CHOICES for Sickle Cell Reproductive Health: Randomized Clinical Trial (RCT) of a Preconception Intervention Model for a Single Gene Disorder

About the study

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 (Sickle Cell Disease) or SCT (Sickle Cell Trait), at-risk, and planning within 2 years to have a child free of SCD.

Study point of contact

Coordinator
352-273-6406
[email protected]
Amelia Greenlee
352-273-6356
[email protected]

Locations

111 United States sites

Age

18 Years - 45 Years

Phase

Not Applicable

Study type

Interventional

Gender

All

Interventions

Other

participation requirements

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.

participation restrictions

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.

Locations

  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]
  • Gainesville, Florida, United States, University of Florida [Recruiting]

MORE INFORMATION

View on ClinicalTrials.gov
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Last updated 2023-07-07