Analysis Sexual Health

The Latest Study on Depo-Provera and HIV: Far More Complex Than Most Headlines Suggest

Emily Bass

Because Depo-Provera is an important contraceptive choice and because in many parts of the world, it is the only long-acting, discreet option available to women, it is vital to take the issue of a link between HIV and hormonal contraception quite seriously while adding nuance to the discussion.

A newly published study by Lauren Ralph et al and an accompanying commentary in the journal Lancet Infectious Diseases is stirring up questions about the relationship between Depo-Provera, and other progestogen-only injectable contraceptives, and the risk of HIV acquisition among HIV-negative women. Based on a meta-analysis of previously published studies, the report’s authors determined that Depo use is associated with a “moderate risk” of HIV infection.

The study triggered a wave of headlines and tweets that boiled down the complexities and caveats of this analysis into an oversimplified statement: Depo increases women’s risk of HIV by 40 percent. Because Depo is an important contraceptive choice—it provides protection against unwanted pregnancy for three months after a single shot—and because in many parts of the world, it is the only long-acting, discreet option available to women, it is vital to add nuance to these headlines, while also taking the issue of a link between HIV and hormonal contraception quite seriously.

The first, and arguably most crucial, thing to understand about this new paper is that it is not based on new data, or raw information. It is simply a new analysis of a set of observational studies of rates of HIV in women using different contraceptive methods. Previous systematic analyses have included all but one of these studies; last week’s paper simply crunched those numbers, so to speak, in a new way.

About that number-crunching: Ralph’s paper concludes that those previously published studies, when analyzed as a group, suggest that there is an overall increase in risk of about 40 percent of contracting HIV associated with using Depo. The increased risk is greatest in women at “high risk” of HIV infection, which the authors define as HIV-negative women who engage in commercial sex work and/or those with known regular HIV-positive partners (women in what are known as “serodiscordant couples”). When these “high-risk” women were excluded from this meta-analysis, there was a 30 percent increase risk associated with Depo use. The study authors described this analysis as the risk for women in the “general population.”

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The question of whether hormonal contraception of any kind—pills, injectables, and implants—increase HIV risk has concerned sexual and reproductive health advocates—who among other things want to simultaneously prevent HIV and ensure people can plan pregnancies—for many years. Previously published systematic reviews of observational data have examined the results from many studies and haven’t settled the question. The Ralph paper is the latest addition to this body of literature.

Like all the previous analyses, Ralph’s paper worked with existing observational data, which was gathered from studies that were either not designed to specifically address the hormonal contraception-HIV link or did not randomly assign women to use a specific method. Observational data of this kind has inherent biases—for example, women who choose a specific contraceptive method might also have other attributes that affect their HIV risk. Observational studies can try to identify factors like these, but it’s not possible to account for everything that might be in play. So although a paper like the Ralph study might be giving what looks like a precise estimate of risk associated with Depo use, it’s on the basis of studies that, by definition, lack a high degree of precision.

Previous analyses have looked at all but one of the studies included in the Ralph paper. These earlier analyses were “systematic reviews” that sifted through available studies, selected ones with high-quality evidence and analyzed the findings. The bottom line from this approach: Some observational studies did show an increased risk linked with Depo use, and others did not. In fact, the conclusions from the most recent systematic review emphasized the ongoing uncertainty around the subject and the need for all women, including those using Depo and other injectables, to be counseled and empowered to access and use male and female condoms and other HIV prevention tools.

Those systematic reviews did not perform statistical analyses that pooled all of the results of the different studies to come up with a single numerical estimate of risk. The Ralph paper did—and this is what makes it both new and particularly prone to alarmist headlines.

The authors argue that the 40 percent estimate of increased risk linked to Depo use should be used to guide more precise models of the impact of Depo on HIV infections in different settings. These models calculate the relative contribution to new HIV infections given different theoretical estimates of the risk associated with Depo use. Such models have been developed to show how much of an impact Depo would have to have on HIV risk to make the number of new infections outweigh the risk of unplanned pregnancy for women. Here, too, it’s important to understand the scenarios in question. Some of the models suggest that the choice is Depo or nothing—which is not necessarily a realistic assessment.

