11832ARC156S
THE TTIMS LRCC FUNCTIONS ARE TO SERVE AS THE BIOSTATISTICAL AND ANALYTICAL CENTER FOR ANALYSES RELEVANT TO THE EVALUATION AND MONITORING OF INFECTIONS INCLUDING THOSE IN HIV (INCIDENT AND PREVALENT), HCV (INCIDENT), HBV (INCIDENT) AND SYPHILIS (RECENT) TEST-POSITIVE BLOOD DONORS BY COLLECTING AND ANALYZING DATA FOR RISK FACTORS, MOLECULAR SURVEILLANCE AND ANTI- RETROVIRAL DRUG USE THAT MAY IMPACT THE DETECTION OF HIV. SPECIFICALLY, THE PRIMARY OBJECTIVES OF THIS CONTRACT ARE TO: Â ¢ EVALUATE AND MONITOR RISK FACTOR CHARACTERISTICS OF DONATIONS CONFIRMED POSITIVE FOR TTIS AS STATED ABOVE, AND COMPARISON TO UNINFECTED US ALLOGENEIC BLOOD DONORS. Â ¢ INTEGRATE RISK FACTOR DATA AND DISEASE MARKER SURVEILLANCE INFORMATION ACROSS DIFFERENT BLOOD COLLECTION ORGANIZATIONS. Â ¢ MONITOR ARV AND PREP/PEP USE IN US ALLOGENEIC BLOOD DONOR POPULATION BASED ON TESTING OF BOTH HIV-POSITIVE AND INFECTION-NEGATIVE DONATIONS FOR THE PRESENCE OF ARV DRUGS. Â ¢ EXPLORE THE CHARACTERISTICS OF BLOOD DONORS WHO USE ARV/PREP/PEP TO BETTER UNDERSTAND THEIR RISKS, KNOWLEDGE, AND MOTIVATIONS FOR DONATING WHILE USING THESE THERAPIES. Â ¢ EVALUATE WELL-CHARACTERIZED US BLOOD DONOR SAMPLES FROM TTIMS AND OTHER SOURCES FOR THE REFINEMENT OF EXISTING ANALYTICAL METHODS SUCH AS THE SEDIA LAG AVIDITY ASSAY TO DERIVE ESTIMATES OF RECENT INFECTION WITH HIV WITH A GOAL OF RAPIDLY OBTAINING MORE ACCURATE AND TIMELY RESULTS. Â ¢ PROVIDE LOGISTICAL SUPPORT FOR THE TTIMS PROJECT AND FOR THE COMMITTEE/SUBCOMMITTEE MEETINGS, CONFERENCES, AND DONATION(S) TRANSFER/SHIPMENT. IN SUPPORT OF THESE OBJECTIVES, ARC WILL RECRUIT, ENROLL AND INTERVIEW ELIGIBLE PARTICIPANTS, PROVIDE DATA AS REQUIRED IN THE TTIMS LRCC STATEMENT OF WORK, PROVIDE BIOSPECIMENS FOR RESEARCH TESTING AT VRI, AND WILL ACTIVELY COLLABORATE IN THE ANALYSIS, INTERPRETATION, AND REPORTING OF FINDINGS IN TTIMS. SUSAN STRAMER, PHD, WILL SERVE AS THE PRINCIPAL INVESTIGATOR (PI) AT ARC. SHE WILL OVERSEE ALL ASPECTS OF ARCÂ S PARTICIPATION IN THE LRCC PORTION OF TTIMS INCLUDING ACQUISITION OF DONOR DATA AND BIOSPECIMENS AND WILL PARTICIPATE IN CALLS AND MEETINGS FOR THE TTIMS PROJECT. IN ADDITION, ROGER DODD, PHD, WILL SERVE AS THE CO-PRINCIPAL INVESTIGATOR AT ARC. HE WILL ASSIST IN THE OVERSIGHT OF THE ACQUISITION OF DONOR DATA AND WILL PARTICIPATE IN CALLS AND MEETINGS FOR THE TTIMS PROJECT WHEN NECESSARY. ARC WILL RECRUIT DONORS WITH QUALIFYING TEST RESULTS; ADMINISTER THE WEB-BASED QUESTIONNAIRE AND ENTER RISK FACTOR