Helping parents with sickle cell disease make informed choices about having children
CHOICES for Sickle Cell Reproductive Health: Randomized Clinical Trial (RCT) of a Preconception Intervention Model for a Single Gene Disorder
NA · University of Florida · NCT05292781
This study is testing whether a new online program can help parents with sickle cell disease or trait make better choices about having healthy children.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 506 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of Florida (other) |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT05292781 on ClinicalTrials.gov |
What this trial studies
This study aims to support adult men and women aged 18-45 who have sickle cell disease (SCD) or sickle cell trait (SCT) and are planning to conceive a child within the next two years. It will utilize web-based data collection and intervention strategies, including an eBook and tailored boosters, to enhance knowledge and behaviors related to having a child free of SCD. Participants will be randomly assigned to receive either the CHOICES intervention or the eBook, with follow-ups at various intervals over two years to assess the impact of these interventions on their decision-making and knowledge retention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-45 with SCD or SCT who plan to conceive a child within the next two years and wish to avoid the risk of having a child with SCD.
Not a fit: Patients who are legally blind, unable to complete study questionnaires, or have undergone procedures that prevent them from bearing children will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could empower at-risk parents with the knowledge and tools to make informed reproductive choices, potentially reducing the incidence of sickle cell disease in future generations.
How similar studies have performed: While similar interventions have been explored, this specific approach combining web-based tools and tailored nudges is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Diana Wilkie, PhD — University of Florida
- Study coordinator: Coordinator
- Email: choices.study@ufl.edu
- Phone: 352-273-6406
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sickle Cell Disease, Sickle Cell Trait