Baseline Clinical Profile of a “Normal Popu-lation” of HIV Exposed Sero-Negative (HESN) Partners May Impact HIV Biomedical Prevention Studies Negatively

Abstract

The burden and viral diversity of HIV in Nigeria makes it suitable to evaluate biomedical prevention strategies including HIV vaccines. We document baseline clinical characteristics of a cohort of HIV Exposed Sero-Negative (HESN) partners to highlight background morbidities that might impact the interpretation of research findings especially in low income countries where “normal control” is based on physical appearance and self-reporting. We established a 2-year prospective cohort of HESN, and obtained, at baseline medical history, general physical examination findings and safety laboratory tests results. Among 534 participants with a mean age of 37 ± 9 years, the commonest symptoms were headache (25.5%) and fever (20%), which occurred more among females. Also, 13% reported a history of urethral/vaginal discharge and genital ulcer. High blood pressure (HBP) (i.e. blood pressure ≥ 140/90 mmhg) was a major abnormal examination finding, which occurred more among males (53.2% vs 26.2%, p < 0.01). More female participants had abnormal laboratory results with 31% having low hemoglobin concentration (<12 g/dl, p = 0.021); 30% with elevated alanine transaminase level (p = 0.019) and 28% with abnormal blood urea nitrogen level (p = 0.093). HBP and abnormal safety laboratory are significant findings among so called “normal population” that could affect interpretation of research findings of HIV biomedical prevention studies in Nigeria.