Updated Interim Zika Clinical Guidance for Pregnant Women and Data on Contraceptive Use to Decrease Zika-affected Pregnancies
Moderator: Marcy Friedman
Presenters: Charlan D. Kroelinger, PhD, MA; Erin Berry-Bibee, MD, MPH; Titilope Oduyebo, MD, MPH
Date/Time: August 9, 2016, 2:00 - 3:00 pm ET
Coordinator: Welcome and thank you for standing by. At this time all participants are in a listen-only mode. During the question and answer session, you may press Star 1 if you would like to ask a question. Today's conference is being recorded. If you have any objections, you may disconnect at this time. I'd now like to turn this meeting over to Ms. Marcy Friedman. You may begin.
Marcy Friedman: Thank you, (Kathy), and good afternoon. I am Marcy Friedman, and I'm representing the Clinician Outreach and Communication Activity, COCA, with the Emergency Risk Communication Branch at the Centers for Disease Control and Prevention.
I'd like to welcome you to today's COCA call, Updated Interim Zika Clinical Guidance for Pregnant Women in Data on Contraceptive Use to Decrease Zika-Affected Pregnancy.
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Questions are limited to clinicians who would like information on Zika. For those who have media questions, please contact CDC Media Relations at 404-639-3286; or you may send an email to firstname.lastname@example.org. Again, that's email@example.com. If you are a patient, please refer your questions to your healthcare provider.
Today's first presenter - correction. At the conclusion of today's session, the participant will be able to discuss revised diagnostic testing for Zika virus infection among pregnant women; discuss clinical management of pregnant women with confirmed or possible Zika virus infection; discuss use of a range of contraceptive methods in states, with a focus on highly effective methods; and discuss strategies for increasing access and availability to highly effective contraception.
Today's first presenter is Dr. Titilope Oduyebo. Dr. Oduyebo is an OB-GYN, and works on the Pregnancy & Birth Defects Task Force for the CDC's Zika Response. She is involved in developing clinical guidance for healthcare providers caring for pregnant women and women of reproductive age with possible exposure to Zika virus.
She is the lead author of recently updated guidance that was published on July 22, 2016. Dr. Oduyebo is also involved with the US Zika Pregnancy Registry, and provides technical assistance to support state, tribal, local and territorial health departments collecting information about pregnancy and infant outcomes following laboratory evidence of confirmed or possible Zika virus infection during pregnancy.
Dr. Oduyebo is also a subject matter expert, and provides clinical consultation to healthcare providers and state, tribal, local and territorial health departments through the CDC Zika Pregnancy Hotline.
Our second presenter is Dr. Erin Berry-Bibee. Dr. Berry-Bibee is a practicing OB-GYN and a guest researcher at the CDC, currently serving on CDC's Zika Virus Emergency Response on the Pregnancy and Birth Defects Task Force Contraception Access Team.
She completed medical school at Oregon Health & Science University, and then both her OB-GYN residency and a fellowship in family planning at Emory University.
Dr. Berry-Bibee has been working as a full-time guest researcher in the Division of Reproductive Health at the CDC, working on recent updates to both the World Health Organization's and the CDC's medical eligibility criteria for contraceptive use and selected practice recommendations for contraceptive use.
And our third presenter is Dr. Kroelinger. Dr. Kroelinger is an epidemiologist and biostatistician who works on the Pregnancy & Birth Defects Task Force on the CDC's Zika virus response. She is involved in reporting contraceptive use data for women of reproductive age in the United States, and identifying strategies for states to consider to improve access to and availability of contraceptives among all women.
She is the senior author of the Morbidity and Mortality Weekly Report on Contraceptive Use Among Women of Reproductive Age at Risk for Unintended Pregnancy in the United States in the Context of Zika-Preparedness. Dr. Kroelinger also works closely with state health departments to support strategy implementation for promoting access to a range of contraceptives, and specifically long-acting reversible contraception.
She is a subject matter expert, and provides consultation to providers, insurers and state, tribal and local health departments through CDC-led activities on contraception.
At this time, please welcome Dr. Oduyebo.
Dr. Titilope Oduyebo: Good afternoon. Thanks to everyone for attending, and thank you also to the COCA staff for organizing this call. I would like to start off with the topics that will be covered in today's presentation.
First we will discuss the updated interim Zika clinical guidance for pregnant women, including some of the rationale for the changes and updates to the testing algorithm, as well as the additional testing recommendations and clinical manager recommendations for pregnant women with suspected Zika virus infections.
My colleagues, Drs. Berry-Bibee and Kroelinger, will review pregnancy planning and contraception during the Zika virus outbreak. Specifically, they will cover unintended pregnancies in states potentially impacted by Zika, data on contraceptive use in the US, and strategies to increase access to and availability of contraception.
The purpose of this portion of today's call is to provide an overview of the CDC's updated interim clinical guidance regarding Zika virus infection during pregnancy.
