The impact of body mass index and physical disability on home-based anal self-sampling.

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.

Acceptability of Anal Human Papillomavirus Home Self-Sampling and Clinician Sampling Among Sexual and Gender Minority Individuals in Milwaukee, Wisconsin: The Prevent Anal Cancer Self-Swab Study.

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.

Concordance of Human Papillomavirus Genotypes in Mailed Home-Based Self-Collected Versus Clinician-Collected Anal Swabs Among Sexual and Gender Minority Individuals.

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.

The Impact of Body Mass Index and Medical Conditions on Home-based Anal Self-Sampling.

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 utilizes data from participants who used the 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 =.04) and swab positioning (aOR=1.11, 95% CI 1.02-1.20, p =.01). Physical disability was not significantly associated with body or swab positioning difficulty. Specimen adequacy did not differ by BMI category ( p =.76) or physical disability ( p =.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.

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.