Sickle Cell DiseaseCHOICES3NCT05292781
CHOICES3: Sickle Cell Disease Parenting CHOICES
A study testing CHOICES and eBook in people with Sickle Cell Disease and Sickle Cell Trait, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Sickle Cell Disease, Sickle Cell Trait
- What is being tested?
- CHOICES and eBook
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 506 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: CHOICES for Sickle Cell Reproductive Health: Randomized Clinical Trial (RCT) of a Preconception Intervention Model for a Single Gene Disorder
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.
Read the 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.
- Conditions
- Sickle Cell Disease, Sickle Cell Trait
- Being tested
- CHOICES, eBook
- Medical subject headings
- Anemia, Sickle Cell, Sickle Cell Trait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOICESOther
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.
eBookOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CHOICES | Experimental | Experimental arm: receives the web-based reproductive education for individuals with sickle cell disease or sickle cell trait Receives: Other: CHOICES |
| eBook (electronic-Book) | Sham comparator | Control arm with eBook education focused on sickle cell disease and sickle cell trait. Receives: Other: eBook |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start1 Dec 2022
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 506 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Responsible party
- Sponsor
- Investigators
- Diana Wilkie, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292781
- Sponsor's protocol ID
- IRB201803021
- Other IDs
- R01HG011927, PRO00035017
- Acronym
- CHOICES3
- Status last verified
- Oct 2026
- First submitted
- 14 Mar 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHOICES for Sickle Cell Reproductive Health: Randomized Clinical Trial (RCT) of a Preconception Intervention Model for a Single Gene Disorder
- ClinicalTrials.gov ID
- NCT05292781
- Acronym / sponsor ID
- CHOICES3 / IRB201803021
- Conditions
- Sickle Cell Disease, Sickle Cell Trait
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 506 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHOICES | Experimental | Other: CHOICESExperimental arm: receives the web-based reproductive education for individuals with sickle cell disease or sickle cell trait |
| eBook (electronic-Book) | Sham comparator | Other: eBookControl arm with eBook education focused on sickle cell disease and sickle cell trait. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHOICESAn 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. | Other | CHOICES |
| eBooke-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. | Other | eBook (electronic-Book) |
Primary outcome
Sickle Cell Reproductive Health Knowledge
Time frame: Baseline up to 24 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Wilkie, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHOICES and eBook in people with Sickle Cell Disease and Sickle Cell Trait, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sickle Cell Reproductive Health Knowledge (time frame: Baseline up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.