NCT03910478

Dried Blood Spot Testing of CMV Detection in HCT Recipients

A Multi-Site, Randomized Trial of Subject-Collected Dried Blood Spot CMV Testing With Mobile Technology Support to Optimize Preemptive Therapy Late After Allogeneic HCT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 622 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 15 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cytomegalovirus Infection

Interventions

Type	Name	Description
DEVICE	DBS Self-Collection Kit	Kit for self-collection of Dried Blood Spot (DBS) samples
OTHER	Standard Control Strategy	Standard of care with office-based testing.

Timeline

• Start date: 2019-05-03
• Primary completion: 2024-01-16
• Completion: 2024-01-16
• First posted: 2019-04-10
• Last updated: 2026-02-25
• Results posted: 2025-03-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study