This is a randomized clinical trial to assess whether a subject centered, self-collection of Dried blood spots (DBS) samples will improve compliance with the clinical recommendation of weekly Cytomegalovirus (CMV) testing of Hematopoietic cell transplantation (HCT) recipients who are at high risk for late CMV disease. In this study, mobile devices will be used to remind HCT survivors to perform CMV monitoring using finger-stick collected DBS testing in their home setting or to visit their doctor's office to perform the test. 150 allogeneic HCT recipients \> /= 15 years of age will be randomized (2:1) to DBS monitoring or standard of care (per local institution) monitoring. Duration of study participation is anticipated to be within a range of 26 weeks to 43 weeks. The primary objective is to evaluate adherence to recommended CMV monitoring duration and interval during the first year after HCT upon enrollment using subject collected dried blood spot testing.
This is a randomized clinical trial to assess whether a subject centered, self-collection of dried blood spots (DBS) samples will improve compliance with the clinical recommendation of weekly Cytomegalovirus (CMV) testing of Hematopoietic cell transplantation (HCT) recipients who are at high risk for late CMV disease. In this study, mobile devices will be used to remind HCT survivors to perform CMV monitoring using finger-stick collected DBS testing in their home setting or to visit their doctor's office to perform the test. 150 allogeneic HCT recipients \> /= 15 years of age will be randomized (2:1) to DBS monitoring or standard of care (per local institution) monitoring. Duration of study participation is anticipated to be within a range of 26 weeks to 43 weeks. The primary objective is to evaluate adherence to recommended CMV monitoring duration and interval during the first year after HCT upon enrollment using subject collected dried blood spot testing. The secondary objectives are 1) To evaluate the mean difference between the recommended monitoring that each subject completes between the DBS and the control arm. 2) To compare the incidence of CMV disease between the DBS monitoring and standard of care arm; 3) To evaluate the safety of DBS monitoring. Additionally, an observational cohort of 450 HCT recipients, who consented for retrospective studies and meet eligibility criteria but are not participating in the DBS testing for CMV, will be used to assess whether randomized study sample is representative of the DBS study population and to obtain a population-based estimate of late CMV disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
622
Kit for self-collection of Dried Blood Spot (DBS) samples
Standard of care with office-based testing.
University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine
Minneapolis, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The University of Texas - MD Anderson Cancer Center - Infectious Diseases
Houston, Texas, United States
Fred Hutchinson Cancer Research Center - Vaccine and Infectious Diseases
Seattle, Washington, United States
The Number of Participants Who Have Completed >90% of Their Recommended Cytomegalovirus (CMV) Monitoring Tests in the DBS and Control Arms in the ITT Population
To evaluate adherence to recommended CMV monitoring duration and interval during the first year after HCT, the number of participants who completed \>90% of their recommended CMV monitoring tests at one year after HCT in the DBS and control arms was collected.
Time frame: At one year after Hematopoietic cell transplantation (HCT)
The Number of Participants Who Have Completed >90% of Their Recommended Cytomegalovirus (CMV) Monitoring Tests in the DBS and Control Arms in the mITT Population
To evaluate adherence to recommended CMV monitoring duration and interval during the first year after HCT, the number of participants who completed \>90% of their recommended CMV monitoring tests at one year after HCT in the DBS and control arms was collected.
Time frame: At one year after Hematopoietic cell transplantation (HCT)
The Total Number of Recommended Cytomegalovirus (CMV) Monitoring Tests That Were Completed Per Participant in the ITT Population
The total number of recommended Cytomegalovirus (CMV) monitoring tests that were completed per participant was reported.
Time frame: By 1 year after Hematopoietic cell transplantation (HCT)
The Total Number of Recommended Cytomegalovirus (CMV) Monitoring Tests That Were Completed Per Participant in the mITT Population
The total number of recommended Cytomegalovirus (CMV) monitoring tests that were completed per participant was reported.
Time frame: By 1 year after Hematopoietic cell transplantation (HCT)
Number of Participants With End-organ Cytomegalovirus (CMV) Disease, Possible and Proven/Probable
Proven or probable CMV disease is a serious adverse event of special interest. The number of participants experiencing proven or probable CMV disease between Hematopoietic cell transplantation (HCT) and 365 days after HCT.
Time frame: By 1 year after Hematopoietic cell transplantation (HCT)
Number of Participants With Finger-stick Procedure-related Grade 3 Adverse Events (AEs) in the DBS Arm
To evaluate the safety of DBS monitoring, Finger-stick procedure-related Grade 3 AEs were abstracted through medical chart review at quarterly contacts and at the final close-out contact. Participants were considered as meeting the outcome measure if they had at least one finger-stick procedure-related Grade 3 AE during the study period.
Time frame: By 1 year after Hematopoietic cell transplantation (HCT)
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