NCT00279331

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,608

participants targeted

Target at P75+ for all trials

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

September 23, 2013

Status Verified

September 1, 2013

First QC Date

January 18, 2006

Last Update Submit

September 20, 2013

Conditions

HIV InfectionsSyphilisSexually Transmitted Diseases

Keywords

HIV SeronegativityMen who have Sex with MenMSMPeruEcuadorIncidencePrevalenceDrug resistance, viral

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Fundación Ecuatoriana Equidad CIPRA CRS

Guayaquil-Guayas, Ecuador

Location

IMPACTA - Miraflores CIPRA CRS

Lima, 18, Peru

Location

IMPACTA - Lince CIPRA CRS

Lima, Peru

Location

IMPACTA - San Miguel CIPRA Project 3B CRS

Lima, Peru

Location

Policlinico Daniel Alcides Carrión CIPRA CRS

Lima, Peru

Location

Asoc. de Servicios Generales de Salud y Educación CIPRA CRS

Sullana, Peru

Location

Related 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, 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.

    PMID: 15572623BACKGROUND

  • 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.

    PMID: 15572646BACKGROUND

  • 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.

    PMID: 15627225BACKGROUND

  • 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.

    PMID: 12830416BACKGROUND

MeSH Terms

Conditions

HIV InfectionsSyphilisSexually Transmitted DiseasesHomosexuality

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesTreponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSexualitySexual BehaviorBehavior

Study Officials

  • 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

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2006

First Posted

January 19, 2006

Study Completion

November 1, 2006

Last Updated

September 23, 2013

Record last verified: 2013-09

Locations

PE(5)EC(1)