ACTIVE_NOT_RECRUITING

CHOICES3: Sickle Cell Disease Parenting CHOICES

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Conditions

Sickle Cell DiseaseSickle Cell Trait

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

CHOICES for Sickle Cell Reproductive Health: Randomized Clinical Trial (RCT) of a Preconception Intervention Model for a Single Gene Disorder

Quick Facts

Study Start:2022-12-01
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05292781

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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);
  2. * Able and intends to conceive a child in the next 2 years (first child or another child);
  3. * Speaks and reads English;
  4. * 18 to 45 years;
  5. * At-risk for having a child with SCD (i.e., sexual/ reproductive partner has SCD, SCT, or unknown sickle cell status); and
  6. * Wants to avoid the risk of a child with SCD.
  7. * The age range is based on typical reproductive age for SCD where median survival is 42 years for men and 48 years for women.
  1. * Legally blind;
  2. * Physically unable to complete the study questionnaires or the intervention;
  3. * Report health history of hysterectomy, tubal ligation, medically or surgically induced menopause, or vasectomy that would
  4. * Prevent ability to bear children;
  5. * Report a desire to remain childless or have no further children;
  6. * Report knowing or being a relative or friend of a participant previously enrolled in the study, or
  7. * Previous participation in a CHOICES study.

Contacts and Locations

Principal Investigator

Diana Wilkie, PhD
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32611
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Diana Wilkie, PhD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-01
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2022-12-01
Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Sickle Cell Disease
  • Sickle Cell Trait