Background:  Large-scale preventive HIV clinical trials will require the recruitment and follow-up of thousands of uninfected volunteers with relatively high HIV incidence. Data on incidence and early infection data will inform trial sample size and definition of endpoints.

Methods:  From 2004 to 2006, International AIDS Vaccine Institute (IAVI) with 7 sites in east and southern Africa have engaged in a collaboration to develop clinical, laboratory, counseling, and community outreach facilities to prepare for large scale HIV vaccine trials. HIV^– adult volunteers are recruited and followed at all sites. Volunteers who become HIV-infected receive appropriate counseling and are enrolled into a separate study. Sites and study populations are shown in the table. Laboratory facilities at each site work to Good Clinical Lab Practices standards and are enrolled in an independent quality assurance program to ensure that HIV testing, and other laboratory parameters are comparable across sites. All study procedures are conducted following International Conference on Harmonization (ICH)/Good Clinical Practices (GCP) guidelines.  Counseling and testing messages and procedures are being tailored for research volunteers.   

Results:  So far, 4392 potential vaccine trial volunteers have enrolled, contributing >6800 person years of observation. The incidence estimates are shown in the table. Since early 2006, 131 volunteers with early HIV infection were enrolled, most within 6 months of estimated infection (range 16 to 380 days). The median age among these volunteers was 33 (range 18 to 62), and 48 infections (37%) were in female volunteers.

Conclusions:  Over 2 years, 7 sites in Sub-Saharan Africa have successfully engendered research facilities capable of recruiting thousands of potential volunteers for vaccine clinical trials. The lessons learned from this work will guide the development of upcoming efficacy trials.