1. Why do epidemiology and clinical trials in international settings? -Or- “Tales of my circuitous career path” Connie Celum, MD, MPH Associate Professor of Medicine University of Washington

2. Why do epidemiology and clinical trials in international settings? Problems of public health importance are most concentrated in resource-poor countries Thus, opportunities are greater for addressing issues with potential impact Allows for potentially lasting contributions in research, training, services, and infrastructure

3. Tales of a circuitous career path Started undergraduate major in International Relations  Human Biology Medical school & internal medicine residency, UCSF MPH (Robert Wood Johnson) & ID fellowship at UW UW faculty since 1991 –Harborview STD clinic director: 1991-98 –HIV & STD epidemiologic research: 1995–now –HIV prevention & clinical trials: 1997-now

4. Evolution of our research program in Peru UW - Fogarty training in epidemiology in 1991 Past decade, >30 Peruvians trained at UW –Very high “return rate” –Critical mass of internists, pediatricians, Ob-Gyns trained in epidemiology; most interested in clinical research Initially observational, descriptive epidemiology Steep growth in clinical trials over past 5 years

5. HIV and STD research in Peru 1998-2000: Development of cohort of men who have sex with men (MSM) to determine HIV seroincidence, STD prevalence & risk behaviors (Dr. Jorge Sanchez) 2000: NIH funding to develop HIV Prevention Trials Unit (HPTU) & Vaccine Unit (HVTU) 2002: NIH funding to develop Int’l AIDS Clinical Trials Unit 2003: Submission of Andean Comprehensive AIDS Research Program (CIPRA)

6. Findings from “Alaska” More than 8000 MSM were screened in Lima between 1998 and 2000

7. High prevalence of bisexuality 30% of HIV positive, and 18% of HIV negative reported sex with women in the past 6 months Estimated incidence among first 2424 MSM screened = 5.1% (95% CI = 3.1 - 9.4) Observed incidence = 3.3% Findings from “Alaska”

8. Large capacity for recruiting MSM in Lima High HIV prevalence (13%) & incidence (3.3%) High STD prevalence –15% syphilis seropositive; 18% with early syphilis –5% rectal GC/CT & 3% urethritis –50% of HIV- MSM and 92% of HIV+ MSM have HSV-2 Mixture of delivery of prevention & clinical services; limited resources and focus on retention –Need to identify effective retention strategies Lessons from “Alaska” cohort

9. Current HIV clinical trials in Peru Phase I HIV vaccine trials: –Canarypox & gp 120: 28 enrolled in 5 mos –Merck adenovirus-gag vector: to begin March 2003 Vaccine preparedness work: –MSM cohort in Iquitos, city of 300,000 in Amazon HIV prevention: –Intervention to test whether HSV-2 suppression reduces HIV acquistion –Cross-over study of HSV-2 suppression on HIV shedding HIV treatment: Randomized trial of 3 regimens of HAART for CD4 <200

10. High HIV incidence in 2 jungle cities: IquitosPucallpa N=405N=508 HIV prevalence13%3.5% Estimated HIV incid.7.1% (2-15.1)4.5% (1.0-10.2) Observed HIV incid.2.2/100 p-yrs3.5/100 p-yrs * by LS EIA on reactive sera Year 2000 sentinel surveillance: 8 medium- sized cities 3101 MSM tested in 8 medium cities Overall HIV prevalence of 7% Estimated HIV incidence 2.9%*

11. Lessons learned from my research collaborations in Peru Feasible & rewarding Requires patience & persistence in start-up phase –Need to train in Good Clinical Practices, protocol adherence –Clinical trials are more demanding than epid studies Need to have the “long view” Collaboration is essential Requires sensitivity to working relationships, institutional history, & barriers

12. My advice Find the questions that “grab” you Find mentors to guide (& hopefully inspire) you Be patient; even circuitous paths get you there Keep your sense of humor and purpose Find good collaborators Stay the course