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A World Without AIDS for American Women

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AIDS
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Written in collaboration with Negar Avaregan, M.P.H

The Impact of HIV/AIDS on Women in America

Last year marked the 20th anniversary of a critical change made to the Centers for Disease Control and Prevention's (CDC) case definition of AIDS so that it would include women. Prior to 1993, HIV/AIDS was defined as a disease affecting only men. Two decades following this pivotal change, now is an opportune time to review the progress made in the fight against this disease and underscore what still needs to be done to end HIV/AIDS for women and girls in America.

Today, women account for one in four of the more than 1.1 million Americans living with HIV, and one in five of the more than 50,000 new infections that occur every year. [1] In 2011, women of color accounted for two-thirds of new AIDS diagnoses among all women, with African-American women being disproportionately affected. At some point in their lifetimes, 1 in 32 black women, 1 in 106 Hispanic/Latina women, and 1 in 526 white women will be diagnosed with HIV in the U.S. [2] In 2010, 84 percent of women infected with HIV acquired the illness through heterosexual transmission, while 16 percent were infected by injection drug use. [3] By the end of 2010, 10 states represented the majority (68 percent) of all women living with an HIV diagnoses in the U.S., with New York and Florida having the greatest number of cases. Women represent one quarter of AIDS deaths in America.

In recent years, there have been some promising signs suggesting that HIV infections are falling among women, including for black women, who account for roughly two-thirds of all new female HIV infections. Comparing rates from 2008 to 2010, there was a 21 percent decline in new infections among black women (7,700 to 6,100) as well as among women overall (12,025 to 9,500). [4] This was the first significant decrease after more than a decade of relatively steady HIV incidence among women. [5] While this evidence is encouraging, further research is needed to determine if the decrease among women is the beginning of a longer trend.

The Past

When HIV/AIDS first emerged in 1981, it was viewed as a disease of men who have sex with men (MSM). Although HIV was soon identified in women, the scientific community failed to address females as a unique target population for research. In addition to being omitted from the clinical definition of AIDS, women were also excluded from clinical trials of HIV/AIDS medications and preventive interventions. Trial inclusion/exclusion criteria at that time read, "No pregnant women and non-pregnant women allowed."

As a result, women had more difficulty getting government disability payments than did men because the standard definition of AIDS at that time did not take into account many of the symptoms experienced by women including candidiasis (yeast infection), cervical cancer and pelvic inflammatory disease. Some hospitals would not even admit women to their HIV wards. Additionally, on average, women were dying of AIDS in half the time as men did from the disease and researchers did not understand why. This omission of women as a focus of research, treatment and prevention efforts at the beginning of the epidemic resulted in a rapid rise in the number of cases in women with HIV/AIDS in America and worldwide.

In the mid 1980s, as a response to a report from the U.S. Public Health Service Task Force on Women's Health Issues, the National Institutes of Health (NIH) issued recommendations that women be included in all applicable research studies. [6] But these recommendations were loosely enforced. In 1987, women of childbearing age were excluded from participating in clinical trials unless they agreed to use birth control -- meanwhile receiving no support services such as childcare, transportation, or on-site gynecological care. [7]

Furthermore, when scientists recognized that the HIV virus was being transmitted from mother to child, treatment programs primarily focused on preventing transmission to infants, with minimal attention to the long-term care of mothers. Myths about HIV in women were spreading throughout the media, including that most heterosexual women were not at risk for contracting HIV. This resulted in millions of women believing that they could not be infected with the virus and therefore not protecting themselves. [7] Moreover, data from studies that did include women were often not analyzed for sex differences in medication dosage, outcomes, and side effects.

Neglecting women in the early years of the epidemic proved to be a major public health oversight and resulted in a startling development in the 21st century: Worldwide, there are now more women than men living with HIV/AIDS.

Progress

A number of steps have since been taken to end AIDS in women. In 1985, I convened the first workshop on Women and AIDS at the NIH to stimulate research studies on this population group. In 1990, a protest occurred at the CDC headquarters with advocates demanding that the agency expand its AIDS definition to include disease symptoms specific to women. In May of that year, ACT UP members gathered at the NIH to protest the lack of women and people of color in clinical trials of drugs being tested to treat AIDS. Advocates also requested a national conference on women and HIV as well as a study of the natural history of HIV infection in women.[7]

Furthermore, in 1990, the General Accounting Office (GAO) published a report, at the request of the Congressional Caucus on Women's Issues, which found that the NIH policy on women's inclusion in clinical research was not being adequately applied to research grant applications. I worked with other scientists and advocates to help bring these inequities to public and scientific attention at that time.

As a result of these efforts, beginning in 1991, NIH strengthened its policy to require, rather than recommend, the inclusion of women in clinical research (when applicable). [6] However, the advocacy community believed more needed to be done. In 1993, the NIH Revitalization Act was passed by Congress that required women and minorities to be included in all research studies funded by the NIH. Additionally, in 1993, the Food and Drug Administration (FDA) released new guidelines on expectations regarding the inclusion of patients of both sexes in drug development, analyses, and assessments entitled "Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs." These guidelines addressed concerns that the drug development process did not include women in clinical trials and therefore there was inadequate information about the metabolism and side effects of medications in females.

Another important development was the establishment of the Women's Interagency HIV Study (WIHS) to investigate the impact and progression of HIV in women. Primarily funded by the NIH, this nationwide study tracked 3,000 HIV-positive women and 1,000 high-risk HIV negative women and investigated the history and course of their HIV infection. The study has produced many important findings about the course of the disease in women including factors that increase the risk of the disease.[8]

That same year, as the country's first Deputy Assistant Secretary for Women's Health in the U.S. Department of Health and Human Services (HHS), my work included ensuring that women's health issues were a major focus of all of the federal health agencies. I established the Women and AIDS Task Force within the U.S. Department of Health and Human Services with representation from more than 60 organizations and developed the National Centers of Excellence program at academic medical centers across the country. We worked with the CDC to revise its case definition of AIDS to include women, as well as to enact the 1995 FDA's policy change that recommended females be included as subjects in clinical trials. [6]

These actions in the 1990s began a series of steps taken by the U.S. government to target women's issues in HIV/AIDS in research, diagnosis, treatment and prevention that have yielded life-saving dividends. For example today, women represent more than 50 percent of subjects in clinical research supported by the NIH; however, females are still underrepresented in studies conducted by pharmaceutical and medical device companies. This year, the NIH revised its policies to require that basic research studies where scientific theories are tested include both male and female animals and that data from this research be analyzed for sex differences.

Researchers who work with cell cultures are also being encouraged to study cells derived from females as well as males, and to do separate analyses to determine sex differences at the cellular level. This is an important development because for decades, scientists have designed their hypothesis testing research by first experimenting on laboratory animals that were most often male. Researchers avoided using female animals because of the cost of adding this variable of hormone fluctuations to their projects as well as the concern that estrus cycle changes could alter the results of their experiments.

As a result of this new national focus on women's health, research has shown that sex matters at the molecular, cellular, organ system levels and in the way the environmental factors impacts health. That is why it is imperative to target the unique needs of women in research, treatment, and prevention of HIV/AIDS as women are at a particularly high risk for acquiring the disease due to a combination of biological, economic, and social factors that increase their vulnerability to the virus.

The transmission of HIV from a man to a woman is two to eight times more efficient than from a woman to a man. [9] Physiologically, women are more susceptible to HIV than men, and a woman's susceptibility to HIV infection is further increased if she or her partner has a sexually transmitted infection, if she has experienced genital trauma, or if her partner is HIV positive and has a high viral load. [10]

Certain customs and practices surrounding gender roles and partner fidelity, along with economic dependency, can create power imbalances within relationships. This may result in women's reluctance to insist that their partners remain monogamous or use condoms, thereby increasing their vulnerability to HIV infections. [11] [12] A powerful tool to help women become more economically independent is education and occupational opportunities. Young women who stay in school are more likely to be exposed to HIV prevention messages, and are less likely to have an economic need to marry early. [13] With higher education and income, women are also more empowered to make healthier choices including protecting themselves from HIV/AIDS. In the United States, young women complete their education at a higher rate than young men. In fact, in 2013, 2 percent more young women graduated with a high school degree and 2.1 million more young women completed their bachelor's degree than young men of the same age. [14] However, in 2010, a smaller percentage of black and Hispanic women had completed high school or college compared with white women. [15]

Access to Care

Antiretroviral treatment (ARV) has resulted in making HIV/AIDS a treatable condition and has resulted in improved quality of life, reduced mortality, and a significantly reduced chance of transmitting the virus to others for women in the United States and worldwide. [16] Yet, more effort is needed to ensure access to these lifesaving medications and prevention strategies for all those women in need.

