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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Coercion and Reproductive Justice

An essential piece of the reproductive justice and sexual rights movement is the right of all women to make reproductive choices free from coercion.

According to the Guttmacher Institute, coercion in any form is wrong and compromises choice. Coercion violates women’s right to decide freely if and when to have a child and the right to have the government respect her decision.

The Guttmacher report condemns coercion in the form of U.S. state legislatures passing increasingly restrictive abortion restrictions to keep women from ending an unwanted pregnancy. Parental notification or consent, mandatory waiting periods, and inaccurate and biased counseling exist under the guise of “preventing coerced abortion”. Rather, these TRAP laws aim not so much to inform women about the abortion procedure, as to dissuade them from choosing an abortion in the first place.

Increasingly, these laws prevent women from making decisions about how and when to give birth, posing a risk to all pregnant women, including those who want to stay pregnant.

Roe v. Wade gave women the right to choose abortion. Roe v. Wade also gave women the right not to choose abortion.

In the United States, a dark history of forced sterilization and present day controversies about the rights of the disabled remind us that as much as women have a freedom to abortion, if she chooses to continue a pregnancy, she has the equal right to do so.

Coerced abortion occurs in many forms. In January 2014, a Florida man was sentenced  to nearly 14 years in prison for tricking his pregnant girlfriend into taking Cytotec, a brand-name version of misoprostol, which causes miscarriage. Further complicating the issue, he was initially charged with first-degree murder under the Unborn Victims of Violence Act, punishable by life in prison, but he pleaded guilty to lesser charges of product tampering. The fetus was estimated to be at seven weeks.

In 2013 in Texas, a pregnant 16 year old girl claimed her parents were pressuring her to have an abortion when she wanted to continue the pregnancy and get married. When the pregnancy was confirmed, the teenager’s father allegedly became angry and insisted that she have an abortion and it was his decision.  Texas is one of the states that requires parental or judicial permission for a minor to obtain abortion; in this case, the minor had to obtain judicial permission not to have an abortion.

Coerced abortion compromises reproductive justice and often results from broader issues such as domestic and sexual violence, birth control access and tampering, economic disadvantage, education expectations, and religious convictions. Abortion is not the problem. The prevention of choice is the problem.

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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

 

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

 

Asking Your Doctor about Birth Control

Studies have shown using contraception consistently and correctly reduces rates of unplanned pregnancy.

For many women, that is easier said than done. Complicated lives, medical issues, and safety concerns are important factors to consider when choosing the best birth control method. And what matters in the end is having a birth control method that meets individual needs.

SHAPE Magazine interviewed Section faculty Dr. Julie Chor about “3 Birth Control Questions You Must Ask Your Doctor”. Dr. Chor is an experienced contraceptive counselor, and in the article she advises all women to talk to their doctor about birth control options. She stresses the basics, such as asking how often you need to remember to take a form of contraception and if that realistically fits into your lifestyle.

Earlier this year, FitPregnancy asked Dr. Chor about the best postpartum birth control and she gave her expert advice about how IUDs help attain a healthy pregnancy interval.

Dr. Chor can answer your questions about birth control during her clinic hours at the University of Chicago Hospitals where she provides contraceptive counseling and family planning services. Make an appointment here.

 

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.

Emergency Contraception Controversy & Gender-Based Violence

Access to emergency contraception (EC) has a storied history in the USA and directly impacts victims of sexual violence. Ci3 and the Section of Family Planning & Contraception Research, along with the Center for the Study of Gender and Sexuality hosted a challenging and informative presentation that explored this intersection. Dr. Susan F. Wood, Associate Professor of Health Policy and Director of the Jacobs Institute of Women’s Health at The George Washington University spoke about her role and observations surrounding over-the-counter EC access.

As Assistant Commissioner for Women’s Health at the FDA, Dr. Wood directed the FDA Office of Women’s Health from 2000 to 2005, at which point she resigned on principle over the continued delay of approval of EC over-the-counter.

Dr. Susan F. Wood

Dr. Susan F. Wood

Dr. Wood’s talk, Controversy over Contraception: From Emergency Contraception to Contraceptive Coverage to the Affordable Care Act, began with the historical context of women’s health and federal funding and ended with the implications of the ACA specifically regarding contraceptive coverage and access.Her talk focused primarily on the ongoing struggle to make EC available to all women over the counter.

In her role at the FDA, Dr. Wood witnessed the agency’s attempts to regulate the practice of medicine and pharmacy when it came to emergency contraception, an unprecedented course of action not only in its role as a government agency but also because of the impact on women’s access to family planning services.

The FDA approved Plan B as EC in 1999 as a prescription product for all women of childbearing potential. The manufacturer sought over-the-counter (OTC) approval in 2003.

At this early stage, it was already known that:

  • EC is safe and suitable for all women.
  • EC does not cause an abortion (“The only relation between EC and abortion is that EC prevents the need for an abortion,” says Dr. Wood.)
  • EC needs to be taken soon after (within hours of) intercourse to be the most effective.
  • EC provides victims of rape the option to prevent an unwanted pregnancy.

