM individuals with cancer. The strategies described herein may be readily scaled at other cancer hospitals seeking to learn and enact system-wide practice changes that support the needs of SGM patients and families.
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Institutos de Câncer , Humanos , Institutos de Câncer/organização & administração , Minorias Sexuais e de Gênero , Neoplasias , Melhoria de Qualidade , Feminino , Liderança , Masculino , AprendizagemRESUMO
Background: Squamous cell carcinoma of the anus (SCCA) annual incidence among sexual minority men with and without HIV is 85/100,000 and 19/100,000 persons, respectively, which is significantly higher than the overall incidence (2/100,000). Incidence may also be higher in transgender women. Since SCCA tumours average ≥30 mm at diagnosis, we assessed the accuracy of individuals to self-detect smaller anal abnormalities. Methods: Using convenience sampling, the study enrolled sexual minority men and transgender women, aged 25-81 years, in Chicago, Illinois and Houston, Texas, USA, during 2020-2022. Individuals were taught the anal self-examination and anal companion examination (ASE/ACE). Then, a clinician performed a digital anal rectal examination (DARE) before participants conducted the ASE or ACE. The sensitivity, specificity and concordance of the ASE/ACE to detect an abnormality were measured along with factors associated with ASE/ACE and DARE concordance. Findings: Among 714 enrolled individuals, the median age was 40 years (interquartile range, 32-54), 36.8% (259/703) were living with HIV, and 47.0% (334/710), 23.4% (166/710), and 23.0% (163/710) were non-Hispanic white, non-Hispanic Black, and Hispanic, respectively. A total of 94.1% (671/713) identified as cisgendered men, and 5.9% (42/713) as gender minorities. A total of 658 participants completed an ASE and 28 couples (56 partners) completed an ACE. Clinicians detected abnormalities in 34.3% (245/714) of individuals. The abnormalities were a median of 3 mm in diameter. Sensitivity and specificity of the ASE/ACE was 59.6% (95% CI 53.5-65.7%) and 80.2% (95% CI 76.6-83.8%), respectively. Overall concordance was 0.73 (95% CI 0.70-0.76) between ASE/ACE and DARE and increased with increasing anal canal lesion size (p = 0.02). Concordance was lower when participants were older and received ASE/ACE training from a lay person rather than a clinician. Interpretation: Sexual minority men/transgender women may self-detect SCCA when malignant lesions are much smaller than the current mean dimension at presentation of ≥30 mm. Funding: National Cancer Institute.
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Objective and Design: Forced anal examinations are used to prosecute sexual and gender minorities (SGM) in at least seven countries under the presumption that decreased sphincter tone, estimated by a finger inserted into the anal canal, can detect persons practicing receptive anal intercourse. In a cross-sectional analysis of the baseline data from a longitudinal study, we aimed to determine factors associated with sphincter tone and the accuracy of sphincter tonality to detect persons engaging in receptive anal intercourse. Setting: Clinicians in Chicago, Houston, and Milwaukee, USA conducted digital anal rectal examinations (DARE) on 838 participants, 94.0% of whom were cisgendered males. Clinicians used the Digital Rectal Examination Scoring System to score sphincter resting tone (RT) and squeeze tone (ST). On a separate survey, individuals reported their preferred position for anal intercourse: i.e., either always/mostly insertive anal intercourse, always/mostly receptive anal intercourse, or both receptive and insertive anal intercourse. Multivariable regression assessed factors associated with decreased sphincter tone while area under the Receiver Operating Characteristic curves (AUC) estimated the accuracy of sphincter tonality to detect receptive anal intercourse. Results: 11.3% had decreased RT (95/838) and 6.3% had decreased ST (53/838). The accuracy of DARE to detect any receptive anal intercourse was little better than random guessing (AUC 0.53, 95% CI 0.51 to 0.55, and AUC 0.51, 95% CI 0.49 to 0.53, respectively. RT and ST decreased with age regardless of sexual behavior (p trend <0.01 for both). Compared to individuals having always/mostly insertive anal intercourse, individuals having always/mostly receptive anal intercourse was associated with decreased RT, but not ST, while those equally preferring both insertive and receptive anal intercourse were not associated with decreased RT or ST. Conclusions: Decreased sphincter tone is uncommon among SGM who prefer receptive anal intercourse. Given virtually no accuracy, a finger inserted into the anus has no utility to detect individuals practicing receptive anal intercourse and thus should not be used as such. Trial registration: NCT04090060. Summary Box: What is already known on this topic: To gather evidence for prosecution of sexual and gender minorities, forced anal exams are used in multiple countries. The examination includes inserting the index finger into the anal canal to detect decreased sphincter tone which is considered evidence of receptive anal intercourse. We found only two small studies (n= 58 and n=24) assessing factors associated with decreased sphincter tone and none assessing the accuracy of sphincter tone to detect sexual and gender minorities having receptive anal intercourse.What this study adds: Our study suggests that a finger inserted into the anal canal is not useful to detect a history of receptive anal intercourse. As such, the sexual practices of individuals cannot be known using a forced anal examination.
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BACKGROUND: Detection and treatment of anal histologic high-grade squamous intraepithelial lesions (hHSIL) prevents anal cancer. However, anal hHSIL incidence among women with human immunodeficiency virus (HIV, WHIV) remains unknown. Performance of anal high-risk human papillomavirus ([hr]HPV), anal cytology (anal-cyt), and both for hHSIL detection longitudinally over 2 years also remains undetermined. METHODS: We determined 2-year incidence and cumulative risk estimates (2-y-CR) of anal hHSIL among WHIV using prevalence and incidence (per 100 person-years [py]) observations stratified by baseline hrHPV and/or anal-cyt results. RESULTS: In total, 229 WHIV with complete baseline data were included in the analysis; 114 women without prevalent anal hHSIL were followed with 2 annual evaluations. Median age was 51, 63% were Black, and 23% were Hispanic. Anal hrHPV or abnormal anal-cyt was associated with an increased risk of incident anal hHSIL at 2 years (18.9/100py [95% confidence interval {CI} 11.4-31.3] and 13.4/100py [95% CI 8.0-22.7], respectively) compared with no detection of anal HPV or negative cytology (2.8/100py [95% CI 1.1-7.4] and 4.2 [95% CI, 1.8-10.2]) The presence of anal hrHPV with abnormal cytology was associated with 2-y-CR of anal hHSIL of 65.6% (95% CI 55.4%-75%); negative hrHPV with negative cytology was associated with 2-y-CR of anal hHSIL of 9.2% (95% CI 7.0-16.0). CONCLUSIONS: Detection of anal hrHPV or abnormal anal cytology are comparable predictors for 2-y-CR of anal hHSIL. The absence of anal hrHPV combined with negative cytology was predictive of a lower (but measurable) risk of developing anal hHSIL. These findings provide important data to inform anal cancer screening guidelines for WHIV.
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Neoplasias do Ânus , Infecções por HIV , Infecções por Papillomavirus , Lesões Intraepiteliais Escamosas , Humanos , Feminino , Pessoa de Meia-Idade , HIV , Incidência , Infecções por HIV/complicações , Infecções por HIV/epidemiologia , Infecções por Papillomavirus/complicações , Infecções por Papillomavirus/epidemiologia , Neoplasias do Ânus/diagnóstico , Lesões Intraepiteliais Escamosas/epidemiologia , Papillomaviridae/genéticaRESUMO
Purpose: Anal cancer has disproportionately high incidence among sexual minority men. We compared acceptability of home versus clinic human papillomavirus (HPV) anal swabbing. Methods: The Prevent Anal Cancer Self-Swab Study recruited sexual and gender minority individuals in Milwaukee, Wisconsin. Eligible participants were randomized to a home or clinic arm. Home participants received a mailed anal HPV self-sampling kit. Clinic participants attended a clinic appointment where a clinician collected an anal HPV swab. We examined acceptability (overall thoughts, comfort with method, pain, and future willingness to swab) of home versus clinic swabbing using postswab survey responses. Results: A total of 191 individuals completed swabbing and a postswab survey (home = 53.4%, clinic = 46.6%). Mean age was 47 years (range = 25-78). Reported overall thoughts about home (71.6%) and clinic (69.7%) swabbing were mostly positive (p = 0.83). Overall thoughts about the home kit did not differ by participant characteristics, but overall thoughts about clinician swabbing differed by race (p = 0.04) and HIV status (p = 0.002). Nearly all participants (98.4%) reported they were comfortable receiving the kit or getting the swabbing in the clinic, reported little or no pain (98.4%), and reported willingness to undergo swabbing in the future (97.9%). After swabbing, clinic participants reported greater trust that swabbing can give accurate information about anal cancer risk (89.9%) than home participants (69.6%) (p < 0.001), and that swabbing will help them avoid anal cancer (clinic = 79.8%, home = 59.8%) (p = 0.01). Conclusion: Anal swabbing acceptability was high and did not differ between home and clinic. Participants reported high confidence and knowledge using the mailed anal self-sampling kit. Clinical Trial Registration number is NCT03489707.
