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NCT00279331 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00279331
Other study ID # CIPRA PE 002
Secondary ID I-U19-AI053218-0
Status Completed
Phase N/A
First received January 18, 2006
Last updated September 20, 2013
Est. completion date November 2006

Study information
Verified date September 2013
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 2608
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Ecuador Fundación Ecuatoriana Equidad CIPRA CRS Guayaquil-Guayas
Peru IMPACTA - Lince CIPRA CRS Lima
Peru IMPACTA - Miraflores CIPRA CRS 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

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Comprehensive International Program of Research on AIDS

Countries where clinical trial is conducted

Ecuador,  Peru, 

References & Publications (4)

Bautista CT, Sanchez JL, Montano SM, Laguna-Torres VA, Lama JR, Sanchez JL, Kusunoki L, Manrique H, Acosta J, Montoya O, Tambare AM, Avila MM, Viñoles J, Aguayo N, Olson JG, Carr JK. Seroprevalence of and risk factors for HIV-1 infection among South American men who have sex with men. Sex Transm Infect. 2004 Dec;80(6):498-504. — View Citation

Cáceres CF, Mendoza W. Monitoring trends in sexual behaviour and HIV/STIs in Peru: are available data sufficient? Sex Transm Infect. 2004 Dec;80 Suppl 2:ii80-4. — View Citation

Goodreau SM, Goicochea LP, Sanchez J. Sexual role and transmission of HIV Type 1 among men who have sex with men, in Peru. J Infect Dis. 2005 Feb 1;191 Suppl 1:S147-58. — View Citation

Hirsch MS, Brun-Vézinet F, Clotet B, Conway B, Kuritzkes DR, D'Aquila RT, Demeter LM, Hammer SM, Johnson VA, Loveday C, Mellors JW, Jacobsen DM, Richman DD. Antiretroviral drug resistance testing in adults infected with human immunodeficiency virus type 1: 2003 recommendations of an International AIDS Society-USA Panel. Clin Infect Dis. 2003 Jul 1;37(1):113-28. Epub 2003 Jun 23. — View Citation

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