Today's Zika virus outbreak is unprecedented, and Zika continues to spread worldwide, including in the US territories such as Puerto Rico, the US Virgin Islands, American Samoa, Guam and the Northern Mariana Islands.
The Florida Department of Health has identified mosquito-borne transmission in a one square mile area of Miami. Subsequently, on August 1, 2016 CDC released a Health Advisory Notice providing recommendations for travel and testing for pregnant women and women of reproductive age living in or traveling to this area after June 15.
The Health Advisory Notice emphasized that this updated interim clinical guidance that I'll be speaking about today should be applied in the context of active Zika virus transmission in Florida.
The diagnostic testing for Zika virus infection is challenging, but can be accomplished using both molecular and serologic methods. Real-time reverse transcription polymerase chain reaction, or rRT-PCR, is the molecular method, and it detects viral RNA in body fluids such as serum, urine, cerebrospinal fluid, or tissues such as placenta. Any time RNA is detected, it provides a definitive diagnosis of recent Zika virus infection.
Serologic tests include the Zika virus immunoglobulin M, or IgM enzyme-linked immunosorbent assay to detect anti-Zika virus IgM antibodies in serum, or CSF; and the plaque reduction neutralization test, or PRNT, which measures virus-specific neutralizing antibody titers.
This figure depicts the detection of Zika RNA and Zika IgM following Zika infection over time. The dashed line represents the detection of Zika virus RNA. The presence of Zika virus RNA is relatively short-lived, with a mean time from infection to viral clearance reported at approximately ten days. However, there may be some individualized differences.
Because viral RNA levels decline over time, a negative result does not rule out Zika virus infection. Therefore, serum IgM antibody testing for Zika infection should be performed. Zika IgM, represented by the dotted line, develops during the first week of illness, and can be detected weeks after infection.
IgM persists up to 12 weeks, but can persist longer in some individuals, depending on individual circumstances. If Zika IgM is detected, PRNT is performed to confirm this result.
There are a number of limitations to keep in mind when interpreting both Zika molecular and serologic assays. First, since Zika virus RNA are short-lived, negative results do not preclude infection. Secondly, testing for Zika virus IgM can result in false positive results, because of significant cross-reactivity with other flaviviruses such as Dengue, and also for other non-specific reasons.
Third, PRNT may not distinguish the type of infecting virus in people previously infected with or vaccinated against a related flavivirus. Emerging data from recently published case reports of some pregnant women provide the rationale for expanded rRT-PCR testing recommendations in the updated guidance to address these limitations. These case reports indicate that Zika virus RNA persists in some pregnant women longer than the one to two weeks previously reported.
One of these case reports that were published in the New England Journal of Medicine describes a pregnant woman with Zika virus infection during the first trimester. Zika virus RNA was found in maternal serum at four and ten weeks after symptom onset -- much longer than expected.
Following this case report, the US Zika Pregnancy Registry was queried to identify pregnant women with reported prolonged detection of Zika virus RNA in serum. There were five pregnant women with Zika virus infection in the first or second trimester, with prolonged detection of Zika virus RNA.
Four women reported symptoms and had Zika virus testing with RNA detected, 17 to 46 days after symptom onset. One pregnant woman was asymptomatic and had Zika virus testing with RNA detected in serum 53 days after last Zika virus exposure.
The case series demonstrated that some pregnant women, including those who are asymptomatic, may have prolonged detection of Zika virus RNA. It also highlighted that expanded rRT-PCR testing can provide a definitive diagnosis of Zika virus infection in some pregnant women for whom serologic testing results do not readily distinguish between Zika virus and other flaviviruses, which was the case for some of the pregnant women described in this case report.
In light of this emerging data, on July 26, 2016, the CDC updated its interim clinical guidance for healthcare providers caring for pregnant women with possible Zika virus exposure. The link for this guidance was supplied in the email invitation.
The updated guidance includes clinical testing recommendations to assist healthcare providers to care for their pregnant patients with possible Zika virus exposure.
Here is the comprehensive testing algorithm which can be found on the CDC's website. I will walk you through one arm at a time. Depending on the information obtained during the prenatal assessment, testing will follow one of two arms of the algorithm, which are referred to as Arm A and Arm B in the figure.
All pregnant women should be assessed for Zika virus exposure, and evaluated for Zika virus disease at each prenatal care visit. On the left side of the slide are some important questions to assess possible exposure to Zika.
One, does she live in or has she traveled to an area with active Zika virus transmission during pregnancy or in the periconceptional period? Two, has she had sexual activity without barrier protection with a partner who lives in or traveled to an area with active Zika virus transmission during her pregnancy or in the periconceptional period? Sexual activity includes vaginal, anal, and oral sex, and the sharing of sex toys. Three, how long ago was the last possible exposure to Zika virus?
On the right side of the slide, are questions for evaluating signs and symptoms of Zika virus disease, and they include one, does the patient report currently having or has she had one or more signs or symptoms of Zika virus disease, including acute onset of fever, rash, arthralgia, or conjunctivitis? Two, how long ago did the symptoms begin?
