The Role of Genital Warts in HIV Acquisition in Peru
Condition: Anogenital Warts; HIV
MeSH terms: Warts; Condylomata Acuminata
Study type: Observational

Summary: 
      The primary objective of this study is to determine the role of genital warts (GW) on Human
      Immunodeficiency Virus (HIV) acquisition among men who have sex with men (MSM) in Peru. The
      secondary objectives are to determine Human Papillomavirus (HPV) prevalence in HIV positive
      MSM in Peru, risk factors associated with GW, and the knowledge of HPV and HIV among MSM.
    

Detailed description: 
      Persons with Human Immunodeficiency Virus (HIV) infection are at higher risk of becoming
      infected with the Human Papillomavirus (HPV) compared to those who are HIV negative. The
      contrary is also true: individuals infected with HPV may be more likely to acquire HIV;
      however, the role of the clinical manifestation of HPV - genital warts (GW) - on HIV
      acquisition is currently unknown. Few studies have shown that GW are independently associated
      with HIV acquisition.

      The primary objective of this study is to determine the role of GW on HIV acquisition among
      MSM in Peru. The secondary objectives are to determine HPV prevalence in HIV positive MSM in
      Peru, risk factors associated with GW, and the knowledge of HPV and HIV among MSM. The
      specific aims of this study are:

        1. To estimate HIV incidence in Peruvian MSM by GW status.

        2. To determine the prevalence of HIV among Peruvian MSM by GW status.

        3. To determine the type-specific prevalence of anal HPV infection in HIV positive Peruvian
           MSM. Linear array testing will estimate prevalence of 37 HPV types including
           carcinogenic (16,18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66) and non-carcinogenic
           types (6, 11, 26, 40, 42, 53, 54, 61, 62, 64, 67, 68, 69, 70, 72, 73, 81, 82, 82var, 83,
           84, and 89) as defined at the 2005 meeting of the International Agency for Research on
           Cancer.

        4. To identify risk factors associated with genital warts (penile, anal, and both) among
           Peruvian MSM.

        5. To assess the knowledge of Peruvian MSM of the role of HPV in HIV infection.

      The study will be conducted in the Gay Men's Community Health Center, Epicentro, the only
      center in Lima that specifically caters to men who have sex with men and sees a high burden
      of genital warts in their patient population. The study includes a population of 600 MSM (300
      with recent or current genital warts). Baseline HIV serostatus will be done by rapid testing,
      and follow-up for HIV incidence will be done every 6 months over a two year time period. We
      will determine HPV status in HIV-positive participants and refer them for free highly active
      antiretroviral therapy (HAART) treatment. We will examine participants for GW presence and
      collect information on history of GW. A survey will be administered at each visit which
      examines changes in risk behaviors over time.

      This novel study proposes to both measure the prevalence of GW in MSM presenting at a
      community clinic environment and prospectively measure HIV incidence in men with GW and those
      without GW. It will be the first study of its kind that we are aware of using HIV infection
      as an endpoint in men with and without GW and will help to better understand the relationship
      between genital warts and HIV infection among MSM in Peru.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Biospecimen description: 
      serum, lesion biopsies
    
Keywords: genital warts; HIV; MSM; Peru; HPV