Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03708731 · ClinicalTrials.gov registry record
Exploring Adherence Monitoring in Sickle Cell Disease
A clinical trial of Sickle Cell Disease, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- 36
- Enrollment target
- 1
- Study location
NCT03708731: Active study of Sickle Cell Disease, sponsored by St. Jude Children's Research Hospital.
NCT03708731 is a study of Sickle Cell Disease that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 36 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03708731, a study of Sickle Cell Disease, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
Despite the well-documented benefits of hydroxyurea (HU) therapy in decreasing morbidity and mortality in youth with Sickle cell disease (SCD), pediatric HU adherence rates range as low as 49% and lead to discontinuation of HU regimens in 8-20%. In addition, treatment non-adherence may lead to unnecessary increases in medication dosage resulting from erroneous assumption that a patient is non-responsive to treatment (versus non-adherent to the regimen as prescribed). Given the detrimental effects of non-adherence, assessment of and intervention for HU non-adherence is essential to improving health outcomes in the pediatric SCD population. Electronic adherence monitoring is widely considered the "gold standard" in objective adherence measurement. These monitors provide continuous, real- time records of medication adherence and reveal problematic behavior patterns, including underdosing, overdosing, delayed dosing, "drug holidays," and "white coat" adherence. Overall, electronic adherence measures are considered valid, reliable, and accurate, with clear advantages over pharmacy refill records, physician estimates and self-report measures. The primary purpose of this pilot study is to determine the use of the AdhereTech as a feasible and valid measure of HU adherence in pediatric SCD. Primary Objective Estimate the association between HU adherence as measured by the AdhereTech device to a) caregiver-report, b) youth-report, c) lab values, d) pill- count, and e) Medication Possession Ratio (MPR) adherence measures Secondary Objectives Estimate the rate of consent to the study, the rate of AdhereTech device use, the rate of AdhereTech device failure, and the perceived acceptability of using the AdhereTech device, as reported by caregivers and youth
Primary Outcome
For each subject, we will calculate the proportion of days of opening the AdhereTech device across the two month study period (days with missing information will not be counted). Caregiver-report of their child's HU adherence will be assessed by the Medical Adherence Measure (MAM), a measure of 7-day self-reported adherence. Each subject's caregiver-reported adherence will be calculated as: \[(medication reported taken \[(medication reported taken ÷ medication prescribed) x 100\]. We will estima
Conditions Studied
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-03-12 |
| Est. Completion | 2026-09-30 |
What the registry record for NCT03708731 still lists
NCT03708731 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 0 interventions.
NCT03708731 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT03708731 about?
NCT03708731 is a clinical study titled "Exploring Adherence Monitoring in Sickle Cell Disease". Despite the well-documented benefits of hydroxyurea (HU) therapy in decreasing morbidity and mortality in youth with Sickle cell disease (SCD), pediatric HU adherence rates range as low as 49% and lead to discontinuation of HU regimens in 8-20%. In addition, treatment non-adherence may lead to unnec...
What is the current status of trial NCT03708731?
This trial is currently active not recruiting. The enrollment target is 36 participants. The study started on 2019-03-12. Estimated completion is 2026-09-30.
What conditions does trial NCT03708731 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
Who is sponsoring clinical trial NCT03708731?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03708731 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sickle Cell Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03708731's enrollment target sits among peer trials
36 130th of 213 higher than 81 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults
RECRUITING · Phase 2
-
Early Life Exposures Among Children With Sickle Cell Disease
RECRUITING · NA
-
Exercise in Child Health
RECRUITING · NA
-
Sickle Cell Children's Exercise Study (SuCCESs)
RECRUITING · NA
-
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
RECRUITING · Phase 1
-
Hematopoietic Stem Cell BCL11A Enhancer Gene Editing for Severe β-Hemoglobinopathies
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00929006 · 36 participants · Early Phase 1
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
- NCT01891318 · 36 participants · Phase 1
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
- NCT02291848 · 36 participants · Phase 1
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
- NCT02366819 · 36 participants · Phase 4
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI