What Have We Learned? Implementation of a Shared Learning Agenda and Access Strategy for the Hormonal Intrauterine Device

Kate H. Rademacher; Tabitha Sripipatana; Kendal Danna; Deborah Sitrin; Aurélie Brunie; Katie M. Williams; Kayode Afolabi; Francia Rasoanirina; Saumya Ramarao; Anne Pfitzer; Devon Cain; Morgan Simon; Elaine Menotti; Anna Hazelwood; Anthony Adindu Nwala; Zainab Saidu; Raveena Chowdhury; Anne Taiwo; Agnes Chidanyika; Gathari Ndirangu; Markus J. Steiner; Marie Chantale Lepine; Rick Homan; Abdulmumin Saad; John Vivalo; Laneta J. Dorflinger

doi:10.9745/GHSP-D-21-00789

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TABLE 1.

Organizations and Projects That Supported Implementation of a Shared Learning Agenda for the Hormonal IUD

Project Name and Description	Funder (Years)	Partner Organizations	References With Key Findings
The EECO project, led by Catalyst Global (formerly WCG Cares), supports the introduction of new and underutilized contraceptive technologies, including the hormonal IUD, in the context of method choice and volunteerism. The project produces roadmaps for product introduction which can be used to scale up access. Under EECO, PSI introduced the hormonal IUD in Zambia beginning in 2017 and Madagascar in 2018.	USAID (2013–2023)	Catalyst Global, PSI	Danna et al.²⁴
The SIFPO-2 project was intended to increase access to and use of high-quality, affordable family planning and other health information, products, and services globally.	USAID
In 2016, under the SIFPO-2 project, MSI and MSION supported expanded hormonal IUD provision in pilot settings in Nigeria.	(2016–2017)	MSI, MSION, FHI 360	Eva et al.¹⁸
PSI’s SIFPO-2 project introduced the hormonal IUD in Nigeria and Zimbabwe in 2017 in collaboration with SFH. (Note: Data from Zimbabwe are unpublished; findings not included in this summary article).	(2014–2021)	PSI, SFH	Same as for EECO project
MCSP focused on 25 high-priority countries to prevent child and maternal deaths. The program introduced and supported high-impact, sustainable reproductive, maternal, newborn and child health interventions in collaboration with ministries of health and other partners. MCSP supported the introduction of the hormonal IUD in Kenya starting in 2016 and in Zambia starting in 2017.	USAID (2014–2019)	Jhpiego	Sitrin et al.²⁰
LEAP Initiative generated timely, actionable evidence to help determine if and how expanded access to the hormonal IUD could increase contraceptive use and continuation rates in sub-Saharan Africa. FHI 360 implemented the initiative in partnership with PSI, SFH Nigeria and Zambia, and Catalyst Global.	Bill & Melinda Gates Foundation (2017–2022)	FHI 360, PSI, SFH	Brunie et al.²¹ Brunie et al.²² Brunie et al.²³ Brunie et al.¹⁹

Abbreviations: EECO, Expanding Effective Contraceptive Options; IUD, intrauterine device; LEAP, Learning about Expanded Access and Potential of the LNG-IUS; MCSP, Maternal and Child Survival Program; MSI, Marie Stopes International; MSION, Marie Stopes International Organisation Nigeria; PSI, Population Services International; SFH, Society for Family Health; SIFPO-2; Support for International Family Planning and Health Organizations; USAID, United States Agency for International Development.

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TABLE 2.

Research Studies That Were Designed to Respond to the Shared Learning Agenda for the Hormonal IUD

Project	Research Time Frame	Country	Participants at Baseline^a	Study Design	Geographic Region	Service Delivery Context	Project Overview
EECO	2018–2020	Madagascar	N=242	Longitudinal prospective survey within 12 months of insertion	Mahajanga, Toamasina, Antsiranana, and Antananarivo	19 social franchise clinics	Private sector Robust demand generation including to youth Higher price for clients for hormonal IUD compared to other LARCs
EECO	2018–2019	Zambia	N=166		Copperbelt and Muchinga	19 public sector clinics	Public sector Free product and services CHW support
SIFPO-2 (MSI)	2016–2017	Nigeria	N/A	Routine service data and supplemental hormonal IUD client data, in-depth interviews with providers	16 states	76 social franchise providers, 9 mobile outreach teams, 20 public-sector providers	Public and private sector Free product and services Included mobile outreach component
SIFPO-2 (PSI)	2017–2019	Nigeria	N=208	Longitudinal prospective survey within 12 months of insertion	18 states	40 social franchise clinics	Private sector Higher price for clients for hormonal IUD compared to other LARCs Limited CHW support
MCSP	2017–2019	Kenya	N=432^b	Provider-led “enhanced” data collection from their clients, follow-up phone interviews, focus group discussions with providers	Kisumu and Migori counties	42 public sector clinics	Public sector Free product and services
MCSP	2017–2019	Zambia	N=754^b		Eastern, Central, Southern, Luapula provinces	41 public sector clinics	Public sector Free product and services Focus on maternity services
LEAP	2018–2019	Nigeria	N=835^c	Mixed methods, prospective cohort studies; in-depth interviews with providers; focus group discussions with adolescent girls/youth; market research among potential users and providers	18 states	40 social franchise clinics	Private sector Higher price for clients for hormonal IUD compared to other LARCs Limited CHW support
LEAP	2018–2019	Zambia	N=607^c		Copperbelt and Muchinga	21 public sector clinics	Public sector Free product and service CHW support

