Liletta: New IUD approved by the FDA

The U.S. Food and Drug Administration (FDA) recently approved Liletta™, a new hormonal intrauterine device (IUD). This levonorgestrel-releasing IUD inhibits uterine lining from thickening and has been FDA approved for up to three years to prevent pregnancy. Liletta, found to be more than 99 percent effective, is already available in Europe and should arrive in the USA within the next few months.

Liletta was developed by Actavis and the non-profit Medicines360. Given the current high cost of IUDs, Medicines360 has focused on making Liletta affordable and accessible to all women. FDA approval was based on results from the largest hormonal IUD trial conducted in the U.S. The Section of Family Planning has been proud to participate in this study since 2010, as part of our broader commitment to research that improves contraceptive access for women.

Our previous research revealed various barriers in accessing the most effective methods, including cost. One recent study, conducted with support from the Office of Population Affairs, explored systems-level barriers to IUD provision. This research led to the development of a toolkit for clinical staff and health care providers to use in identifying and addressing barriers in their own clinics. We are also currently researching the feasibility and effectiveness of using mobile applications for contraceptive counseling in clinic waiting rooms. Our current studies follow previous research on an initial application, available here as an iOS app.

The Section supports the FDA’s approval of Liletta given its effectiveness at preventing pregnancy and ease of use for most women.

“Increasing the array of available and affordable contraceptive methods helps women find a method that best helps them achieve their reproductive health goals”, said Dr. Melissa Gilliam, Chief of the Section of Family Planning and lead investigator for the Section’s study site.

 

Dr. Melissa Gilliam at Discover UChicago San Francisco – Feb. 3

Dr. Gilliam Inquiry Impact Seattle

Dr. Melissa Gilliam presents on games and learning at Discover UChicago Seattle. Photo courtesy of UChicago Alumni.

Section of Family Planning Chief and Ci3 Founder and Director Dr. Melissa Gilliam will present as part of Discover UChicago San Francisco on Tuesday, February 3.

The event is part of the University of Chicago Campaign: Inquiry and Impact. According to the campaign website, Inquiry and Impact is the most ambitious campaign in UChicago history, aiming to support faculty and research, practitioners and patients, and students and programs across the University. Over the next several months, the campaign will hold events in Los Angeles, Chicago, Hong Kong, New York and London. Watch the campaign video.

Dr. Gilliam previously participated in Discover UChicago Seattle on January 13.

RSVP to Discover UChicago San Francisco.

Dr. Melissa Gilliam to Present at Discover UChicago Seattle

Dr. Melissa Gilliam. Photo: Associated Press

Dr. Melissa Gilliam. Photo: Associated Press

Dr. Melissa Gilliam will present as part of Discover UChicago Seattle on Tuesday, January 13. The event will take place at the Four Seasons Hotel in Seattle from 6:30-8:30 p.m., and is part of the University of Chicago Campaign: Inquiry and Impact.

Click here for details and to RSVP.

Dr. Gilliam is Chief of the University of Chicago Section of Family Planning & Contraceptive Research, Founder and Director of Ci3, and Co-founder of Game Changer Chicago Design Lab.

Inquiry and Impact is the most ambitious and comprehensive campaign in the University of Chicago’s history. The Campaign will raise $4.5 billion to support faculty and researchers, practitioners and patients, and students and programs across the University. Over the next several months, the campaign will hold events in San Francisco, Los Angeles, Chicago, Hong Kong, New York and London.

New Section research promotes parent–daughter communication about abortion before pregnancy occurs

parent_daughters

Press Release

Published: 13 October 2014

 

Discussing sexuality and reproductive health is a complex issue for parents and their daughters. Parents often feel ill-prepared to initiate these talks, and their daughters often fear a negative reaction or perceive judgment for their sexual activity. Yet, numerous studies have shown that, in general, parent-daughter communication leads to positive sexual health outcomes with regards to pregnancy and STI/HIV prevention.

New Section research, published online ahead of print in the Journal of Adolescent Health, discusses the role and potential impact of parent-daughter communication about abortion among non-pregnant adolescents. These conversations, the authors suggest, may decrease pregnancies and abortion and obviate the need for forced communication.

