Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05000489 |
| Other study ID # |
60336 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 16, 2021 |
| Est. completion date |
July 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Children's Hospital Los Angeles |
| Contact |
Jessica N Rocha, MA |
| Phone |
(323)3612416 |
| Email |
jrocha[@]chla.usc.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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. What adolescents and young adults from ethnically diverse, economically underserved
communities know about LARCs
2. If and how LARCs fit into their considerations and decision making about contraception
choices
3. Perceived barriers to LARC among AYA with chronic medical conditions
4. Information, perceptions, experiences that inform choices that may be unique to AYA
living with chronic conditions
Research Objectives
1. Explore the impact of the experience of living with chronic medical conditions on AYA
patient attitudes toward and acceptance of LARCs
2. Identify AYA patient concerns and perceptions related to historical coercion and
reproductive injustice experienced by minority communities that may reduce acceptance of
LARC
3. 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
4. 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.
5. Explore other social, cultural or psychological factors that influence perception and
represent barriers to LARC access
Hypotheses
1. 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.
2. 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.
3. 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.
4. 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.
5. 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
Description:
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:
1. What adolescents and young adults from ethnically diverse, economically underserved
communities know about LARCs
2. If and how LARCs fit into their considerations and decision making about contraception
choices
3. Perceived barriers to LARC among AYA with chronic medical conditions
4. Information, perceptions, experiences that inform choices that may be unique to AYA
living with chronic conditions
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:
- 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
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.
