HPTN 036

Study Purpose

To provide biomedical and behavioral data critical for the planning and implementation HPTN of HIV prevention trials in Lima, Perú.

Study Design

(1) Prospective cohort study with a six-month accrual period and 12 months of follow-up for enrolled HIV-uninfected participants; (2) cross-sectional study of risk behaviors, partnership status, and HSV-2 serostatus of HIV-infected men who have sex with men.

Study Population

HIV-uninfected and HIV-infected men who have sex with men (MSM)

Study Size

500 HIV-uninfected MSM; 150-200 HIV-infected MSM

Study Duration

Accrual will require six months. HIV-uninfected participants will complete one year of follow-up. Therefore, the entire study should be completed within approximately 18 months.

Treatment Regime

None. However STD and HIV pre-test, risk reduction, and post-test counseling will be provided at each testing timepoint. In addition, participants will be referred for STD treatment if needed.

Primary Objectives

To determine prevalence, incidence, and risk factors for syphilis, HSV-2, and HIV among high-risk HIV-uninfected MSM.
Among HSV-2 seropositive men, evaluate informed consent procedures, eligibility criteria, and willingness to participate in a trial of daily suppressive acyclovir for HIV prevention.
To identify effective follow-up strategies for high-risk MSM in Lima to achieve at least 90% retention at 12 months.

Secondary Objectives

To measure the use of condoms, barriers, and facilitators to enhance condom use with male and female partners.
To characterize the sexual networks of MSM, and the proportion of HIV-infected and HIV-negative men who are sexually active with both men and women.

Other Objectives