Dried Blood Spot Testing of CMV Detection in HCT Recipients (NCT03910478) | Clinical Trial Compass
CompletedNot Applicable
Dried Blood Spot Testing of CMV Detection in HCT Recipients
United States622 participantsStarted 2019-05-03
Plain-language summary
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.
Who can participate
Age range15 Years – 99 Years
SexALL
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Inclusion criteria
✓. Must be \>/= 15 years of age at the time of enrollment
✓. Must be able to provide written consent and complete the informed consent
✓. Must have received allogeneic hematopoietic cell transplantation within 60-180 days prior to randomization
✓. Cytomegalovirus (CMV) seropositive or had a donor who was CMV positive
✓. One or both of the following:
✓. Direct availability to the internet either by a computer in the residence or a smart phone
✓. Had at least one or more of these conditions:
✓. Must be \>/= 15 years of age at the time of enrollment
Exclusion criteria
✕. Inability to fully comprehend the study website and study procedures
✕. Any other condition, which in the opinion of the investigator would interfere with successful completion of this clinical trial
What they're measuring
1
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
Timeframe: At one year after Hematopoietic cell transplantation (HCT)
2
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
Timeframe: At one year after Hematopoietic cell transplantation (HCT)
Trial details
NCT IDNCT03910478
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)