Estimating the Incidence of HIV Infection Among Men Who Have Sex With Men in Peru and Ecuador
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|ClinicalTrials.gov Identifier: NCT00279331|
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : September 23, 2013
|Condition or disease|
|HIV Infections Syphilis Sexually Transmitted Diseases|
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.
|Study Type :||Observational|
|Estimated Enrollment :||2608 participants|
|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|
|Actual Study Completion Date :||November 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279331
|Fundación Ecuatoriana Equidad CIPRA CRS|
|IMPACTA - Miraflores CIPRA CRS|
|Lima, Peru, 18|
|IMPACTA - Lince CIPRA CRS|
|IMPACTA - San Miguel CIPRA Project 3B CRS|
|Policlinico Daniel Alcides Carrión CIPRA CRS|
|Asoc. de Servicios Generales de Salud y Educación CIPRA CRS|
|Study Chair:||Juan Guanira, MD, MPH||Asociación Civil Impacta Salud y Educación, Lima, Peru|
|Principal Investigator:||Jorge Sanchez, MD, MPH||Asociación Civil Impacta Salud y Educación, Lima, Peru|
|Principal Investigator:||Javier R. Lama, MD, MPH||Asociación Civil Impacta Salud y Educación, Lima, Peru|