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

Primary Purpose

HIV Infections, Herpes Genitalis, HIV Seronegativity

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring Syphilis, Herpes Genitalis, Risk Factors, Incidence, Prevalence, Homosexuality, Male, Informed Consent, Peru, HIV Seronegativity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Rachael McClennen

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 10, 2001
Last Updated
August 7, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00023582
Brief Title
HIV and Genital Herpes Among High-Risk Men Who Have Sex With Men (MSM) in Lima, Peru
Official Title
HIV Prevalence, Incidence and HSV-2 Prevalence Among High-Risk MSM in Lima, Peru
Study Type
Observational

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Herpes Genitalis, HIV Seronegativity, Syphilis
Keywords
Syphilis, Herpes Genitalis, Risk Factors, Incidence, Prevalence, Homosexuality, Male, Informed Consent, Peru, HIV Seronegativity

7. Study Design

Enrollment
250 (false)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie Celum
Official's Role
Study Chair
Facility Information:
Facility Name
Rachael McClennen
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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

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