PRIMARY OBJECTIVES:
I. Evaluate the sensitivity \& specificity, predictive positive value (PPV), \& predictive negative value (PNV) (test characteristics) \& cellularity, beta-globin, deoxyribonucleic acid (DNA), ribonucleic acid (RNA), \& protein (quality measures) from nylon-flocked (NF)- \& Dacron-swab protocols to detect biopsy-detected high-grade anal intraepithelial neoplasia (HG-AIN) \& human papillomavirus (HPV)-infections, using randomized-controlled study design.
II. Evaluate the test characteristics for anal cancer screening algorithms that incorporate sequentially or simultaneously performed high-threshold molecular HPV tests, with \& without cytology, to predict HG-AIN.
III. Evaluate the cost-effectiveness \& relative cost of single- \& multiple-test anal cancer screening algorithms.
OUTLINE:
Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Papanicolaou (Pap) staining, HPV genotyping, and polymerase chain reaction (PCR).
