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Successful Implementation of HIV Successful Implementation of HIV Prevention Trials in PeruPrevention Trials in Peru
The Peruvian CTUThe Peruvian CTU
Jorge Sánchez, MD, MPHJorge Sánchez, MD, MPH
Javier Lama, MD MPHJavier Lama, MD MPH
OverviewOverview
HIV Epidemiology in PeruHIV Epidemiology in Peru
IMPACTA PERU Clinical Trial UnitIMPACTA PERU Clinical Trial Unit
Recruitment and retention strategies for Recruitment and retention strategies for MSM implemented in Peruvian SitesMSM implemented in Peruvian Sites
IPREXIPREX
HIV Epidemiology in PeruHIV Epidemiology in Peru
89,000 estimated HIV infected Peruvians89,000 estimated HIV infected PeruviansConcentrated Epidemic in MSM:Concentrated Epidemic in MSM:– Prevalence in General Population: 0.2% among Prevalence in General Population: 0.2% among
women and 0.6% among men.women and 0.6% among men.– Prevalence in Female sex workers: 1-2%Prevalence in Female sex workers: 1-2%– Prevalence in MSM: 13% overall, over 23% in LimaPrevalence in MSM: 13% overall, over 23% in Lima
Predominandtly Clade B. Rare BF recombinantsPredominandtly Clade B. Rare BF recombinantsHIV Resistance in 2002: 3.3% in treatment HIV Resistance in 2002: 3.3% in treatment naive; 3.3% in treatment experience.naive; 3.3% in treatment experience.HIV Incidence among MSM in observational HIV Incidence among MSM in observational cohorts: Lima (3-6.5%); Iquitos (3.2%)cohorts: Lima (3-6.5%); Iquitos (3.2%)
Trends in HIV/STITrends in HIV/STI
Resistencia a drogas anti-Resistencia a drogas anti-retrovirales 2002retrovirales 2002
Epidemiologia molecular del VIH-1Epidemiologia molecular del VIH-1
Hierholzer et al. AIDS Research and Human Retroviruses, 2002;18:1339-1350
PERUVIAN CTU
HVTNWorking Group
HPTN Working Group
ACTG Working Group
Universidad de WashingtonGldstone Institute-UCSFUniversidad de Harvard
Community Advisory Board
Administrative RU
ClinicaL ResearchRU
LaboratoryRU
Biostat, Data Mng
InformaticsRU
Community Education
RU
Scientific Steering Committee
CIPRA Working Group
Clinical Research RUClinical Research RU
INMENSA LinceINMENSA Lince
IMPACTA Miraflores IMPACTA Miraflores
IMPACTA San MiguelIMPACTA San Miguel
ACSA, IquitosACSA, Iquitos
Cayetano Heredia, Cayetano Heredia, PucallpaPucallpa
Equidad, GuayaquilEquidad, Guayaquil
Dos de Mayo HospitalDos de Mayo Hospital
Guillermo AlmenaraGuillermo Almenara
Edgardo RebagliatiEdgardo Rebagliati
Clinical Research Resource UnitClinical Research Resource Unit
Miraflores CRS (IMPACTA): HPTN, HVTN, ACTG, Miraflores CRS (IMPACTA): HPTN, HVTN, ACTG, CIPRA.CIPRA.Lince CRS (INMENSA): HPTN, ACTG, PREPLince CRS (INMENSA): HPTN, ACTG, PREPSan Miguel CRS (IMPACTA): HPTN, PREP, CIPRA, San Miguel CRS (IMPACTA): HPTN, PREP, CIPRA, CFAR/HLACFAR/HLADos de Mayo CRS: Independent R01Dos de Mayo CRS: Independent R01Guillermo Almenara Hospital: CPCRA, SMARTGuillermo Almenara Hospital: CPCRA, SMARTEdgardo Rebagliati Hospital: CPCRA, SMARTEdgardo Rebagliati Hospital: CPCRA, SMARTIquitos CRS (ACSA): HPTN, HVTN, PREPIquitos CRS (ACSA): HPTN, HVTN, PREPPucallpa CRS (Cayetano Heredia): HPTNPucallpa CRS (Cayetano Heredia): HPTNGuayaquil CRS (Equidad): CIPRA, PREPGuayaquil CRS (Equidad): CIPRA, PREP
Bioestatistics, Data Management and Bioestatistics, Data Management and Health Informatics Resource UnitHealth Informatics Resource Unit
Data Management Center validated by Data Management Center validated by ParexelParexel
Quality Control/Quality Assurance PlanQuality Control/Quality Assurance Plan
Clinical Research Management Software: Clinical Research Management Software: development and supportdevelopment and support
Biostatistical supportBiostatistical support
Community Education Community Education Resource UnitResource Unit
Community Advisory BoardCommunity Advisory Board
Recruitment and RetentionRecruitment and Retention
Development of Educational Development of Educational MaterialsMaterials
HIV/STI ClearinghouseHIV/STI Clearinghouse