The authors pick up on this theme, arguing that the moderate risk associated with Depo use should be weighed against the risks of maternal morbidity and mortality if Depo is “banned.” This is a misleading analysis: In the many discussions at the World Health Organization, country, and community level that have taken place in the past few years on this issue, there is no scenario or proposal in which Depo would be banned or even removed from programs without provision of a comparable alternative.

Instead, the relevant proposals and programs—as exemplified by South Africa’s new contraceptive policy—seek to expand “method mix” (the range of options women can choose from). Specifically, the proposals and programs identified by advocates, funders, and many other stakeholders focus on expanding the use of other long-acting, discreet methods such as implants and the intrauterine device (IUD) that could be used instead of Depo by women making informed choices based on what is known and unknown about all the options available.

That said, having a more precise estimate to use in models can help policymakers, communicators, advocates, and program implementers have more informed conversations about what to do given the current uncertainty. It’s also really important to remember that all of the models conclude that the question of whether Depo increases risk is of greatest relevance in East and Southern Africa, where injectable contraceptive use—Depo is often one of a very limited number of contraceptive options available—and HIV rates are both high.

Every time a new study about Depo and other hormonal contraception and HIV comes out, women ask their peers, the Internet, or the Twitterverse, what it means for them. The meta-analysis isn’t designed to provide guidance for individuals per se, and the authors steer clear of it. So we’re left with existing guidance and precedent to help make practical suggestions. A few things stand out: For the individual Depo user, the reality is that there is uncertainty about how this contraceptive method affects her risk of HIV. But there are data that suggest that Depo use might increase risk of HIV acquisition. Women who don’t know their partners’ status, or do know that they have an HIV-positive partner, or who have many partners and are concerned about HIV, should be using condoms, and this has always been the case. Women using Depo who fall into these categories can consider switching contraceptive methods if there is another one that is available that meets their needs—but it is an individual choice, and there is no normative guidance (such as from the WHO) that says what the best alternative option is.

In addition, one interpretation of the study’s results is that there is an urgent need for a trial that would use a randomized design to directly measure HIV rates of women using three different methods: Depo, the Jadelle implant, and the copper IUD. This type of trial design would eliminate many of the biases associated with observational data and could provide much-needed clarity on the issue. It would also gather data on newer methods, such as the implant, which also contain hormones. Right now, there’s no information on the implant and HIV risk.

As the study authors and the authors of the commentary acknowledge, there has been a lot of debate and discussion about such a trial. AVAC has worked in coalition with ICW East Africa, the ATHENA Network, and many other women’s organizations to articulate the urgent need for clarity on the relationship between HIV risk and Depo, and other hormonal contraceptive methods. We have articulated the need for a trial that provides clarity and shifts policy.

But this is one viewpoint. There is a robust civil society constituency following the issues around hormonal contraception and HIV. Members of this dialogue have diverse views on whether a randomized trial is the correct path. This study is a potent reminder that this issue needs all hands on deck to clarify what is known and unknown, and to help articulate that the way forward doesn’t hinge on one number, one trial, or one opinion. HIV programming and family planning must address the uncertainty with clear messages on the risks and benefits of all methods; invest in increased method mix today; and sustain investment in developing new contraceptive, HIV prevention and, especially, multi-purpose prevention options that could, in the future, reduce HIV risk and prevent unwanted pregnancies. It is a multi-faceted approach to match the multi-faceted reality of women’s health needs—that may not fit in a headline, but it’s the honest truth and an urgent priority.

News Abortion

Study: United States a ‘Stark Outlier’ in Countries With Legal Abortion, Thanks to Hyde Amendment

Nicole Knight Shine

The study's lead author said the United States' public-funding restriction makes it a "stark outlier among countries where abortion is legal—especially among high-income nations."

The vast majority of countries pay for abortion care, making the United States a global outlier and putting it on par with the former Soviet republic of Kyrgyzstan and a handful of Balkan States, a new study in the journal Contraception finds.

A team of researchers conducted two rounds of surveys between 2011 and 2014 in 80 countries where abortion care is legal. They found that 59 countries, or 74 percent of those surveyed, either fully or partially cover terminations using public funding. The United States was one of only ten countries that limits federal funding for abortion care to exceptional cases, such as rape, incest, or life endangerment.

