Clinical trial NCT01387412: The Role of Genital Warts in HIV Acquisition in Peru
Official title: The Role of Genital Warts in HIV Acquisition Among MSM in Peru"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anogenital Warts
HIV
Keywords: genital warts
HIV
MSM
Peru
HPV
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Espacio Comun
name: Universidad Peruana Cayetano Heredia
First posted: 2011-07-04
Enrollment: 600
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

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.

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.

Eligibility 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.

Primary outcomes:
measure: HIV incidence
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Barranco
country: Peru
facility: Espacio Comun
state: Lima
Study officials:
affiliation: University of California, Los Angeles
name: Brandon Brown, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Espacio Comun
name: Jerome Galea, MSW
role: STUDY_DIRECTOR
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