Table 1.

Inclusion and exclusion criteria for the Kisumu Incidence Cohort Study, Kisumu, Kenya, 2007–2008

Inclusion criteria

Male and female residents of the Kisumu catchment area

Age 18 to 34 years

Engagement in sexual activity ≥ one time within the past 3 months

HIV seronegative by licensed rapid HIV testing in parallel

Available for 12 months of participation in the study

Able and willing to provide informed consent

Able to provide detailed locator information to ensure adequate, timely follow-up

Meet the following laboratory criteria: serum creatinine < 1.5mg/dl, haemoglobin ≥ 9.0g/dl, platelets > 50,000/ml, ALT < 2.5 times the upper limit of normal

Willing to comply with study procedures and requirements if meet criteria for study eligibility

Exclusion criteria

HIV seropositive

Pregnant or plan to become pregnant in next 12 months if female

Plan to reside outside the Kisumu catchment area for >3 months

Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, or allergic disease that would compromise the ability of the participant to provide competent informed consent, or to complete study procedures or study requirements as determined by the principal investigator or designated associate.

The clinical significance of any abnormality is to be evaluated in the context of the safety of the patient volunteer and the objectives of this study.

Active participation in HIV intervention studies that might influence HIV incidence or risk behaviour