Among the 40 “high-income” countries included in the survey, 31 provided full or partial funding for abortion care—something the United States does not do.

Dr. Daniel Grossman, lead author and director of Advancing New Standards in Reproductive Health (ANSIRH) at the University of California (UC) San Francisco, said in a statement announcing the findings that this country’s public-funding restriction makes it a “stark outlier among countries where abortion is legal—especially among high-income nations.”

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The researchers call on policymakers to make affordable health care a priority.

The federal Hyde Amendment (first passed in 1976 and reauthorized every year thereafter) bans the use of federal dollars for abortion care, except for cases of rape, incest, or life endangerment. Seventeen states, as the researchers note, bridge this gap by spending state money on terminations for low-income residents. Of the 14.1 million women enrolled in Medicaid, fewer than half, or 6.7 million, live in states that cover abortion services with state funds.

This funding gap delays abortion care for some people with limited means, who need time to raise money for the procedure, researchers note.

As Jamila Taylor and Yamani Hernandez wrote last year for Rewire, “We have heard first-person accounts of low-income women selling their belongings, going hungry for weeks as they save up their grocery money, or risking eviction by using their rent money to pay for an abortion, because of the Hyde Amendment.”

Public insurance coverage of abortion remains controversial in the United States despite “evidence that cost may create a barrier to access,” the authors observe.

“Women in the US, including those with low incomes, should have access to the highest quality of care, including the full range of reproductive health services,” Grossman said in the statement. “This research indicates there is a global consensus that abortion care should be covered like other health care.”

Earlier research indicated that U.S. women attempting to self-induce abortion cited high cost as a reason.

The team of ANSIRH researchers and Ibis Reproductive Health uncovered a bit of good news, finding that some countries are loosening abortion laws and paying for the procedures.

“Uruguay, as well as Mexico City,” as co-author Kate Grindlay from Ibis Reproductive Health noted in a press release, “legalized abortion in the first trimester in the past decade, and in both cases the service is available free of charge in public hospitals or covered by national insurance.”

Analysis Abortion

‘Pro-Life’ Pence Transfers Money Intended for Vulnerable Households to Anti-Choice Crisis Pregnancy Centers

Jenn Stanley

Donald Trump's running mate has said that "life is winning in Indiana"—and the biggest winner is probably a chain of crisis pregnancy centers that landed a $3.5 million contract in funds originally intended for poor Hoosiers.

Much has been made of Republican Gov. Mike Pence’s record on LGBTQ issues. In 2000, when he was running for U.S. representative, Pence wrote that “Congress should oppose any effort to recognize homosexual’s [sic] as a ‘discreet and insular minority’ [sic] entitled to the protection of anti-discrimination laws similar to those extended to women and ethnic minorities.” He also said that funds meant to help people living with HIV or AIDS should no longer be given to organizations that provide HIV prevention services because they “celebrate and encourage” homosexual activity. Instead, he proposed redirecting those funds to anti-LGBTQ “conversion therapy” programs, which have been widely discredited by the medical community as being ineffective and dangerous.

Under Pence, ideology has replaced evidence in many areas of public life. In fact, Republican presidential nominee Donald Trump has just hired a running mate who, in the past year, has reallocated millions of dollars in public funds intended to provide food and health care for needy families to anti-choice crisis pregnancy centers.

Gov. Pence, who declined multiple requests for an interview with Rewire, has been outspoken about his anti-choice agenda. Currently, Indiana law requires people seeking abortions to receive in-person “counseling” and written information from a physician or other health-care provider 18 hours before the abortion begins. And thanks, in part, to other restrictive laws making it more difficult for clinics to operate, there are currently six abortion providers in Indiana, and none in the northern part of the state. Only four of Indiana’s 92 counties have an abortion provider. All this means that many people in need of abortion care are forced to take significant time off work, arrange child care, and possibly pay for a place to stay overnight in order to obtain it.

This environment is why a contract quietly signed by Pence last fall with the crisis pregnancy center umbrella organization Real Alternatives is so potentially dangerous for Indiana residents seeking abortion: State-subsidized crisis pregnancy centers not only don’t provide abortion but seek to persuade people out of seeking abortion, thus limiting their options.

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“Indiana is committed to the health, safety, and wellbeing [sic] of Hoosier families, women, and children,” reads the first line of the contract between the Indiana State Department of Health and Real Alternatives. The contract, which began on October 1, 2015, allocates $3.5 million over the course of a year for Real Alternatives to use to fund crisis pregnancy centers throughout the state.

Where Funding Comes From

The money for the Real Alternatives contract comes from Indiana’s Temporary Assistance for Needy Families (TANF) block grant, a federally funded, state-run program meant to support the most vulnerable households with children. The program was created by the 1996 Personal Responsibility and Work Opportunity Reconciliation Act signed by former President Bill Clinton. It changed welfare from a federal program that gave money directly to needy families to one that gave money, and a lot of flexibility with how to use it, to the states.

This TANF block grant is supposed to provide low-income families a monthly cash stipend that can be used for rent, child care, and food. But states have wide discretion over these funds: In general, they must use the money to serve families with children, but they can also fund programs meant, for example, to promote marriage. They can also make changes to the requirements for fund eligibility.

As of 2012, to be eligible for cash assistance in Indiana, a household’s maximum monthly earnings could not exceed $377, the fourth-lowest level of qualification of all 50 states, according to a report by the Congressional Research Service. Indiana’s program also has some of the lowest maximum payouts to recipients in the country.

Part of this is due to a 2011 work requirement that stripped eligibility from many families. Under the new work requirement, a parent or caretaker receiving assistance needs to be “engaged in work once the State determines the parent or caretaker is ready to engage in work,” or after 24 months of receiving benefits. The maximum time allowed federally for a family to receive assistance is 60 months.

“There was a TANF policy change effective November 2011 that required an up-front job search to be completed at the point of application before we would proceed in authorizing TANF benefits,” Jim Gavin, a spokesman for the state’s Family and Social Services Administration (FSSA), told Rewire. “Most [applicants] did not complete the required job search and thus applications were denied.”

Unspent money from the block grant can be carried over to following years. Indiana receives an annual block grant of $206,799,109, but the state hasn’t been using all of it thanks to those low payouts and strict eligibility requirements. The budget for the Real Alternatives contract comes from these carry-over funds.

According to the U.S. Department of Health and Human Services, TANF is explicitly meant to clothe and feed children, or to create programs that help prevent “non-marital childbearing,” and Indiana’s contract with Real Alternatives does neither. The contract stipulates that Real Alternatives and its subcontractors must “actively promote childbirth instead of abortion.” The funds, the contract says, cannot be used for organizations that will refer clients to abortion providers or promote contraceptives as a way to avoid unplanned pregnancies and sexually transmitted infections.

Parties involved in the contract defended it to Rewire by saying they provide material goods to expecting and new parents, but Rewire obtained documents that showed a much different reality.

Real Alternatives is an anti-choice organization run by Kevin Bagatta, a Pennsylvania lawyer who has no known professional experience with medical or mental health services. It helps open, finance, and refer clients to crisis pregnancy centers. The program started in Pennsylvania, where it received a $30 million, five-year grant to support a network of 40 subcontracting crisis pregnancy centers. Auditor General Eugene DePasquale called for an audit of the organization between June 2012 and June 2015 after hearing reports of mismanaged funds, and found $485,000 in inappropriate billing. According to the audit, Real Alternatives would not permit DHS to review how the organization used those funds. However, the Pittsburgh Post-Gazette reported in April that at least some of the money appears to have been designated for programs outside the state.

Real Alternatives also received an $800,000 contract in Michigan, which inspired Gov. Pence to fund a $1 million yearlong pilot program in northern Indiana in the fall of 2014.

“The widespread success [of the pilot program] and large demand for these services led to the statewide expansion of the program,” reads the current $3.5 million contract. It is unclear what measures the state used to define “success.”

 

“Every Other Baby … Starts With Women’s Care Center”

Real Alternatives has 18 subcontracting centers in Indiana; 15 of them are owned by Women’s Care Center, a chain of crisis pregnancy centers. According to its website, Women’s Care Center serves 25,000 women annually in 23 centers throughout Florida, Illinois, Indiana, Michigan, Minnesota, Ohio, and Wisconsin.

