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| ID | Type | Description | Link |
|---|---|---|---|
| I-U19-AI053218-01A2 | |||
| Project 3B | |||
| 10408 | Registry Identifier | DAIDS ES |
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| Name | Class |
|---|---|
| Comprehensive International Program of Research on AIDS | OTHER |
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.
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.
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Guanira, MD, MPH | Asociación Civil Impacta Salud y Educación, Lima, Peru | Study Chair |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación Ecuatoriana Equidad CIPRA CRS | Guayaquil-Guayas | Ecuador | ||||
| IMPACTA - Miraflores CIPRA CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15572623 | Background | 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. | |
| 15572646 |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D013587 | Syphilis |
| D012749 | Sexually Transmitted Diseases |
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Lima |
| 18 |
| Peru |
| IMPACTA - Lince 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 | Peru |
| 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. |
| 15627225 | Background | 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. |
| 12830416 | Background | 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. |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |