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

November 30, 2015 updated by: Brandon Brown, University of California, Los Angeles

The Role of Genital Warts in HIV Acquisition Among MSM in Peru"

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
    • Lima
      • Barranco, Lima, Peru
        • Espacio Comun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Community sample

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV incidence
Time Frame: 2 years
new cases of HIV in our cohort in either the group with or without genital warts
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

Universidad Peruana Cayetano Heredia
Espacio Comun

Investigators

  • Principal Investigator: Brandon Brown, PhD, University of California, Los Angeles
  • Study Director: Jerome Galea, MSW, Espacio Comun

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

June 30, 2011

First Submitted That Met QC Criteria

June 30, 2011

First Posted (Estimate)

July 4, 2011

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Merck IISP 39619

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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