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Successful Implementation of HIV Prevention Trials in Peru

Successful Implementation of HIV Prevention Trials in Peru. The Peruvian CTU. Jorge Sánchez, MD, MPH Javier Lama, MD MPH. Overview. HIV Epidemiology in Peru IMPACTA PERU Clinical Trial Unit Recruitment and retention strategies for MSM implemented in Peruvian Sites IPREX.

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Successful Implementation of HIV Prevention Trials in Peru

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  1. Successful Implementation of HIV Prevention Trials in Peru The Peruvian CTU Jorge Sánchez, MD, MPH Javier Lama, MD MPH

  2. Overview • HIV Epidemiology in Peru • IMPACTA PERU Clinical Trial Unit • Recruitment and retention strategies for MSM implemented in Peruvian Sites • IPREX

  3. HIV Epidemiology in Peru • 89,000 estimated HIV infected Peruvians • Concentrated Epidemic in MSM: • Prevalence in General Population: 0.2% among women and 0.6% among men. • Prevalence in Female sex workers: 1-2% • Prevalence in MSM: 13% overall, over 23% in Lima • Predominandtly Clade B. Rare BF recombinants • HIV Resistance in 2002: 3.3% in treatment naive; 3.3% in treatment experience. • HIV Incidence among MSM in observational cohorts: Lima (3-6.5%); Iquitos (3.2%)

  4. Trends in HIV/STI

  5. Resistencia a drogas anti-retrovirales 2002

  6. Epidemiologia molecular del VIH-1 Hierholzer et al. AIDS Research and Human Retroviruses, 2002;18:1339-1350

  7. PERUVIAN CTU Scientific Steering Committee HVTN Working Group HPTN Working Group ACTG Working Group CIPRA Working Group Universidad de Washington Gldstone Institute-UCSF Universidad de Harvard Community Advisory Board Administrative RU ClinicaL Research RU Laboratory RU Biostat, Data Mng Informatics RU Community Education RU

  8. Clinical Research RU • INMENSA Lince • IMPACTA Miraflores • IMPACTA San Miguel • ACSA, Iquitos • Cayetano Heredia, Pucallpa • Equidad, Guayaquil • Dos de Mayo Hospital • Guillermo Almenara • Edgardo Rebagliati

  9. Clinical Research Resource Unit • Miraflores CRS (IMPACTA): HPTN, HVTN, ACTG, CIPRA. • Lince CRS (INMENSA): HPTN, ACTG, PREP • San Miguel CRS (IMPACTA): HPTN, PREP, CIPRA, CFAR/HLA • Dos de Mayo CRS: Independent R01 • Guillermo Almenara Hospital: CPCRA, SMART • Edgardo Rebagliati Hospital: CPCRA, SMART • Iquitos CRS (ACSA): HPTN, HVTN, PREP • Pucallpa CRS (Cayetano Heredia): HPTN • Guayaquil CRS (Equidad): CIPRA, PREP

  10. Bioestatistics, Data Management and Health Informatics Resource Unit • Data Management Center validated by Parexel • Quality Control/Quality Assurance Plan • Clinical Research Management Software: development and support • Biostatistical support

  11. Community Education Resource Unit • Community Advisory Board • Recruitment and Retention • Development of Educational Materials • HIV/STI Clearinghouse

  12. R&R StrategiesImplementedforPreventionTrials • Recruitment strategies • Venues mapping - visits and phone calls to past surveillance participants program • Community education material development • Recruiter incentive and training • Retention strategies • Patient management software • Phone call reminder program • Home and work visits • Intramural and extramural activities

  13. Recruitment strategies • Sentinel Surveillance Venues list • Venues mapping • Peer recruiter leadership • Public activities in venues • Visits and phone calls to past surveillance participants • Free hot line 0800

  14. Mapped venues in Lima More than 1000 mapped venues at the end 2006 in Lima

  15. Iquitos Recruiters

  16. Venues Motels Beaches Porno Theaters Streets Parks Gay volleyball championship

  17. Recruitment strategies - cont • MSM focus group to generate messages • Protocol information in paper (fliers, brochures) • Web publishing of Trials info in local gay webs • Recruitment of experimented recruiters of Ministry of Health from Peru • Program of compensation and incentive to efficient recruiters

  18. Educational Materials

  19. Protocol info web publishing

  20. NUESTROS PROGRAMAS Community Involvement

  21. Community Development Workshops Open Houses Travestites workshops Sports

  22. Community Mobilization

  23. Retention Strategies • Clinic information system (CLIS) to manage patient schedule • Phone call reminders for each participant visit – managed by CLIS • Missed visit activities – home and work visit – alerted by email for CLIS • Weekly and bimonthly intramural and extramural activities

  24. CLIS reminding next visit Screening 1 Visit status Status in protocol Email to alert the next visit Patient advocate Screened 2 to FU Phone call Phone call results R&R coordinator Study coordinator

  25. CLIS alerting a missed visit Recruited participant Screening 1 Contact information Recruiter ~90% Screened 2 / all Phone call Home visit Status in protocol Visit status Screened 2 missed Contact results Email alert Site visit providers Recruiter R&R coordinator Visit window Study coordinator

  26. CohortStudies in Peru

  27. HPTN 039 Screened and EnrolledParticipants

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