Significant progress has been made in the prevention of mother-to-child transmission (PMTCT) in the United States. PMTCT has decreased dramatically in America since its peak in 1991 as a result of over 1.5 million HIV-positive pregnant women receiving antiretroviral drugs to prevent the passing of the virus to their infants. [17] [18] Since the mid-1990s, preventative HIV testing and interventions have led to a 90 percent decline in the number of infants perinatally infected with HIV. In fact, transmission to infants has been virtually eliminated in America. [18] Perinatal HIV infections declined, from 193 in 2007 to 164 in 2010. [18] While PMTCT infections continue to remain low, the NIH's Office of AIDS Research Advisory Council (OARAC) updated their PMTCT guidelines and recommendations for use of antiretroviral drugs in pregnant HIV infected women for maternal health as a means to reduce perinatal HIV transmission in the United States. The guidelines provide recommendations for HIV-infected women contemplating pregnancy, as well as up to date reproductive options for HIV concordant and serodiscordant couples. New recommendations for use of ARV during pregnancy is addressed, as well as advanced information on HIV/Hepatitis C coinfection and HIV-2 infection and pregnancy.[19]

Limited access to health care has compromised the health of HIV-positive women in the United States. As many as 15-20 percent do not know they are infected; only 41 percent of HIV positive women are in regular care, 36 percent are prescribed anti-retroviral medications, and only 26 percent are virally suppressed. [20] Challenges that prevent women from accessing the health services they need include stigma and discrimination as well as socio-economic and structural barriers including the lack of health insurance, poverty, cultural inequities, lack of transportation and violence.

Two recent developments, the National HIV/AIDS Strategy (NHAS) and the Patient Protection and Affordable Care Act of 2010 (ACA), should improve health care for women including advancing HIV/AIDS prevention and treatment.

The National HIV/AIDS Strategy, released in July 2010, details several actions that are needed to effectively address HIV/AIDS in women. The NHAS has three main goals: 1) decrease new infections, 2) improve health outcomes and access to care, and 3) reduce health disparities associated with HIV/AIDS. [21] Among the actions outlined in the National Strategy call for increasing the number of HIV clinical care providers as well as support services for women. [22]

The Patient Protection and Affordable Care Actwhich passed in March 2010 is expanding health insurance coverage to an estimated 32 million Americans, over half of whom are women. [23] Under the ACA, insurance companies are prohibited from charging women more than men for premiums and they cannot deny coverage for pre-existing conditions including HIV/AIDS. [24] Health insurance must -- with no cost sharing -- cover certain preventive services to improve women's health, including free testing and counseling for HIV, sexually-transmitted infections, and intimate partner violence. [25] It is estimated that these ACA preventive services will benefit approximately 45 million women, [26] while also resulting in an additional 466,153 HIV tests done nationally by 2017. [27]

Additionally, efforts are needed to ensure that insurance companies participating in the ACA cover at an affordable cost the lifesaving medications and other technologies that women need to treat and prevent HIV infection.

What's Needed

Since the passage of the NIH Revitalization Act over 20 years ago that mandated women be included in clinical trials, more than 90 NIH-supported studies on women and HIV have been conducted producing findings that have improved the treatment and prevention of the disease in women. [28] The CDC is also supporting the national dissemination of effective HIV behavioral interventions including many designed for women. An educational campaign is being conducted to increase HIV testing among African American women, aged 18-34; another campaign is fighting stigma by sharing stories of women who are living with HIV.

Yet despite this significant progress, women continue to be under-represented and even excluded in some areas of HIV research and care. [29] Some studies still do not analyze for sex differences to provide women-specific evidence to guide prevention and treatment decisions. Women and men may differ in terms of susceptibility to HIV infection, the course of the infection, response to treatment, drug pharmacokinetics and toxicity. Basic science research using animal models where hypotheses are tested have often excluded females; but this will now change as a result of revisions to NIH grant policy issued this year requiring both female and male animals in such studies.

Until recently, the FDA still did not require data analysis by sex in the drug and device approval process or in making recommendations about medication dosing. The omission of women and female animals from the development of the evidence base that informs medical practice has impeded health professionals' ability to identify and address important sex and racial/ethnic differences that could benefit the health of everyone. Thus, the impact of sex/gender differences needs to be better defined and addressed in both basic and clinical studies to improve patient care. [30]

More effort is needed to increase the numbers of females participating in HIV/AIDS research and to provide sex-specific information about treatment, diagnosis, prevention and cure. It is our hope that the new guidelines required by the NIH will encourage such participation. Key knowledge gaps related to women and HIV/AIDS that require further attention include the impact of sex/gender differences on clinical management; how different ARVs and pre-exposure prophylaxis (PrEP) interact with endogenous and exogenous sex hormones and other drugs commonly used in clinical practice; evaluating health outcomes by sex/gender; increasing interventions to end violence against women; reducing the stigma and discrimination faced by women with HIV; and increasing access to HIV testing and care for women.

