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KAIS 2007 1 - Kenya National AIDS & STI Control Programme ...

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The KEMRI Ethical Review Committee and the Institutional Review Board of the CDCapproved the <strong>2007</strong> <strong>KAIS</strong> protocol prior to survey implementation. All participants providedoral informed consent and had the choice to consent separately to the interview, blood draw,and blood specimen storage for future testing.. Oral consent was requested from the KEMRIEthical Review Committee and the Institutional Review Board of the CDC due to the highrate of illiteracy in some regions of the country and its potential to negatively impact surveyuptake. For minors aged 15‐17 years, parental consent and minor assent were both requiredfor participation. Data collectors signed the consent form for each of the components andindicated whether or not oral consent was provided. Data collectors informed all eligiblepersons that participation in the survey was strictly voluntary and that there would be noconsequences if a household or person refused participation. Every effort was made toidentify space in households that provided privacy during the interview.A.4 LABORATORY METHODSThe <strong>2007</strong> <strong>KAIS</strong> included several novel concepts and methods for maximising laboratorytesting in a national surveillance effort.Recruitment and trainingField and core laboratory staff were recruited from existing laboratory staff within NPHLSand from KEMRI laboratories. Training included the following components: a didacticoverview of the <strong>2007</strong> <strong>KAIS</strong> methodology; a detailed description of the roles and structure offield and core laboratory survey teams; a review of basic laboratory operations, includingcollection, handling, and transport of blood specimens and bio‐safety considerations; and areview of technical procedures, including specific assays, quality assurance, and generallogistics.Ensuring sufficient staff capacity was critical given the large volume of samples received perweek (on average 500 samples per week), the rapid turnover required to quantify CD4 cellswithin seven days of sample collection, and the need to report test results for an entirecluster within six weeks of sample collection.Laboratory field processThe laboratory field process consisted of three main components: sample collection at theparticipants’ home; preparation of samples at temporary field laboratories, which werelaboratory facilities within the cluster or hotel rooms designated for sample processing iflaboratory facilities were not available; and proper packing and documentation of samplesbefore transport to the central laboratory in Nairobi. The procedures for each of theseelements are summarised in the following sections.Sample collection. Trained, experienced laboratory technicians were responsible for thecollection of blood from the arm by venipuncture using an evacuated tube collection system.Five milliliters (ml) of blood were collected into a “red‐top” glass tube without anticoagulantfor HIV, HSV‐2, and syphilis testing. Immediately after the first 5 ml of blood was collected,<strong>KAIS</strong> <strong>2007</strong> 286

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