Reproductive health concerns have profound effects on both individual lives and societies. Globally, 89 million unintended pregnancies, nearly 870,000 new HIV infections, and millions more other sexually transmitted infections occur among women each year.
In the global fight against the HIV pandemic, a key milestone was the 2012 introduction of oral PrEP, a daily pill that, if taken correctly and consistently, prevents HIV transmission. Oral PrEP remains the only drug for this purpose, and it isn’t easy for everyone, especially younger women, to adhere to the daily routine without occasional missed doses.
Contraception, meanwhile, is available in many forms, but each has its own pros and cons. Women have different characteristics that they prefer. Some women want a long-acting method, others want one that’s quickly reversible, and still others value discretion above all other qualities. The users’ priorities are as diverse as their circumstances.
RTI’s work in global health and gender equity has led us to work on many HIV prevention projects, especially in sub-Saharan Africa, where the risk of HIV infection is greatest. In 2013, with funding from USAID, and later in 2016, with additional funds from the Bill and Melinda Gates Foundation, we began working on an implantable long-acting HIV prevention device. Known as TIP, this ongoing program merges our experience in HIV prevention with our decades of work in medical device innovation.
SCHIELD has successfully expanded the achievements of TIP. Launched in 2017, the USAID-funded SCHIELD project aims to create a multipurpose prevention technology (MPT) implantable product that provides both contraception and HIV prevention. This MPT implant offers a combination of attributes that surpass existing delivery systems: user independence, biodegradation, long-term protection, and discretion of use. It adds to women’s options in that it is removable in the event of a serious adverse reaction or a woman’s desire for return to fertility. As a biodegradable product, there is no need for device removal after depletion of the drug, eliminating the necessity for follow-up visits to a health care clinic, a known burden on end-users and health care providers (HCPs).
Over the past year, the SCHIELD team made critical advancements in optimizing the drug formulations and device configuration. In in vitro studies, we achieved sustained release of both antiretroviral (ARV) and hormonal contraceptive with a constant release rate over 12 months. In collaboration with the Magee-Womens Research Institute and Foundation at the University of Pittsburgh, we completed our first in vivo preclinical study and demonstrated a drug-delivery duration of three months. Current goals include extending the implant therapeutic duration to six or even 12 months. Results from these studies are critical to the continued advancement and optimization of the MPT implant.
To optimize future uptake of this technology by women and HCPs globally, we have also incorporated end-user feedback into early stage of product development. Working with partners in South Africa and Zimbabwe, we have conducted interviews and focus groups of health care providers and potential end users, exploring their preferences for the implants along with potential future marketing strategies.
The way I see it, SCHIELD implant is the best compared to other implants available. Actually, it's excellent because it's 2-in-1 and it does not have to be removed. This means less pain.
Early-stage feedback from end users is crucial to the implant’s future success. The findings from our qualitative studies help inform the research chemists and engineers who are combining their expertise to create the implant. Some of its features include:
- Consistent dosing of both contraceptive and HIV preventive drugs
- Effective for at least 1 year
- Removable if desired or needed, but also biodegradable, to avoid the pain of removal or cost and time associated with a clinic visit
- Flexible when palpating, so health providers can find and remove it easily, but discreet for the user
End users in these focus groups who had given birth before preferred the longest possible duration offered, which was 3 years. However, we learned that women who have never had children tended to prefer a device that would be effective for 1 to 2 years. Because they also face a higher risk of HIV infection, they may be the ideal audience for our implant.
I think that, it’s ok not to have it removed because if I think of the removal, I think of the pain. And that pain is what sometimes makes a woman avoid going for removal.
Future avenues of research include whether similar implants could be used to treat cancer, other infectious diseases, and opioid use disorder. Our hope is that the implants we develop will impact end-users by providing a new option for contraception and HIV prevention, seamlessly integrated into women’s lives, making it easier for them to plan pregnancies and protect themselves from HIV, even in high-risk circumstances.