Pregnant women presenting for care within two weeks of symptoms or exposure should be tested in accordance with Arm A. Arm A is applicable to one, pregnant women presenting less than two weeks after symptom onset; and two, asymptomatic pregnant women not living in an area with active Zika virus transmission, whose possible exposure occurred less than two weeks prior.
In this arm, initial testing should include Zika virus rRT-PCR on both serum and urine. A positive result in either serum or urine indicates recent Zika virus infection; while a negative rRT-PCR result does not exclude infection, because viral RNA levels decline over time.
For a symptomatic pregnant woman, a negative rRT-PCR should lead to immediate IgM testing for Zika and Dengue; while an asymptomatic pregnant woman, not living in an area with active Zika virus transmission, should have another specimen drawn 2 to 12 weeks after possible exposure for a Zika virus IgM test.
The delay in performing the IgM is because asymptomatic pregnant women may still be in the incubation period, and may have not had time to mount an immune response. The testing in the 2- to 12-week window after possible exposure provides an opportunity to identify patients who may have acquired infection on the last day of possible Zika virus exposure.
If the Zika virus and Dengue virus IgM results are negative, then the interpretation is that there is no evidence of recent Zika virus infection, and no additional laboratory testing is indicated. If the Zika or Dengue IgM are positive or equivocal, PRNT should be performed to rule out false positive results.
Interpretations of the PRNT results vary depending on the Zika and Dengue IgM titer. If the result is that the Zika virus PRNT titer is greater than or equal to 10, and Dengue titer is less than 10, the interpretation is recent Zika virus infection.
If the result is that the Zika virus PRNT titer is greater than or equal to 10, and the Dengue titer is also greater than or equal to 10, the interpretation is recent flavivirus infection, specific virus cannot be identified. Finally, if the result is that the Zika virus PRNT titer is less than 10, the interpretation is no evidence of recent Zika virus infection.
You'll recall that Arm A of the algorithm was applicable to all pregnant women presenting less than two weeks after symptom onset, or last possible Zika virus exposure.
Now let's move to Arm B of the algorithm. This arm is applicable for pregnant women presenting 2 to 12 weeks after symptom onset, or last possible exposure.
The categories of pregnant women in Arm B include one, pregnant women presenting 2 to 12 weeks after symptom onset; two, an asymptomatic pregnant woman who does not live in an area with active Zika virus transmission, presenting 2 to 12 weeks after possible exposure; and three, an asymptomatic pregnant woman living in or with frequent travel -- daily, weekly -- to an area with active Zika virus transmission, presenting in the first or second trimester of pregnancy.
The testing indicated for symptomatic pregnant woman includes testing for both Zika virus IgM and Dengue virus IgM; while the testing indicated for a asymptomatic pregnant woman includes Zika IgM only. Dengue virus IgM antibody testing is recommended only for symptomatic pregnant women.
If the results of the Zika IgM test are negative, and the Dengue IgM test results are positive or equivocal, PRNT should be performed. But if the result for the Zika virus IgM test is positive or equivocal, regardless of the Dengue IgM results, reflex Zika virus rRT-PCR testing should be performed on both serum and urine. Reflex rRT-PCR testing is indicated here because it provides a potential for a definitive diagnosis of Zika virus infection, given the emerging data of prolonged detection of Zika virus RNA in some pregnant women. But if the results of both the Zika and Dengue virus IgM tests are negative, the interpretation is no evidence of recent Zika virus infection, and no further laboratory testing for Zika is indicated.
If the results of the rRT-PCR tests are negative on serum and urine, PRNT should be performed. But if the results of the rRT-PCR tests are positive on serum or urine, the interpretation is recent Zika virus infection.
Again, interpretation of the PRNT results are very dependent on the Zika and Dengue IgM titers. If the result is that the Zika virus PRNT titer is greater than or equal to 10, and the Dengue titer is less than 10, the interpretation is recent Zika virus infection.
But if the titers are greater than or equal to 10 for both Zika and Dengue, the interpretation is recent flavivirus infection, specific virus cannot be identified. Finally, if the result is that the Zika virus PRNT titer is less than 10, the interpretation is no evidence of recent Zika virus infection.
Additional steps and recommendations have been developed for symptomatic and asymptomatic pregnant women who seek care greater than 12 weeks after symptom onset or possible exposure. For this group of women, IgM antibody testing might be considered. If fetal abnormalities are present, rRT-PCR testing should also be performed.
However, a negative IgM or rRT-PCR result greater than 12 weeks after symptom onset or possible exposure does not rule out recent Zika virus infection during pregnancy, because Zika virus IgM antibody and RNA levels decrease over time. Given the limitations of testing beyond 12 weeks after symptom onset or exposure, serial fetal ultrasounds should be considered.
Now that we have reviewed the testing recommendations, I would like to discuss the clinical management of pregnant women with suspected Zika virus infection based on the interpretation of their laboratory results.
