Following the closure of IAVI’s early infection cohort study, Protocol C, it became clear that continued viral surveillance for assay and reagent development would remain a priority for the field. Technology had begun to evolve such that the cost and logistics of identifying persons with very early HIV infection became more manageable. Within a year of ending Protocol C enrolment, IAVI partners began screening for acute (i.e., pre-seroconversion) HIV infection among adolescent girls and young women in South Africa. Since that time, this program has expanded to new sites in Kenya, Zambia, Rwanda, and soon Uganda and IAVI has entered into an agreement with Cepheid to provide GeneXpert real-time PCR platforms to allow rapid diagnosis of per-seroconversion HIV infection. While treatment is now offered immediately and so-called “natural history” cohort studies are no longer ethical, identifying persons very soon after infection both serves to provide currently circulating virus to study and to immediately put these people on treatment during a very infectious period, when they typically go undiagnosed.

Type: Prospective cohort studies of volunteers with incident HIV infection identified prior to, or during antibody seroconversion, using real-time PCR on the GeneXpert platform, or overnight traditional PCR. Dozens of volunteers identified during this acute phase of HIV infection have been offered treatment, and are followed over time.
Study Status: Studies in Zambia, Kenya, and South Africa are active. Studies in Rwanda are complete. Studies in Uganda are in development.
Enrollment Status: Open
Countries: Kenya; Rwanda; South Africa; Uganda; Zambia
Partners: HIV Pathogenesis Program, Durban, South Africa; Kenya Medical Research Institute-Centre for Geographic Medicine Research-Coast, Kilifi, Kenya; MRC, UVRI & LSHTM (MUL) Uganda Research Unit, Masaka, Uganda; Center for Family Health Research in Zambia, Lusaka and Ndola

Study Summary:
Identifying acute (pre-seroconversion) HIV infection is important because initiating early treatment has positive benefits for the volunteer, and early events in HIV infection may provide clues for vaccines, therapeutics, and cure research. New technologies have made identifying acute HIV infection increasingly easier.