Persistent anal human papillomavirus (HPV) infection is the primary cause of anal cancer which is a common cancer among men having sex with men (MSM). Annual anal cancer screening is standard of care for HIV+ MSM and recommended by expert opinion for HIV- MSM; thus, Pap cytology and high-resolution anoscopy (HRA) are now increasingly offered by clinics. But most HIV+ and HIV- MSM do not screen. Since home-based self-sampling increases rates of cervical cancer screening and self-sampling is acceptable to MSM, it is im- portant to investigate home-based screening for anal cancer among MSM. No one has assessed compliance with annual home-based anal canal self-sampling which is required to detect persistent HPV infections among MSM. Current anal cancer screening protocols already mirror cervical cancer screening protocols with in- creased reliance on a molecular biomarker (e.g., HPV DNA testing). DNA collection works well with home- based kits, but one-time DNA screening is of no value for MSM given their high HPV prevalence; thus, an ex- periment of repeated DNA screening can efficiently test important questions: Will MSM comply with annual bi- omarker screening? Will home-based sampling increase compliance? What other factors are associated with repeated annual screening? And, what proportion of men will agree to clinic-based HRA-directed biopsy (the definitive test for precancerous lesions) after home-based self-sampling? Our long-term goal is to reduce mor- bidity and mortality from anal cancer given increasing incidence of disease. Using a 2-arm randomized con- trolled trial, our primary objective is to determine compliance with annual DNA-based screening among Hou- ston HIV+ and HIV- MSM, aged ?27 years. Men randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months and those in arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months. Then, men will receive HRA-directed biopsy to assess precancerous lesions by study arm. We will recruit a total of 400 men, with oversampling of African American and Latino men. We hypothesize that a majority of men will comply with annual screening with increased compliance among men in the home-based arm vs clinic-based arm. We will test our hypothesis with 3 specific aims: 1. Determine men?s compliance with annual anal HPV DNA specimen collection; 2. Determine factors associated with annual screening compliance; 3. Establish the proportion of men in each arm who agree to have HRA. The current research will deliver: 1) The first estimates of compliance with an annual bi- omarker screening program among MSM; 2) The first estimates of the relative ability of home-based screening to increase annual compliance; and 3) Evidence of the influence that home-based vs clinic-based screening has on uptake of HRA-directed biopsy. The proposed research could indicate that annual HPV DNA testing may identify at-risk MSM who then agree to follow up with HRA; thus, we will determine how high-risk men are identified for treatment in light of very limited screening resources.
This study is relevant to public health because it will assess two core components of public health screening, i.e., repeat screening and targeted screening. The proposed research will provide knowledge on how to stratify the highest-risk populations for screening and if they will adhere to repeated screening for anal cancer, which, as with cervical cancer screening, may successfully reduce disease incidence.
