CHOICES3: Sickle Cell Disease Parenting CHOICES

Not Applicable

Recruiting

• Conditions: Sickle Cell Disease; Sickle Cell Trait
• Interventions: Other: CHOICES; Other: eBook

• Registration Number: NCT05292781
• Lead Sponsor: University of Florida

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

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 interventions on knowledge and behaviors across time (baseline, immediate posttest, 6, 12, 18, 24 months). The study will provide boosters tailored to knowledge deficits at 6 and 12 months and add monthly reinforcement nudges toward concordant behavior during the first 12 months.

Study Timeline

• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-23
• Study Start: 2022-12-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 506

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHOICES	CHOICES	Experimental arm: receives the web-based reproductive education for individuals with sickle cell disease or sickle cell trait
eBook (electronic-Book)	eBook	Control arm with eBook education focused on sickle cell disease and sickle cell trait.

Primary Outcome Measures

Name	Time	Method
Sickle Cell Reproductive Health Knowledge	Baseline up to 24 months	Knowledge. The Sickle Cell Reproductive Health Knowledge Questionnaire measures knowledge of the genetic transmission of SCD and SCT, etiology of SCD, parenting options for people with SCD or SCT, types of contraceptives safe for people with SCD or SCT, and risks of complications during pregnancy for the woman with SCD. Responses are multiple choice options. Scores are totaled across all items, ranging from 0 to 17; higher scores reflect better knowledge than lower scores.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States