HIV Testing and Treatment to Prevent Onward HIV Transmission Among MSM and Transgender Women in Lima, Peru
This is three-step study. Step 1 will screen men who have sex with men (MSM) and
transgender women who are unaware of their HIV status and 1) report high risk behaviors for
acquiring HIV-1 infection or 2) who have symptoms of acute retroviral syndrome or 3) who
have a sexual partner with newly-diagnosed acute or recent HIV infection. HIV testing will
be conducted for several thousand MSM and transgender women from study opening until July
2015. In Step 2, high risk HIV-1 uninfected MSM and transgender women with high risk for
acquiring HIV will be tested at regular intervals for incident HIV-1 (using tests for HIV
p24 and/or HIV RNA). (During this period, men will receive standard HIV prevention
interventions.) In Step 3, individuals with acute or recent HIV-1 infection will be enrolled
in a 48-week randomized, open-label study of the effects of immediate vs. deferred ART on
the decay dynamics of HIV viral load in plasma, semen and rectal secretions. (ART will be
provided prior to 24 weeks for any participant in the deferred ART arm who meets initiation
criteria.) All participants will be followed for 48 weeks after which they will continue
ART from other sources.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
HIV viral load
To quantify HIV viral load in plasma, semen and rectal secretions in individuals with early HIV infection in immediate versus deferred treatment groups.
Ann Duerr, M.D.
Fred Hutchinson Cancer Research Center
United States: Institutional Review Board