HIV and Genital Herpes Among High-Risk Men Who Have Sex With Men (MSM) in Lima, Peru

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00023582
Collaborator
(none)
250
1

Study Details

Study Description

Brief Summary

The purpose of this study is to provide biomedical and behavioral information that is necessary for planning and starting HIV prevention trials in Lima, Peru.

The occurrence of HIV is high among men who have sex with men (MSM) in Lima, Peru, and bacterial sexually transmitted diseases (STDs) and HSV-2 (genital herpes) are very prevalent in HIV-positive and -negative MSM there. Methods to reduce both HIV and STDs are urgently needed among MSM in Peru. The information gained from this study is very important for future HIV prevention and vaccine trials that will take place in Peru.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    HIV incidence is high among MSM in Lima, Peru, and bacterial sexually transmitted diseases (STDs) and HSV-2 are prevalent in both recently and chronically HIV-infected MSM as well as HIV-uninfected MSM. Bisexual HIV-infected MSM could be an important "bridge" transmitting HIV and other STDs to women. Interventions to reduce both HIV and STDs are urgently needed among MSM in Peru. Given these associations and the high prevalence of STDs among MSM in Lima, prevention of HIV infections is dependent partially on innovative methods to control bacterial and viral STDs among high-risk HIV-uninfected MSM. The data from this prevention preparedness study is critical for future HIV prevention and vaccine trials that will be conducted in Peru.

    All MSM are counseled and tested for HIV, HSV-2, and syphilis at the screening visit. [AS PER AMENDMENT 07/23/02: The syphilis test results are provided at screening, whereas the HIV and HSV-2 test results are provided at the enrollment visit.] High-risk HIV-uninfected MSM in Lima, Peru, are enrolled. Men are interviewed about risk behaviors in the past 6 months. Trained counselors provide risk-reduction counseling according to locally accepted standards. Men are followed at 3-month intervals for 1 year to determine the incidence of and risk factors for prevalent and incident HIV and HSV-2, and to evaluate the effectiveness of retention strategies. In the baseline questionnaire, 2 additional modules address sexual networks and willingness to participate in HIV vaccine or prevention trials, including an acyclovir trial. Study data are collected and entered into a local database.

    Study Design

    Study Type:
    Observational
    Official Title:
    HIV Prevalence, Incidence and HSV-2 Prevalence Among High-Risk MSM in Lima, Peru

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      Male
      Accepts Healthy Volunteers:
      Yes

      Inclusion Criteria

      Volunteers may be eligible for the initial screening visit if they are:
      • Men aged 18 years and older who have had sex with another man in the past 12 months.
      Volunteers may be eligible for enrollment if they:
      • Are able to stay on the study for 12 months;

      • Are willing and able to provide information on how they can be located;

      • Have had high-risk sexual behavior and have tested negative for HIV.

      Exclusion Criteria

      Volunteers will not be eligible if they:
      • Have obvious mental problems that would prevent them from fully understanding and participating in the study.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Rachael McClennen Seattle Washington United States 98104

      Sponsors and Collaborators

      • National Institute of Allergy and Infectious Diseases (NIAID)

      Investigators

      • Study Chair: Connie Celum,

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00023582
      Other Study ID Numbers:
      • HPTN 036
      First Posted:
      Sep 11, 2001
      Last Update Posted:
      Aug 8, 2008
      Last Verified:
      Nov 1, 2006

      Study Results

      No Results Posted as of Aug 8, 2008