Despite these facts and extensive studies on the safety for women of all ages, politics and myths about EC — that it would increase adolescent sexual activity, encourage pedophilia, or cause an abortion — delayed FDA approval.

Not until August 2006 did the FDA approve Plan B over-the-counter (OTC) at pharmacies and health clinics, and this approval was limited to women 18 years and older; younger women would still require a prescription. Between 2003-2006, recommendation for approval had been overruled several times, Dr. Wood resigned, and activists across the country lobbied the FDA to make decisions that reflect good medicine and public interest.

In March 2009, a US district court ruled that the FDA decision to restrict access to women under 18 was “arbitrary and capricious” and ordered the FDA to lift restrictions on 17-year-olds within 30 days. Also in 2009, the FDA approved One Step (a one-dose version of Plan B) and Next Choice (a two-dose generic version), but the age restriction remained at 17. In 2010, with the age restriction still in place, The Center for Reproductive Rights filed for contempt of court citing the delays.

In 2011, Teva (One Step) released new data and filed an application to lift the age restriction. With the age restriction ready to be lifted, the FDA was overruled by Health and Human Services Secretary Kathleen Sebelius, who cited the lack of evidence on 11- to 12-year-olds’ ability to use the product. Although this argument was unprecedented and unfounded, President Obama agreed with Kathleen’s lack of evidence argument and the age restriction remained.

It took until June 2013 for the FDA to approve Plan B One Step OTC for all women without age restriction. That is, it took 10 years for women to have OTC access to a safe medicine approved by the FDA for women of all ages.

Plan B as seen over-the-counter. Image from Dr Wood's presentation 11/19/13.

Plan B as seen over-the-counter. Image from Dr. Wood’s presentation 11/19/13.

How does this history of EC approval, restrictions, stigma, and accessibility relate to gender-based violence and the 16 Days of Activism Against Gender-Based Violence campaign?

  1. EC is an essential contraceptive option for women who experience sexual violence. According to the FDA: “Seven out of every eight women who would have gotten pregnant will not become pregnant after taking Plan B, Plan B One-Step, or Next Choice.” Dr. Wood adds, “There isn’t any difference in efficacy for the use of EC for victims of sexual violence.”
  2. EC potentially prevents the extra burden of an unwanted pregnancy for rape victims.
  3. The cost of EC may be prohibitive; EC costs about $50 OTC in most pharmacies. Under the Affordable Care Act, the cost should still be covered through prescription. According to Dr. Wood, in the cases of rape, specifically for populations who cannot afford the $50, access to EC through family planning clinics may reduce the cost.
  4. If a victim of sexual violence seeks care at an emergency room, EC should be provided as part of her treatment.
  5. Even though EC is available OTC, doctors should continue prescribing and counseling EC, especially for victims of sexual violence. According to Dr. Wood, “Time is of the essence, so provision of information, and advance provision of EC can be helpful for all women. In addition, awareness by providers of other EC methods, such as insertion of copper IUD or use of Ella (a prescription only emergency contraception that is effective for up to 5 days) is important.”

Contraception & STI Prevention: What Do Young African American Men Think?

This month, researchers from the Section of Family Planning & Contraceptive Research presented results of several ongoing studies at the North American Forum on Family Planning. Dr. Elisabeth Woodhams, now a physician at Thomas Jefferson University Hospital, discussed her findings from a focus group study that sought to understand African American adolescent males’ perceived responsibility for pregnancy prevention. Dr. Woodhams also received the award for the top presentation from an investigator in training.

Dr. Elisabeth Woodhams

Dr. Elisabeth Woodhams

Men, particularly young men, are often left out of conversations about how to improve contraception use, but male partners can have significant influence over the contraceptive and pregnancy decisions of their female partners. Several studies indicate that women are more likely to stick to a chosen method if their partners know they’re using it, or if the partner is involved in the decision to use that method. The reality of this influence drove Dr. Woodhams to wonder how the partners regard this responsibility. Her study included teenaged African American males enrolled in charter schools on Chicago’s South Side. Several compelling themes emerged in Dr. Woodhams’ findings. One theme throughout was that even though the young men reported feeling responsible for the outcome of an unplanned pregnancy, it did not mean they acted to prevent pregnancy.

Focus on condoms, lacking knowledge of non-barrier methods

When asked about ways to prevent pregnancy, the most common answers were condoms, pull out, or don’t have sex. All had heard of pills, some had heard of IUDs or vaginal rings, and none knew about the contraceptive implant. Some had heard of Plan B, but often thought of it as a shot. Several quotes below reflect some of the misunderstandings about methods:

 “…I heard about one where you put it under a layer of skin in your arm. It’s called….Nuvaring.”

“She get the morning after shot and they’ll just kill all the sperm…”

“I also heard of that thing…they take the top off and put it in their vagina or whatever. Like it knock out, it blocks it. It works for years. It’s called… starts with ovulation.”

