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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.
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Protocol Status:
Concluded
Study Summary
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.
SDMC Protocol Specialist:
Leslie Cottle
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Protocol Chair:
Connie Celum
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Protocol Chair:
Jorge L. Sanchez
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CORE Protocol Specialist:
Scott Rose
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