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.

 

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Youth Ages 14-18 Needed for PAID Research Study 12/9

hexacago playtest

Ci3/Game Changer Chicago are seeking youth ages 14-18 to participate in a paid research study on Tuesday, December 9 from 5:30-7 p.m. The study will take place at Ci3 (1225 E. 60th St., on The University of Chicago campus in Hyde Park).

Participants will play the Hexacago board game (pictured above) with peers and complete two short surveys. Time commitment is approximately 75 minutes, and each participant will be compensated $15. Feel free to bring a friend!

Please note, parental consent is required for all participants under 18.

For more information or to register, contact Erin Jaworski at (773) 834-9965 or ejaworski@bsd.uchicago.edu. Note: you are NOT officially registered until you receive a confirmation email from Erin.

 

Three new studies focus on lowering clinic barriers to help women obtain desired contraceptive method

Contraception is the cornerstone of pregnancy prevention and the intrauterine device (IUD) is one of the most effective methods available. IUDs require little user maintenance, last between 7 and 12 years, and are more than 99 percent effective at preventing pregnancy. Thus, it is critical to remove unnecessary obstacles that prevent women from receiving a desired IUD.

The University of Chicago Section of Family Planning (the Section) has published three articles that discuss research on implementing interventions to the systematic barriers to IUD care. This research was funded by the Office of Population Affairs.

In collaboration with three Planned Parenthood of Illinois clinics, the research began with an in depth evaluation of all aspects of IUD service delivery called Failure Modes Effects and Criticality Analysis (FMECA). Health care providers and patients were interviewed to see the way in which the system could be redesigned to better deliver care. This step-by-stop process identified “failures” using qualitative and quantitative data, and determined the frequency and impact in order to prioritize redesign and improvements.

A systematic approach to improving intrauterine device services in family planning clinics appeared in Contraception. This publication outlines the Section’s analysis of the FMECA approach and identification of 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.

After reviewing the FMECA data, the research and clinical care teams created two solutions to the identified failures: implementing a revised scheduling call script, and developing an iOS counseling app to be used in the waiting room.

Impact of a revised appointment scheduling script on IUD service delivery in three Title X family planning clinics, also published in Contraception, discusses the implementation of the revised scheduling script.

Mindful of the systems-level barriers identified by the FMECA, Section researchers created a simple and scalable intervention: revising the appointment-scheduling call script. 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.

Through implementation of the revised script, no-show rates decreased from 40 to 23 percent, and in particular, young women were more likely to keep their scheduled appointment.

Development and Testing of an iOS Waiting Room “App” for Contraceptive Counseling in a Title X Family Planning Clinic, published in the American Journal of Obstetrics and Gynecology, describes the Section’s development and testing of a theory-based behavioral app. The app, developed with young women, features young women describing their contraceptive experiences. Testers were highly satisfied with the app and found it 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.

The Section continues to research the app for comprehensive contraceptive counseling.

The research team has also developed an online toolkit describing processes, procedures, and tools for an FMECA and shared with Title X clinics nationally.

For more about recent Section research and publications, visit familyplanning.uchicago.edu or our Sexual and Reproductive Health and Justice blog.

Special thanks to the Office of Population Affairs and Planned Parenthood of Illinois for their support.

TOMORROW: Research/Playtest Opportunity for Teens at Ci3/GCC

the source hexacago
Ci3 and Game Changer Chicago are seeking high school students ages 14-18 to participate in a paid research study tomorrow night (Tuesday, Nov. 25) from 5-6:30 p.m. on The University of Chicago campus in Hyde Park. The time commitment is approximately 75 minutes, during which teens will play the Hexacago board game with peers and complete two short surveys. Teens will be compensated $15 for the session. Feel free to bring a friend! Please note, parental consent will be required for all participants under 18.
 
If you are interested, please contact Erin Jaworski through phone (773-834-9965) or by email (ejaworski@bsd.uchicago.edu).  You are not officially registered until you received a confirmation email from Erin. 

 

Ci3 Seeks Youth Ages 15-24 for Mobile App Dev – First Meeting 12/3

Creating Belief 4

Are you between the ages of 15-24 years and interested in contraception, STI prevention and technology?

Ci3 is seeking young people to assist in the development of a mobile app to help youth make healthy decisions about contraception and STI prevention.

Our first meeting will be held Wednesday, December 3, from 4:30-6 p.m. at Ci3’s offices at 1225 E. 60th St., on The University of Chicago campus in Hyde Park.

RSVP is required. Please contact Dr. Lucy Hebert at (773) 834-7196 or lhebert@bsd.uchicago.edu to confirm your spot.

  • What will I be doing? You will help to design a mobile app, by engaging in a series of group discussions focusing on pregnancy and STI prevention. We will lead every session, all you have to do is come ready to participate. We even provide dinner!
  • What is the time commitment? You will participate in 8 sessions over the next 2 years. Each session will last 1-2 hours.
  • Where will it take place? All sessions will be held at the Ci3 offices (1225 E. 60th St. on The University of Chicago campus in Hyde Park).
  • What do I get out of it? Over the course of 2 years, you will be compensated $300.

Why you should work with us:

  • Help create a dynamic tool to encourage young people like you to engage in healthy sexual behavior
  • Learn about mobile app development, human-centered design, and sexual and reproductive health
  • Collaborate with clinicians, researchers and your peers as an interdisciplinary team

For more information or to RSVP to the Dec. 3 session, please contact Dr. Lucy Hebert at (773) 834-7196 or lhebert@bsd.uchicago.edu.

