examining core elements of international...

Examining Core Elements of Examining Core Elements of International ResearchInternational ResearchInternational Research International Research

Collaboration: An Collaboration: An I t ti l C St dI t ti l C St dInternational Case StudyInternational Case Study

William A. Blattner, MDWilliam A. Blattner, MDInstitute of Human VirologyInstitute of Human VirologyInstitute of Human VirologyInstitute of Human Virology

University of MarylandUniversity of MarylandJ l 26 2010J l 26 2010July 26, 2010July 26, 2010

Questions to be Addressed

• How do you work out authorship issues?– Dr. Blattner

• How did you develop capacity to assure data integrity?g y– Dr. Aliyu Gambo Gumel

• How do you confirm data integrity?How do you confirm data integrity?– Dr. Aliyu Gambo Gumel

Criteria for Authorship

• Substantial contributions to study conception and design, y p gor acquisition of data, or analysis and interpretation of data;;

• AND• Drafting the paper or revising• Drafting the paper or revising

it critically for important intellectual content

• AND• Final approval of the version pp

to be published

Recruiting Acute Cases ofRecruiting Acute Cases of HIV (REACH Study) in NigeriaNigeria

Collaboration:

Institute of Human Virology, University of Maryland School of Medicine

U.S. Centers for Disease Control and Prevention Division of HIV/AIDS Preventionof HIV/AIDS Prevention

Nigerian Federal Ministry of Health

International Research Collaboration

Lab DirectorStudy Director ab ectoStudy ecto

CDC Program Officer/Grant PI Nigeria PI

Asokoro Study Team

Dr. Aliyu Gambo GumelDr. Aliyu Gambo Gumel

PLASVIREC Lab Team

Objective

• Sponsor deliverable – Create a repository of samples from non-subtype B acute HIV infection

h tcohort • Research goals –

– Describe magnitude and l t f l t HIV

gcorrelates of prevalent HIV infection

– Evaluate uptake to HIV care for HIV+ study participantsHIV study participants

– Describe genetic diversity of HIV among risk groups targeted

– Evaluate performance of:Th Ni i R id T t– The Nigerian Rapid Test algorithm and the Roche Amplicor 1.5 for pooled screening for acute infectionsg

REACH Study Sites and Mobile VCT Coverage

REACH Study SitesIHV-UMD PCR labs

Supported by CDC-Nigeria

Recruitment Strategy

• Facility-based– ANC attendees– GOPD/STI attendees

C it b d i bil VCT• Community-based via mobile VCT– Brothel-based sex workers– Street-based sex workers– Motorcycle taxi drivers “Okada” (MCTD)

Outreach community groups– Outreach community groups• Two-stage informed consent

– Screening consent for all individuals counseled and tested

– Seroconverter follow-up consent for acute infections identified

• Enroll persons not previously known to be HIV infected and greater than 18 years ofHIV infected and greater than 18 years of age

• Provide PwP (Prevention w/ Positives) and refer to care and treatment

Night recruiting l l t ton local streets

and clubs

High HIV Prevalence Across Risk-groups

HIV prevalence according to risk groups

60.0

Total Enrolled = 14025Total Enrolled = 14025

40 0

50.0National average in 2008

Total Enrolled = 14025Total Enrolled = 14025

30.0

40.0

20.0

0.0

10.0

Motor cyle andtaxi drivers

(n=994)

Antenatal clinicattendees(n=4576)

Street-based SW(n=1114)

Outreachcommunitytesting/SW

clients (n=1051)

Other HIVcounselinga and

testings(n=5516)

Brothel-basedSW (n=774)

HIV prevalence may be increasing in certain risk groups

n=8370.00

80.00Motor cycle taxi drivers

Street-based SW

O t h it t ti

60.00

Outreach community testing

Brothel-based SW

Antenatal clinic attendees

n=246

n=161n=88

n=32

n=87

40.00

50.00

n=133 n=1103

n=649

1369

n=171

n=31

n=57

30.00

n=193

n=234n=352n=186

n=582

n=432 n=204n=178n=257

n=292

n=1103n=1269

n=358 n=1369n=842n=937

n=593n=437801n=61510.00

20.00

n=593n=493n=483n 437

n=539n=1204n=801n=911

0.002005.2 2005.3 2005.4 2006.1 2006.2 2006.3 2006.4 2007.1 2007.2 2007.3

Lower Awareness of HIV Care Services among Female Sex Workers

List of Abstracts and Papers – Nigerian Co-Authors in RedTypes Authors Title

Abstract Charurat M Saidu A Delaney K Villalba Diebold Identification of HIV Infection in 5 Populations inAbstractICASA 2006

Charurat M, Saidu A, Delaney K, Villalba-Diebold, Aliyu G, Constantine N, Onoja A, Vertefeuille J, Blattner W, Nasidi A.

Identification of HIV Infection in 5 Populations in Abuja, Nigeria

AbstractAIDS 2008

Villalba-Diebold P, Saidu A, Charurat M, Martins E, Gurumdi S, Aliyu G, Nasidi A, Farley J, Blattner W.

Linking Community Information with Prevalence Data to Identify Underserved Most-at-risk Populations in Need of Access to Servicesp

AbstractIAS 2009

Delaney K, Charurat M, Constantine N, Owen M, Keating S, Candal D, Ethridge S, Saidu A, Saleh A,Croxton T, Villalba-Diebold P, Aliyu G, Vertefeuille J, Sill A, Busch M, Nasidi A, Blattner W

Evaluation of Five Incidence Assays Using Nigerian Seroconversion Specimens: Implication for Surveillance Programs in Nigeria.

