Finger-Prick test at home boosts virus monitoring in transplant patients
NCT ID NCT03910478
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether having patients collect a small blood sample at home (using a finger prick) and getting reminders on their phone could help them stick to weekly testing for cytomegalovirus (CMV) after a stem cell transplant. About 150 transplant recipients took part. The goal was to see if this approach improved how many recommended tests were completed compared to standard care. The findings could make monitoring easier and more convenient for patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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622 people
The number who actually took part.
- Started
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May 2019
- Finished
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Jan 2024
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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15 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Randomized Cohort: 1. Must be \>/= 15 years of age at the time of enrollment 2. Must be able to provide written consent and complete the informed consent 3. Must have received allogeneic hematopoietic cell transplantation within 60-180 days prior to randomization 4. Cytomegalovirus (CMV) seropositive or had a donor who was CMV positive 5. One or both of the following: * CMV event\* within the first 100 days post-transplant requiring anti-viral treatment * Receipt of CMV prophylaxis\*\*(for at least 30 days) prior to randomization. Continuation of letermovir or acyclovir/valacyclovir (high and low dose) prophylaxis after day 100 per institutional standard of care is permitted \* CMV event defined as deoxyribonucleic acid (DNA) detection or disease \*\* Anti-viral treatment or prophylaxis includes ganciclovir, valganciclovir, foscarnet, letermovir, maribavir or acyclovir/valacyclovir (high and low dose) 6. Direct availability to the internet either by a computer in the residence or a smart phone 7. Had at least one or more of these conditions: * HLA mismatch\* * umbilical cord blood source\*\* * Graft versus host disease (GVHD)\*\*\* * T-cell depletion\*\*\*\* \* Human leukocyte antigen (HLA)-related (sibling) donor with at least one mismatch at one of the following three HLA-gene loci: HLA-A, -B, or -DR, Haploidentical donor, Unrelated donor with at least one mismatch at one of the following four HLA-gene loci: HLA-A, -B, -C and -DRB1 * Use of umbilical cord blood as stem cell source \*\*\*Acute or chronic GVHD requiring topical steroid for gastrointestinal (GI) GVHD and/or systemic steroid treatment (\>/= 1 mg/kg/day of prednisone or equivalent dose of another corticosteroid) within 6 weeks prior to enrollment * Subjects who have received partial or full T-cell depletion (with or without GVHD). T-cell depletion can be given as either ex-vivo or in-vivo for GVHD prophylaxis. T-cell depleting agents include, but are not limited to, anti-thymocyte globulin (ATG) and alemtuzumab Observation Cohort: 1. Must be \>/= 15 years of age at the time of enrollment 2. Must have one of the following: * Consented for retrospective studies at their transplant center, or * Be included under the auspices of the site's IRB approved waiver of additional consent for retrospective studies 3. Must have received allogeneic hematopoietic cell transplantation during or within 1 year prior to the conduct of the randomized trial (defined as time during which randomization is done) 4. CMV seropositive or had a donor who was CMV positive 5. One or both of the following: * CMV event\* within the first 100 days post-transplant requiring anti-viral treatment * Receipt of CMV prophylaxis\*\*(for at least 30 days) prior to registration. Continuation of letermovir prophylaxis or acyclovir/valacyclovir (high and low dose) after day 100 per institutional standard of care is permitted \* CMV event defined as DNA detection or disease \*\* Anti-viral treatment or prophylaxis includes ganciclovir, valganciclovir, foscarnet, letermovir, maribavir or acyclovir/valacyclovir (high and low dose) 6. Meet at least one or more of criteria of the following: * HLA mismatch\* * umbilical cord blood source\*\* * GVHD\*\*\* * T-cell depletion\*\*\*\* * Human leukocyte antigen (HLA)-related (sibling) donor with at least one mismatch at one of the following three HLA-gene loci: HLA-A, -B, or -DR, Haploidentical donor, Unrelated donor with at least one mismatch at one of the following four HLA-gene loci: HLA-A, -B, -C and -DRB1 * Use of umbilical cord blood as stem cell source \*\*\*Acute or chronic GVHD requiring topical steroid for GI GVHD and/or systemic steroid treatment (\>/= 1 mg/kg/day of prednisone or equivalent dose of another corticosteroid) within 6 weeks prior to enrollment \*\*\*\*Subjects who have received partial or full T-cell depletion (with or without GVHD). T-cell depletion can be given as either ex-vivo or in-vivo for GVHD prophylaxis. T-cell depleting agents include, but are not limited to, anti-thymocyte globulin (ATG) and alemtuzumab Exclusion Criteria: Randomized Cohort: 1. Inability to fully comprehend the study website and study procedures 2. Any other condition, which in the opinion of the investigator would interfere with successful completion of this clinical trial 3. Morphological relapse (bone marrow or peripheral blood blast) prior to registration Observational Cohort: 1. Did not meet all inclusion criteria 2. Morphological relapse (bone marrow or peripheral blood blast) prior to registration
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fred Hutchinson Cancer Research Center - Vaccine and Infectious Diseases
Seattle, Washington, 98109-4433, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065-6007, United States
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The University of Texas - MD Anderson Cancer Center - Infectious Diseases
Houston, Texas, 77030-4000, United States
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University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine
Minneapolis, Minnesota, 55455-0356, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can cord blood t cells be trained to stop viral infections after transplant?
- Can a new IV antiviral tame two stubborn viruses?
- A new drug combo may shield kidney transplant patients from a common viral threat
- Blood test could tailor CMV prevention after stem cell transplants
- Can 'Supercharged' donor cells beat viruses that drugs Can't?
- Banked immune cells show promise against Life-Threatening viruses in transplant patients