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Lessons Learned from the History of Contraception are Relevant for HIV PrEP Implementation

Achieving widespread and appropriate use of HIV pre-exposure prophylaxis (PrEP) will take several years and will require considerable attention to the shape and quality of health services, according to a commentary in the January edition ofCurrent Opinion in HIV and AIDS from researchers who have looked at the way in which contraceptive methods have been introduced.

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"With 5 decades of experience with development and implementation, contraception has a lot to offer the PrEP field in terms of lessons learned for new method introduction," Sinead Delany-Moretlwe and colleagues write in the January issue of Current Opinion in HIV and AIDS. "A narrow focus on promotion of a new technology alone will not increase choice; service delivery systems and providers are equally important to the success of PrEP introduction."

The Introduction of the Pill

This is not the first time that the history of contraception has been reviewed in order to identify parallels with PrEP. Writing 3 years ago in Clinical Infectious Diseases, Julie Myers and Kent Sepkowitz noted that American controversies around the oral contraceptive pill are similar to those surrounding the introduction of PrEP.

Prior to its introduction in the U.S. in 1960, many doubted that large numbers of women would want to take a medication in order to prevent pregnancy, and pharmaceutical companies did not believe the market had much potential. Scale-up was slowed by its high initial cost, equivalent to around $80 a month in today’s prices. This, together with a need for regular clinic visits, created economic and logistical hurdles that only more socially privileged women could overcome, said Myers and Sepkowitz.

After some years, however, subsidized programs and government funding helped to narrow inequalities in access. Moreover, media coverage, word of mouth endorsement, and promotion by pharmaceutical companies led to a swell of interest and acceptance. Women actively sought out the pill from their doctors.

Similarly, the high cost of PrEP makes it controversial for some, publicly funded PrEP programs are only available in a few areas, and there is a risk that its use may exacerbate health disparities by only protecting those able to afford it. Since the article was published, awareness of PrEP has grown considerably in gay communities.

As with PrEP, there was concern about the potential side effects of the contraceptive pill, as medications taken by healthy people are expected to be safer than those used to treat an illness. While the contraceptive pill’s short-term side effects were understood, its long-term safety profile was initially unclear. Evidence of a raised risk of deep vein thrombosis only emerged after a few years and resulted in necessary changes in the way the pill was prescribed.

The authors noted that, as with initial contraceptive research, most participants in PrEP studies were located outside of the U.S. "While safety seems promising for emtricitabine/tenofovir [the drugs in Truvada PrEP], we should expect some surprises as use is scaled up to populations who were not included in the clinical trials," they argued.

Most famously, the contraceptive pill was thought by some to promote promiscuity and to have led to a "sexual revolution" in the 1960s and 1970s. Similarly, some predict that PrEP will result in reductions in condom use and increases in sexually transmitted infections.

However, the authors suggested that both claims ignore gradual, ongoing changes in sexual norms that had begun before the new medical technologies were introduced. "Changes in behavior should not automatically be blamed on the new HIV prevention pill," they said.

Method Mix and Health Services

The more recent article by Delany-Moretlwe and colleagues draws on some of the more recent history, especially in lower and middle income countries. They note that increasing choice by introducing new contraceptive products has been seen as key to increasing the use of contraception. In places where a wide range of delivery systems are available, both short-acting (e.g., pills and diaphragms) and long-acting (e.g., implants and injections), usage tends to be higher.

This suggests that adding PrEP to the range of HIV prevention options that are already available will increase the number of people who are protected in some way from HIV. Moreover, the option of non-daily dosing of PrEP, and the possible future development of PrEP as a long-acting injection or a vaginal ring, would increase usage.

Despite such innovations, adherence may remain imperfect. Even among women using contraceptive injections, discontinuation rates are high, users often switch between methods, and they are frequently late for their next injection. In some cases, this is due to failings in health services. For example, services may be difficult or costly to access, or staff may not have warned users about the potential for side effects.

Delany-Moretlwe and colleagues warn that if health services are unable or unwilling to deliver new health technologies with good quality care, then the potential of the new products may not be realized. "Too often, the focus on product development leads to a focus on a single technology, and not on investing in the larger programmatic and policy initiatives that are essential to product uptake and use," they write.

The first-generation of oral PrEP products have complex requirements, including monitoring for side effects and drug resistance. While this may suggest delivery by providers who have experience with antiretrovirals, they may not reach those needing PrEP.

"The channels through which products reach users are important for ensuring access," the authors say. Efforts which attempt to integrate PrEP into existing HIV prevention programs or health services -- such as reproductive health services for women -- will need to be carefully evaluated. The experience with contraception shows that institutional changes to health services are difficult to achieve and to maintain, for example when the results from pilot projects are transferred to larger settings.

In the case of contraception, medical barriers to access have been removed as increasing evidence of safety has emerged. Products may be available over the counter or through community-based distribution agents. Although this expanded access has occasionally come at the cost of lower quality provision and monitoring, similar efforts will need to be made for PrEP. "All possible mechanisms for providing access to PrEP will need to be explored to ensure that PrEP is accessible to those with the greatest need," Delany-Moretlwe and colleagues argue.

Both contraception and PrEP draw attention to the broader social, economic, and political context in which sexual relationships occur. Although they both have the potential to be empowering technologies, uptake may be limited where gender inequalities are strong. Adolescents may be prevented from accessing contraception by official policies or due to healthcare providers' personal views about young people’s sexual activity. Marginalized "key populations" such as sex workers and men who have sex with men may have particular barriers to accessing health services.

But the authors say that if PrEP is primarily offered to specific groups, such as sex workers, then this risks undermining wider acceptance of the product. This has sometimes occurred with female condoms, but this has been avoided in other countries by providing female condoms in family planning clinics. If PrEP is to be successfully introduced, the needs and views of all users will need to be carefully considered.

The authors warn against expectations that PrEP will be an overnight success. Several different contraceptive methods have taken decades to be widely used, showing that slow initial uptake of a product should not be interpreted as a fundamental problem with acceptability. Products which require different practices from users, communities, or healthcare providers may take some time to get off the ground.

Conclusion

PrEP advocates can learn many lessons from contraception, Sinead Delany-Moretlwe and colleagues argue. "Perhaps the most important of these is that a narrow focus on a single technology alone is unlikely to solve health and social challenges associated with HIV," they write. "That, however, is no cause for inaction, but rather a call for innovation to expand the HIV prevention mix, to pay careful attention to access and service delivery issues and constraints, and to incorporate the views and perspectives of all stakeholders."

1/10/16

References

S Delany-Moretlwe, S Mullick, R Eakle, et al. Planning for HIV preexposure prophylaxis introduction: lessons learned from contraception. Current Opinion in HIV and AIDS 11(1):87-93. January 2016.

JE Myers and KA Sepkowitz. A Pill for HIV Prevention: Déjà Vu All Over Again? Clinical Infectious Diseases 56(11):1604-1612. June 2013.