CHOICES3: Sickle Cell Disease Parenting CHOICES

NCT05292781 | Active Not Recruiting DMC

• 3 other identifiers: IRB201803021R01HG011927PRO00035017
• Study Type: interventional
• Target: 506
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Sickle Cell Trait

Outcome Measures

Primary Outcomes (1)

• Sickle Cell Reproductive Health Knowledge

  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.

  Baseline up to 24 months

Study Arms (2)

CHOICES

EXPERIMENTAL

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

Other: CHOICES

eBook (electronic-Book)

SHAM COMPARATOR

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

Other: eBook

Interventions

CHOICES OTHER

An innovative web application to provide interactive information about reproductive health options for people with SCD or SCT. CHOICES is a multimedia intervention that provides targeted and tailored information for participants to become informed ns about their reproductive health options. Targeted to their sex and tailored to their SC reproductive health knowledge, reproductive health behavior during the previous 6 mo, and parenting plan (e.g., intention to have child with SCD or not), CHOICES presents information about options to help the participant achieve their parenting plan through reproductive partner selection based on sickle cell status, prenatal testing, ovum and sperm donation, advanced reproductive technologies, and options to avoid pregnancy or adopt. The website will be housed on secure University of Florida (UF) servers and accessible via computers or mobile devices (e.g., tablets, smart phones); device capture will inform plans for long-term dissemination.

CHOICES

eBook OTHER

e-Book contains information typically shared in clinical SCD care, including stick figure representation of inheritance because the investigator considers it unethical to withhold this basic information. It does not include other information related to the SCKnowIQ knowledge items or any of the behaviors needed to implement a parenting plan. Although not as long as CHOICES, the e-Book is sufficiently long, attractive, and engaging to retain participants randomized to the usual care control group; key factors for an adequate control condition. Interestingly, during the study and in interviews after the study, many e-Book participants commented that they were pleased to be assigned to the intervention group (they had not), which indicates that the control condition is sufficient for its intent--2-yr longitudinal retention of the sample. Also, human contact is the same for both groups, and the time-on-task on the computer is unlikely to influence study knowledge and behavior endpoints.

eBook (electronic-Book)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Human Genome Research Institute (NHGRI): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Sickle Cell Trait

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Diana Wilkie, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: December 1, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)