HPTN 036

HIV Prevalence, Incidence, and HSV-2 Prevalence Among High-Risk MSM in Perú

Study Summary

What was HPTN 036?

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

Who participated in the study?

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

What happened during the study?

No treatment regimen, however STD and HIV pre-test, risk reduction, and post-test counseling were provided at each testing time point. In addition, participants were referred for STD treatment if need.

Study Documents

Study Details

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 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 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.