Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00279331
Status:
COMPLETED
Last Update Posted:
2013-09-23
First Post:
2006-01-18
Brief Title:
Estimating the Incidence of HIV Infection Among Men Who Have Sex With Men in Peru and Ecuador
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Implementation of a Third Generation Sentinel Surveillance Approach Among Men Who Have Sex With Men at High Risk for HIV Type-1 Acquisition in the Andean Region
Status:
COMPLETED
Status Verified Date:
2013-09
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 observational study is to estimate the number of new HIV infections and the number and variability of antiretroviral-resistant HIV strains among men who have sex with men MSM Participants will be recruited from four sites in Peru and one site in Ecuador
Detailed Description:
The governments of Peru and Ecuador signed an agreement with the Global Fund to Fight AIDS Tuberculosis and Malaria to help guarantee comprehensive quality of care to people living with HIV including access to antiretrovirals ARVs Current methods of surveillance are inadequate in estimating the true burden of disease Broad access to ARVs in countries without regular drug resistance testing can also cause rapid development of ARV resistance By establishing a more sophisticated surveillance system able to capture HIV incidence prevalence patterns of HIV resistance and genetic variability of viral strains Peru and Ecuador will be better equipped to monitor the HIV epidemic develop personalized prevention and control measures and track patterns of HIV resistance among infected patients This study will estimate the incidence of HIV syphilis and herpes simplex virus 2 HSV-2 among MSM in Peru and Ecuador as well as examine the number and variability of ARV-resistant HIV strains
This study will last about 2 weeks Medical history a physical exam an HIV rapid test and HIV pre- and post-test counseling will occur at study entry Those who test HIV positive will be asked to return to the test site in about 2 weeks to receive confirmatory test results Patients confirmed to be infected with HIV will be referred to HIV treatment clinics in their area
At study entry participants will also undergo a syphilis test Those who test positive for syphilis will receive same-day treatment at the clinic and be asked to return during Week 1 and 2 to complete treatment for sexually transmitted diseases STDs according to local guidelines STD treatment will not be provided by the study Those who test negative to both the HIV rapid test and the syphilis test at screening will not participate in any more study visits Patients who consent to having samples stored for further investigations will also have their samples tested for HSV-2 infection following completion of the study
This study will last about 2 weeks Medical history a physical exam an HIV rapid test and HIV pre- and post-test counseling will occur at study entry Those who test HIV positive will be asked to return to the test site in about 2 weeks to receive confirmatory test results Patients confirmed to be infected with HIV will be referred to HIV treatment clinics in their area
At study entry participants will also undergo a syphilis test Those who test positive for syphilis will receive same-day treatment at the clinic and be asked to return during Week 1 and 2 to complete treatment for sexually transmitted diseases STDs according to local guidelines STD treatment will not be provided by the study Those who test negative to both the HIV rapid test and the syphilis test at screening will not participate in any more study visits Patients who consent to having samples stored for further investigations will also have their samples tested for HSV-2 infection following completion of the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10408 | REGISTRY | DAIDS ES | None |
| I-U19-AI053218-01A2 | None | None | None |
| Project 3B | None | None | None |