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CHOICES3: Sickle Cell Disease Parenting CHOICES (CHOICES3)

Primary Purpose

Sickle Cell Disease, Sickle Cell Trait

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHOICES
eBook
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sickle Cell Disease

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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;
  • 18 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.

Sites / Locations

  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

CHOICES

eBook (electronic-Book)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 14, 2022
Last Updated
July 7, 2023
Sponsor
University of Florida
Collaborators
National Human Genome Research Institute (NHGRI)
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1. Study Identification

Unique Protocol Identification Number
NCT05292781
Brief Title
CHOICES3: Sickle Cell Disease Parenting CHOICES
Acronym
CHOICES3
Official Title
CHOICES for Sickle Cell Reproductive Health: Randomized Clinical Trial (RCT) of a Preconception Intervention Model for a Single Gene Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Human Genome Research Institute (NHGRI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Sickle Cell Trait

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
506 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CHOICES
Arm Type
Experimental
Arm Description
Experimental arm: receives the web-based reproductive education for individuals with sickle cell disease or sickle cell trait
Arm Title
eBook (electronic-Book)
Arm Type
Sham Comparator
Arm Description
Control arm with eBook education focused on sickle cell disease and sickle cell trait.
Intervention Type
Other
Intervention Name(s)
CHOICES
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
eBook
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sickle Cell Reproductive Health Knowledge
Description
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.
Time Frame
Baseline up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Coordinator
Phone
352-273-6406
Email
choices.study@ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amelia Greenlee
Phone
352-273-6356
Email
greenleeal@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Wilkie, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Coordinator
Phone
352-273-6406
Email
choices.study@ufl.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CHOICES3: Sickle Cell Disease Parenting CHOICES

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