“All I heard is it goes inside them, but if you hitting it, if you playing bump around, you can knock it out of place.”

Primary role in sex was condom use and provision

Participants did know a lot about condoms, felt responsibility to provide and use a condom, and really only considered condom use when they talked about “protection.”

“…she like grabbin’ me…and just automatically stop and be like ‘you got the rubber?’ and I’m like ‘what?!’ … and most of the time I do because I always carry condoms like in my back pocket or something…”

“I take at least a third of the condoms… and I take ‘em to my girl crib. Cause I might come over there and then, you know, something might happen, I know that if I didn’t bring a condom I got somethin’ over there with her.”

STI prevention greatest motivator in condom use

STI prevention was the greatest motivator for condom use and reflected attitudes about partners.

I’mma need some condoms ’cause. Like, it wasn’t the fear of me havin’ a baby as the fear of me catchin’ something.”

 “You still use a condom. I don’t know what she got.  No matter what. Like, a girl could be on birth control all her life.  She could be on the best birth control. I’m still not gon’ go in raw.”

“Even before you get down to the having sex part you should always ask a girl when the last time she got checked up.”

Partner type, access, and family indirectly impacts condom use

Motivation to use condoms in a specific sexual encounter was indirectly mediated by several things, the most notable being the “type” of girl they’re having sex with, access to condoms, and family influence. The vast majority of the conversations were actually about the various names and terms the teens had for the girls they have sex with. For instance, “thots” were considered “dirty girls” who sleep with anyone, are likely to have an STI, and are not worthy of respect. “Mains” are a more regular partner, although not necessarily a monogamous partner.  Young men behaved differently when they were with casual partners than when they were with more regular partners, who in general they spoke about with more modesty and respect. With regular partners they often would forgo condoms, but several guys mentioned going to get STI testing with their partners before they made that leap. They did not universally mention discussing pregnancy prevention, although some did.

“Mod: If the thot’s like ‘man, come on get down, but you can’t use nuttin’.” Resp: “If we don’t use it then we ain’t doin’ it. Point blank.” Mod: “Okay. But wit’ yo main you not that way.” Resp: “mmm-mmm [MEANING NO]“.

“But, when it comes to like fuckin’ thots …you don’t know who they be fuckin’, you don’t know what they got, so you always wanna be protected.”

Access was also an issue, both in terms of immediate access and terms of cost and availability. As one participant observed, “We in the basement, I know I ain’t got no condoms, they’re upstairs. I’m not about to go to the 3rd floor, leaving a thot downstairs.”

Finally, participants referred to the women in their family as motivators to protect themselves, more from STIs than from pregnancy. They generally felt comfortable telling their family they were having sex, and depended on their mothers/grandmothers/aunts to provide condoms.

 “Like when you first talk to yo’ moms about it, you don’t wanna tell her cause feel like somethin’ bad gon’ happen. But after you tell her it turns out different…she gonna force condoms on you because she don’t want her child to catch no disease…”

Responsible for pregnancy, but not prevention

While the participants did not prioritize pregnancy prevention, when asked directly whose job it is to prevent pregnancy they reported it was a shared responsibility. However, if pregnancy happened, it was mostly the young man’s fault, especially if they weren’t using a condom. They feared unplanned pregnancies and felt a very strong sense of responsibility if pregnancy happened – this often came out within the context of manhood. When they talked about unplanned pregnancy there was a sense of helplessness; they weren’t interested in fathering but there was little they could do about it aside from use condoms.

 “And I shoulda used a condom. And basically, I’mma have to like get two jobs and like I can’t like, I’mma have to finish school so I could get a better job and I’m not even ready yet.  And you thinkin’ all of this, and how your parents is gon’ react. And you havin’ a child. Like how that’s gon’ make you growin’ up so much faster and your life is basically through.”

 “With the guy he has to know that he has two options that he can take.  Face it like a man or basically run away.  Run away and then he has that title saying ‘you a coward, you’re not a man that gon’ step up to the challenge of taking care of a child.’  But if he stays there he knows that he has to be dedicated, committed, make a sacrifice in his life.”

Conclusions

Dr. Woodhams found the young men in the study were much more focused on STI prevention rather than pregnancy prevention, even though they would feel responsibility if a pregnancy occurred. The concern for STIs prompts condom use, but if they believe their partner is low-risk, they will also stop using condoms. Dr. Woodhams suggested that one approach would be to leverage awareness and comfort with condom use among these young men to emphasize that condoms can also be part of pregnancy prevention. While other contraceptive methods may be more effective, young men may respond more positively to education about a method they already use. In addition, Dr. Woodhams observed that the young men perceived their sexual relationships completely based on risk, rather than on the relationship they were in with their partner. In fact, they rarely referred to a relationship at all, but easily categorized the young women they were having sex with into “good” or “bad,” “clean” or “dirty.” She suggested that sex education programs work to emphasize healthy and fulfilling relationship-building and respect as a response to these attitudes and their influence on condom use.