A Roadmap for Action

There are several critical steps that can be taken towards ending AIDS in America for women. Women and girls need better information with messages targeted to vulnerable groups, particularly women of color, about avoiding risky behaviors and how to access resources for prevention and treatment. Since 16 percent of women are infected with HIV through injection drug use, lifting the ban on federal funding for syringe exchange programs is a critical measure. Greater investment in behavioral research is needed to give women the tools they need to prevent HIV infection and to increase adherence to medication regimens. Educational campaigns must targeting specific populations of women and girls. The importance of routine HIV testing must be underscored that is now covered as a preventive benefit without any cost-sharing in the ACA.

Listed below is a roadmap of high priority policies across all sectors of society for achieving an America without HIV/AIDS for women:

  • Make Women a Priority in America's National HIV/AIDS Strategy:Ensure that the National HIV/AIDS strategy implements policies across all sectors to empower women while promoting gender equality and the human rights of women and girls. [31] Provide women with the knowledge and tools they need to prevent HIV. Government agencies must address sex/gender in designing, implementing and evaluating research, services, and the health system.
  • Increase Public Knowledge and Decrease Stigma and Discrimination:Eradicate stigma and discrimination against women living with HIV/AIDS through greater investment in community-specific educational and awareness campaigns.
  • Increase the Focus on Sex Differences in HIV/AIDS Research and Programs:Focus research on the unique biological factors and the social, economic, and cultural issues that increase women's vulnerability to HIV/AIDS. Ensure that female animals are included in basic science studies and that results are reported and analyzed by sex.
  • Reduce Barriers Faced by Women in Disadvantaged Populations:Re-evaluate existing HIV/AIDS programs to ensure that they address the social, economic, cultural, and linguistic needs of women from disadvantaged populations.
  • Increase Women's Access to HIV Testing and Counseling Services:While over half of women in the U.S. ages 18-64 report having been tested for HIV at some point, only 22 percent were tested in the past year. Among those who are HIV positive, 31 percent were tested for HIV late in their illness. CDC guidelines for HIV testing and counseling should be incorporated into routine healthcare visits for all sexually active women. Screening should be repeated at least annually for those at high risk. [32]
  • Improve Women's Reproductive Health:HIV is associated with women's reproductive health in many different ways. Women are more vulnerable to HIV infection and those who have other sexually transmitted infections are at increased risk for acquiring the virus. Implement evidenced-based public policies to promote sexual and reproductive health services for women and girls. Family planning sites provide an important entry point for reaching women who are at risk and living with HIV/AIDS.
  • Invest in the Development of Female-Controlled and Other Prevention Methods: Promote the acceptability and use of the female condom. Continue studies to evaluate the effectiveness of PrEP (pre-exposure prophylaxis with ARV medications) including long-acting PrEP preparations in women. Implement new federal guidelines for health care providers that recommend that PrEP be considered for women at high-risk for HIV infection (HIV-negative, heterosexual women who do not regularly use condoms during sex with partners of unknown HIV status). [33] Increase investments in microbicide development, as topical microbicides offer women a method to prevent HIV infection that can be used without negotiating with a partner, which often must occur when using condoms.
  • Eliminate Mother-to-Child-Transmission (PMTCT):Continue to expand the availability of HIV screening programs, education programs, better surveillance, and treatment to eliminate perinatal transmission of HIV from mother to child in the U.S. While mother to child transmission has decreased dramatically in America since its peak in 1991 as a result of ARV treatment, some cases still occur each year, which represents missed opportunities for prevention.
  • Health Care Professional Education: Provide education and training on sex/gender differences in HIV/AIDS in health care provider and scientists' professional training.
  • Increase Women's Access to Health Care: Expand the sources of care for women in the U.S. including government programs such as Medicaid and Ryan White for those who are eligible. The ACA increases access to testing, prevention and treatment services for HIV/AIDS and other diseases for millions of women, and as implementation of the legislation proceeds, state and federal programs should be coordinated to enhance access to and affordability of comprehensive care for women to prevent and treat HIV/AIDS. [34] Advocate for the expansion of Medicaid in states that opted out of this provision in the ACA. Ensure that the health data and reporting of outcomes collected by the ACA are analyzed for sex/gender, racial/ethnic and age differences. [30]
  • Stop Violence Against Women: National, state, and local governments must enact and enforce laws and prevention and intervention programs to protect women from violence.
  • Enforce Women's Rights and Expand their Opportunities, and Leadership in Society: Ensure the human rights of women and girls, and promote their education, empowerment, occupational opportunities, and participation and leadership in all sectors of society.
  • Invest in global health and AIDS: Global health is America's health and America's health is global health. In an interdependent world, the spread of HIV/AIDS crosses state and national borders. Investing in global health is essential for humanitarian, economic and national security reasons. Strengthen investments and innovation in programs including PEPFAR and the Global Fund to Fight AIDS, TB and Malaria to improve women's health and the fight against AIDS worldwide.