The prenatal management is similar for pregnant women with confirmed recent Zika or flavivirus infection, and presumptive recent Zika virus or flavivirus infection.
Clinical management includes serial fetal ultrasounds every three to four weeks to assess fetal anatomy and monitor growth. Amniocentesis should be individualized for pregnant women with confirmed recent Zika virus or flavivirus infection, and can be considered for pregnant women with presumptive recent Zika virus or flavivirus infections.
The post-natal management is also similar for pregnant women with confirmed recent Zika or flavivirus infection, and for presumptive recent Zika virus or flavivirus infection.
For pregnancies that result in a live birth, infant serum should be tested for Zika RNA, Zika IgM and Dengue IgM, regardless of the presence or absence of phenotypic abnormalities in the infant. CSF can also be tested if obtained for other reasons.
There have been challenges to using cord blood, because it can yield inaccurate results because of maternal blood contamination and other factors. Therefore, infant serum testing should be prioritized. Pathology testing with rRT-PCR and/or immunohistochemical staining of the umbilical cord and placenta is recommended.
If the pregnancy ends in fetal loss, pathology testing with rRT-PCR and/or immunohistochemical staining of fetal tissue is recommend. This testing might provide insight into the etiology of the fetal loss, which could inform a woman's future pregnancy planning.
Pregnant women with no evidence of Zika virus or Dengue virus infection should have an ultrasound to evaluate for fetal abnormalities consistent with Zika virus infection. If a fetal ultrasound is abnormal, repeat the Zika virus rRT-PCR and IgM antibody test. Clinical management should be based on corresponding laboratory results.
If a fetal ultrasound is normal, obstetric care should be based on whether the pregnant woman has ongoing risk of Zika virus exposure.
CDC has developed tools and resources for healthcare providers to care for pregnant women with possible Zika virus exposure. Here is a table found on the CDC Web site that summarizes the clinical management of a pregnant woman with suspected Zika virus infection.
CDC also maintains a 24-hour, 7 day a week Zika consultation service for healthcare officials and healthcare providers caring for pregnant women. To contact the service, call 770-488-7100, and ask for the Zika Pregnancy Hotline; or email firstname.lastname@example.org.
Healthcare providers should work closely with their state, local or territorial health departments to ensure that the appropriate test is ordered and interpreted correctly.
Next I will turn the presentation over to Dr. Erin Berry-Bibee to discuss contraception and the strategy to minimize adverse outcomes associated with unintended pregnancies during the Zika virus outbreak, and current data on contraception use in US states potentially impacted by Zika.
Dr. Erin Berry-Bibee: Thank you so much, Titi. During this call, we will cover the following areas -- considerations for women and couples interested in conceiving during a Zika virus outbreak; unintended pregnancy in states potentially impacted by Zika virus; contraception to minimize Zika-affected pregnancies; and contraception method effectiveness.
Then my colleague, Dr. Charlan Kroelinger, will discuss data on contraceptive use in the United States, and strategies to increase access to and availability of long-acting reversible contraception.
Decisions about pregnancy planning are personal, and circumstances for women and their partners are different. We recognize that counseling women and couples in the context of the Zika virus outbreak is challenging, and that multiple factors need to be taken into consideration.
Client-centered counseling by a healthcare provider should include information that will aid in decision-making. This information can include the woman or couple's reproductive life plans; the patient's environmental risk for exposure to Zika, including her home and work environments; the current level of Zika virus transmission in the local area; personal measures to prevent mosquito bites; personal measures to prevent sexual transmission of Zika virus -- this includes the patient's willingness to use condoms or to abstain from sex for the duration of her pregnancy.
It is also important to educate patients about signs and symptoms of Zika virus disease, as well as the possible adverse consequences of Zika virus infection during pregnancy. Additionally, those patients with confirmed or possible Zika virus infection should be educated on the need to wait until the risks for viremia or viral shedding is minimized prior to attempting conception.
CDC has created a tool to aid healthcare providers in counseling women and men who are interested in conceiving, and live in areas with active Zika virus transmission. This guide is available on CDC's Web site, and includes recommendations from the updated guidance; key questions to ask patients; and sample scripts to help facilitate these discussions. All tools are free and available on our Web site in English and in Spanish.
For women and couples who choose to delay or avoid pregnancy during the Zika virus outbreak, healthcare providers can discuss contraceptive methods to prevent unintended pregnancies. CDC defines an unintended pregnancy as either unwanted -- that is the pregnancy occurred when no children or no more children were desired; or as mistimed -- that is the pregnancy occurred earlier than desired.
Recent estimates indicate that 45% of all pregnancies in the United States are unintended. This map highlights the rate of unintended pregnancy in each state in the continental US. The shades of blue depict ranges of unintended pregnancy per 1000 women of reproductive age. The darker shades of blue indicate states with higher rates of unintended pregnancy, compared with the states shaded a lighter blue, indicating lower rates of unintended pregnancy.
