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