AbstractAIDS 2010

Delaney K, Charurat M, Villalba-Diebold P, Saidu A, Aliyu G, Abimiku A, Vertefeuille J, Nasidi A, Blattner W

Counseling and Testing for Nigerian Sex Workers: Increased Knowledge, Increased Condom Used, No Change in Risk of Infection

PaperAIDS 2010

Charurat M, Delaney K, Saidu A, Villalba-Diebold P, Aliyu G, Constantine N, Onoja A, Vertefeuille J,

HIV Counseling and testing and access to care needs of populations most-at-risk for HIV in y , , j , ,

Blattner WA, Nasidi Ap p

Nigeria

Paperin progress

Charurat M, Saidu A, Delaney K, Eyzaguirre LM, Nasidi A, Carr J, Blattner W.

Identification and Characterization of Acute HIV-1 Infections in High-Risk Population In Nigeria

Abstract Curtis KenneCurtis KA Kennedy S Charurat M IgG3 as a Biomarker for Distinguishing RecentAbstractHIV Diag 2010

Curtis, KenneCurtis KA, Kennedy S, Charurat M, Owen M, Delaney K

IgG3 as a Biomarker for Distinguishing Recent from Established HIV-1 Infection

AbstractHIV Diag 2010

Masciotra S, Dobbs T, Candal D, Hanson D, Delaney K, Rudolph D, Charurat M, Harrigan R, McDougal S, Owen S

Antibody avidity-based assay for identifying recent HIV-1 infections based on Genetic System ½ olus O EIA

AbstractHIV Diag 2008

Constantine N, Croxton T, Charurat M, Villalba-Diebold P, Abimiku A, Blattner W.

Alternative Confirmatory Testing Strategy Using Rapid HIV Assays

Goals of International Research Collaboration

• Develop of culture of mutuality• Strengthen Capacity of international

collaborators to participate in all phases of research per authorship criteriaresearch per authorship criteria

• “Level the playing Field” through international training and the practicalinternational training and the practical application of research principles to protocol development and implementation

• Support international partners in obtaining independent research funding for projects of their own designg

REACH STUDYPerspective of the Host Perspective of the Host

InvestigatorGambo Gumel Aliyu

Fogarty FellowIHV UMDIHV-UMD

QuestionsQuestions

1 How was the team empowered to:1. How was the team empowered to:– Collect– Capture– Capture– Store/transmit

Analyze/interpret– Analyze/interpretdata that were correct and consistent for

the REACH study?the REACH study?

2 H did i i i i th 2. How did we minimize errors in the process?

Capacity for data integrityCapacity for data integrityBaseline Onset

Two years Five years

0 2 4 6 8 10 0 2 4 6 8 10

Data Collection Data Capture

Data Storage Data Analysis

Capacity development• Site trainings (baseline and in the

process) mainly by IHV and occasionally proc ss) ma n y y HV an occas ona y local resource persons

• 3 teams ( counselors, lab. tech and data)• 1 year from baseline to kick off

D ll ( f )– Data collection (paper forms)• Counseling • consent taking• consent taking• survey administration • sample collectionsample collection• Laboratory assays

Capacity developmentCapacity development

– capturing and storagecapturing and storage

•Microsoft access•Forms labeling•Forms labeling•Storage of hard copies•Storage of electronic data•Transfer of electronic data•Transfer of electronic data

Capacity developmentCapacity development

– Analysis and interpretationAnalysis and interpretation

• Over 90% done in the USOver 90% done in the US• Huge gap• Not much capacity developed• Not much capacity developed• Responsible for the imbalance in

manuscript development and authorshipsmanuscript development and authorships

– Privacy and confidentiality– Privacy and confidentiality– Responsible conduct of research

Capacity developmentCapacity development• Well written SOP

– outlined all study procedures– responsibilities of every staffp y

• Other resources• Other resources• Office facility• Equipment• Consumables• Regular fund transfer

ChallengesChallenges• Collection

– Multiple screenings– Same IDs for different participantsm f ff p p– Missing forms– Unsigned consentUnsigned consent

• Data entry• Data entry– Missing data

M ltipl nt i s– Multiple entries– Data base design issues

ChallengesChallenges

• Storage and transferStorage and transfer

– Weak back ups at the beginning•Flash drives CDs•Flash drives, CDs

– Unstable electricity supply

ValidationValidation• Direct supervision

– Host investigator• Monitor and evaluate• Log books• SOPs• Weekly meetings

• External monitoring• Weekly conference callsWeekly conference calls• Regular visits by IHV, CDC

Strengthening Capacity for data i t itintegrity

• Trainings: Long and short termd– conduct

– analysis – interpretation– interpretation

• Reflecting on selfg

– Short term training• Developed a proposal• Developed a proposal• Conducted the study

– Long term training• Analyzed• Published

Strengthening CapacityStrengthening Capacity

• Long termLong term..• Designed a study to look at the possible

association between HIV and bovine TB association between HIV and bovine TB in Nigeria for the PhD thesis

• Developed – Protocol, forms, SOPs, Data base and

secure ethical approvals– Concluded site preparations– To begin data collection next month