This past summer, Everlyne Ombati, an intrepid researcher with the Kenyan Medical Research Institute, trekked five times through the dilapidated slums outside the nation’s capital of Nairobi, dodging trash, raw sewage and stray dogs, to do her heart’s work: talk to women and girls about preventing unintended pregnancies and sexually transmitted infections, including HIV, and introduce them to the work of researchers trying to create two-for-one products that could do both.
From advocacy centers in Sacramento and Washington, D.C., to research institutes in Pittsburgh and Nairobi, a network of women scientists, experts, health advocates, and innovators are leading the reproductive health field to develop single products called multipurpose prevention technologies, or MPTs. These new technologies would simultaneously prevent two leading causes of death for women: sexually transmitted infections, including HIV, which disproportionately strike women of reproductive age, and unintended pregnancies, which are more likely to result in maternal morbidity or mortality, compared to planned pregnancies.
To some, these women leaders are the “Zena warrior princesses of the vagina,” a play on the name of the mythical superhero, Xena: Warrior Princess, because many of them take inspiration from Dr. Zena Stein, a groundbreaking South African epidemiologist and professor emerita at Columbia University who helped navigate her country and the world through solutions for the HIV crisis, particularly for women, starting in the early 1990s. In 1990, Stein published a seminal call for “comprehensive prevention for women.”
Three decades later, as the United Nations marks World AIDS Day on December 1, women’s sexual and reproductive health care remains fragmented. While women’s health organizations and practitioners are able to offer about a dozen methods of contraception, only male and female condoms prevent sexually transmitted infections and unintended pregnancies.
Many health care experts say the new frontier in women’s health is the development of these multipurpose prevention technologies that researchers are creating as vaginal rings, gels, IUDs, and other formulations, combining contraceptives with antiretrovirals and other compounds that prevent HIV and other sexually transmitted infections.
In Kenya, medical professionals such as Dr. Elizabeth Bukusi, a research professor at the University of Washington and a chief research officer at the Kenya Medical Research Institute, work at the forefront of this innovative women’s health research, preparing to test products and surveying young women to make certain their preferences and needs are better understood for eventual integration into product design.
“Creating MPTs that prevent unintended pregnancy and sexually transmitted infections is the future and promise of women’s health care,” Dr. Bukusi told Women in the World in an interview. “Women urgently need these new products to improve the condition of their lives, and they need them now.”
Founding a movement
In the early 1990s, Bethany Young Holt, Ph.D., saw this need as a former Peace Corps rural health volunteer in Mauritania and Senegal, and, later, as an intern with the Centers for Disease Control on the Sudanese border of Ethiopia, working with two vulnerable populations: refugees and those at high risk for HIV. Young Holt said that “while women were generally enthusiastic about condoms, the men were not. The women wanted protection they could control.” Relying on men to use condoms left the refugee women and sex workers too often defenseless against disease and unintended pregnancy.
Returning home to California to work on earning her Ph.D., Young Holt said, “I saw that U.S. populations are also vulnerable. From Africa to Oakland, California, I realized the need for these new multipurpose prevention technologies. Health care was and still is very siloed for women. It has inspired me to advocate for a comprehensive solution.”
In 2009, Young Holt, by then a young epidemiologist, collaborated with other experts to launch the Initiative for Multipurpose Prevention Technologies (IMPT) with early grants from the Mary Wohlford Foundation and the U.S. Agency for International Development (USAID), to encourage donors and industry professionals to invest in new products for women’s health. From the beginning, researchers, advocates and others provided countless hours of in-kind support, contributing technical expertise and convening scientific symposiums to advance the MPT field. USAID, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the National Institutes of Health, among others, have also steadily increased investment in MPTs.
Together, these partners work to advance MPT development from a theoretical concept to nearly a dozen product candidates in clinical testing.
“Research and development for these revolutionary new products is part art and part science. Science takes a lot of creativity,” says Young Holt. “The science is there to prevent unintended pregnancies and many sexually transmitted infections, but the art of combining them into one product that women will want to use hasn’t yet been realized.”
Addressing a global crisis
There is no doubt that better protection is much-needed in the United States and globally. These products could help women prevent not only HIV, but other sexually transmitted infections, including Herpes Simplex Virus (HSV-2, or genital herpes), chlamydia, gonorrhea, and syphilis, while also preventing unintended pregnancies. Earlier this fall, the CDC reported that chlamydia, gonorrhea, and syphilis cases hit an “all-time high” in the United States.
In sub-Saharan Africa, researchers say that young women continue to bear a “disproportionate burden” of new HIV infections. Of the estimated 6,000 new infections occurring globally each day, two out of three are in sub-Saharan Africa, with adolescent girls and young women between the ages of 15 and 24 having up to eightfold higher rates of HIV infection, compared to their male peers. Furthermore, women with HIV and other sexually transmitted infections face a greater risk of ectopic pregnancies, or “tubal pregnancies,” a dangerous condition in which the embryo implants in one of the fallopian tubes or somewhere else in the abdomen, instead of the uterus.
Bukusi has been seeing the linkages between sexually transmitted infections and maternal morbidity and mortality since the 1980s, when she began her medical research career, working on the border between Kenya and Uganda where entire villages were decimated from people dying from AIDS-related complications, as the world struggled to understand the epidemic. There, she says, she saw “countless” cases of ectopic pregnancies. Since then, research has confirmed the link between sexually transmitted infections, ectopic pregnancies, and maternal morbidity and mortality.
