Grant Number:	1R01CA298844-01A1 Interpret this number
Primary Investigator:	Nyitray, Alan
Organization:	Medical College Of Wisconsin
Project Title:	Self-Sampling to Optimize Anal Lesion Outcomes (SOLO)
Fiscal Year:	2025

Human papillomavirus causes squamous cell carcinoma of the anus (SCCA) which has a heterogenous incidence depending on population; thus, this application continues research toward our long-term goal of reducing SCCA morbidity and mortality among those at highest risk for anal cancer. Treatment of SCCA precancers reduces SCCA risk after using high-resolution anoscopy (HRA) to detect the precancers; however, anal cancer screening research has not addressed the suboptimal uptake of in-clinic procedures like cytology and HRA and there is mounting evidence that uptake is even poorer among those at highest risk for anal cancer. Barriers to uptake, e.g., embarrassment, stigma, and health care access, if addressed, may reduce cancer incidence. For example, our prior study concluded that, compared to clinic screening, home-based self-sampling (HBSS) improved screening participation among populations at highest risk for anal cancer by >50%. We now seek to extend these findings. The objective of the Self-sampling to Optimize anal Lesion Outcomes (SOLO) study is to use a randomized controlled trial to test the effect of self-sampling on attendance at cytology and HRA appointments. The study will randomize 572 individuals, recruited by our ongoing collaborators in Chicago, Houston, and Milwaukee, to either the intervention: a self-sampling cascade of HBSS + education, in-clinic self-sampling for cytology, and HRA, or the control: a healthcare provider-sampling cascade of education, in-clinic healthcare provider-sampling for cytology, and HRA. All participants will be invited to complete the cascades, regardless of results from home-based self-sampling or cytology. Our overall hypothesis is that self-sampling at home and in the clinic will increase attendance at cytology and HRA, respectively, compared to standard healthcare provider (HCP) sampling. We have 2 aims: Aim 1. To increase in-clinic cytology uptake, estimate the effect of self-sampling on cytology appointment attendance. H1: Those at highest risk in the self-sampling arm will have increased cytology attendance vs the HCP-sampling arm; H2: Regardless of comorbidities, those who are randomized to the self-sampling arm will have increased cytology attendance vs the HCP-sampling arm; H3: Participants randomized to a preferred sampling method will have increased cytology attendance compared to those randomized to a non-preferred sampling method. Aim 2. To enhance SCCA precancer detection, assess the proportion of individuals who go to HRA in each study arm. H4: People with comorbidities in the self-sampling arm will have increased HRA attendance vs those in the HCP-sampling arm. H5: Regardless of comorbidities, those who are randomized to the self-sampling arm will have increased HRA attendance vs the HCP-sampling arm. Our expected outcomes are quantification of the effect of self-sampling on in-clinic cytology and HRA attendance. These outcomes will inform optimal approaches to SCCA screening among populations at high risk for anal cancer, for whom SCCA is a significant threat to health and well-being.





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