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The Role of Genital Warts in HIV Acquisition in Peru (VIVA)

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ClinicalTrials.gov Identifier: NCT01387412
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : December 2, 2015
Sponsor:
Collaborators:
Espacio Comun
Universidad Peruana Cayetano Heredia
Information provided by (Responsible Party):
Brandon Brown, University of California, Los Angeles

Study Description
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Brief Summary:
The primary objective of this study is to determine the role of genital warts (GW) on Human Immunodeficiency Virus (HIV) acquisition among men who have sex with men (MSM) in Peru. The secondary objectives are to determine Human Papillomavirus (HPV) prevalence in HIV positive MSM in Peru, risk factors associated with GW, and the knowledge of HPV and HIV among MSM.

Condition or disease
Anogenital Warts HIV

Detailed Description:

Persons with Human Immunodeficiency Virus (HIV) infection are at higher risk of becoming infected with the Human Papillomavirus (HPV) compared to those who are HIV negative. The contrary is also true: individuals infected with HPV may be more likely to acquire HIV; however, the role of the clinical manifestation of HPV - genital warts (GW) - on HIV acquisition is currently unknown. Few studies have shown that GW are independently associated with HIV acquisition.

The primary objective of this study is to determine the role of GW on HIV acquisition among MSM in Peru. The secondary objectives are to determine HPV prevalence in HIV positive MSM in Peru, risk factors associated with GW, and the knowledge of HPV and HIV among MSM. The specific aims of this study are:

  1. To estimate HIV incidence in Peruvian MSM by GW status.
  2. To determine the prevalence of HIV among Peruvian MSM by GW status.
  3. To determine the type-specific prevalence of anal HPV infection in HIV positive Peruvian MSM. Linear array testing will estimate prevalence of 37 HPV types including carcinogenic (16,18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66) and non-carcinogenic types (6, 11, 26, 40, 42, 53, 54, 61, 62, 64, 67, 68, 69, 70, 72, 73, 81, 82, 82var, 83, 84, and 89) as defined at the 2005 meeting of the International Agency for Research on Cancer.
  4. To identify risk factors associated with genital warts (penile, anal, and both) among Peruvian MSM.
  5. To assess the knowledge of Peruvian MSM of the role of HPV in HIV infection.

The study will be conducted in the Gay Men's Community Health Center, Epicentro, the only center in Lima that specifically caters to men who have sex with men and sees a high burden of genital warts in their patient population. The study includes a population of 600 MSM (300 with recent or current genital warts). Baseline HIV serostatus will be done by rapid testing, and follow-up for HIV incidence will be done every 6 months over a two year time period. We will determine HPV status in HIV-positive participants and refer them for free highly active antiretroviral therapy (HAART) treatment. We will examine participants for GW presence and collect information on history of GW. A survey will be administered at each visit which examines changes in risk behaviors over time.

This novel study proposes to both measure the prevalence of GW in MSM presenting at a community clinic environment and prospectively measure HIV incidence in men with GW and those without GW. It will be the first study of its kind that we are aware of using HIV infection as an endpoint in men with and without GW and will help to better understand the relationship between genital warts and HIV infection among MSM in Peru.


Study Design
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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Genital Warts in HIV Acquisition Among MSM in Peru"
Study Start Date : April 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Warts
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Genital warts
Those with and without ano-genital warts


Outcome Measures
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Primary Outcome Measures :
  1. HIV incidence [ Time Frame: 2 years ]
    new cases of HIV in our cohort in either the group with or without genital warts


Biospecimen Retention:   Samples With DNA
serum, lesion biopsies

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

Inclusion Criteria:

  • Anatomical males 18-40 years of age,
  • Self-reported anal sex with another man within 12 months prior to enrollment,
  • Willing to provide informed consent for the collection of demographic and sexual behavior data, as well as blood for HIV and Syphilis testing, swabs of anal mucosa for HPV testing and urine for Chlamydia testing,
  • Resident of metropolitan Lima.

Exclusion Criteria:

  • Prior participation in an HPV vaccine clinical trial,
  • Prior participation in an HIV vaccine clinical trial,
  • Presence of a known immunodeficiency that increases risk of acquiring HIV.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387412


Locations
Peru
Espacio Comun
Barranco, Lima, Peru
Sponsors and Collaborators
University of California, Los Angeles
Espacio Comun
Universidad Peruana Cayetano Heredia
Investigators
Principal Investigator: Brandon Brown, PhD University of California, Los Angeles
Study Director: Jerome Galea, MSW Espacio Comun
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Brandon Brown, Faculty, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01387412     History of Changes
Other Study ID Numbers: Merck IISP 39619
First Posted: July 4, 2011    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by Brandon Brown, University of California, Los Angeles:
genital warts
HIV
MSM
Peru
HPV

Additional relevant MeSH terms:
Warts
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
 Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases