An observational study in Chronic Conditions, Multiple, sponsored by Children's Hospital Los Angeles. Completed at 1 site in United States. Open to female participants aged 16 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by Children's Hospital Los Angeles · Observational
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:
Research Objectives
Hypotheses
Long acting reversible contraceptives (LARC), including the subdermal etonogestrel implant, and both the copper and levonogestrel intrauterine devices (IUDs), are recommended as first line birth control methods for adolescents and young adults (AYA) by both the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. LARC have been noted to be particularly safe for reproductive age AYA with chronic illness, a population that needs and benefits greatly from careful guidance about contraception choice. It is well documented that AYA with chronic illness are often as sexually active as their "healthy" peers, but can face both greater health and psychosocial complications if pregnancy is unplanned, and health risks if their contraceptive method interacts adversely with medication regimes. Additionally, in both pediatric and adult specialty care, despite frequent visits, addressing sexual health issues is often omitted, whether by intent or lack of comfort, or due simply to limited time for visits and the precedence given to the primary disease for which the care is being provided.
While there is growing evidence that AYA females are opting for LARC as their contraceptive method few have explored attitudes towards and acceptance of LARC by AYA with chronic illness. Even less is understood about the impact of AYA perceptions of their subspecialty providers' comfort, knowledge, or ability to counsel around sexual health issues on their contraceptive planning and choices. Additionally, little is known about how medical condition, age or other factors may influence perceptions of type of LARC, i.e., implant vs. IUD, or how they may influence decisions to use either type in this population of AYA. The Contraceptive Choice Study did demonstrate greater interest in and use of the implant over IUDs among younger teens, but there was no qualitative inquiry exploring reasons for this difference by age, that investigators are aware of. Lastly, the recent attention to the reproductive justice framework, including a greater understanding of the historical legacy of institutionalized and structural reproductive coercion of non-Caucasian communities in the United States, sheds light on an even greater knowledge gap regarding the intersectionality of minority ethnicity/race, chronic illness, and attitudes towards LARC among AYA. As research aims to move forward into a model of sexual and reproductive care for transition age youth that is grounded in both reproductive justice and cultural humility, the understanding of this intersection becomes critical.
Los Angeles County is one of the most demographically, culturally, and linguistically diverse urban metropolitan areas in the world. The patient populations served by Children's Hospital Los Angeles (CHLA) mirror this diversity. In 2018, CHLA provided care to 133,325 unique patients. Currently, 11,970 adolescents and young adults between 16-21 years of age are receiving care for chronic illness or disability. Over half (52%) are female. Many of CHLA's patients come from immigrant families with limited education and ability to communicate in English. Nearly 60% of CHLA's patients identify as Latinx/Hispanic, and while many adolescent and young adult patients' parents/caretakers are monolingual Spanish speaking, most patients are bilingual in Spanish and English. Over three-quarters (76%) of CHLA's patients rely on Medicaid and Title V benefits for their care. Ranked 5th best pediatric tertiary care institution in the U.S., CHLA is the only pediatric institution among the nation's top 10 to serve as a safety net provider. In fact, CHLA provides care to over a third of Los Angeles county's children with special healthcare needs eligible for Title V benefits. Investigators anticipate that the patients participating in this study will reflect this same ethnic/racial, socio-economic, and cultural diversity.
CHLA's AYA patients are affected by a group of conditions that reflect diversity in their degree of visibility and physical disability, chronicity vs intermittency, number of organ systems involved, and types of treatments. The study team's interest is therefore to also explore differences in attitudes, behavior and perceptions toward LARC that may relate to the nature of their particular condition and treatment regimen.
The CHLA Division of Adolescent and Young Adult Medicine serves as the primary sexual/reproductive health referral point for CHLA's AYA patients with chronic illness; it has offered placement of the etonogestrel implant since shortly after it was introduced into the U.S. market by Organon, and has offered IUD placements since spring of 2017. However, uptake of LARC among CHLA AYA patients is low. Since 2013, approximately 200 LARCs have been placed; approximately 30 were placed in 2019.
The study team's aim is to perform a qualitative study exploring attitudes and perceived barriers to LARC, both implants and IUDs, among 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:
This observational study will employ qualitative methods targeting adolescent and young adult (AYA) females 16-21 years of age living with chronic illness or disability. A key research question underlying these themes will be to explore the extent to which their experiences living with chronic illness and their engagement in ongoing medical management has an impact on their contraception decision making and perception of LARC as a viable option.
Approximately 90-110 sexually active and non-sexually active young women or transmale identified (have the potential for pregnancy) 18-21 years of age who are receiving ongoing healthcare from subspecialty teams at Children's Hospital Los Angeles will be recruited to participate in a one-time focus group session, with the focus group being comprised of 5-10 individuals each. There is expected to be 11 adult aged focus groups, with each comprised of 5-10 individuals. An additional 20 adolescents, 16-17 years of age who may or may not be sexually active (not asked for minors to disclose when screening) will be invited to participate in two focus groups designed to understand and compare perceptions and contraception decision making and choice of younger vs. older adolescents and young adults, anticipating differences in perception and behavior borne out in studies of AYA LARC uptake and contraceptive choice. A subsample of 22 focus group participants (18-21 years of age) will be invited to participate in an in-depth, individual interview designed to explore more intimate experiences and considerations related to relationships, feelings about their reproductive futures, personal issues related to living with their condition, and how culture and family influence their perceptions and use of contraception options.
In the interest of ensuring representation of young women living with a variety of chronic conditions, both visible and invisible, investigators will recruit AYA patients receiving care from the following subspecialty services:
Focus groups with young adult women or transmale identified (have the potential for pregnancy) 18-21 years of age will be organized into groups of patients sharing the same condition (e.g., sickle cell disease, cystic fibrosis, etc.) or receiving care from the same subspecialty service, (e.g., pulmonology, nephrology, etc.). The groups will also be organized by sexually active and non-sexually active if there are a large number of adult aged participants who have not engaged in sexual activity. The team will randomly select two patients per subspecialty to be invited to participate in individual in-depth interviews.
The two focus groups with younger adolescent patients 16-17 years of age will include representation from each of the targeted subspecialty services (i.e. a mix of medical conditions), approximately two patients per subspecialty.
Findings from this study will inform the development of improved and more patient-centered counseling that takes into account these numerous intersecting factors. It will also 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. Investigators expect that these, in turn, will contribute to better and more just sexual and reproductive health outcomes for medically complex AYA.
89 studies on the registry are indexed under Multiple Chronic Conditions; 16 are open to participants now.
This study's enrollment of 67 is below the median of 160 across 16 observational studies indexed under Multiple Chronic Conditions.
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Adolescent and young adults with a chronic condition being treated at Children's Hospital Los Angeles
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.
Parent/caregiver Inclusion Criteria (parents/caregivers of minor participants)
Exclusion Criteria:
Parent/caregiver Exclusion Criteria (parents/caregivers of minor participants)
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
Time frame: 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.
Time frame: Immediately after the focus groups and analysis have been completed
This research will identify how to improve sexual and reproductive health outcomes for medically complex AYAs
This research will contribute to better and more just sexual and reproductive health outcomes for medically complex adolescent and young adults by providing first-hand patient experience to learn and improve from.
Time frame: Immediately after the focus groups and analysis have been completed
Plan to share: No — There is no plan to share individual participant data with other researchers
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in Apr 2022, 11 months.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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