HIV InfectionsNCT00279331
Estimating the Incidence of HIV Infection Among Men Who Have Sex With Men in Peru and Ecuador
An observational study of HIV Infections and Syphilis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Syphilis, Sexually Transmitted Diseases
- How many people
- 2,608 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Start not givento Nov 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- HIV infected
- Unwilling to participate in HIV screening
- Any psychiatric or mental condition that may interfere with the study
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Peru5 sites
IMPACTA - Miraflores CIPRA CRS
Lima, 18
IMPACTA - Lince CIPRA CRS
Lima
IMPACTA - San Miguel CIPRA Project 3B CRS
Lima
Policlinico Daniel Alcides Carrión CIPRA CRS
Lima
Asoc. de Servicios Generales de Salud y Educación CIPRA CRS
Sullana
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections, Syphilis, Sexually Transmitted Diseases
- Keywords
- HIV Seronegativity, Men who have Sex with Men, MSM, Peru, Ecuador, Incidence, Prevalence, Drug resistance, viral
- Medical subject headings
- HIV Infections, Syphilis, Sexually Transmitted Diseases, Homosexuality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 2,608 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Comprehensive International Program of Research on AIDS
- Responsible party
- Sponsor
- Investigators
- Juan Guanira, MD, MPH, Study chair, Asociación Civil Impacta Salud y Educación, Lima, PeruJorge Sanchez, MD, MPH, Principal investigator, Asociación Civil Impacta Salud y Educación, Lima, PeruJavier R. Lama, MD, MPH, Principal investigator, Asociación Civil Impacta Salud y Educación, Lima, Peru
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279331
- Sponsor's protocol ID
- CIPRA PE 002
- Other IDs
- I-U19-AI053218-01A2, Project 3B, 10408
- Status last verified
- Sep 2013
- First submitted
- 18 Jan 2006
- Last updated
- 23 Sep 2013
- Results posted
- No
Publications
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.
PubMed 15572623Caceres 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.
PubMed 15572646Goodreau 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.
PubMed 15627225Hirsch 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.
PubMed 12830416
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00279331
- Acronym / sponsor ID
- CIPRA PE 002
- Conditions
- HIV Infections, Syphilis, Sexually Transmitted Diseases
- Keywords
- HIV Seronegativity, Men who have Sex with Men, MSM, Peru, Ecuador, Incidence, Prevalence, Drug resistance, viral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,608 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Comprehensive International Program of Research on AIDS
- Study completion
- Nov 2006 (actual)
- First posted
- 19 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (3 listed)
- HIV infected
- Unwilling to participate in HIV screening
- Any psychiatric or mental condition that may interfere with the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
- Background: PubMed 15572623Bautista 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.
- Background: PubMed 15572646Caceres 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.
- Background: PubMed 15627225Goodreau 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.
- Background: PubMed 12830416Hirsch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Guanira, MD, MPH study chair
Asociación Civil Impacta Salud y Educación, Lima, Peru
Jorge Sanchez, MD, MPH principal investigator
Asociación Civil Impacta Salud y Educación, Lima, Peru
Javier R. Lama, MD, MPH principal investigator
Asociación Civil Impacta Salud y Educación, Lima, Peru
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Syphilis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Peru, Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00279331, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2013.