DATA INTO AN ELECTRONIC DATABASE; PERFORM QUALITY CONTROL (QC) ON ALL DATA ENTERED INTO THE DATABASE; RESPOND TO REQUESTS FROM THE LRCC REGARDING DATA QUALITY ASSURANCE AND QC; DEVELOP AND SUBMIT TO THE LOCAL IRB DOCUMENTS AND AMENDMENTS FOR APPROVAL. ARC STAFF WILL PROVIDE TO VRI 5 X 1 ML PLASMA CRYOVIALS AND A SINGLE 5 ML PLASMA CRYOVIAL FOR EACH PARTICIPANT. IN COLLABORATION WITH THE LRCC, ARC WILL COORDINATE SAMPLE SHIPMENT WITH DESIGNATED VRI STAFF. IN ADDITION, ARC WILL WORK WITH THE LRCC AND CTS TO SOURCE SPECIMENS FOR ARV/PEP/PREP TESTING. ARC WILL ALSO WORK THE LRCC TO FACILITATE SURVEYS AND QUALITATIVE INTERVIEWS OF ARV/PEP/PREP TEST-POSITIVE BLOOD DONORS. ARC WILL BE A COLLABORATOR IN THE COLLECTION OF THESE SURVEY AND QUALITATIVE INTERVIEW DATA AND WILL ASSIST IN IDENTIFYING AND RECRUITING PARTICIPANTS FOR THESE ACTIVITIES. ADDENDUMS TO THIS SOW WILL BE DEVELOPED AFTER THE RESEARCH PROTOCOLS TO SUPPORT EXPANDED ART/PEP/PREP STUDIES ARE FULLY DEFINED AND APPROVED BY THE TTIMS STEERING COMMITTEE.
The American National Red Cross
Definitive Contract 75F40121C00196
$814.1k 1/12/24 11832NYBC158S
THE TTIMS LRCC PROJECT PURPOSE IS TO SERVE AS THE BIOSTATISTICAL AND ANALYTICAL CENTER FOR SPECIFIC ANALYSES RELEVANT TO THE EVALUATION AND MONITORING OF HIV (INCIDENT AND PREVALENT INFECTIONS), HCV (INCIDENT) AND HBV (INCIDENT), AND SYPHILIS POSITIVE BLOOD DONORS. SPECIFICALLY, THE PRIMARY OBJECTIVES OF THIS CONTRACT ARE TO: Â ¢ EVALUATE AND MONITOR RISK FACTOR CHARACTERISTICS OF DONATIONS CONFIRMED POSITIVE FOR TTIS AND COMPARISON UNINFECTED (CONTROL) DONORS. Â ¢ COMPARE/ANALYZE RISK FACTOR DATA TO THAT OBTAINED IN THE EARLIER TTIMS STUDY PERIOD AND THE REDS-II TTVI MARKER PREVALENCE AND RISK FACTOR STUDY. Â ¢ INTEGRATE RISK FACTOR DATA AND DISEASE MARKER SURVEILLANCE INFORMATION ACROSS DIFFERENT BLOOD COLLECTION ORGANIZATIONS. Â ¢ MONITOR ARV AND PREP/PEP USE IN US ALLOGENEIC BLOOD DONOR POPULATION BASED ON TESTING OF BOTH HIV- POSITIVE AND INFECTION NEGATIVE DONATIONS FOR THE PRESENCE OF ARV DRUGS. Â ¢ EXPLORE THE CHARACTERISTICS OF BLOOD DONORS WHO USE ARV/PREP/PEP TO BETTER UNDERSTAND THEIR RISKS, KNOWLEDGE, AND MOTIVATIONS FOR DONATING WHILE USING THESE THERAPIES. Â ¢ EVALUATE WELL-CHARACTERIZED US BLOOD DONOR SAMPLES FROM TTIMS AND OTHER SOURCES FOR THE REFINEMENT OF EXISTING ANALYTICAL METHODS SUCH AS THE SEDIA LAG AVIDITY ASSAY TO DERIVE ESTIMATES OF RECENT INFECTION WITH HIV WITH A GOAL OF RAPIDLY OBTAINING MORE ACCURATE AND TIMELY RESULTS. Â ¢ PROVIDE LOGISTICAL SUPPORT FOR THE TTIMS PROJECT AND FOR THE COMMITTEE/SUBCOMMITTEE MEETINGS, CONFERENCES, AND DONATION(S) TRANSFER/SHIPMENT. IN SUPPORT OF THESE OBJECTIVES, NYBC WILL RECRUIT, ENROLL AND INTERVIEW ELIGIBLE PARTICIPANTS, PROVIDE DATA AS REQUIRED IN THE TTIMS LRCC STATEMENT OF WORK, PROVIDE BIOSPECIMENS FOR RESEARCH TESTING AT VRI, AND WILL ACTIVELY COLLABORATE IN THE ANALYSIS, INTERPRETATION, AND REPORTING OF FINDINGS IN TTIMS. DEBRA KESSLER, WILL SERVE AS THE PRINCIPAL INVESTIGATOR (PI) AT NYBC. SHE WILL OVERSEE ALL ASPECTS OF NYBCÂ S PARTICIPATION IN THE LRCC PORTION OF TTIMS INCLUDING ACQUISITION OF DONOR DATA AND BIOSPECIMENS AND WILL PARTICIPATE IN CALLS AND MEETINGS FOR THE TTIMS PROJECT. IN ADDITION, CARLOS DEL VALLE, WILL SERVE AS THE STUDY MANAGER AT NYBC. HE WILL ASSIST IN THE OVERSIGHT OF THE ACQUISITION OF DONOR DATA, AND WILL PARTICIPATE IN CALLS AND MEETINGS FOR THE TTIMS PROJECT WHEN NECESSARY. NYBC WILL RECRUIT DONORS WITH QUALIFYING TEST RESULTS; ADMINISTER THE WEB-BASED QUESTIONNAIRE AND ENTER RISK FACTOR DATA INTO AN ELECTRONIC DATABASE; PERFORM QUALITY CONTROL (QC) ON ALL DATA ENTERED INTO THE DATABASE; RESPOND TO REQUESTS FROM THE LRCC REGARDING DATA QUALITY ASSURANCE AND QC; DEVELOP AND SUBMIT TO THE LOCAL IRB DOCUMENTS AND AMENDMENTS FOR APPROVAL. NYBC STAFF WILL FORWARD PLASMA BAGS AND/OR PILOT TUBES TO CREATIVE TESTING SOLUTIONS (CTS) SO THAT CTS CAN CREATE UP TO 5 X 2 ML PLASMA CYROVIALS AND A SINGLE 15 ML PLASMA CRYOVIAL FOR EACH PARTICIPANT AND PREPARE ALIQUOTS FOR SHIPMENT TO THE REPOSITORY AND ADDITIONAL TESTING AT VRI FOR ALL INFECTIONS OF INTEREST AS DEFINED BY THE TTIMS STEERING COMMITTEE. IN COLLABORATION WITH THE LRCC, NYBC WILL COORDINATE SAMPLE SHIPMENT WITH DESIGNATED CTS STAFF. IN ADDITION, NYBC WILL WORK WITH THE LRCC AND CTS TO SOURCE SPECIMENS FOR ARV/PEP/PREP TESTING. NYBC WILL ALSO WORK THE LRCC TO FACILITATE SURVEYS AND QUALITATIVE INTERVIEWS OF ARV/PEP/PREP REACTIVE BLOOD DONORS. NYBC WILL NOT BE EXPECTED TO LEAD THE COLLECTION OF THESE SURVEY AND QUALITATIVE INTERVIEW DATA BUT WILL ASSIST IN IDENTIFYING AND RECRUITING PARTICIPANTS FOR THESE ACTIVITIES. ADDENDUMS TO THIS SOW WILL BE DEVELOPED AFTER THE RESEARCH PROTOCOLS TO SUPPORT EXPANDED ART/PEP/PREP STUDIES ARE FULLY DEFINED AND APPROVED BY THE TTIMS STEERING COMMITTEE. A PROTOCOL FOR EXPANDED DONOR SAMPLE COLLECTION FOR PREP/PEP TESTING IS UNDER DEVELOPMENT AND WILL TRIGGER AN ADDENDUM TO THIS SOW.
New York Blood Center, Inc.