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Neoplasias do Ânus , Infecções por Papillomavirus , Minorias Sexuais e de Gênero , Neoplasias do Colo do Útero , Masculino , Humanos , Adulto , Pessoa de Meia-Idade , Idoso , Feminino , Papillomavirus Humano , Infecções por Papillomavirus/diagnóstico , Infecções por Papillomavirus/prevenção & controle , Infecções por Papillomavirus/epidemiologia , Wisconsin , Papillomaviridae , Neoplasias do Ânus/diagnóstico , Neoplasias do Ânus/prevenção & controle , Detecção Precoce de Câncer/métodosRESUMO
INTRODUCTION: Self-sampling for human papillomavirus testing is increasingly recognized as a strategy to expand cervical cancer screening access and utilization. Acceptability is a key determinant of uptake. This study assesses the acceptability of and experiences with mailed self-sampling kits for human papillomavirus testing among underscreened patients in a safety net health system. METHODS: A nested telephone survey was administered between 2021 and 2023 to a sample (n=272) of the 2,268 participants enrolled in the Prospective Evaluation of Self-Testing to Increase Screening trial. Trial participants include patients of a safety net health system aged 30-65 years who were not up to date on screening. Participants were asked about barriers to provider-performed screening. Kit users and nonusers were asked about their experiences. RESULTS: Prevalent barriers to provider-performed screening included perceived discomfort of pelvic examination (69.4%), being uncomfortable with male providers (65.4%), and embarrassment (57.0%). Among participants who reported using the mailed kit (n=164), most reported good experiences (84.8%). Most reported self-sampling as more/equally convenient (89.0%), less/equally embarrassing (99.4%), and less/equally stressful (95.7%) than provider-performed screening. Among kit nonusers (n=43), reasons for not using the kit included forgetting about it (76.7%), preferring provider-performed screening (76.7%), and fearing cancer (67.4%). CONCLUSIONS: Prospective Evaluation of Self-Testing to Increase Screening trial participants generally had a positive experience with self-sampling for human papillomavirus testing. Increased comfort and reduced embarrassment/anxiety with self-sampling are relevant attributes because these were the most prevalent reported barriers to provider-performed screening. High acceptability suggests potentially high uptake when self-sampling for human papillomavirus testing receives regulatory approval and is available in safety net health systems.