Women’s Care Centers in Indiana received 18 percent of their operating budget from state’s Real Alternatives program during the pilot year, October 1, 2014 through September 30, 2015, which were mostly reimbursements for counseling and classes throughout pregnancy, rather than goods and services for new parents.

In fact, instead of the dispensation of diapers and food, “the primary purpose of the [Real Alternatives] program is to provide core services consisting of information, sharing education, and counseling that promotes childbirth and assists pregnant women in their decision regarding adoption or parenting,” the most recent contract reads.

The program’s reimbursement system prioritizes these anti-choice classes and counseling sessions: The more they bill for, the more likely they are to get more funding and thus open more clinics.

“This performance driven [sic] reimbursement system rewards vendor service providers who take their program reimbursement and reinvest in their services by opening more centers and hiring more counselors to serve more women in need,” reads the contract.

Classes, which are billed as chastity classes, parenting classes, pregnancy classes, and childbirth classes, are reimbursed at $21.80 per client. Meanwhile, as per the most recent contract, counseling sessions, which are separate from the classes, are reimbursed by the state at minimum rates of $1.09 per minute.

Jenny Hunsberger, vice president of Women’s Care Center, told Rewire that half of all pregnant women in Elkhart, LaPorte, Marshall, and St. Joseph Counties, and one in four pregnant women in Allen County, are clients of their centers. To receive any material goods, such as diapers, food, and clothing, she said, all clients must receive this counseling, at no cost to them. Such counseling is billed by the minute for reimbursement.

“When every other baby born [in those counties] starts with Women’s Care Center, that’s a lot of minutes,” Hunsberger told Rewire.

Rewire was unable to verify exactly what is said in those counseling sessions, except that they are meant to encourage clients to carry their pregnancies to term and to help them decide between adoption or child rearing, according to Hunsberger. As mandated by the contract, both counseling and classes must “provide abstinence education as the best and only method of avoiding unplanned pregnancies and sexually transmitted infections.”

In the first quarter of the new contract alone, Women’s Care Center billed Real Alternatives and, in turn, the state, $239,290.97; about $150,000 of that was for counseling, according to documents obtained by Rewire. In contrast, goods like food, diapers, and other essentials for new parents made up only about 18.5 percent of Women’s Care Center’s first-quarter reimbursements.

Despite the fact that the state is paying for counseling at Women’s Care Center, Rewire was unable to find any licensing for counselors affiliated with the centers. Hunsberger told Rewire that counseling assistants and counselors complete a minimum training of 200 hours overseen by a master’s level counselor, but the counselors and assistants do not all have social work or psychology degrees. Hunsberger wrote in an email to Rewire that “a typical Women’s Care Center is staffed with one or more highly skilled counselors, MSW or equivalent.”

Rewire followed up for more information regarding what “typical” or “equivalent” meant, but Hunsberger declined to answer. A search for licenses for the known counselors at Women’s Care Center’s Indiana locations turned up nothing. The Indiana State Department of Health told Rewire that it does not monitor or regulate the staff at Real Alternatives’ subcontractors, and both Women’s Care Center and Real Alternatives were uncooperative when asked for more information regarding their counseling staff and training.

Bethany Christian Services and Heartline Pregnancy Center, Real Alternatives’ other Indiana subcontractors, billed the program $380.41 and $404.39 respectively in the first quarter. They billed only for counseling sessions, and not goods or classes.

In a 2011 interview with Philadelphia City Paper, Kevin Bagatta said that Real Alternatives counselors were not required to have a degree.

“We don’t provide medical services. We provide human services,” Bagatta told the City Paper.

There are pregnancy centers in Indiana that provide a full range of referrals for reproductive health care, including for STI testing and abortion. However, they are not eligible for reimbursement under the Real Alternatives contract because they do not maintain an anti-choice mission.

Parker Dockray is the executive director of Backline, an all-options pregnancy resource center. She told Rewire that Backline serves hundreds of Indiana residents each month, and is overwhelmed by demand for diapers and other goods, but it is ineligible for the funding because it will refer women to abortion providers if they choose not to carry a pregnancy to term.

“At a time when so many Hoosier families are struggling to make ends meet, it is irresponsible for the state to divert funds intended to support low-income women and children and give it to organizations that provide biased pregnancy counseling,” Dockray told Rewire. “We wish that Indiana would use this funding to truly support families by providing job training, child care, and other safety net services, rather than using it to promote an anti-abortion agenda.”

