Feasibility of Measuring Immune Resp, Activation in Foreskin/Mucosa in HIV-, Uncircumcised High-HIV-risk MSM, Lima Peru
Condition: HIV Infections; Acquired Immunodeficiency Syndrome; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases
MeSH terms: Infections; Communicable Diseases; Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases; RNA Virus Infections; Sexually Transmitted Diseases, Viral; Retroviridae Infections; Lentivirus Infections; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Syndrome
Study type: Interventional

Summary: 
      Rectal and genital sampling in HIV prevention trials permits assessments at the site of HIV
      entry. Yet the safety and acceptability of circumcision and sigmoidoscopy (and associated
      abstinence recommendations) are unknown in uncircumcised men who have sex with men (MSM) at
      high risk of HIV infection. The purpose of this study is to evaluate the feasibility of
      methods for assessing baseline characteristics of the mucosa of MSM at risk of HIV infection
      in Lima, Peru.
    

Detailed description: 
      The worldwide HIV/AIDS epidemic may only be controlled through development and utilization of
      a safe and effective vaccine that will prevent HIV infection. To fill gaps in the
      understanding of HIV vaccines, studies of mucosal immunity aim to complement assessments of
      systemic immunity. Yet it is unclear, and important to understand, how mucosal collections
      and the kinetics of immune activation they might initiate may impact peripheral blood
      endpoints in HIV vaccine trials. The HIV Vaccine Trials Network (HVTN) and the National
      Institute of Allergy and Infectious Diseases (NIAID) are conducting a single-site,
      exploratory cohort study evaluating the feasibility of sampling mucosa and assessing cellular
      immune responses in sexually active men who have sex with men, a population in which
      later-phase HIV vaccine clinical trials are often conducted.

      The primary purpose of HVTN 914 is to assess the feasibility of performing safe and tolerable
      circumcision and rectosigmoid biopsy studies on a study population of 30 healthy,
      HIV-seronegative, uncircumcised men in Lima, Peru, aged 21 to 30 years, who have sex with men
      and who are at high risk for acquisition of HIV; to assess institutional capacities to
      process mucosal samples; and to identify methods of evaluating foreskin and rectosigmoid
      mucosal immune responses that provide minimal variability for analysis of small sample sizes.

      The study is designed to mimic an HIV vaccine study mucosal collection protocol. Participants
      agree to elective sigmoidoscopy biopsy collections and circumcision, and actively participate
      in this study for approximately 7 months. The primary analysis will focus on pre- and
      post-procedure retention, safety laboratory values, sexual satisfaction, HIV risk behaviors,
      and levels of activation markers associated with vulnerability to HIV infection in samples of
      peripheral blood mononuclear cells. A total of 11 study visits (including a screening visit)
      occur at Weeks 0-5, 10, and 26-28. Study procedures include physical exams, blood and urine
      collection, HIV testing, and questionnaire. Elective rectosigmoid bioscopy is performed at
      Weeks 2 and 27. Elective circumcision is performed at Week 4. Some blood collected from
      participants will be stored and used in future research. Risk-reduction counseling will be
      conducted at all study visits.
    

Intervention name(s): Circumcision; Flexible sigmoidoscopy
Intervention type(s): Procedure; Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: HIV Preventive Vaccine; HIV Seronegativity; Immune Response, Mucosal