The solid and dotted lines represent CDC's best estimates for the potential range of Aedes aegypti and Aedes albopictus mosquitoes. These are the mosquitoes that are known to carry the Zika virus. As you can see, some of the highest rates of unintended pregnancies are present in many states where mosquito-borne Zika virus transmission is possible.
The best way for sexually active women and their partners to reduce the risk of unintended pregnancy is to use effective birth control consistently and correctly. Preventing unintended pregnancy during the Zika virus outbreak is a primary strategy to prevent the poor pregnancy and birth outcomes linked to Zika virus during pregnancy.
When providing contraceptive counseling during a Zika virus outbreak, healthcare providers should discuss the prevention of unintended pregnancy with women and couples who wish to delay or avoid becoming pregnant; provide information about contraceptive methods that best meet the needs of the woman and/or couple, and can be used correctly and consistently; and review the role of correct and consistent use of condoms and other barrier methods to reduce the risk of sexually transmitted infections, including sexual transmission of Zika.
CDC and the US Office of Population Affairs have published recommendations for providing quality family planning services. These recommendations include taking a client-centered approach to contraceptive counseling.
A client-centered approach respects the patient's primary purpose for seeking services; notes the importance of confidential services; encourages the availability of a broad range of contraceptive methods, so that clients can make a selection based on their unique individual needs and preferences; and delivers services in a culturally competent manner as to meet the needs of all clients, including adolescents, those of limited English proficiency, those with disabilities, and those who are lesbians, gay, bisexual, transgender or questioning their sexual identity.
CDC has contraceptive guidance for healthcare providers that can be used to guide provision of contraceptive services. The U.S. Medical Eligibility Criteria for Contraceptive Service Use, or U.S. MEC, includes recommendations for the safety of using specific contraceptive methods by women and men who have certain medical conditions or characteristics.
The U.S. Selected Practice Recommendations for Contraceptive Use, or U.S. SPR, include clinical guidance for healthcare providers about how to use contraceptive methods -- for example, when to initiate a method, or what exams and tests are needed prior to initiation. The SPR also includes recommendations on how to manage common problems with contraceptive use.
Therefore, the U.S. MEC gives guidance on who can safely use which methods of contraception, and the SPR gives guidance on how to provide those contraceptive methods.
CDC and the Office of Population Affairs have published recommendations for providing quality family planning services or QFP. These recommendations include guidance for healthcare providers on what services should be offered during a family planning visit; how these services should be provided; what services should be available for female and male clients, as well as special populations; and how to provide selective preventative healthcare services during a family planning visit.
The OPA has also developed a toolkit specifically for providing family planning care for non-pregnant women and men of reproductive age in the context of Zika.
This toolkit was developed to help family planning providers educate their non-pregnant clients about the risk of Zika virus infection, and is focused on the Zika-related health needs of non-pregnant women and men of reproductive age. All of these tools can be found on CDC and OPA's Web site.
In addition to the guidelines themselves, CDC and OPA have developed tools to help healthcare providers implement these guidelines and recommendations. Tools are available in English and in Spanish, and can be downloaded to mobile devices.
For women and couples who choose to delay or avoid pregnancy during the Zika virus outbreak, one key element in choosing which method of contraception fits the best into their life includes contraceptive method effectiveness.
The effectiveness of birth control is critically important for reducing risk of unintended pregnancy. We describe contraceptive effectiveness rates as failure rates, or the number of pregnancies per 100 women during the first year of use.
Highly effective contraceptive methods have a failure rate of less than 1 pregnancy per 100 women who use this method in the first year of use. Highly effective permanent contraceptive methods include female sterilization, or partner vasectomy.
Also known as long-acting reversible contraceptive methods, or LARCs, highly effective reversible contraceptives include intrauterine devices and contraceptive implants. LARC methods are the most effective types of reversible contraception available.
They are safe for most women; after correct insertion, require no effort by the user; remain effective for several years, depending on the type chosen; have higher rates of user satisfaction and continuation than any other method of reversible contraception; and can be removed by a healthcare provider at any time with immediate return to fertility.
As demonstrated by the graph to the right, LARC use is increasing nationally. However, its use remains relatively low among US women using contraception at approximately 8%, far less common than moderately or less effective methods of birth control such as pills or condoms.
Moderately effective contraception methods have a failure rate of approximately 6 to 12 pregnancies per 100 women who use these methods during the first year of use. Moderately effective methods include hormone injections, contraceptive pills, transdermal contraceptive patches, vaginal rings and diaphragms.
Less effective contraceptive methods have a failure rate of 18 or more pregnancies per 100 women who use this method each year. Less effective methods include male and female condoms, cervical caps, sponge, withdrawal, spermicide, and fertility-based awareness methods.
My colleague, Dr. Charlan Kroelinger, will now discuss data on contraception use in states where mosquito-borne Zika virus transmission is possible. Charlan?
