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eBook + CHOICES Intervention for Sickle Cell Disease (CHOICES3 Trial)
N/A
Recruiting
Led By Diana Wilkie, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At-risk for having a child with SCD
18 to 45 years
Must not have
Physically unable to complete the study questionnaires or the intervention
Legally blind
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 24 months
Summary
This trial will test whether nudges and tailored boosters can help people with sickle cell disease or thalassemia have a child free of their condition.
Who is the study for?
This trial is for adults aged 18-45 with Sickle Cell Disease (SCD) or Sickle Cell Trait (SCT), who can read and speak English, want to conceive within the next two years, and aim to have a child free of SCD. It's not open to those who've been in CHOICES studies before, are unable to complete study tasks, or cannot have children due to medical reasons.
What is being tested?
The CHOICES3 trial is testing a web-based program designed to help people with SCD/SCT make informed decisions about having children. Participants will use an online platform offering educational content and personalized support strategies aimed at reducing the risk of conceiving a child with SCD.
What are the potential side effects?
Since this intervention involves educational content delivered through an eBook rather than medication, there are no direct physical side effects expected from participating in this clinical trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at risk of having a child with sickle cell disease.
Select...
I am between 18 and 45 years old.
Select...
I have been diagnosed with sickle cell disease or carry the sickle cell trait.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to fill out study forms or participate in the study activities.
Select...
I am legally blind.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Sickle Cell Reproductive Health Knowledge
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CHOICESExperimental Treatment1 Intervention
Experimental arm: receives the web-based reproductive education for individuals with sickle cell disease or sickle cell trait
Group II: eBook (electronic-Book)Placebo Group1 Intervention
Control arm with eBook education focused on sickle cell disease and sickle cell trait.
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,409 Previous Clinical Trials
766,953 Total Patients Enrolled
National Human Genome Research Institute (NHGRI)NIH
270 Previous Clinical Trials
293,563 Total Patients Enrolled
Diana Wilkie, PhDPrincipal InvestigatorUniversity of Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at risk of having a child with sickle cell disease.I am between 18 and 45 years old.I plan to try for a baby within the next 2 years.I want to prevent having a child with sickle cell disease.I am unable to fill out study forms or participate in the study activities.I have been diagnosed with sickle cell disease or carry the sickle cell trait.I am legally blind.I do not wish to have children in the future.I know someone or have myself been part of this or a related study before.
Research Study Groups:
This trial has the following groups:- Group 1: CHOICES
- Group 2: eBook (electronic-Book)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.