1. HIV Prevention Trials Network

2. HIV Prevention Trials Network: An investigator-led clinical research network designed to evaluate promising HIV prevention approaches in both international and domestic settings.

3. HPTN Overview: A worldwide collaborative clinical trials network established by the U.S.National Institutes of Health (NIH) to evaluate the safety and efficacy of prevention interventions. The HPTN is a successor to the HIVNET, a research network that conducted Phase I, II, and III trials at 11 U.S. and 11 international sites.

4. Types of Clinical Trials • Preparedness • Phase I • Phase II • Phase III • See CRIA Booklet in Training Manual

5. HPTN Basics • HPTN provides careful evaluation of the non-vaccine HIV prevention approaches that have the greatest potential impact on slowing HIV spread worldwide. • 25 research sites • 16 international • 9 domestic

7. Key Elements to HPTN Trial Success Science Development HPTN TRIALS Adequate Resources Site Preparation

8. HPTN Strengths: • Leadership by experts in the prevention sciences • Coordinated domestic-international research agenda • Multi-disciplinary study teams of behavioral, clinical, epidemiological, laboratory, operations, and statistical researchers • Capability to conduct cross-cultural comparisons among different populations • Emphasis on high ethical standards in research.

9. HPTN Trial Success:Science Development • Trial Development up to implementation • Concept plan • Protocol development • Based on: • Scientific merit • Feasibility • Public health impact

10. HPTN Trial Success:Site Preparation • Scientific feasibility: • Existing cohort • Baseline data • Sufficient HIV Incidence/prevalence • Sufficient research infrastructure • Community participation • Established relationships • Plan for community participation activities • Community mobilization

11. HPTN Trial Success:Adequate Resources • Staffing • Facilities / Space • Equipment • Datafax • Computers • Freezers • Speaker phones • Budget

12. HPTN Scientific Management • HPTN Committees • Protocol Review • Study Monitoring • Network Evaluation • Manuscript Review • Ethics Executive Committee Prevention Leadership Group External Advisory Committee HPTN Community Working Group Perinatal Science Working Group Microbicides Science Working Group Behavioral Interventions Science Working Group STD Control Science Working Group Antiretroviral Therapies Science Working Group Substance Use Science Working Group

13. HPTN Challenges • Optimizing the highest HPTN scientific priorities and site capabilities/interest • Addressing the increasingly complex international ethical and regulatory issues • Merging scientific fields • Identifying adequate resources for a diverse scientific agenda

14. HIVNET Ongoing Studies

15. HPTN “Go” Concepts/Sites

16. HPTN “Go” Concepts/Sites

17. HPTN “Go” Concepts/Sites

18. HPTN “Pipeline” Concepts/Sites

19. HPTN “Pipeline” Concepts/Sites

20. HPTN Science Development - 8/01 • 31 Protocols • 10 HIVNET: • 12,000 participants • 14 PTN: • funds identified • 20,000 participants • 7 Pipeline • 18 Face-to-face meetings • 8 Discretionary Projects • “Lean and mean”