Dr. Charlan Kroelinger: Thank you, Erin. On Friday, August 5, CDC released a new report estimating contraception use among sexually active U.S. women of reproductive age, including women who recently delivered a live-born infant, and female high school students, living in states where mosquito-borne Zika virus transmission is possible.
This report is timely, based on the first reported cases of local mosquito-borne Zika virus transmission in the continental United States, as mentioned earlier in this Webinar.
There are many ways that CDC collects surveillance data from states to better understand behaviors and experiences of adults and youth in the U.S. For this report, CDC used 2011 to 2013, and 2015 data from four state-based surveillance systems -- the Behavioral Risk Factor Surveillance System, or BRFSS; the Pregnancy Risk Assessment Monitoring System, or PRAMS; the Maternal and Infant Health Assessment, or MIHA; and the Youth Risk Behavior Survey, or YRBS.
Each surveillance system surveys the health behaviors of women, including non-pregnant women, post-partum women, and sexually active female high school students. All of these surveillance systems regularly publish summary reports for public use, and have public use data available for researchers.
For this analysis, we relied on Trussell's 2011 definitions of contraceptive effectiveness. Less effective contraception was operationally defined as a failure rate of greater than 10 pregnancies [per 100 women] in the first year of typical use. Moderately effective contraception was defined as 6 to 10 pregnancies per 100 women in the first year of typical use.
This differs from what Dr. Berry-Bibee just described, that moderately effective contraception has a failure rate between 6 and 12 pregnancies per 100 users over the first year of use.
Prior to the 2016 Zika virus outbreak, overall contraception use varied across states.
Moderately effective and less effective contraceptive methods were used more frequently than highly effective methods across all age groups, and by race and ethnicity.
Data from the BRFSS surveillance system demonstrated that between 5.5% and 18.9% of women of reproductive age reported LARC use. However, a substantial proportion of women aged 18 to 44, at risk for unintended pregnancy, were not using contraception, or were using less effective methods.
Between 12.3% and 34.3% of women of reproductive age were using no contraception at last intercourse. If you average across states, just under 1 in 4 women reported not using contraception at last sexual intercourse.
Post-partum women reported the highest rates of contraception use at last intercourse. Up to one-third of women, or between 6.9% and 30.5%, who recently delivered a live birth reported using LARC. Between 3.5% and 15.3% of post-partum women reported not using contraception.
Between 1.7% and 8.4% of sexually active female high school students reported LARC use. Additionally, a substantial proportion of sexually active female high school students were not using contraception, or were using less effective methods. Between 7.3% and 22.8% of sexually active female high school students, or more than 1 in 5, reported not using contraception at last sexual intercourse.
A number of barriers limit LARC use. Barriers to the access and availability of LARC methods may include the high cost of devices; limited provider reimbursement; lack of healthcare provider training on insertion and removal; lack of knowledge or misperception about LARC methods; as well as cultural and other factors, including limited availability of youth-friendly services that address adolescent confidentiality concerns, and low consumer awareness of the most effective contraceptive methods.
Multiple strategies exist to increase women's access to effective contraception and availability of LARC. To address high costs, healthcare providers can remove administrative barriers for contraceptive services and supplies, including eliminating policies requiring pre-approval and step therapy restrictions.
Also, providers can partner with healthsystem payers to implement contraceptive services. Providers can work with state health agencies and insurers to reimburse for the full range of contraceptive services, including screening for pregnancy intention; providing client-centered contraception counseling; fully funding device insertion, removal, replacement and re-insertion at a follow-up visit.
All healthcare providers can be trained on the most current insertion and removal techniques for LARC, including pediatricians, nurse practitioners, and family physicians. In addition, providers can improve the same-day access to services by removing non-essential requirements such as a Pap or STD tests prior to contraceptive initiation.
Providers can use CDC's evidence-based contraceptive guidance and family planning services guidelines to increase awareness of LARC to clients of all ages.
Providers can support the incorporation of youth-friendly, culturally appropriate reproductive health services that reinforce the needs of all clients, including adolescents, those with limited English proficiency, those with disabilities, and those who are lesbian, gay, bisexual, transgender, or questioning their sexual identity, or LGBTQ.
For example, youth-friendly services including understanding the confidentiality concerns of female minors; modifying the automated distribution of Explanation of Benefits; offering extended clinical hours; and providing youth-focused materials during healthcare visits.
CDC has implemented a number of activities addressing barriers to contraceptive access and unintended pregnancy. CDC's 6|18 initiative is working to address inadequate reimbursement rates, to expand coverage, and to remove administrative and logistical barriers to LARC among states.
Additionally, CDC has partnered with the Association of State and Territorial Health Officials, the Office of Population Affairs, and the Centers for Medicare and Medicaid Services to implement a learning community on increasing contraceptive access, including LARC.
The LARC learning community has identified eight strategies to assist states in implementing and sustaining LARC initiatives. Please see the Web links at the bottom of this slide for further information on these CDC-led activities.
