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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00023582
Recruitment Status : Completed
First Posted : September 11, 2001
Last Update Posted : August 8, 2008
Sponsor:
Information provided by:

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
HIV Infections Herpes Genitalis HIV Seronegativity Syphilis

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
Estimated Enrollment : 250 participants
Official Title: HIV Prevalence, Incidence and HSV-2 Prevalence Among High-Risk MSM in Lima, Peru

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00023582


Locations
United States, Washington
Rachael McClennen
Seattle, Washington, United States, 98104
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Connie Celum
More Information

ClinicalTrials.gov Identifier: NCT00023582     History of Changes
Other Study ID Numbers: HPTN 036
First Posted: September 11, 2001    Key Record Dates
Last Update Posted: August 8, 2008
Last Verified: November 2006

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Syphilis
Herpes Genitalis
Risk Factors
Incidence
Prevalence
Homosexuality, Male
Informed Consent
Peru
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Syphilis
Herpes Genitalis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Infection
Genital Diseases, Male
Genital Diseases, Female
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections