A Randomized Trial to Evaluate the Effectiveness of
Antiretroviral Therapy Plus HIV Primary Care versus HIV Primary Care Alone
to Prevent the Sexual Transmission of
HIV-1 in Serodiscordant Couples
Choice of Vendors for the AIDS Clinical Trials Network (ACTN) Fetal Bovine Serum (FBS) to cryopreserve Peripheral Blood Mononuclear Cells (PBMC).
Heat inactivated FBS is being held on reserve at both Sigma Aldrich (for U.S. and non-U.S. sites) and Gemini Bio-products (for U.S sites). Please note that the VQA and IQA validation testing of these lots for use in culture experiments and for Peripheral Blood Mononuclear Cell (PBMC) cryopreservation have been completed and the results have been summarized. The results of the 2009 VQA and IQA validation testing have been posted to the web at http://www.hanc.info/labs/Pages/FBSOrdering.aspx . A certificate of analysis of each company's lot is available upon request.
Test Strip Ordering Information
As indicated in Section 10.7 of the HPTN 052 SSP Manual, the following types of samples will be shipped to the HPTN Network Laboratory: cervical Tear-Flo strips for HIV-1 RNA, seminal plasma for HIV-1 RNA, and genital ulcer swab for multiplex PCR. In addition, plasma samples for QA testing will be sent to the Network Lab
QA Testing Shipping Schedule
Each site will ship plasma samples to the NL on a routine basis throughout the study, and the SDMC will provide a listing of samples to be included in each shipment.
Remote Testing Shipping Schedule
Throughout the course of HPTN 052, the following types of samples will be shipped to the HPTN Network Laboratory: cervical Tear-Flo strips for HIV-1 RNA, seminal plasma for HIV-1 RNA, and genital ulcer swab for multiplex PCR. International sites should send these samples to the HPTN Network Laboratory whenever they accumulate 15 specimens. U.S. sites may send these samples in real time. Different types of samples can be sent in the same shipment to the HPTN Network Laboratory.
The frozen samples should be placed in the cryovial box in the order of the shipping manifest for shipments of 15 vials or more. If less then 15 vials are to be sent, they can be placed in plastic shipping baggies inside the orange topped shipping canister. A photocopy of the Specimen Tracking Sheet should accompany the specimen to the laboratory as well as shipping manifest, boxmap, and LDMS diskette.
The orange-topped canister should have absorbent material included. This is then placed in its cardboard box, which is placed inside the shipping box and the box filled with sufficient carbon dioxide (dry ice) to last at least 48 hours. If shipping more than 15 vials, wrap the box in absorbent material and place inside a shipping bag, seal, and place in the shipping container. Samples should be shipped as diagnostics packing code 650, UN 3373. If the site has any questions regarding ordering and purchasing of the appropriate shipping boxes, please contact your local courier company. Please consult your affiliate U.S. institution if you are having trouble obtaining this item.
Prior to shipment, please contact Estelle Piwowar-Manning at 410-614-6736 (phone), 410-614-0430 (fax) or firstname.lastname@example.org to set up the shipment with World Courier.
Any questions relating to specimen handling, shipping, or identification should be directed to Estelle Piwowar-Manning at 410-614-6736.
The Johns Hopkins University Hospital
For 052 Genotyping shipments to South Africa please email the following people when shipping: