specificity on GC/CT for all 60 swab samples. Method 2 achieved a78% concordance; CT had 6 false negatives = 70% sensitivity;85% specificity; while GC had 4 false negatives = 80% sensitivity;90% specificity. CAP panels achieved 100% pass on both methods.Conclusions: Method 1 as per package insert was superior tomethod 2 achieving a higher sensitivity and specificity. It is vitalin populations with high HIV risk with co-infections with CT andNG that methods used for detection are accurate, specific and inkeeping with the package insert which this study illustrates.

P38.07Hematologic and Chemistry Normal LaboratoryValues among Healthy Ugandan Women Screenedfor a Pre-exposure Prophylaxis Trial: The MTN-003(VOICE) Study

Flavia Matovu Kiweewa1, Holly M. Gundacker2, Mike Mubiru1,Betty Kamira1, Brenda Mirembe Gati1, David Ojok3, SamuelKabwigu1, Philippa Musoke1,4, Clemensia Nakabiito1, MaryGlenn Fowler1,5

1MU-JHU Research Collaboration, Kampala, Uganda,2SCHARP-FHCRC, Seattle, WA, United States, 3MU-JHUCore Laboratory, Kampala, Uganda, 4Makerere UniversityCollege of Health Sciences, Department of Pediatrics and ChildHealth, Kampala, Uganda, 5Johns Hopkins University, Balti-more, MD, United States

Background: Universal laboratory toxicity grading tables areused to screen and monitor adverse event (AE)s in clinical trialsfor HIV prevention and treatment; use of these tables excludesotherwise eligible volunteers and can make AE assessment andproduct management challenging in specific populations. Wecomputed selected hematologic and chemistry normal rangesspecific to healthy non-HIV infected women screened for anHIV prevention trial (MTN-003) and compared findings to U.S.established intervals.Methods: Excluding women with hepatitis, syphilis, and preg-nancy, we analyzed data from 538 women aged 18–45 screenedin Kampala from Nov 2009-Dec 2011. We calculated 95%normal intervals as the 2.5% and 97.5% limits for the population,and compared data against U.S.-derived lab intervals fromMassachusetts General Hospital and Division of AIDS(DAIDS), Dec 2004 toxicity tables (clarification dated Aug2009) to determine the number of women with any AE perDAIDS grading criteria.Results: Compared to intervals from the U.S., we found slightlylower 2.5th centiles for red cell indices (hemoglobin (Hgb), he-matocrit, MCV, red blood cell counts), lower white blood cellsand neutrophils, but higher eosinophils. Chemistry parameterswere comparable with U.S.-based ranges except for a lower 2.5th

centile for serum phosphorus and higher 97.5th centile for ALTand AST. When graded against U.S.-derived DAIDS criteria, weobserved 96 AEs from 87 (16%) volunteers with grade ‡ 1 re-sults including decreased neutrophils and phosphorus in 48 (9%)and 23 (4%) women respectively. There were 8 (1%) grade 3 andno grade 4 AEs.Conclusions: Similar to existing local intervals, we found dif-ferences in upper and lower ranges for some hematologic andchemistry indices among healthy Ugandan women compared toUS norms. About 1 in 6 women were described as havinggrade ‡ 1 toxicity for either Hgb, white cell indices, or phos-phorus. Local laboratory ranges should be considered for tox-icity grading in international research settings.

P38.08Strategies to Optimise Data Quality Metricsin the ASPIRE Trial at the Wits Reproductive Healthand HIV Institute in Johannesburg

Pranitha Ramchuran, Krishnaveni Reddy, Helen Rees, TheslaPalanee

Wits Reproductive Health & HIV Institute, School of ClinicalMedicine, University of the Witwatersrand, Johannesburg,South Africa

Background: Quality data collection and their timeous report-ing are critical in clinical trials. In ASPIRE, a phase 3 safety andeffectiveness study of the Dapivirine Vaginal Ring in HIVprevention, data quality is assessed by the quality control (QC)error rate calculated by the number of errors per 100 case reportforms (CRFs) submitted to the Data Management Centre(DMC). Data timeliness is defined as the percentage of CRFsreceived at the Data Management Centre (DMC) within 7 daysof the visit.Methods: To ensure good quality data and timeliness at Wits RHI,several strategies were implemented that include the formation ofa multi-disciplinary quality management (QM) team comprisingClinical Quality Improvement Mentors (CQIMs), Quality Assur-ance (QA)/QC officers and a datafax team. The CQIMs conductclinical review and immediate retraining of the clinical team, QA/QC officers conduct error trend analyses and the site datafax teamconducts a final QC prior to datafax. Other strategies includeregular review and revision of QM processes within the ClinicalQuality Management Plan; timely re-training of the team on errorstrends identified and collective team review and ownership ofmonitoring and audit findings. An additional tool assisting thisprocess is iDataFax; a DMC data system that provides early accessto errors identified on datafaxed CRFs. Its use facilitates identifi-cation of errors trends more frequently to inform improved CRFcompletion and shorter QC resolution times.Results: Implementation of these strategies has led to the de-velopment of a more structured and focused QM team and in-stilled a culture of accountability among the study team whoconsider quality in all aspects of trial implementation.Conclusions: These strategies are continuously reviewed andamended to suit the needs of the study and the dynamic nature ofdata collection and with consistent implementation have andcontinue to assist the team to strive to optimize data quality andtimeliness metrics in ASPIRE.

Molecular Epidemiology

P39.01Using Viral Dynamics to Connect Clinical Markersof Disease Progression to Sequence Evolution duringHIV Infection

Andrew E. Adams1, Zabrina L. Brumme2, Alexander R. Ruther-ford1, Ralf W. Wittenberg1

1Simon Fraser University, Mathematics, Burnaby, BC, Canada,2Simon Fraser University, Faculty of Health Sciences, Burnaby,BC, Canada

Background: Understanding how HIV establishes infectionand, if left untreated, eventually overcomes the immune systemis crucial to the development of a vaccine or cure. The high ratesof turnover and evolutionary adaptability exhibited by HIV pose

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