CHOICES3: Sickle Cell Disease Parenting CHOICES

University of Florida

Status: Active, not recruiting

Conditions: Sickle Cell Trait; Sickle Cell Disease

Treatments: Other: CHOICES; Other: eBook

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05292781

PRO00035017 (Other Identifier)

IRB201803021

R01HG011927 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 506 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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506 participants in 2 patient groups

CHOICES

Experimental group

Description:

Experimental arm: receives the web-based reproductive education for individuals with sickle cell disease or sickle cell trait

Treatment:

Other: CHOICES

eBook (electronic-Book)

Sham Comparator group

Description:

Control arm with eBook education focused on sickle cell disease and sickle cell trait.

Treatment:

Other: eBook