Definitive Contract 75F40121C00196
$386.3k 12/29/23 11832CTS157S
THE TTIMS LRCC PROJECT PURPOSE IS TO SERVE AS THE BIOSTATISTICAL AND ANALYTICAL CENTER FOR SPECIFIC ANALYSES RELEVANT TO THE EVALUATION AND MONITORING OF HIV (INCIDENT AND PREVALENT INFECTIONS), HCV (INCIDENT) AND HBV (INCIDENT), AND SYPHILIS POSITIVE BLOOD DONORS. SPECIFICALLY, THE PRIMARY OBJECTIVES OF THIS CONTRACT ARE TO: Â ¢ EVALUATE AND MONITOR RISK FACTOR CHARACTERISTICS OF DONATIONS CONFIRMED POSITIVE FOR TTIS AND COMPARISON UNINFECTED (CONTROL) DONORS. Â ¢ COMPARE/ANALYZE RISK FACTOR DATA TO THAT OBTAINED IN THE EARLIER TTIMS STUDY PERIOD AND THE REDS-II TTVI MARKER PREVALENCE AND RISK FACTOR STUDY. Â ¢ INTEGRATE RISK FACTOR DATA AND DISEASE MARKER SURVEILLANCE INFORMATION ACROSS DIFFERENT BLOOD COLLECTION ORGANIZATIONS. Â ¢ MONITOR ARV AND PREP/PEP USE IN US ALLOGENEIC BLOOD DONOR POPULATION BASED ON TESTING OF BOTH HIV-POSITIVE AND INFECTION NEGATIVE DONATIONS FOR THE PRESENCE OF ARV DRUGS. Â ¢ EXPLORE THE CHARACTERISTICS OF BLOOD DONORS WHO USE ARV/PREP/PEP TO BETTER UNDERSTAND THEIR RISKS, KNOWLEDGE, AND MOTIVATIONS FOR DONATING WHILE USING THESE THERAPIES. Â ¢ EVALUATE WELL-CHARACTERIZED US BLOOD DONOR SAMPLES FROM TTIMS AND OTHER SOURCES FOR THE REFINEMENT OF EXISTING ANALYTICAL METHODS SUCH AS THE SEDIA LAG AVIDITY ASSAY TO DERIVE ESTIMATES OF RECENT INFECTION WITH HIV WITH A GOAL OF RAPIDLY OBTAINING MORE ACCURATE AND TIMELY RESULTS. Â ¢ PROVIDE LOGISTICAL SUPPORT FOR THE TTIMS PROJECT AND FOR THE COMMITTEE/SUBCOMMITTEE MEETINGS, CONFERENCES, AND DONATION(S) TRANSFER/SHIPMENT. IN SUPPORT OF THESE OBJECTIVES, CTS WILL PROVIDE BIOSPECIMENS FOR THE TTIMS REPOSITORY FOR SOME OF THE PARTICIPATING BLOOD CENTERS, PARTICIPATE IN EXISTING SPECIMEN ACQUISITION FOR ADDITIONAL APPROVED PROTOCOLS, AND WILL ACTIVELY COLLABORATE IN THE ANALYSIS, INTERPRETATION, AND REPORTING OF FINDINGS IN TTIMS. DR. PHILLIP WILLIAMSON WILL SERVE AS THE PRINCIPAL INVESTIGATOR (PI) AT CTS. HE WILL OVERSEE ALL ASPECTS OF CTSÂ PARTICIPATION IN THE LRCC PORTION OF TTIMS, INCLUDING ACQUISITION OF BIOSPECIMENS AND PROVISION OF DATA RELEVANT TO BE ABLE TO LINK SPECIMENS TO DONOR DEMOGRAPHIC DATA SUPPLIED BY THE PARTICIPATING BLOOD CENTERS. DR. WILLIAMSON OR HIS DESIGNEES WILL ALSO PARTICIPATE IN CALLS AND MEETINGS FOR THE TTIMS PROJECT LIKE THE TTIMS STEERING COMMITTEE. BLOOD CENTER STAFF WILL FORWARD PLASMA BAGS AND/OR PILOT TUBES TO CTS SO THAT CTS CAN CREATE UP TO 5 X 2 ML PLASMA CYROVIALS AND A SINGLE 15 ML PLASMA CRYOVIAL FOR EACH PARTICIPANT