R&R Strategies Implemented for R&R Strategies Implemented for Prevention TrialsPrevention Trials
Recruitment strategies Recruitment strategies – Venues mapping - visits and phone calls to past Venues mapping - visits and phone calls to past
surveillance participants programsurveillance participants program– Community education material developmentCommunity education material development– Recruiter incentive and trainingRecruiter incentive and training
Retention strategies Retention strategies – Patient management software Patient management software – Phone call reminder programPhone call reminder program– Home and work visitsHome and work visits– Intramural and extramural activitiesIntramural and extramural activities
Recruitment strategiesRecruitment strategies
Sentinel Surveillance Venues listSentinel Surveillance Venues list
Venues mapping Venues mapping
Peer recruiter leadershipPeer recruiter leadership
Public activities in venuesPublic activities in venues
Visits and phone calls to past surveillance Visits and phone calls to past surveillance participantsparticipants
Free hot line 0800Free hot line 0800
Mapped venues in LimaMore than 1000 mapped venues at the end 2006 in Lima
Iquitos RecruitersIquitos Recruiters
Venues
Porno Theaters
Streets
Motels
Gay volleyball championship
Parks
Beaches
Recruitment strategies - contRecruitment strategies - cont
MSM focus group to generate messagesMSM focus group to generate messages
Protocol information in paper (fliers, brochures)Protocol information in paper (fliers, brochures)
Web publishing of Trials info in local gay websWeb publishing of Trials info in local gay webs
Recruitment of experimented recruiters of Recruitment of experimented recruiters of Ministry of Health from PeruMinistry of Health from Peru
Program of compensation and incentive to Program of compensation and incentive to efficient recruiters efficient recruiters
Educational Materials
Protocol info web publishing
NUESTROS PROGRAMASCommunity Involvement
WorkshopsOpen Houses
SportsTravestites workshops
Community DevelopmentCommunity Development
Community MobilizationCommunity Mobilization
Retention StrategiesRetention Strategies
Clinic information system (CLIS) to Clinic information system (CLIS) to manage patient schedulemanage patient schedule
Phone call reminders for each participant Phone call reminders for each participant visit – managed by CLIS visit – managed by CLIS
Missed visit activities – home and work Missed visit activities – home and work visit – alerted by email for CLIS visit – alerted by email for CLIS
Weekly and bimonthly intramural and Weekly and bimonthly intramural and extramural activities extramural activities
CLIS reminding next visitCLIS reminding next visit
Screened 2 to FU
Status in protocol
Phone call results
Patient advocate
R&R coordinator
Email to alert the next visit
Screening 1
Visit status
Study coordinator
Phone call
CLIS alerting a missed visitCLIS alerting a missed visitRecruited participant
Screening 1
Contact information
RecruiterScreened 2 / all
Status in protocol
Site visit providers
Visit status Screened 2 missed
Phone call Home visit
Recruiter
Contact results
Study coordinator
R&R coordinatorVisit window
Email alert
~90%
Cohort Studies in Peru Cohort Studies in Peru
Cohorte Ciudad AñosNumero de reclutados
Retención a 12 meses
Incidencia Observada
(%año)
ALASKA Lima 1998-2000 1056 3.5
HPTN 036 Lima 2002-2004 254 94% 6.2
HVTN 903 Iquitos 2002-2004 200 92% 3.2
HPTN 039 Lima (Lince) 2004-2007 200 90% 4.2
HPTN 039 Lima (Miraflores) 2004-2007 600 87% 4.5
HPTN 039 Lima (San Miguel) 2004-2007 84 75% 4.7
HPTN 039 Iquitos 2004-2007 300 91% 3.3
HPTN 039 Pucallpa 2004-2007 200 90% 0.6
HVTN 502 Lima 2004-2007 250 88% 4.2
HPTN 039 Screened and Enrolled HPTN 039 Screened and Enrolled ParticipantsParticipants
3281
600
1195
200
632
300446
200441
810
500
1000
1500
2000
2500
3000
3500
Miraflores Lince Pucallpa Iquitos San Miguel
Screening
Enrollment