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Infecções por Papillomavirus , Neoplasias do Colo do Útero , Feminino , Humanos , Masculino , Papillomavirus Humano , Neoplasias do Colo do Útero/prevenção & controle , Autocuidado , Detecção Precoce de Câncer , Infecções por Papillomavirus/diagnóstico , Papillomaviridae , Programas de Rastreamento , Aceitação pelo Paciente de Cuidados de Saúde , Esfregaço VaginalRESUMO
BACKGROUND: Although immunotherapy has emerged as a therapeutic strategy for many cancers, there are limited studies establishing the safety and efficacy in people living with HIV (PLWH) and cancer. METHODS: PLWH and solid tumors or Kaposi sarcoma (KS) receiving antiretroviral therapy and a suppressed HIV viral load received nivolumab at 3 mg/kg every 2 weeks, in two dose deescalation cohorts stratified by CD4 count (stratum 1: CD4 count > 200/µL and stratum 2: CD4 count 100-199/µL). An expansion cohort of 24 participants with a CD4 count > 200/µL was then enrolled. RESULTS: A total of 36 PLWH received nivolumab, including 15 with KS and 21 with a variety of other solid tumors. None of the first 12 participants had dose-limiting toxicity in both CD4 strata, and five patients (14%) overall had grade 3 or higher immune related adverse events. Objective partial response occurred in nine PLWH and cancer (25%), including in six of 15 with KS (40%; 95% CI, 16.3-64.7). The median duration of response was 9.0 months overall and 12.5 months in KS. Responses were observed regardless of PDL1 expression. There were no significant changes in CD4 count or HIV viral load. CONCLUSIONS: Nivolumab has a safety profile in PLWH similar to HIV-negative subjects with cancer, and also efficacy in KS. Plasma HIV remained suppressed and CD4 counts remained stable during treatment and antiretroviral therapy, indicating no adverse impact on immune function. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02408861.
Assuntos
Síndrome da Imunodeficiência Adquirida , Infecções por HIV , Sarcoma de Kaposi , Humanos , Síndrome da Imunodeficiência Adquirida/tratamento farmacológico , Nivolumabe/efeitos adversos , Infecções por HIV/complicações , Infecções por HIV/tratamento farmacológico , Sarcoma de Kaposi/tratamento farmacológico , Contagem de Linfócito CD4 , Carga ViralRESUMO
PURPOSE: Self-sampling is increasingly being used in screening programs, yet no studies to date have examined the impact of bodily characteristics on self-sampling experiences. Our objective was to assess whether body mass index (BMI) and physical disability were associated with anal self-sampling difficulty. METHODS: We recruited sexual minority men (SMM) and trans persons in Milwaukee, Wisconsin to participate in an anal cancer screening study. Between January 2020 and August 2022, 240 participants were randomized to a home (n = 120) or clinic (n = 120) screening arm. Home participants received a mailed at-home anal self-sampling kit and were asked to attend a baseline clinic visit where biometric measurements were collected. Participants were asked to complete a survey about their experience with the kit. This research utilized data from participants who used the at-home kit and completed a baseline clinic visit and post-swab survey (n = 82). We assessed the impact of BMI and physical disability on reported body or swab positioning difficulty. RESULTS: Most participants reported no or little difficulty with body positioning (90.3%) or swab positioning (82.9%). Higher BMI was significantly associated with greater reported difficulty with body positioning (aOR = 1.10, 95% CI 1.003-1.20, p = 0.04) and swab positioning (aOR = 1.11, 95% CI 1.02-1.20, p = 0.01). Although not significant, participants who said body positioning was difficult had 2.79 higher odds of having a physical disability. Specimen adequacy did not differ by BMI category (p = 0.76) or physical disability (p = 0.88). CONCLUSION: Anal self-sampling may be a viable option to reach obese persons who may be more likely to avoid screening due to weight-related barriers.
