CHOICES3: Sickle Cell Disease Parenting CHOICES (CHOICES3)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2025
  • participants needed
    506
  • sponsor
    University of Florida
Updated on 13 June 2022
electrophoresis
thalassemia

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 18-35 yr with SCD or SCT, at-risk, and planning within 2 years to have a child free of SCD.

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 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 mo.

Details
Condition Sickle Cell Disease, Sickle Cell Trait
Treatment CHOICES, CHOICES, eBook
Clinical Study IdentifierNCT05292781
SponsorUniversity of Florida
Last Modified on13 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of SCD (HbSS, HbSC, HbS-beta-0 thalassemia, and HbS-beta+ thalassemia) or report of SCT (both SCD/ SCT is Hgb electrophoresis confirmed)
Able and intends to conceive a child in the next 2 years (first child or another child)
Speaks and reads English
to 35 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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