Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023582
Status:
COMPLETED
Last Update Posted:
2008-08-08
First Post:
2001-09-10
Brief Title:
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
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
HIV Prevalence Incidence and HSV-2 Prevalence Among High-Risk MSM in Lima Peru
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 072302 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
All MSM are counseled and tested for HIV HSV-2 and syphilis at the screening visit AS PER AMENDMENT 072302 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None