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
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