The influence of home versus clinic anal human papillomavirus sampling on high-resolution anoscopy uptake in the Prevent Anal Cancer Self-Swab Study.

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.

Home-based self-sampling vs clinician sampling for anal precancer screening: The Prevent Anal Cancer Self-Swab Study.

Sexual minority men are at increased risk for anal squamous cell carcinoma. Our objective was to compare screening engagement among individuals randomized to self-collect an anal canal specimen at home or to attend a clinic appointment. Specimen adequacy was then assessed for human papillomavirus (HPV) DNA genotyping. A randomized trial recruited cisgendered sexual minority men and transgender people in the community and assigned them to use a home-based self-collection swabbing kit or attend a clinic-based swabbing. Swabs were sent for HPV genotyping. The proportions of participants completing screening in each study arm and the adequacy of their specimens for HPV genotyping were assessed. Relative risks were estimated for factors associated with screening. A total of 240 individuals were randomized. Age (median, 46 years) and HIV status (27.1% living with HIV) did not differ by study arm. A total of 89.2% and 74.2% of home-arm and clinic-arm individuals returned the swab, respectively (P = .003), difference between groups, 15.0% (95% CI 5.4%-24.6%). Among black individuals, 96.2% and 63.2% in the home and clinic arms screened (P = .006). Among individuals with HIV, 89.5% and 51.9% in the home and clinic arms screened (P < .001). Self-collected swabs and clinician-collected swabs were comparable in adequacy for HPV genotyping (96.3% and 93.3%, respectively). People at highest risk for anal cancer may be more likely to screen if they are able to self-collect swabs at home rather than attend a clinic.

Factors associated with decreased anal sphincter tone and the accuracy of forced anal examinations to detect individuals having receptive anal intercourse: An observational study.

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.

Engagement and factors associated with annual anal human papillomavirus screening among sexual and gender minority individuals.

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.

The influence of home versus clinic anal human papillomavirus sampling on high-resolution anoscopy uptake in the Prevent Anal Cancer Self-Swab Study.

Background: Anal cancer disproportionately affects men who have sex with men (MSM) 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. Method: MSM and trans persons 25 years and older were randomized to home-based self-sampling or clinical sampling. All were asked to attend in-clinic HRA one year later. We regressed HRA attendance on study arm using multivariable Poisson regression and assessed HRA acceptability using χ 2 tests. Results: 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 1.44, 95% CI 1.11 - 1.87) and lower among participants preferring 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); however, 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.

Effect of the environment on home-based self-sampling kits for anal cancer screening.

BACKGROUND: Anal cancer incidence has increased in Western countries in recent decades and currently there are no consensus screening guidelines. Home-based self-sampling kits might facilitate screening for anal precancer/cancer but could require travel through postal mail where they may experience extreme temperatures or long transport times. OBJECTIVE: To determine the effect of the environment on specimen adequacy for HPV genotyping of a mailed home-based self-sampling anal cancer screening kit. STUDY DESIGN: The Prevent Anal Cancer (PAC) Study in Milwaukee, Wisconsin recruited men who have sex with men (MSM) and transgender persons 25 years of age and older. Participants were randomized to receive a mailed self-sampling kit or attend a clinic for screening. Kits were insulated with foam and included a device to record temperature every twenty minutes. Samples were returned via mail and underwent HPV genotyping using the SPF10-LiPA25 assay which also detected human RNase P to determine specimen adequacy by qPCR. For the first 93 kits, logistic regression assessed associations between specimen inadequacy and temperature, freeze-thaw cycle, presence of fecal matter, and number of days in an uncontrolled environment. RESULTS: Most specimens (92.5%) were adequate for HPV genotyping. Specimen inadequacy was not associated with temperature, freeze-thaw cycle, or transit time. Fecal matter was present more often in inadequate (71.4%) compared to adequate specimens (16.3%) (p = .004). CONCLUSIONS: These real-world data from mailed home-based anal self-sampling kits found that environmental conditions did not affect specimen adequacy. While over 90% of specimens were adequate, presence of fecal matter predicted specimen inadequacy.

Rationale and design of the Prevent Anal Cancer Self-Swab Study: a protocol for a randomised clinical trial of home-based self-collection of cells for anal cancer screening.

INTRODUCTION: Squamous cell carcinoma of the anus is a common cancer among sexual minority men, especially HIV-positive sexual minority men; however, there is no evidenced-based national screening protocol for detection of anal precancers. Our objective is to determine compliance with annual anal canal self-sampling or clinician-sampling for human papillomavirus (HPV) DNA. METHODS AND ANALYSIS: This is a prospective, randomised, two-arm clinical study to evaluate compliance with annual home-based versus clinic-based HPV DNA screening of anal canal exfoliated cells. The setting is primary care community-based clinics. Recruitment is ongoing for 400 HIV-positive and HIV-negative sexual minority men and transgender persons, aged >25 years, English or Spanish speaking, no current use of anticoagulants other than nonsteroidal anti-inflammatory drugs and no prior diagnosis of anal cancer. Participants are randomised to either receive a swab in the mail for home-based collection of an anal canal specimen at 0 and 12 months (arm 1) or attend a clinic for clinician collection of an anal canal specimen at 0 and 12 months (arm 2). Persons will receive clinic-based Digital Anal Rectal Examinations and high-resolution anoscopy-directed biopsy to assess precancerous lesions, stratified by study arm. Anal exfoliated cells collected in the study are assessed for high-risk HPV persistence and host/viral methylation. The primary analysis will use the intention-to-treat principle to compare the proportion of those who comply with 0-month and 12-month sampling in the home-based and clinic-based arms. The a priori hypothesis is that a majority of persons will comply with annual screening with increased compliance among persons in the home-based arm versus clinic-based arm. ETHICS AND DISSEMINATION: The study has been approved by the Medical College of Wisconsin Human Protections Committee. Results will be disseminated to communities where recruitment occurred and through peer-reviewed literature and conferences. TRIAL REGISTRATION NUMBER: NCT03489707.