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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 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
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%)
Epidemiologia molecular del VIH-1 Hierholzer et al. AIDS Research and Human Retroviruses, 2002;18:1339-1350
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
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
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
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
Community Education Resource Unit • Community Advisory Board • Recruitment and Retention • Development of Educational Materials • HIV/STI Clearinghouse
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
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
Mapped venues in Lima More than 1000 mapped venues at the end 2006 in Lima
Venues Motels Beaches Porno Theaters Streets Parks Gay volleyball championship
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
NUESTROS PROGRAMAS Community Involvement
Community Development Workshops Open Houses Travestites workshops Sports
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
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
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