Currently, 38 states legislate communication between abortion-seeking minors and their parents via Parental Involvement (PI) laws, which require minors 18 years old and under to notify or obtain consent from a parent(s) or guardian before obtaining an abortion. PI supporters argue that these laws promote communication and provide young women with family support. PI opponents maintain that forced communication during the time of crisis can harm young women and delay treatment, increasing the medical risk of a procedure. Furthermore, studies show that most adolescents voluntarily involve parents in their decisions about pregnancy resolution, especially when they anticipate support.

Our qualitative study found that only 43 percent of nonpregnant African-American adolescent females had ever discussed abortion with a parent. Almost half were sexually active, and the vast majority stated they would voluntarily tell a parent of an abortion decision “as soon as possible” or “within one to two weeks.” However, nearly 20 percent acknowledged risk and expressed fears of hurt, punishment, and eviction if their parent learned about an abortion.

The study identified several correlates of parent-daughter communication about abortion. Parents who had had talked about other sexual health topics (e.g. birth control and STIs) were more likely to have discussed abortion with their daughter. If daughters perceived parental acceptance of sexual activity, they were more likely to have an abortion communication. A mother’s experience with teenage pregnancy was positively associated with abortion communication, although the study did not assess the positive or negative quality of the communication. Of concern, sexually active adolescents were less likely to communicate about abortion.

Ultimately, this study found that rather than mandating communication at the time of abortion, policies should focus on general parent-daughter communication about sexual health. Policies that force communication at the time of abortion appear misplaced.

Read the full article here.

Reference

Sisco K, Martins S, Kavanaugh E, Gilliam M. Parent-Daughter Communication About Abortion Among Nonpregnant African-American Adolescent Females. Journal of Adolescent Health. Published online ahead of print September 27, 2014: DOI: 10.1016/j.jadohealth.2014.07.010

 

Dr. Melissa Gilliam Featured in AP News Story on Contraception Access

AP Photo

Section Chief Dr. Melissa Gilliam was featured and quoted in an Associated Press news story regarding Illinois’ recent effort to ensure comprehensive and continuous birth control coverage for those with Medicaid.

The story, which has been picked up by outlets nationwide including CBS News, discusses a plan from Illinois Gov. Pat Quinn’s administration to improve access to family planning services for individuals with Medicaid, including long-acting birth control methods, by increasing reimbursement and education. The plan was announced at last month’s Illinois Contraceptive Equity Summit, an event hosted by the Section and EverThrive Illinois. The public is invited to comment on the plan until September 15.

According to the article, the current Illinois Medicaid payment system creates a financial barrier to doctors for offering LARC methods. For example, IUDs cost doctors’ offices between $300 and $800 each to keep in stock. Clinics pay the upfront cost of an IUD and absorb the loss of denied or delayed Medicaid claims. By implementing the Illinois Family Planning Action Plan,  the state would double doctors’ reimbursement rates for inserting IUDs and performing vasectomies, thus alleviating the cost for both patient and provider.

Dr. Gilliam commented on access to contraceptive methods within Medicaid, saying that “for some providers, [the state’s plan] will make a very big difference and will be a very welcome change.”

Photo: M. Spencer Green, AP

Ci3 Welcomes New Executive Director, Dr. Brandon Hill

brandon hill

Ci3 (the Center for Interdisciplinary Inquiry and Innovation in Sexual and Reproductive Health at The University of Chicago) is pleased to introduce its new Executive Director, Brandon Hill, PhD.

Dr. Hill joined Ci3 in July 2013. Previously, he worked at Indiana University’s Kinsey Institute for Research in Sex, Gender, and Reproduction. In the past year, Dr. Hill has concentrated on interdisciplinary research, with a special focus on STI/HIV prevention interventions, lesbian, gay, bisexual, and transgender (LGBT) health, and health disparities. His current projects include studies examining mental and physical health disparities among racial and sexual minorities—particularly young transgender women of color and young men who have sex with men.

Recently, Dr. Hill coauthored the article “Digital Media and Sexually Transmitted Infections” in this month’s Current Opinion in Obstetrics and Gynecology, and commented on transgender service member mental health in JAMA Psychiatry.

“Over the past year and a half, Ci3 has demonstrated the importance of linking programs, research, and policy,” said Dr. Melissa Gilliam, Ci3 Founder and Director. She added, “Dr. Hill brings research expertise and experience in interdisciplinary research with diverse populations. We now have a terrific opportunity to build on the foundation that Angela Heimburger [departing Executive Director] has established as Ci3 continues to develop as a hub for innovative research focused on young people’s sexual and reproductive health and wellbeing, linking our intervention lab, the Game Changer Chicago Design Lab, with research and policy.”

