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

18 Years
40 Years
Open (Enrolling)
Anogenital Warts, HIV

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Trial Information

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

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
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.

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

HIV incidence

Outcome Description:

new cases of HIV in our cohort in either the group with or without genital warts

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Brandon Brown, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles


United States: Institutional Review Board

Study ID:

Merck IISP 39619



Start Date:

April 2012

Completion Date:

September 2015

Related Keywords:

  • Anogenital Warts
  • HIV
  • genital warts
  • HIV
  • MSM
  • Peru
  • HPV
  • Condylomata Acuminata
  • Warts