The hormonal Intrauterine Device (IUD) is a popular contraceptive choice where it is available.(1) The highly effective and reversible method releases a low dose of the hormone levonorgestrel into the uterus. The hormonal IUD offers unique therapeutic and non-contraceptive benefits, such as lighter bleeding and relief from menstrual pain, and reduced side effects relative to other hormonal methods.(2) In the United States, where the Mirena® brand of hormonal IUD was first marketed in 2001, the method has contributed to an increase in the prevalence of all Intrauterine Devices (IUDs) among American women using contraception, from 2% of the method mix in 2000 to more than 12% in 2014.(3) The hormonal IUD has also provided an alternative for women who may otherwise turn to a more invasive hysterectomy procedures for treatment of menorrhagia and conditions such as endometriosis.(4) Rates of hormonal IUD satisfaction and continuation are high;(5) however, most of the evidence generated to date has been from high-income markets.
The hormonal IUD has remained widely inaccessible for populations in low- and middle-income countries (LMICs), with product cost as a key barrier. Low volumes of commercially available hormonal IUD products, from suppliers such as Bayer and Pregna, are available in some LMIC countries. A range of costs to the client have been documented at up to $400, putting the method out of reach for the majority of the population.(1) Since 2003, the International Contraceptive Access (ICA) Foundation, a public-private partnership between Bayer Pharmaceuticals and the Population Council, has donated limited quantities of an unbranded hormonal IUD product to organizations in 36 countries that offer women free or low-cost family planning services, with roughly 21,000 units donated per year between 2017–2019.(6)
Affordability of the hormonal IUD has improved with recent shifts in the global supply landscape. In 2015, the US Food and Drug Administration approved a lower cost hormonal IUD from Medicines360, a non-profit pharmaceutical company. Medicines360 registered their product under the brand name Avibela® in four African countries, as of 2020. Global health stakeholders and procurement agencies have shown increased interest in the potential to expand method choice with the hormonal IUD in LMIC markets.(1)
In 2015, The United States Agency for International Development (USAID) convened the Hormonal IUD Technical Working Group. This coordination group aims to increase the range of highly effective contraceptive options available to women through a commitment to strengthen the body of evidence for the hormonal IUD. The group includes donors, suppliers, research agencies, and service delivery organizations that work together to explore and address the barriers that have, thus far, excluded the hormonal IUD from developing markets.[1] This research was designed to meet the need for stronger evidence in these contexts. In 2021, both USAID and UNFPA added the method to their commodity procurement catalogs, meaning the hormonal IUD will soon be available for widespread procurement through regular commodity procurement channels. This research will continue to inform global efforts for introduction and scaled-up access to this method.
1.1 Introduction of the hormonal IUD into LMIC programs
From 2017 to 2020, Population Services International (PSI) introduced the hormonal IUD in three countries through two projects funded by USAID. Through the Expanding Effective Contraceptive Options (EECO) project led by WCG Cares (WCG), PSI added the hormonal IUD to voluntary family planning programs in Madagascar and Zambia. Through the Support for International Family Planning and Health Organizations 2 (SIFPO2) project, PSI did the same in Nigeria. These countries were selected for introduction with the aim of understanding the uptake and acceptability of the hormonal IUD in both public and private sectors with varying demand generation strategies, all within the context of access to a broad mix of methods. This evidence will be used to improve, and potentially further expand, global efforts to introduce the hormonal IUD.
The three programs took place in countries where a minority of women use contraception. According to Track20, the modern contraceptive prevalence rates (mCPR) in 2019 among all women are 36% in Madagascar, 14% in Nigeria, and 35% in Zambia. Method skew, which can signal that women have too few contraceptive options, is particularly evident in Madagascar, where more than 60% of contraceptive users use injectables. In Nigeria and Zambia, injectables, oral contraceptive pills, implants, and condoms are the most widely used methods. IUD use is low in all three countries.(7–9)
PSI Madagascar and the Society for Family Health (SFH) Nigeria began offering the hormonal IUD through private facilities in their social franchise networks beginning in 2018 and 2017, respectively. These social franchises comprise private clinics supported by PSI with medical training in all methods (including copper IUDs and implants) and continuing education, supportive supervision for quality assurance, medical equipment, and consumables. At these sites, clients paid a service fee to receive a voluntary hormonal IUD insertion. In contrast, SFH Zambia offered the hormonal IUD through public facilities where all methods are free. Master trainers led the provider trainings in the hormonal IUD and supervised insertion and removal procedures until providers met competency requirements.
The three programs raised community awareness of the new method within the context of informed choice. Interpersonal Communication (IPC) agents working for PSI Madagascar and SFH Nigeria spoke with individuals and groups about the range of family planning methods available, including the hormonal IUD, and made referrals to providers for balanced counseling and a wide range of family planning methods. In Nigeria, this IPC support for demand generation was programmed only at one quarter of facilities offering the hormonal IUD. In Zambia, public sector IPC agents included the hormonal IUD in their communication with communities about family planning and many other health areas. The Madagascar program also used hormonal IUD promotional materials, including clinic wall posters that highlighted the potential for lighter periods as a primary benefit of the hormonal IUD.
To understand the introduction of the hormonal IUD into these three LMIC markets from the user perspective, PSI designed an accompanying pilot study to descriptively explore key questions related to the programmatic introduction of this new method. The primary objectives were to understand: 1) What are the demographic profiles of the clients who will use this product?; 2) Does introduction of the hormonal IUD help reach new modern contraceptive users (current non-users)?; 3) Do users of the hormonal IUD ‘switch’ from other methods and if so, from what other methods (e.g., from short-acting methods)?; 4) Do users experience a high level of satisfaction with this method?; and 5) What are continuation rates at 12 months and reasons for removal?