“Women are especially vulnerable to HIV/AIDS and other sexually transmitted infections because of their biology, sociocultural norms and the persistent gender inequalities,” said Bukusi.
UNAIDS, a dedicated United Nations program to end the AIDS crisis, warns that current prevention strategies are not decreasing the rate of new HIV infections quickly enough to end the epidemic — with young women at the highest risk.
Meanwhile, an estimated 214 million women of reproductive age in developing countries have an unmet need for contraception, wanting to avoid pregnancy but not using a modern contraceptive method, according to the Guttmacher Institute, a New York-based research and policy organization committed to advancing sexual and reproductive health and rights.
Multiple studies, from the NIH to the IMPT effort, document women’s interest in using a single product to prevent unintended pregnancies and sexually transmitted infections, including HIV, particularly in Africa, where data show women would prefer to use an HIV-prevention product if it is coupled with contraception.
“I’m heartened by the voices of women advocating for themselves,” said Bukusi.
Milestones and momentum
Recently, efforts to develop MPTs have hit important milestones.
This past May, the International Partnership for Microbicides (IPM), a nonprofit based in Silver Spring, Md., began its first clinical trial of a three-month vaginal ring designed to prevent both HIV and unintended pregnancy. The ring slowly — and simultaneously — releases the antiretroviral drug dapivirine to prevent HIV and the contraceptive hormone levonorgestrel. The goal is to test the ring’s safety, acceptability and how the body processes the two drugs, so researchers can identify next steps for the ring’s formulation and future trial designs. Phase I trial results of the three-month ring are due in 2018.
This month, at Albert Einstein College of Medicine, the Population Council, a nonprofit based in New York City, completed the early portion of the first in-human trial of griffithsin, a naturally occurring protein found in algae that researchers are investigating as an MPT that could inhibit HIV and other pathogens, including HSV-2.
And, in another signal of progress, CONRAD, a leading health research nonprofit based in Arlington, Va., is developing a product combining a contraceptive with tenofovir, an antiretroviral drug approved to prevent HIV that may also prevent HSV-2 infection. In Norfolk, Va., and the Dominican Republic, researchers are testing the product in a second clinical trial. Next year, CONRAD plans a larger study in Africa.
Other products currently in various stages of clinical development in the MPT pipeline include intravaginal rings, vaginal inserts, gels, films, barrier methods, and barrier methods plus gels. Future products could include co-formulated longer-acting products such as injectables, subcutaneous implants, intrauterine systems, as well as co-packaging or co-administering two already approved products.
“I’m incredibly excited and optimistic,” said Dr. Sharon Hillier, a Ph.D. researcher and professor of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh, leading the team conducting the clinical evaluation of the IPM ring. “From U.S. cities to communities in sub-Saharan Africa, women need a contraception that also provides protection from HIV and other sexually transmitted infections. It’s not rocket science. Women in areas with high rates of HIV are especially facing two serious unmet needs: modern contraception and HIV protection.”
Hillier was motivated to enter the women’s health field in the early 1980s. “I got into health care as a young scientist,” she says, “sitting in rooms with men, hearing that women’s health problems were all in their head. This made me angry, and made me think we need change. I was politicized early in women’s health, based on my experiences,” says Hillier, a self-described “scientist feminist.”
While critics used to mock reproductive health research, she says, “Today, the vaginal microbiome is a hot research topic.”
Hillier adds, “There has been bias against multipurpose prevention technologies because they are only for women. Some of this relates to power dynamics in the field. But women are the fastest-growing part of the HIV epidemic, they are the most vulnerable at the youngest ages. We need to listen to what end-users say they need and develop products accordingly. And we need more women at the table where funding decisions are made.”
In Washington, Heather Boonstra, director of public policy at the Guttmacher Institute, says, “These new multipurpose prevention technologies would be a real game changer.”
Inspired to women’s health care in the 1990s as a graduate student, Boonstra says, “Women have many options for contraception, but they don’t have many options for what also prevents disease. One of the challenges we face is imagination. Many women don’t imagine this is possible but, then, when we talk about it, people on the ground are so excited about it.”
What is needed to advance product development?
Boonstra says, “We need political will and funding.”
Back in Kenya, at the Lunga Lunga Health Centre, a health facility within the slums of Nairobi’s congested industrial center, about 25 women, including young, unemployed single mothers, and those at high risk for HIV, told Ombati, the intrepid local researcher, about their struggles trying to stay healthy — and alive.
Later, at the Shauri Moyo slum, along Jogoo Road in Nairobi, about 30 women, most of them living in single-room homes with communal toilets, gathered inside an impromptu meeting room, assembled with iron metal sheets as walls.
Ombati patiently fielded each of their questions and told the women about the plans for the new multipurpose prevention technologies. The women, hopeful, smiled.
Below watch a video on the effort to develop MPTs as a complement to condoms as a solution to prevent sexually transmitted infections and unwanted pregnancies.
Pamela M. Norick is a global women’s health expert with decades of experience advocating for women’s health innovations worldwide. She can be reached at email@example.com.