Status:
ACTIVE_NOT_RECRUITING
CHOICES3: Sickle Cell Disease Parenting CHOICES
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Human Genome Research Institute (NHGRI)
Conditions:
Sickle Cell Disease
Sickle Cell Trait
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
The study will use web-based data collection (SCKnowIQ) and intervention delivery strategies enhanced by nudges and tailored boosters in a sample of 430 adult men and women, aged 18-45 yr with SCD (Si...
Detailed Description
In a 2-year, randomized, longitudinal, repeated measures, controlled trial in 430 at-risk young adults with SCD (50%) or SCT (50%) to compare the effects of e-Book (electronic-Book) and CHOICES interv...
Eligibility Criteria
Inclusion
- Diagnosis of SCD (HbSS, HbSC (Hemoglobin Sickle C Disease), HbS-beta-0 thalassemia, and HbS-beta+ thalassemia) or report of SCT (SCD is Hgb electrophoresis confirmed; SCT evaluated by SickleScan);
- Able and intends to conceive a child in the next 2 years (first child or another child);
- Speaks and reads English;
- 18 to 45 years;
- At-risk for having a child with SCD (i.e., sexual/ reproductive partner has SCD, SCT, or unknown sickle cell status); and
- Wants to avoid the risk of a child with SCD.
- The age range is based on typical reproductive age for SCD where median survival is 42 years for men and 48 years for women.
Exclusion
- Legally blind;
- Physically unable to complete the study questionnaires or the intervention;
- Report health history of hysterectomy, tubal ligation, medically or surgically induced menopause, or vasectomy that would
- Prevent ability to bear children;
- Report a desire to remain childless or have no further children;
- Report knowing or being a relative or friend of a participant previously enrolled in the study, or
- Previous participation in a CHOICES study.
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT05292781
Start Date
December 1 2022
End Date
June 30 2027
Last Update
August 27 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32611