1. Innovative Biotech Ltd Nigeria Dr Simon Agwale

2. General overview (1) n Nigeria is the tenth largest country in the world and the most populous in Africa. It is situated within sub Saharan Africa which harbors about 67% of the world HIV/AIDS burden n It has an estimated population of 120 million (1999), representing over one fifth of the total population of the African continent n It is a democratic Federal Republic consisting of 36 states and the Federal Capital Territory (FCT) n The literacy level is estimated to be 55%

3. n Ever since HIV was reported in the country in 1996, the infection rate has continued to rise steadily from less than 0.1% in 1987, to 1.8% in 1991, to 5.8% in 2001, with a slight decrease in 2003 sentinel survey to 5.0% n The HIV prevalence rates in the two States chosen for the study are 12% for Benue and 9% for Nasarawa. Most of the female sex workers have low literacy rates n Presently, no study has effectively addressed the incidence of the disease among this group till date General overview (2)

4. HIV prevalence in Nigeria (1)

5. n According to the National survey, HIV prevalence rate among female sex workers in Nigeria has remained high, and is on the increase from 17.5% in 1991 through 22.5%(1993), to 35.6% in 1995 n Female sex workers constitutes an important core group of HIV transmission to the general population HIV prevalence in Nigeria (2)

6. n Innovative Biotech Ltd (IBL) is a company registered in Nigeria n Investigators have experience with clinical research n Current research at IBL includes:  Development of HIV candidate vaccines  Subtyping of HIV 1 and 2 in Nigeria  HIV drug resistance Surveillance in Nigeria  Prevalence of co-infection of HIV with Hepatitis B & C  Subtyping of Hepatitis C virus in Nigeria  Cross-sectional HIV incidence study among female sex workers based at brothels in Nasarawa and Benue states Site overview

7. Site locations

8. Interim study findings ( Feb. 07- April 11, 2006) Total number of brothels28 Total number recruited266 Total number HIV positive192 Total number of HIV negative74 Total number of co-infection (HIV-1 and 2)12 Number of HIV-1alone180 Number of HIV-2Nil HIV prevalence so far72% Prevalence of co-infection4.5%

9. ChallengesChallenges n Subjects being skeptical of our intention-  such trials are relatively new in the area  Not comfortable with staff leaving with their blood samples  Some think their blood will be used for ritual purpose n Resistance sometimes from their male clients n Brothel owners not being cooperative in some places n Outright refusal to grant us entrance in some brothels n Resistance to the ideal of someone witnessing after signing the informed consent form

10. Current infrastructure n DNA sequencer-DNA analyses n Real time PCR for Viral load quantification n Facs count for CD4/8 measurement n ELISA washer and reader n Chemistry analyzer n Vaccine administration and post-vaccination surveillance n Training and capacity building for health workers, organizations and the general public n Treatment services for HIV an other tropical infectious diseases n Internet and Data entry/analyses n Pharmacy n Counselling unit

11. ReceptionReception

12. Data entry and processing

13. Serology lab

14. Lab equipment

15. IT Equipment

16. IBL Boardroom