NCT05000489

Brief Summary

The investigators aim to perform a qualitative study exploring attitudes and perceived barriers to Long Acting Reversible Contraception (LARC), both implants and IUDs, among adolescent and young adults (AYA) with chronic illness at CHLA. While the literature examining barriers to LARC uptake is growing, its focus has been on older women and women who are not living with chronic illness. There remains a significant gap in the understanding of:

  1. 1.What adolescents and young adults from ethnically diverse, economically underserved communities know about LARCs
  2. 2.If and how LARCs fit into their considerations and decision making about contraception choices
  3. 3.Perceived barriers to LARC among AYA with chronic medical conditions
  4. 4.Information, perceptions, experiences that inform choices that may be unique to AYA living with chronic conditions
  5. 5.Explore the impact of the experience of living with chronic medical conditions on AYA patient attitudes toward and acceptance of LARCs
  6. 6.Identify AYA patient concerns and perceptions related to historical coercion and reproductive injustice experienced by minority communities that may reduce acceptance of LARC
  7. 7.Explore the relationship between patients' perception of pediatric subspecialty care providers' attitudes regarding sexual health and contraception guidance and patients' attitudes toward and acceptance of LARC
  8. 8.Identify factors related to patient's age, family's values, and medical condition, as well as historical events or legacies that may impact preference of implant vs intra-uterine device (IUD), independent of safety/medical contraindications, if choosing a LARC method.
  9. 9.Explore other social, cultural or psychological factors that influence perception and represent barriers to LARC access
  10. 10.The impact of chronic illness on AYA sense of bodily autonomy (including self-concept, history of other medical procedures, and concerns around mortality) reduces the attractiveness of LARC methods.
  11. 11.The intersectionality of multiple oppressions, including racism, xenophobia, sexism, and historical reproductive coercion and injustice implicitly reduce the attractiveness of LARC methods for AYA patients from minority communities with chronic medical conditions at CHLA.
  12. 12.Pediatric subspecialty providers' attitudes about sex, and comfort with providing patient-centered contraception counseling, as perceived by AYA patients, impact AYA patient attitudes towards and acceptance of LARC.
  13. 13.Preference of implant vs. IUD is related to patient's age, family values, and type of medical condition, as well as their knowledge of historical events related to contraception in their community, independent of safety/medical contraindications.
  14. 14.Additional perceived barriers, including fear or skepticism about LARC conferred by trusted sources of information such as family or social media, reduce the attractiveness and acceptance of LARC by AYA with chronic medical conditions

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2022

Completed
Last Updated

April 17, 2025

Status Verified

May 1, 2022

Enrollment Period

12 months

First QC Date

July 1, 2021

Last Update Submit

April 14, 2025

Conditions

Keywords

long acting reversible contraceptionbirth controlreproductive healthchronic illnessadolescentsyoung adultsIUDLARC

Outcome Measures

Primary Outcomes (2)

  • This research will identify chronically ill individuals experiences with sexual and reproductive health patient-centered counseling from their subspecialty providers

    Findings from this study will inform the development of improved and more patient-centered counseling that takes into account the numerous intersecting factors CHLA patients experience. By hearing first-hand experiences from patients, investigators will be able to identify the gaps in knowledge and care as it pertains to the sexual and reproductive health of patients with chronic medical conditions.

    Immediately after the focus groups and analysis have been completed

  • Focus groups will help identify gaps and areas for continuing education for pediatric sub-specialty providers as it pertains to the sexual and reproductive health of their patients

    This research will contribute to the development of improved continuing education for pediatric specialty providers around the sexual and reproductive health needs of their patients, grounded in a cultural humility model and reproductive justice framework. By hearing from patients' experiences, investigators will be able to identify the areas that providers require extra knowledge or support to better educate their patients about their own sexual and reproductive health, especially as it relates to their chronic condition.

