Anal HPV Infection and Risk for Anal High-grade Squamous Intraepithelial Lesion Among Thai MSM With Acute HIV Infection

Arms (1)

1. type

   OTHER

   label

   sample size 100

   description

   Study Design: This is a prospective observational cohort of Thai MSM who initiated ART at the time of AHI, defined as the first 30 days after HIV acquisition (Fiebig stages 1 through 5). Volunteers will be examined at baseline to determine the prevalence of HPV infection and HSIL at HIV diagnosis. They will then be followed longitudinally for new incidence of HPV and HSIL, as well as progression or regression of existing lesions.

   interventionNames

   1. Behavioral: SEARCH010/RV254

Primary outcomes (1)

1. measure

   The prevalence and incidence of anal HSIL among MSM who initiate ART during AHI will be lower than among chronically-infected HIV-positive MSM, Anal HSIL is diagnosed based on histology specimen and cytology (2001 Bethesda system)

   timeFrame

   12 months

   description

   The prevalence of anal HSIL and the incidence of anal HSIL during the follow-up period. Anal HSIL is diagnosed based on histology specimen. A composite anal HSIL outcome (including both cytologic HSIL/ASC-H and histologic HSIL) will also be used. Incidence of HSIL during the follow-up period will be calculated as the number of new diagnoses per person time at risk. 95% confidence intervals (CI) will be calculated assuming a Poisson distribution. Cox proportional hazards regression will be used to identify factors associated with incident HSIL.