 

 

Game Changer Chicago Seeks Teens for Paid Research Study

GCC Seed boys

Ci3’s Game Changer Chicago Design Lab  is looking for high school students ages 14 – 18 to participate in a paid research study. The time commitment would be roughly 75 minutes during which participants would play the Hexacago board game with peers and complete two short surveys. Participants would be compensated $15 for the session. If eligible, you will receive an email from our research coordinator with information on the game and goal of the study. Note: written parental consent will be required for all participants under 18.

Learn more and sign up here.

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.

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.

“Cookies and Conversation With Ci3” April 8

cookies

The next “Cookies and Conversation” will take place Tuesday, April 8 from noon-1 p.m. in the Living Room space of the Institute of Politics (5707 S. Woodlawn Ave., on The University of Chicago campus).

The discussion of the April “Cookies and Conversation” will revolve around emergency contraception, on a local, national and international level.

Held on the first Tuesday of every month, “Cookies and Conversation with Ci3” is a brown-bag informal discussion, about sexual and reproductive health issues in the news and how they intersect with research on campus. The event is moderated by Ci3 staff and consultants, and is open to students.

For questions, please contact Ci3/Section Policy Coordinator Lee Hasselbacher at lhasselbacher@babies.bsd.uchicago.edu.

Pregnant Teens Under Age 15 Have Unique Risk Factors: Study

The following is the text of a Reuters article summarizing a study conducted by Dr. Marcela Smid, a former OB-GYN resident at The University of Chicago Medical Center who conducted a study on pregnant teenagers with the support of The University of Chicago Section of Family Planning. This study was coauthored by Section chief Dr. Melissa Gilliam, Section faculty Dr. Amy Whitaker, and then-Section staff Summer Martins, MPH. The original story can be found here.

Girls who became pregnant before age 15 were more likely to report having sex with much older partners and initially forgoing contraception than their slightly older peers, according to a new study.

Nearly 36 percent of girls who first got pregnant before age 15 had sex for the first time with a partner at least six years older, compared to 17 percent of girls who got pregnant between 15 and 19.

That statistic “is very serious and represents complicated relationships with unequal power,” said lead author and obstetrician Dr. Marcela Smid, from the University of North Carolina at Chapel Hill. She worked on the study while at The University of Chicago.

To make better use of public health awareness and intervention campaigns, Smid and her team (Dr. Gilliam, Dr. Whitaker, and Ms. Martins) wanted to know more about how very young teens were at risk of becoming pregnant.

They used data from the National Survey of Family Growth collected between 2006 and 2010. A total of 3,384 women reported on the survey that they had their first pregnancy before age 20. Within that group, 289 women had become pregnant before age 15 and the rest between 15 and 19.

Girls who became pregnant before age 15 were twice as likely as older girls to be Hispanic or black, the researchers found.

Younger pregnant teens were less likely to have been living with both biological parents at age 14 and less likely to have been brought up within the Catholic or Protestant religions.

Only 25 percent of the youngest teen group reported using contraceptives the first time they had sex, compared to 56 percent of older girls.

While it is “a little bit easier to study live births with national survey and surveillance data,” those statistics don’t tell the complex story of pregnancies, Smid said.

Teen pregnancy study

Image: growingyourbaby.com

Many pregnancies among very young girls end in miscarriage or abortion, she noted.

“We know that their risk of poor pregnancy outcomes is the highest of any age group, even when compared with women who get pregnant at age 45,” Smid said.

In general, U.S. teen pregnancy rates have gradually declined, but, for the youngest teens especially, “any pregnancy rate above zero is too high,” she said.

About one in 1,000 girls under the age of 15 became pregnant in 2008, the researchers write in the journal Obstetrics and Gynecology. That compares with about 68 per 1,000 girls between ages 15 and 19.

The researchers also found that 89 percent of the under-15 group did not want to become pregnant in the first place, compared with 75 percent of teens between ages 15 and 19.

“There are still things we don’t know,” Smid said. “For example, we looked at the first sex experience, but we don’t know the circumstance or the partner involved in the first pregnancy.”

“Measuring pregnancy intention is an extremely complicated thing to do,” said Phillip Levine, an economist at Wellesley College in Massachusetts who has studied teen pregnancy.

“Asking someone years after the fact what was going on in their minds during the act – that’s difficult to untangle,” he said.

Women in the new study were in their early 30s, on average, when asked about past pregnancies.

Levine also noted that for some girls, tough economic and family situations mean there’s not much of an incentive to avoid early pregnancies.

“What we need to consider to fix the problem is think about how these disadvantages contribute to teens becoming pregnant,” Levine, was not involved in the current study, told Reuters Health.

“Teens must want to avoid getting pregnant, or else it doesn’t matter what the intervention is,” whether sex education or better contraceptive access.

If young girls are already on a path that does not include college or a job that leads to a change in socioeconomic status, then having a baby may not seem like such a bad idea, he explained.

“A lot of the problem is about opportunity,” Levine said.

“We live in a society where income inequality is large and growing,” he said. “Teen pregnancy can be seen as a symptom of this broader problem. We need to find ways to allow people to be upwardly mobile.”

SOURCE: bit.ly/1eXPm0Y Obstetrics & Gynecology, online February 4, 2014.