Summary

Thirty years since the emergence of HIV in America, there are hopeful signs in recent years suggesting that the number of new infections is declining among women in the United States. To sustain this promising trend, continuing efforts to address the epidemic's impact on women, particularly women of color, are needed. For all too long, women's health had been neglected in research, in clinical settings, and in public policy. The intensified national focus on women and girls that began two decades ago in our country's domestic and foreign policy agendas including in the conduct of medical research and the provision of health services are not only critical steps towards empowering women, reducing their risk of HIV infection, and supporting women living with HIV and AIDS -- they are also critical steps towards increased prosperity and health for all people in the U.S. and worldwide.

For more information about HIV/AIDS, please visit amfar.org and AIDS.gov.

Rear Admiral Susan Blumenthal, M.D., M.P.A. (ret.) is the Public Health Editor of The Huffington Post. She is the Senior Policy and Medical Advisor at amfAR, The Foundation for AIDS Research in Washington, D.C. and also a Clinical Professor at Tufts and Georgetown University Schools of Medicine. Dr. Blumenthal served for more than 20 years in senior health leadership positions in the federal government in the Administrations of four U.S. Presidents including as Assistant Surgeon General of the United States, the first Deputy Assistant Secretary of Women's Health, and as Senior Global Health Advisor in the U.S. Department of Health and Human Services. She also served as a White House advisor on health. Prior to these positions, Dr. Blumenthal was Chief of the Behavioral Medicine and Basic Prevention Research Branch and Chair of the Health and Behavior Coordinating Committee at the National Institutes of Health. She has chaired numerous national and global commissions and conferences and is the author of many scientific publications. Admiral Blumenthal has received numerous awards including honorary doctorates and has been decorated with the highest medals of the U.S. Public Health Service for her pioneering leadership and significant contributions to advancing health in the United States and worldwide. Named by the New York Times, the National Library of Medicine and the Medical Herald as one of the most influential women in medicine, Dr. Blumenthal was named the 2009 Health Leader of the Year by the Commissioned Officers Association and as a Rock Star of Science by the Geoffrey Beene Foundation. She is the recipient of the Rosalind Franklin Centennial Life in Discovery Award. Her work has included a focus on HIV/AIDS since the beginning of the epidemic in the early 1980s.

Negar Avaregan, M.P.H. serves as an Allan Rosenfield Public Policy Fellow with amfAR, The Foundation for AIDS Research in Washington, D.C. Negar earned her Master of Public Health degree from the Rollins School of Public Health at Emory University and her B.A. from UCLA in International Development Studies.

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[21] The White House Office of National AIDS Policy. (2010). National HIV/AIDS Strategy for the United States. (page 8-9) Available online at http://www.whitehouse.gov/sites/default/files/uploads/NHAS.pdf.

[22] The White House Office of National AIDS Policy. (2010). National HIV/AIDS Strategy for the United States. (page 21-29) Available online at http://www.whitehouse.gov/sites/default/files/uploads/NHAS.pdf

[23] Kenney, Genevieve M., Stephen Zuckerman, Lisa Dubay, Michael Huntress, Victoria Lynch, Jennifer Haley, and Nathaniel Anderson. Opting in to the Medicaid Expansion under the ACA: Who Are the Uninsured Adults Who Could Gain Health Insurance Coverage? -Timely Analysis of Immediate Health Policy Issues. Rep. N.p.: n.p., 2012. Print.

[24]HealthCare.gov. (2012). Women and the Affordable Care Act. Available online at http://www.healthcare.gov/news/factsheets/2011/08/women.html.

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[34] Goldman, Dana, Timothy Juday, Mark T. Linthicum, Lisa Rosenblatt, and Daniel Seekins. "The Prospect Of A Generation Free Of HIV May Be Within Reach If The Right Policy Decisions Are Made." Health Affairs 33.3 (2014): 428-33. Web. Mar. 2014.

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