AND PREPARE ALIQUOTS FOR SHIPMENT TO THE REPOSITORY AND ADDITIONAL TESTING AT VRI FOR ALL INFECTIONS OF INTEREST AS DEFINED BY THE TTIMS STEERING COMMITTEE. IN COLLABORATION WITH THE LRCC, CTS WILL COORDINATE SAMPLE SHIPMENT WITH DESIGNATED CTS STAFF TO THE TTIMS REPOSITORY HELD IN SAN FRANCISCO. CTS WILL ASSIST TO SOURCE SPECIMENS FOR ARV/PEP/PREP TESTING FROM RESIDUAL SAMPLE VOLUMES FOLLOWING ROUTINE INFECTIOUS DISEASE MARKER TESTING. ADDENDUMS TO THIS SOW WILL BE DEVELOPED AFTER THE RESEARCH PROTOCOLS TO SUPPORT EXPANDED ART/PEP/PREP STUDIES ARE FULLY DEFINED AND APPROVED BY THE TTIMS STEERING COMMITTEE. CTS MAY ALSO CONDUCT ADDITIONAL TESTING AS REQUIRED BY THE TTIMS PROGRAM. AN EXAMPLE OF THIS TESTING IS THE 10-FOLD REPLICATE TESTING TO CONFIRM HIV SEROLOGY-ONLY SAMPLE RESULTS. THIS TESTING WILL BE CHARGED TO THE PRIME AWARD RATHER THAN BUDGETED IN THE CTS SUBCONTRACT.
Creative Testing Solutions
Definitive Contract 75F40121C00196
$612.6k 12/18/23 11832OB159S
THE TTIMS LRCC PROJECT PURPOSE IS TO SERVE AS THE BIOSTATISTICAL AND ANALYTICAL CENTER FOR SPECIFIC ANALYSES RELEVANT TO THE EVALUATION AND MONITORING OF HIV (INCIDENT AND PREVALENT INFECTIONS), HCV (INCIDENT) AND HBV (INCIDENT), AND SYPHILIS POSITIVE BLOOD DONORS. SPECIFICALLY, THE PRIMARY OBJECTIVES OF THIS CONTRACT ARE TO: Â ¢ EVALUATE AND MONITOR RISK FACTOR CHARACTERISTICS OF DONATIONS CONFIRMED POSITIVE FOR TTIS AND COMPARISON UNINFECTED (CONTROL) DONORS. Â ¢ COMPARE/ANALYZE RISK FACTOR DATA TO THAT OBTAINED IN THE EARLIER TTIMS STUDY PERIOD AND THE REDS-II TTVI MARKER PREVALENCE AND RISK FACTOR STUDY. Â ¢ INTEGRATE RISK FACTOR DATA AND DISEASE MARKER SURVEILLANCE INFORMATION ACROSS DIFFERENT BLOOD COLLECTION ORGANIZATIONS. Â ¢ MONITOR ARV AND PREP/PEP USE IN US ALLOGENEIC BLOOD DONOR POPULATION BASED ON TESTING OF BOTH HIV-POSITIVE AND INFECTION NEGATIVE DONATIONS FOR THE PRESENCE OF ARV DRUGS. Â ¢ EXPLORE THE CHARACTERISTICS OF BLOOD DONORS WHO USE ARV/PREP/PEP TO BETTER UNDERSTAND THEIR RISKS, KNOWLEDGE, AND MOTIVATIONS FOR DONATING WHILE USING THESE THERAPIES. Â ¢ EVALUATE WELL-CHARACTERIZED US BLOOD DONOR SAMPLES FROM TTIMS AND OTHER SOURCES FOR THE REFINEMENT OF EXISTING ANALYTICAL METHODS SUCH AS THE SEDIA LAG AVIDITY ASSAY TO DERIVE ESTIMATES OF RECENT INFECTION WITH HIV WITH A GOAL OF RAPIDLY OBTAINING MORE ACCURATE AND TIMELY RESULTS. Â ¢ PROVIDE LOGISTICAL SUPPORT FOR THE TTIMS PROJECT AND FOR THE COMMITTEE/SUBCOMMITTEE MEETINGS, CONFERENCES, AND DONATION(S) TRANSFER/SHIPMENT. IN SUPPORT OF THESE