Assuntos
Neoplasias do Ânus , Infecções por Papillomavirus , Minorias Sexuais e de Gênero , Neoplasias do Colo do Útero , Masculino , Humanos , Feminino , Índice de Massa Corporal , Manejo de Espécimes , Obesidade/complicações , Neoplasias do Ânus/diagnóstico , Infecções por Papillomavirus/diagnóstico , Detecção Precoce de Câncer , Papillomaviridae , Neoplasias do Colo do Útero/diagnósticoRESUMO
BACKGROUND: Home-based self-sampling may be a viable option for anal cancer screening among sexual minority men (SMM). Yet limited research has compared home-based self-collected with clinician-collected anal swabs for human papillomavirus (HPV) genotyping. METHODS: The Prevent Anal Cancer Self-Swab Study recruited SMM and transgender persons 25 years and over in Milwaukee, WI to participate in an anal cancer screening study. Participants were randomized to a home or clinic arm. Home-based participants were mailed an anal self-sampling kit to complete and return via postal mail. They were also asked to attend a clinic appointment where a clinician collected an anal swab. Swabs were HPV-genotyped using the SPF 10 -LiPA 25 assay. We analyzed 79 paired self and clinician swabs to determine HPV prevalence, percent agreement, and sensitivity and specificity of the mailed home-based anal self-swab to detect HPV genotypes using the clinician-collected swab as the reference. RESULTS: The median number of days between the home and clinic swab was 19 days (range = 2 to 70). Human papillomavirus was detected in 73.3% of self and 75.0% of clinician anal swabs ( P = 0.99). Prevalence of any HPV, any high-risk HPV, any low-risk HPV, and individual HPV types did not significantly differ between self and clinician anal swabs. Agreement between self and clinician swabs was over 90% for 21 of the 25 HPV genotypes. Mailed home-based self-collected swabs had a sensitivity of 94.1% (95% confidence interval, 82.9-99.0) for detection of high-risk HPV versus clinician-collected sampling. CONCLUSIONS: Mailed home-based self-collected and clinician-collected anal swabs demonstrated high concordance for HPV genotyping.
Assuntos
Neoplasias do Ânus , Infecções por Papillomavirus , Pessoas Transgênero , Masculino , Humanos , Papillomavirus Humano , Infecções por Papillomavirus/epidemiologia , Papillomaviridae/genética , Genótipo , Detecção Precoce de CâncerRESUMO
Anal cancer incidence is significantly higher in people living with HIV as HIV increases the oncogenic potential of human papillomavirus. The incidence of anal cancer in the United States has recently increased, with diagnosis and treatment hampered by high loss-to-follow-up rates. Novel methods for the automated, real-time diagnosis of AIN 2+ could enable "see and treat" strategies, reducing loss-to-follow-up rates. A previous retrospective study demonstrated that the accuracy of a high-resolution microendoscope (HRME) coupled with a deep learning model was comparable to expert clinical impression for diagnosis of AIN 2+ (sensitivity 0.92 [P = 0.68] and specificity 0.60 [P = 0.48]). However, motion artifacts and noise led to many images failing quality control (17%). Here, we present a high frame rate HRME (HF-HRME) with improved image quality, deployed in the clinic alongside a deep learning model and evaluated prospectively for detection of AIN 2+ in real-time. The HF-HRME reduced the fraction of images failing quality control to 4.6% by employing a high frame rate camera that enhances contrast and limits motion artifacts. The HF-HRME outperformed the previous HRME (P < 0.001) and clinical impression (P < 0.0001) in the detection of histopathologically confirmed AIN 2+ with a sensitivity of 0.91 and specificity of 0.87.
Assuntos
Neoplasias do Ânus , Aprendizado Profundo , Infecções por HIV , Humanos , Estados Unidos , Endoscopia , Diagnóstico por Imagem , Neoplasias do Ânus/diagnóstico por imagem , Infecções por HIV/complicaçõesRESUMO
While rare in the larger population, anal cancer incidence is significantly higher in groups such as sexual minority men and people living with HIV. This qualitative analysis examined participants' experiences and perceptions of barriers to anal self-examination and anal companion examination through interviews completed as a part of a larger clinical trial. Interviews were conducted online with participants (n = 131) within a week of their baseline appointment between January 2020 and October 2021. Content analysis denoted participants' thoughts and perceptions about anal self-examination and anal companion examinations. Of the 131 cisgender men interviewed (mean age 49.9 years, SD 12.7), 92.4% identified as gay, 54.9% identified as white, 22.1% identified as Black, 19.9% identified as Latino, and 44.3% of participants were living with HIV. Participants did not report feelings of excessive anxiety when an abnormality was detected. However, three salient themes emerged as to why participants may not perform an anal self-examination or anal companion examination: (1) physical limitation(s), (2) potential sexualisation of the examination, and (3) level of comfort discussing anal health. Future work must continue to explore methods that not only decrease stigma surrounding anal health but also bolster feelings of accessibility to perform self and couple examinations.