HPTN 036
HIV Prevalence, Incidence, and HSV-2 Prevalence Among High-Risk MSM in Perú
What is HPTN 036?Interventions to reduce both HIV and STDs are urgently needed among MSM in Perú. Given the the high prevalence of STDs among MSM in Lima, prevention of HIV infections is partially dependent on innovative methods to control bacterial and viral STDs among high-risk HIV-uninfected MSM. A previous cohort of MSM enrolled in 1998-2000 documented an important need for acceptable and accessible HIV counseling and testing and STD services for MSM. The data from this prevention preparedness study is critical for future HIV prevention and vaccine trials that will be conducted in Perú. HPTN 036 is a prospective cohort study of HIV uninfected and HIV infected MSM. One of the primary objectives of this study are to determine prevalence, incidence, and risk factors for syphilis, HSV-2, and HIV among high-risk HIV-uninfected MSM. |
Protocol Status: Concluded
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 Sites: Lima, Peru
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 Regimen: 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.