All of this work is the work of many people. Many thanks to all of our collaborators, and thank you for listening to this call today.
Marcy Friedman: Thank you so much, presenters, for providing our COCA audience with such valuable information. We will now open up the phone lines for the question and answer session.
As a reminder, questions are limited to clinicians who would like information on Zika. For those who have media questions, please contact CDC Media Relations at 404-639-3286, or send an email to email@example.com. If you are a patient, please refer your questions to your healthcare provider.
When asking a question, please state your organization. And also remember you can submit questions through the Webinar system as well. Operator, we'll go ahead and start off our Q and A session with a question that came in from the Webinar.
This question came in from Janice Matthews-Greer, and her question is for Dr. Oduyebo. It says, Dr. Oduyebo stated that an asymptomatic pregnant woman had detectable RNA at 53 days. Was it tested before that date and negative?
Dr. Titilope Oduyebo: Hello, this is Dr. Oduyebo speaking. So for that particular case, she was tested prior to 53 days. She was tested at 25 days after her last possible exposure, and Zika virus RNA was detected
both in serum and urine. For further information about the cases that we've presented, this was published in the Obstetrics and Gynecology Journal on August 2, and it's on their website.
Marcy Friedman: Thank you so much, Dr. Oduyebo. Operator, do we have any questions coming in from the phone lines, please?
Coordinator: We have a couple questions, and the first one comes from Warner Hudson of UCLA. And, sir, you have an open line.
Warner Hudson: Great, thank you. This is Dr. Warner Hudson, Medical Director for Occupational and Employee Health at UCLA. We have a lot of research going on Zika -- mouse models -- as do many institutions nowadays. And questions have come up about surveillance of the lab workers with no known exposure. And the answer I have learned is, no, can't do that, from the local LA health department and California health department.
Should we have a lab exposure, like a needle stick with live Zika, we would treat that as a real exposure and get testing. I guess the question is, do you have any guidance on surveillance of lab researchers working with live Zika in areas where there's not Zika transmission? And any thoughts about contraception by the lab researchers, as these questions will come up. And I have my own thoughts, but I'd just love to hear yours. Thank you.
Dr. Titilope Oduyebo: So we'll see if Dr. Staples can answer the first question about - the first part of your question about surveillance of lab workers in areas where Zika virus transmission is not ongoing but may have possible, you know, lab exposure given what they're doing.
Dr. Erin Staples: Hi, this is Erin Staples. I'm a medical epidemiologist with the Arboviral Diseases Branch in Fort Collins, Colorado, and have been covering Zika for years. We do not have any active surveillance programs for researchers that currently work with Zika virus, though of course here at CDC we do have our clinical diagnostic lab as well as researchers who work on the virus in the virology section here.
You know, those people practice standard techniques. It's a BSL-2 agent. And no additional testing was deemed to be warranted. However, with that said, you know, it's generally recommended that pregnant women or women that are thinking about becoming pregnant are not actively, you know, engaged in the research.
And I think your plan is correct, that if someone was to be exposed, they should be actually evaluated and tested for it. There have been a couple of incidences that we've become aware of at the CDC. One exposure did not lead to symptoms, and the person did not seroconvert. And the second one led to a person becoming symptomatic and actually seroconverting from laboratory exposures.
So I think that the plan that you currently have is adequate. And if we have any additional information, we'll definitely provide that through our different channels and website on specific lab research questions, and I'll turn it over to Titi's group to talk about contraception for lab workers.
Warner Hudson: Thank you.
Dr. Erin Berry-Bibee: Hi, this is Dr. Berry-Bibee. And as far as contraception for lab workers, contraception is a complex and personal decision that is left up to the individual patient, so that's really all the guidance we have from that perspective.
Warner Hudson: Okay, thank you.
Coordinator: Our next question comes from Dr. Ann Bilowitz.
Dr. Ann Bilowitz: Yes, hi. Thank you. So if we have a situation in which a physician desires to learn more about the technique of the LARC insertion, removal, et cetera, do you have some resources that are available in that regard? Hello?
Dr. Erin Berry-Bibee: Hi, this is Dr. Berry-Bibee. So there are many resources on the CDC website, including the active LARC learning community and the (16|18) initiative, that are targeted both towards healthcare systems and healthcare providers.
CDC does not provide training itself, but there are many training organizations that are included in the Zika OPA toolkit that the Office of Population Affairs provides for taking care of women in the context of Zika virus. And there's a list of resources within that toolkit.
Dr. Ann Bilowitz: Okay, are those actual courses that provide hands-on training?
Dr. Erin Berry-Bibee: So there are online resources for online as well as hands-on. It's very individualized depending on the provider and what system they work in.
Dr. Ann Bilowitz: Oh, okay. Just to throw out there, it might be helpful if the - some of the state chapters, you know, be they OB-GYN, internal medicine, pediatric, whatever, or the national entities, become a little bit more proactive in offering this opportunity for CMEs.
Dr. Erin Berry-Bibee: That's a great suggestion.