“I am thrilled to oversee such a dynamic academic center [Ci3], and look forward to its continued growth both nationally and globally as we roll out our future research initiatives,” Hill stated. Dr. Hill will begin his position September 1st.

For more information please contact Lauren Whalen, Ci3 Communications Manager, at lwhalen@bsd.uchicago.edu or 773-834-8351.

Digital Media and Sexually Transmitted Infections

Image from the Huffington PostYoung people account for nearly half of all new cases of sexually transmitted infections (STI) each year. In order to reduce risk behaviors and related health problems, new approaches and strategies for STI prevention increasingly employ digital media, which includes computer programs, smartphone apps, digital videos and audio recordings, web pages and websites, and social media.

Dr. Melissa Gilliam, Dr. Julie Chor, and Dr. Brandon Hill reviewed the recent literature on this intersection of technology and sexual health in the latest issue of Current Opinion in Obstetrics and Gynecology. Their article Digital Media and Sexually Transmitted Infections presents and critiques the potentiality to reduce sexual risk behaviors by employing technological interventions.

In particular, the article explores the impact of digital media use on increasing STI risk, how digital media can disseminate public health information, and what new and innovative digital media interventions are currently employed to prevent and treat STIs.

The literature points out that since young people interact with digital media daily, health care providers should not only embrace these technologies for their health interventions, but also recognize the potential risks of using these types of communication. For example, young people send and receive up to 100 texts per day. Such ubiquity has ushered in new modes of sexual communication, including sexting. In addition to the risks that come when sharing sexually explicit words or photographs, public health researchers have asked whether sexting can influence STI or HIV risk behaviors — this article reviews some of that data.

New modes of digital media and communication also impact health-seeking behaviors, whereby youth obtain health information by actively engaging with peers or anonymously searching for content. Although adolescents use digital media to disclose information and engage in relationships, studies show that they also express strong privacy concerns about seeking health information on these platforms.

The authors also comment on sexual health interventions that used a technology, including one that tested a text messaging system that sent reminders about an STI checkup and another study that used Facebook to create HIV awareness and intervention. The authors found these varying studies inconclusive, but acknowledge the value of establishing the potential of using these technologies in public health research and advocacy. However, a better understanding of how social media and other digital media contribute to sexual behaviors is critical to understanding increasing STI rates among adolescents.

Read the entire article and summaries of existing research here.

 

New Section research assesses systematic barriers to IUD care

iudAt the Section of Family Planning & Contraceptive Research, we are committed to conducting quality research about the effectiveness of IUDs as birth control, especially for young women.

IUDs require little user maintenance, last between 7 and 12 years, and are highly effective at preventing pregnancy. As our earlier research has shown, in order to reduce undesired pregnancy amongst young women, it is critical to remove unnecessary barriers to choosing the IUD. One way to improve the quality of IUD services and the number of women receiving this contraceptive method is to assess the underlying problems that prevent women from receiving an IUD at their scheduled appointment.

Section Chief Dr. Melissa Gilliam’s research on these systematic barriers to IUD care was published in the July 2014 online edition of Contraception.

This article describes the novel use of a systematic approach to evaluating clinical care, called Failure Modes Effects and Criticality Analysis (FMECA). This step-by-step approach was originally developed by engineers to evaluate high-risk industries such as nuclear power and commercial aviation in order to identify practices that contribute to poor quality, unsafe, or unreliable inefficiencies. When adapted to healthcare, team members use FMECA to evaluate the systems and processes of a specific type of clinic care (eg IUD care). “Failures” are identified from qualitative and quantitative data, determining the frequency and impact in order to prioritize redesign and improvements.

For example, a failure in IUD delivery would be a patient calling and cancelling an appointment, but the cancellation is not entered into the scheduling system.

Dr. Gilliam’s study used the FMECA process to evaluate IUD services at three Title X clinics and identified three main failures during the scheduling and intake processes: 1) The patient does not show up for appointment or cancels; 2) The patient recently had unprotected intercourse; and 3) Limited time for counseling, informing, and placing IUDs. This FMECA drew upon interviews with IUD clients, the clinical care team, and reviewed administrative data at all three clinics.

