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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00023582 |
Purpose
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 |
|---|
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HIV Infections Herpes Genitalis HIV Seronegativity Syphilis |
| Study Type: | Observational |
| Official Title: | HIV Prevalence, Incidence and HSV-2 Prevalence Among High-Risk MSM in Lima, Peru |
| Estimated Enrollment: | 250 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Volunteers may be eligible for the initial screening visit if they are:
Volunteers may be eligible for enrollment if they:
Exclusion Criteria
Volunteers will not be eligible if they:
Contacts and Locations
More Information
| Study ID Numbers: | HPTN 036 |
| Study First Received: | September 10, 2001 |
| Last Updated: | August 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00023582 History of Changes |
| Health Authority: | United States: Federal Government |
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Syphilis Herpes Genitalis Risk Factors Incidence Prevalence |
Homosexuality, Male Informed Consent Peru HIV Seronegativity |
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Bacterial Infections Herpes Simplex Sexually Transmitted Diseases, Bacterial RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Herpes Genitalis Acquired Immunodeficiency Syndrome Genital Diseases, Male Infection Immunologic Deficiency Syndromes |
Gram-Negative Bacterial Infections Herpesviridae Infections Genital Diseases, Female Virus Diseases Treponemal Infections Spirochaetales Infections HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections Syphilis Retroviridae Infections |