Epidemiological studies of people who are in the early, acute stages of HIV infection are a high-value resource for vaccine design and development, as well as for cure research. In the Protocol C project launched in 2006, IAVI and a wide range of research partners studied volunteers in Kenya, Uganda, Rwanda, Zambia and South Africa to learn more about how HIV progresses and is transmitted. More than 600 volunteers with incident HIV infection were enrolled in Protocol C. All volunteers were provided with or referred for routine HIV care, including ART provision. Some 190,000 Protocol C samples were collected and more than 26,000 shared with researchers around the world.

Type: Prospective cohort
Study Status: Ongoing
Enrollment Status: Closed
Countries: Kenya; Uganda; Rwanda; Zambia; South Africa
Partners: Kenya AIDS Vaccine Initiative-Kangemi (KAVI-Kangemi), Nairobi, Kenya; Kenya AIDS Vaccine Initiative-Kenyatta National Hospital (KAVI-KNH), Nairobi, Kenya; Kenya Medical Research Institute-Centre for Geographic Medicine Research-Coast (KEMRI-CGMRC), Kilifi, Kenya; Medical Research Council (MRC-Entebbe)-Entebbe, Uganda; Medical Research Council (MRC-Masaka)-Masaka, Uganda; Uganda Virus Research Institute-International AIDS Vaccine Initiative (UVRI-IAVI)-Entebbe, Uganda; Projet San Francisco (PSF-Kigali)-Kigali, Rwanda; Zambia-Emory Research Project (ZEHRP)-Copperbelt, Kitwe, Zambia; Zambia-Emory Research Project (ZEHRP)-Copperbelt-Ndola, Zambia; Zambia-Emory Research Project (ZEHRP)-Lusaka, Zambia; Aurum Institute, Rustenburg, South Africa; Desmond Tutu HIV Foundation (DTHF), Cape Town, South Africa.

Study Summary:
To evaluate clinical, laboratory, immunologic and viral markers of disease progression in volunteers with recent HIV infection to prepare for activities relevant to the execution of preventive HIV vaccine efficacy trials. If identifiable and willing, HIV-infected partner(s) of enrolled volunteers were assessed for virologic and immunogenetic parameters relevant to transmission.