After reviewing the failures, the researchers and clinical care team created solutions to the identified failures: implementing a revised scheduling call script and developing an app to be used in the waiting room. To address cancellations and no-shows, the new call center script reminded patients to keep their appointment or call to cancel beforehand. The script also addressed the need to abstain from unprotected intercourse prior to the appointment. The third failure, limited time, was also addressed by this revision, which identified potentially eligible IUD patients beforehand and saved time at the actual appointment. The barrier of limited time was also addressed with the waiting room “app”, which maximized the wait time by counseling women about contraceptive options.

After the completion of this study, the research team developed an online toolkit describing processes, procedures, and tools for an FMECA and shared with Title X clinics nationally.

To read our published research on the impact of the revised call script and the waiting room app, click here and here.

Clear communication during appointment scheduling can increase LARC uptake

Portrait of a female doctor using a computer while being on the phone

UPDATE: the final version of this article is now online. Read the abstract and download the full article in PDF format.

A new study from Dr. Melissa Gilliam and former Section staff discusses why some scheduled IUD appointments do not result in placement.

“Impact of a revised appointment scheduling script on IUD service delivery in three Title X family planning clinics” was published in the June 2014 online issue of Contraception.

This study began by reviewing clinic administrative data, which showed that women did not receive a desired IUD because of cancellations, no-shows, the need for an IUD-specific appointment, lack of awareness of clinic guidelines, and unknown pregnancy status.

With these systems-level barriers in mind, the researchers created a simple and scalable intervention: revising the appointment scheduling call script. The revised script used by telephone schedulers at a call center addressed these common mishaps and met national Title X guidelines. Along with the revised script, visual tools reminded schedulers to explain behavior prerequisites such as “Do not have unprotected sex at least two weeks prior to an appointment” and “Continue to use pills, patches, or rings up until the appointment”. The script also prompted schedulers to communicate logistical requirements such as bringing an ID, proof of insurance or cash to pay for the procedure, and instructions to call and cancel an appointment if necessary.

Before the new script was instituted, only 47 percent of patients at these sites successfully received an IUD at their scheduled appointment. After implementation of the revised script, 60 percent of scheduled appointments resulted in the desired IUD insertion. Additionally, the no-show rates decreased from 40 to 23 percent, and in particular, young women were more likely to keep their scheduled appointment.

This study shows that a simple IUD appointment scheduling script with clear communication improves LARC uptake. Additionally, as many clinics in the US move forward to computerized and centralized call centers, improving patient communication during the scheduling process may have a broad impact on clinical efficiency.

Related: Development and testing of an iOS waiting room “app” for contraceptive counseling in a Title X family planning clinic

 

Use of an iOS Waiting Room “App” Improves LARC Knowledge

image from www.securedgenetworks.comSection Chief and Ci3 Founder and Director Dr. Melissa Gilliam has published a research article in the American Journal of Obstetrics and Gynecology called Development and Testing of an iOS Waiting Room “App” for Contraceptive Counseling in a Title X Family Planning Clinic.

Data shows that long-acting reversible contraception (LARC) methods (the IUD and implant) are highly effective forms of contraception, but used by less than 10 percent of US women. After talking to clinic staff and analyzing appointment data at three Title X clinics in Chicago, this study found that a lack of contraceptive counseling during a scheduled appointment contributes to the under-use of LARC methods.

This study began by identifying key failures in IUD service delivery, including inadequate counseling time, non-use of waiting room pamphlets, and failure to counsel all women on LARC methods. As a result, the research team opted to create a counseling “app” to increase women’s contraceptive knowledge and interest in the most effective methods.

Results showed that users were highly satisfied with the app and it was easy to use. A brief (<15 min) app session significantly improved women’s knowledge scores on the relative effectiveness of LARC compared with other methods—before she even met with the healthcare provider. App testers (n=17) preferred the interactive, visually appealing design and video testimonials. In the pilot RCT (n=52), app users had significantly higher knowledge of contraceptive effectiveness (p=0.0001) and increased interest in the implant (7.1% to 32.1%, p=0.02) post-intervention. While app users reported increased interest in the contraceptive implant, the app had no discernible impact on women’s interest in the IUD.

The study concluded that integrating app usage into the Title X setting is highly acceptable, informative, and easily integrated into waiting room situations or downloaded onto smartphones in advance of a visit. Thus, apps could be a mechanism for implementing timely, evidenced-based educational information to a wide network of clinics and clients.