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Estimating the Incidence of HIV Infection Among Men Who Have Sex With Men in Peru and Ecuador

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00279331
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : September 23, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
HIV Infections Syphilis Sexually Transmitted Diseases

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.

Study Design

Study Type : Observational
Estimated Enrollment : 2608 participants
Time Perspective: Prospective
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
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • HIV uninfected or unaware of HIV infection status
  • Male at birth
  • Report having anal intercourse, either insertive or receptive, with another man 6 months prior to study entry
  • Living in one of the participating study cities at time of study entry
  • Self-report at least one of the following behaviors:

    • No condom use during the last receptive or insertive anal intercourse
    • Receptive or insertive anal intercourse with more than five sex partners 6 months prior to study entry
    • Exchange of money, gifts, drugs, or shelter for sex 6 months prior to study entry
    • STD symptoms 6 months prior to study entry
    • Inconsistent condom use with an HIV infected sex partner 6 months prior to study entry

Exclusion Criteria:

  • HIV infected
  • Unwilling to participate in HIV screening
  • Any psychiatric or mental condition that may interfere with the study
Contacts and Locations

Information from the National Library of Medicine

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
Guayaquil-Guayas, Ecuador
Lima, Peru, 18
Lima, Peru
IMPACTA - San Miguel CIPRA Project 3B CRS
Lima, Peru
Policlinico Daniel Alcides Carrión CIPRA CRS
Lima, Peru
Asoc. de Servicios Generales de Salud y Educación CIPRA CRS
Sullana, Peru
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Comprehensive International Program of Research on AIDS
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
More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00279331     History of Changes
Other Study ID Numbers: CIPRA PE 002
Project 3B
10408 ( Registry Identifier: DAIDS ES )
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: September 23, 2013
Last Verified: September 2013

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Seronegativity
Men who have Sex with Men
Drug resistance, viral

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections