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

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Presentation on theme: "Successful Implementation of HIV Prevention Trials in Peru The Peruvian CTU Jorge Sánchez, MD, MPH Javier Lama, MD MPH."— Presentation transcript:

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%)

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5 Trends in HIV/STI

6 Resistencia a drogas anti- retrovirales 2002

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

8 PERUVIAN CTU HVTN Working Group HPTN Working Group ACTG 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 Scientific Steering Committee CIPRA Working Group

9 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

10 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

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12 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

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

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15 R&R Strategies Implemented for Prevention Trials 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

16 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

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

18 Iquitos Recruiters

19 Venues Porno Theaters Streets Motels Gay volleyball championship Parks Beaches

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23 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

24 Educational Materials

25 Protocol info web publishing

26 NUESTROS PROGRAMAS Community Involvement

27 Workshops Open Houses SportsTravestites workshops Community Development

28 Community Mobilization

29 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 for CLIS Weekly and bimonthly intramural and extramural activities

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

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

32 Cohort Studies in Peru Cohort Studies in Peru CohorteCiudadAños Numero de reclutados Retención a 12 meses Incidencia Observada (%año) ALASKALima HPTN 036Lima %6.2 HVTN 903Iquitos %3.2 HPTN 039Lima (Lince) %4.2 HPTN 039Lima (Miraflores) %4.5 HPTN 039Lima (San Miguel) %4.7 HPTN 039Iquitos %3.3 HPTN 039Pucallpa %0.6 HVTN 502Lima %4.2

33 HPTN 039 Screened and Enrolled Participants


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