OBJECTIVES, ONEBLOOD WILL RECRUIT, ENROLL AND INTERVIEW ELIGIBLE PARTICIPANTS, PROVIDE DATA AS REQUIRED IN THE TTIMS LRCC STATEMENT OF WORK, PROVIDE BIOSPECIMENS FOR RESEARCH TESTING AT VRI, AND WILL ACTIVELY COLLABORATE IN THE ANALYSIS, INTERPRETATION, AND REPORTING OF FINDINGS IN TTIMS. DR. RITA A. REIK, MD, WILL SERVE AS THE PRINCIPAL INVESTIGATOR (PI) AT ONEBLOOD. SHE WILL OVERSEE ALL ASPECTS OF ONEBLOODÂ S PARTICIPATION IN THE LRCC PORTION OF TTIMS INCLUDING ACQUISITION OF DONOR DATA AND BIOSPECIMENS AND WILL PARTICIPATE IN CALLS AND MEETINGS FOR THE TTIMS PROJECT. IN ADDITION, DR. TISHA FOSTER, MD, WILL SERVE AS THE CO-PRINCIPAL INVESTIGATOR AT ONEBLOOD. DR. FOSTER WILL ASSIST IN THE OVERSIGHT OF THE ACQUISITION OF DONOR DATA, AND WILL PARTICIPATE IN CALLS AND MEETINGS FOR THE TTIMS PROJECT WHEN NECESSARY. ONEBLOOD WILL RECRUIT DONORS WITH QUALIFYING TEST RESULTS; ADMINISTER THE WEB-BASED QUESTIONNAIRE AND ENTER RISK FACTOR DATA INTO AN ELECTRONIC DATABASE; PERFORM QUALITY CONTROL (QC) ON ALL DATA ENTERED INTO THE DATABASE; RESPOND TO REQUESTS FROM THE LRCC REGARDING DATA QUALITY ASSURANCE AND QC; DEVELOP AND SUBMIT TO THE LOCAL IRB DOCUMENTS AND AMENDMENTS FOR APPROVAL. Â ¢ ONEBLOOD WILL ALSO MAINTAIN AND UPDATE THE STUDY MANAGEMENT SYSTEM (SMS) THAT SUPPORTS THESE ACTIVITIES AT ALL PARTICIPATING SITES, WORKING THE LRCC TO DEFINE TECHNICAL REQUIREMENTS AND RESOURCES NECESSARY TO SUPPORT THIS ACTIVITY. ONEBLOOD STAFF WILL FORWARD PLASMA BAGS AND/OR PILOT TUBES TO CREATIVE TESTING SOLUTIONS (CTS) SO THAT CTS CAN CREATE UP TO 5 X 2 ML PLASMA CYROVIALS AND A SINGLE 15 ML PLASMA CRYOVIAL FOR EACH PARTICIPANT AND PREPARE ALIQUOTS FOR SHIPMENT TO THE REPOSITORY AND ADDITIONAL TESTING AT VRI FOR ALL INFECTIONS OF INTEREST AS DEFINED BY THE TTIMS STEERING COMMITTEE. IN COLLABORATION WITH THE LRCC, ONEBLOOD WILL COORDINATE SAMPLE SHIPMENT WITH DESIGNATED CTS STAFF. IN ADDITION, ONEBLOOD WILL WORK WITH THE LRCC AND CTS TO SOURCE SPECIMENS FOR ARV/PEP/PREP TESTING. ONEBLOOD WILL ALSO WORK THE LRCC TO FACILITATE SURVEYS AND QUALITATIVE INTERVIEWS OF ARV/PEP/PREP REACTIVE BLOOD DONORS. ONEBLOOD WILL NOT BE EXPECTED TO LEAD THE COLLECTION OF THESE SURVEY AND QUALITATIVE INTERVIEW DATA BUT WILL ASSIST IN IDENTIFYING AND RECRUITING PARTICIPANTS FOR THESE ACTIVITIES. ADDENDUMS TO THIS SOW WILL BE DEVELOPED AFTER THE RESEARCH PROTOCOLS TO SUPPORT EXPANDED ART/PEP/PREP STUDIES ARE FULLY DEFINED AND APPROVED BY THE TTIMS STEERING COMMITTEE.
Oneblood, Inc.
Definitive Contract 75F40121C00196
$636.7k 12/7/23