Marcy Friedman: Thank you. I do have another question that came in from the Webinar. And it's from (Lee Chen). And the question is, based on one slide with Zika RNA in IgM detection versus time, Zika virus can be detected prior to onset of symptoms.
How many days prior to onset of symptoms do you think the New York female case had sex with her partner prior to her onset? I am wondering how many days we should ask for any sexually transmitted case if we have such a scenario? Three days? With a question mark, three days.
Dr. Titilope Oduyebo: This is Dr. Oduyebo speaking. So the figure has shown that, you know, there are individualized differences. We suspect that, you know, Zika virus, the incubation for Zika virus infection is anywhere from, you know, about 3 days to 2 weeks - 14 days, you know, maximum. And so some people may have, you know, some viral RNA in their serum before they have symptom onset.
I will defer to Dr. Erin Staples, who may have more concrete information about the exact number of days that, you know, the virus can be detected in serum or, you know, specimens.
Dr. Erin Staples: Yeah, thanks, Titi. Unfortunately we do not have a lot more specific information about how long a person will be viremic before they develop symptoms. You know, some different diseases where there's - information was obtained really from experiments which has not been done with Zika virusin terms of injecting it and then detecting the virus, and then to determine when they become symptomatic.
But as Titi already alluded to, we did look at least travel-related cases of Zika virus, and looked at when they traveled to denote when they were exposed, and then looked at when they became symptomatic. And that's where that range of 3 to 14 days' incubation period between when a person is exposed - that is for travel-related cases that are most likely mosquito-acquired.
There could be differences in the incubation period based on the different routes of exposure, like sexual exposure. But unfortunately we don't have enough data at this time to provide better estimates, so we are currently using 3 to 14 days as an incubation period.
Marcy Friedman: Great. Thank you so much. We do have another question from the Webinar that I'd like to address. And the question is from (Kathy Ferris). Her question is, she is getting many questions from her staff regarding risk of acquiring Zika from a needle stick. Staff not working in lab, but with patients. Of particular concern are labor and delivery. What would be the follow-up if someone were to be stuck by a needle?
Dr. Titilope Oduyebo: So CDC has published guidance for precautions that should be taken on labor and delivery in the setting of ongoing Zika virus outbreak. And, you know, we recommend, just as with any infectious diseases, standard precautions should be practiced. If there is a needle stick, I would defer to Dr. Erin Staples to answer that question, but I do believe that that would be an exposure that would lead to testing for Zika virus infection.
Dr. Erin Staples: Yeah, thanks, Titi. And this also gets back to Dr. Hudson's points. A lot of this is actually institutional-based. Different institutions will set their own policies. Minimally it would be definitely recommended that that person potentially be followed for any signs of disease -- so a fever, rash, conjunctivitis.
Many individuals - or many institutions may implement more routine follow-up with testing, particularly if there are sensitivities related to the health of the person that might have been exposed. But unfortunately I think a lot of this is institutional-based, and I think of following up with your institution. And if there aren't standard policies, then either considering just the fever and look for symptoms, or a more proactive testing if it's available
Marcy Friedman: Thank you very much. Operator, do we have any other questions coming in from the phone line, please?
Coordinator: And there are no questions in the phone line queue.
Marcy Friedman: Okay, thank you. We do have a question that came in from the Webinar. It's from Rossi Hassad at Mercy College in New York. It starts off with, let me preface my question by saying that I recognize this is a very sensitive issue, and indeed extreme; and that most infections are asymptomatic.
Given the uncertainty surrounding Zika virus infection and the associated severe fetal disorders in particular, would it not be wise to isolate and treat all cases while the incidence and prevalence are relatively low, so as to contain the spread of the virus from a known source (the infected person)? In parentheses.
Dr. Erin Staples: Yeah, this is Erin Staples. I'll probably try to take that one, and I think Dr. Hassad pointed out to one of the most pressing issues, is that most people that get infected with Zika virus are probably asymptomatic. But they do replicate the virus in their blood, and therefore can contribute to the - in many cases, a naïve mosquito obtaining the virus and then being able to infect more people.
So being able to just isolate symptomatic people would not necessarily curb or potentially stop any additional spread that might occur, as asymptomatic people are just as likely [to be a source of infection].
However, it gets at the recommendation that is if you do have a person who's suspected to have symptomatic disease that it's recommended that they should, at least during that first week after their illness onset, avoid mosquito exposure, to potentially lower the risk of infecting local mosquito populations.
In addition, many state health departments, when they receive reports of suspected or confirmed Zika virus, will actually go to the location of that case and do pre-emptive education, as well as vector control if they have the capacity. So it's very important, again, for clinicians to alert their local and state health departments of any suspected or probable cases of Zika virus infection to help mitigate the spread.
Marcy Friedman: Okay, thank you so much to all of our presenters, with a special thank you to Drs. Oduyebo, Kroelinger, Berry-Bibee, and Dr. Staples.
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