Clinical trial NCT00279331: Estimating the Incidence of HIV Infection Among Men Who Have Sex With Men in Peru and Ecuador
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Syphilis
Sexually Transmitted Diseases
Keywords: HIV Seronegativity
Men who have Sex with Men
MSM
Peru
Ecuador
Incidence
Prevalence
Drug resistance, viral
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Comprehensive International Program of Research on AIDS
First posted: 2006-01-19
Enrollment: 2608
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Guayaquil-Guayas
country: Ecuador
facility: Fundación Ecuatoriana Equidad CIPRA CRS
city: Lima
country: Peru
facility: IMPACTA - Miraflores CIPRA CRS
city: Lima
country: Peru
facility: IMPACTA - Lince CIPRA CRS
city: Lima
country: Peru
facility: IMPACTA - San Miguel CIPRA Project 3B CRS
city: Lima
country: Peru
facility: Policlinico Daniel Alcides Carrión CIPRA CRS
city: Sullana
country: Peru
facility: Asoc. de Servicios Generales de Salud y Educación CIPRA CRS
Study officials:
affiliation: Asociación Civil Impacta Salud y Educación, Lima, Peru
name: Juan Guanira, MD, MPH
role: STUDY_CHAIR
affiliation: Asociación Civil Impacta Salud y Educación, Lima, Peru
name: Jorge Sanchez, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Asociación Civil Impacta Salud y Educación, Lima, Peru
name: Javier R. Lama, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, Vinoles 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. doi: 10.1136/sti.2004.013094.
citation: Caceres 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(Suppl 2):ii80-4. doi: 10.1136/sti.2004.012021.
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(0 1):S147-58. doi: 10.1086/425268.
citation: Hirsch MS, Brun-Vezinet 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. doi: 10.1086/375597. Epub 2003 Jun 23.