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CompletedNCT00023582Updated Aug 8, 2008

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

An observational study in HIV Infections, Herpes Genitalis and HIV Seronegativity, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-08-08.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

Study type
Observational
Enrollment
250
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV Infections
  • Herpes Genitalis
  • HIV Seronegativity
  • Syphilis

Keywords

  • Syphilis
  • Herpes Genitalis
  • Risk Factors
  • Incidence
  • Prevalence
  • Homosexuality, Male
  • Informed Consent
  • Peru
  • HIV Seronegativity
03

In context

Herpes Simplex

305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.

This study's enrollment of 250 is above the median of 180 across 55 observational studies indexed under Herpes Simplex.

Browse Herpes Simplex studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Enrollment
250 participants
06

Study locations

1 site
  • Rachael McClennen
    Seattle, Washington 98104, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00023582
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
First posted
Sep 11, 2001
Last update
Aug 8, 2008

Study contacts

Connie Celum
study chair
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.

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