    Immediately after the focus groups and analysis have been completed

Secondary Outcomes (1)

  • This research will identify how to improve sexual and reproductive health outcomes for medically complex AYAs

    Immediately after the focus groups and analysis have been completed

Study Arms (13)

Minors 1

a one-time focus group will be conducted with 16-17 year old patients who have a variety of diagnoses

Other: No intervention being administered

Minor 2

a one-time focus group will be conducted with 16-17 year old patients who have a variety of diagnoses

Other: No intervention being administered

Spina Bifida

a one-time focus group will be conducted with adult patients (18-21) who are being seen in the Spina Bifida clinic

Other: No intervention being administered

Pulmonology

a one-time focus group will be conducted with adult patients (18-21) who are being seen in the pulmonology clinic

Other: No intervention being administered

Endocrinology 1

a one-time focus group will be conducted with adult patients (18-21) who are being seen in the Endocrinology clinic and have a diagnosis of Type I Diabetes

Other: No intervention being administered

Endocrinology 2

a one-time focus group will be conducted with adult patients (18-21) who are being seen in the Endocrinology clinic and have a diagnosis of Type II Diabetes

Other: No intervention being administered

Rheumatology

a one-time focus group will be conducted with adult patients (18-21) who are being seen in the Rheumatology clinic

Other: No intervention being administered

Gastroenterology

a one-time focus group will be conducted with adult patients (18-21) who are being seen in the Gastroenterology clinic

Other: No intervention being administered

Neurology

a one-time focus group will be conducted with adult patients (18-21) who are being seen in the Neurology clinic

Other: No intervention being administered

Cardiology

a one-time focus group will be conducted with adult patients (18-21) who are being seen in the Cardiology clinic

Other: No intervention being administered

Hematology

a one-time focus group will be conducted with adult patients (18-21) who are being seen in the Hematology clinic

Other: No intervention being administered

Nephrology

a one-time focus group will be conducted with adult patients (18-21) who are being seen in the Nephrology clinic

Other: No intervention being administered

Oncology

a one-time focus group will be conducted with adult patients (18-21) who are being seen in the Oncology clinic

Other: No intervention being administered

Interventions

No intervention will be administered. Each patient will participate in a qualitative focus group discussing their beliefs/attitudes about their reproductive health and birth control

CardiologyEndocrinology 1Endocrinology 2GastroenterologyHematologyMinor 2Minors 1NephrologyNeurologyOncologyPulmonologyRheumatologySpina Bifida

Eligibility Criteria

Age16 Years - 21 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescent and young adults with a chronic condition being treated at Children's Hospital Los Angeles

You may qualify if:

  • years of age
  • female or transmale identified (i.e. have potential for pregnancy)
  • ICD9/10 diagnostic codes corresponding with chronic illness/disability from the following CHLA subspecialty services:
  • rheumatology (e.g., lupus, JIA, scleroderma, etc.)
  • hematology (sickle cell disease, thalassemia)
  • oncology (survivors)
  • cardiology (congenital and acquired cardiac disease, including transplant)
  • endocrinology (Type 1/2 diabetes)
  • neurology (epilepsy, multiple sclerosis, cerebral palsy)
  • pulmonology (cystic fibrosis)
  • gastroenterology (inflammatory bowel disease, liver transplant)
  • nephrology (chronic kidney disease, kidney transplant) and
  • spina bifida multidisciplinary clinic
  • Receiving ongoing care (at least one visit per year for more than one year) in one of the ten sub-specialty services targeted for the study
  • English speaking
  • +4 more criteria

You may not qualify if:

  • Patients from the above sub-specialty services less than 16 years of age or greater than 21 years of age
  • Non-English speaking
  • Consult patients or patients who have not received ongoing care (i.e., care at least one visit per year for more than one year) from these subspecialty services
  • Neurocognitive disability
  • Patients with known infertility and/or history of receiving gonadotoxic therapies, for whom childbearing is known to be impossible
  • Patients who do not have access to digital platforms necessary to participate in the study
  • Adult accompanying patient who is not legal parent/caregiver
  • Non-English/non-Spanish speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Multiple Chronic ConditionsChronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Claudia Borzutzky, MD

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR
  • Ellen Iverson, MPH

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD; Program Director, Adolescent Medicine Fellowship, CHLA; Clinical Associate Professor of Pediatrics, Keck School of Medicine, USC

Study Record Dates

First Submitted

July 1, 2021

First Posted

August 11, 2021

Study Start

April 16, 2021

Primary Completion

April 7, 2022

Study Completion

April 7, 2022

Last Updated

April 17, 2025

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data with other researchers

Locations