ClinicalTrials.gg
Active, not recruitingNCT05292781CHOICES3Updated Oct 23, 2026

CHOICES3: Sickle Cell Disease Parenting CHOICES

An interventional study of CHOICES and eBook in Sickle Cell Disease and Sickle Cell Trait, sponsored by University of Florida. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-23.

Primary conditionSickle Cell TraitRegistry: Anemia, Sickle CellReclassifiedWhy we changed it
Registry
Anemia, Sickle Cell — the first condition term the registry derived for this study.
ClinicalTrials.gg
Sickle Cell Trait
Why
  1. The study's listed conditions name Sickle Cell Trait, a narrower term within Anemia, Sickle Cell.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Florida · Not applicable, Interventional, and Prevention

Updated Oct 23, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
506
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Sickle Cell Disease
  • Sickle Cell Trait

Browse trials for

03

In context

Sickle Cell Trait Reclassified

43 studies on the registry are indexed under Sickle Cell Trait; 11 are open to participants now.

This study's planned enrollment of 506 is above the median of 63 across 22 interventional studies indexed under Sickle Cell Trait.

Browse Sickle Cell Trait studies →

Lead sponsor

University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.

Compared within Sickle Cell Trait, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anemia, Sickle Cell. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of SCD (HbSS, HbSC ( 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
506 participants (estimated)

Study arms

  • Experimental
    CHOICES

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

    Other: CHOICES

  • Sham comparator
    eBook (electronic-Book)

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

    Other: eBook

Interventions

  • OtherCHOICES

    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.

  • OthereBook

    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.

06

What researchers measure

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.

    Time frame: Baseline up to 24 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Dec 2022 (actual). Primary completion is estimated for Sep 2027, 57 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 23, 2026: primary completion Jun 2027 → Sep 2027 and completion Jun 2027 → Sep 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 14, 2022
First posted
Mar 23, 2022
StartActual
Dec 1, 2022
Primary completionEst.
Sep 30, 2027was Jun 2027
CompletionEst.
Sep 30, 2027was Jun 2027
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Jun 30, 2027→Sep 30, 2027
Oct 23, 2026
Study completion
Jun 30, 2027→Sep 30, 2027
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    Primary completion Jun 30, 2027→Sep 30, 2027
    Study completion Jun 30, 2027→Sep 30, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05292781
Responsible party
Sponsor
First posted
Mar 23, 2022
Start date
Dec 1, 2022
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Oct 23, 2026

Study contacts

Diana Wilkie, PhD
principal investigator · University of Florida

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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