“Life Is Winning in Indiana”

Time and again, Bagatta and Hunsberger stressed to Rewire that their organizations do not employ deceitful tactics to get women in the door and to convince them not to have abortions. However, multiple studies have proven that crisis pregnancy centers often lie to women from the moment they search online for an abortion provider through the end of their appointments inside the center.

These studies have also shown that publicly funded crisis pregnancy centers dispense medically inaccurate information to clients. In addition to spreading lies like abortion causing infertility or breast cancer, they are known to give false hopes of miscarriages to people who are pregnant and don’t want to be. A 2015 report by NARAL Pro-Choice America found this practice to be ubiquitous in centers throughout the United States, and Rewire found that Women’s Care Center is no exception. The organization’s website says that as many as 40 percent of pregnancies end in natural miscarriage. While early pregnancy loss is common, it occurs in about 10 percent of known pregnancies, according to the American Congress of Obstetricians and Gynecologists.

Crisis pregnancy centers also tend to crop up next to abortion clinics with flashy, deceitful signs that lead many to mistakenly walk into the wrong building. Once inside, clients are encouraged not to have an abortion.

A Google search for “abortion” and “Indianapolis” turns up an ad for the Women’s Care Center as the first result. It reads: “Abortion – Indianapolis – Free Ultrasound before Abortion. Located on 86th and Georgetown. We’re Here to Help – Call Us Today: Abortion, Ultrasound, Locations, Pregnancy.”

Hunsberger denies any deceit on the part of Women’s Care Center.

“Clients who walk in the wrong door are informed that we are not the abortion clinic and that we do not provide abortions,” Hunsberger told Rewire. “Often a woman will choose to stay or return because we provide services that she feels will help her make the best decision for her, including free medical-grade pregnancy tests and ultrasounds which help determine viability and gestational age.”

Planned Parenthood of Indiana and Kentucky told Rewire that since Women’s Care Center opened on 86th and Georgetown in Indianapolis, many patients looking for its Georgetown Health Center have walked through the “wrong door.”

“We have had patients miss appointments because they went into their building and were kept there so long they missed their scheduled time,” Judi Morrison, vice president of marketing and education, told Rewire.

Sarah Bardol, director of Women’s Care Center’s Indianapolis clinic, told the Criterion Online Edition, a publication of the Archdiocese of Indianapolis, that the first day the center was open, a woman and her boyfriend did walk into the “wrong door” hoping to have an abortion.

“The staff of the new Women’s Care Center in Indianapolis, located just yards from the largest abortion provider in the state, hopes for many such ‘wrong-door’ incidents as they seek to help women choose life for their unborn babies,” reported the Criterion Online Edition.

If they submit to counseling, Hoosiers who walk into the “wrong door” and “choose life” can receive up to about $40 in goods over the course their pregnancy and the first year of that child’s life. Perhaps several years ago they may have been eligible for Temporary Assistance for Needy Families, but now with the work requirement, they may not qualify.

In a February 2016 interview with National Right to Life, one of the nation’s most prominent anti-choice groups, Gov. Pence said, “Life is winning in Indiana.” Though Pence was referring to the Real Alternatives contract, and the wave of anti-choice legislation sweeping through the state, it’s not clear what “life is winning” actually means. The state’s opioid epidemic claimed 1,172 lives in 2014, a statistically significant increase from the previous year, according to the Centers for Disease Control and Prevention. HIV infections have spread dramatically throughout the state, in part because of Pence’s unwillingness to support medically sound prevention practices. Indiana’s infant mortality rate is above the national average, and infant mortality among Black babies is even higher. And Pence has reduced access to prevention services such as those offered by Planned Parenthood through budget cuts and unnecessary regulations—while increasing spending on anti-choice crisis pregnancy centers.

Gov. Pence’s track record shows that these policies are no mistake. The medical and financial needs of his most vulnerable constituents have taken a backseat to religious ideology throughout his time in office. He has literally reallocated money for poor Hoosiers to fund anti-choice organizations. In his tenure as both a congressman and a governor, he’s proven that whether on a national or state level, he’s willing to put “pro-life” over quality-of-life for his constituents.