Abbreviations: CHW, community health worker; EECO, Expanding Effective Contraceptive Options; IUD, intrauterine device; LARCs, long-acting reversible contraceptives; LEAP, Learning about Expanded Access and Potential; MCSP, Maternal and Child Survival Program; MSI, Marie Stopes International; PSI, Population Services International; SIFPO-2, Support for International Family Planning and Health Organizations.
↵a Number of participants in quantitative surveys at baseline.
↵b Baseline total includes hormonal IUD and copper IUD adopters.
↵c Baseline total includes hormonal IUD, copper IUD, and implant users. Longitudinal data were collected from 367 women.

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TABLE 3.

Shared Learning Agenda Questions That Were Addressed by Project^a

Shared Learning Agenda: 2015–2020	EECO	SIFPO2 (MSI)	SIFPO2 (PSI)	MCSP	LEAP
Shared Learning Agenda: 2015–2020	Madagascar, Zambia	Nigeria	Nigeria, Zimbabwe	Kenya, Zambia	Kenya, Nigeria, Zambia
A. Client demand
1. What are the profile(s) of the clients who will use this product?	X^b		X	X	X
a. Is there or would there be demand for this product among subpopulations with high unmet need for FP (e.g., women in lower wealth quintiles, PP women, adolescents, WLHIV, PAC clients)?	(x)^c		(x)	(x)	(x)
b. Will introduction of the hormonal IUD help reach new FP users (i.e., current non-users)?	X		X	(x)	X
c. To what degree will introduction of the hormonal IUD result in “switching” and from what methods?	X		X	(x)	X
2. Does the hormonal IUD have the potential to “revitalize” the IUD market in FP2020 countries?
a. Would demand for the hormonal IUD be higher than demand for the copper IUD has been?		(x)		(x)	(x)
3. Would introduction of the hormonal IUD increase FP use overall/increase contraceptive prevalence rate(s)?
a. Can scale-up of this product help meet FP2020 goals?
4. How do continuation rates of the hormonal IUD compare to continuation rates of other LARCs?	(x)		(x)	(x)	X
5. Does immediate postpartum access to the hormonal IUD increase use of postpartum FP overall?
B. Marketing
6. What are effective demand creation strategies with different populations and in different sectors?	(x)		(x)		(x)
7. Can promotion of FP including the hormonal IUD be integrated into other health sectors?				(x)
C. Service delivery
8. How can we overcome barriers that have impacted provision of copper IUD when introducing hormonal IUD?	(x)	(x)	(x)	(x)	(x)
9. What are health care providers' perceptions of this product?	X	X	X	X	X
10. What are effective service delivery models for hormonal IUD provision? How does it differ by context?	(x)	(x)	(x)	(x)	(x)
a. What are effective provider training strategies for the hormonal IUD?				(x)
D. Noncontraceptive attributes
11. How does knowledge of noncontraceptive attributes of the hormonal IUD affect uptake and use?	X	(x)	(x)		X
a. What noncontraceptive attributes are most attractive to women in different contexts?	X	(x)	(x)		X
b. What noncontraceptive attributes are seen as most beneficial by providers?	X	(x)	(x)	(x)	X
12. What are perceptions of amenorrhea among providers and various client segments?	(x)	(x)	(x)	(x)	X
13. Can scale-up of the hormonal IUD help reduce rates of anemia?
E. Cost-effectiveness and pricing
14. To what extent is the hormonal IUD cost-effective compared to other FP methods including other LARCs?					X
15. What is the willingness-to-pay for the hormonal IUD among different populations of clients/groups?					(x)

Abbreviations: EECO, Expanding Effective Contraceptive Options; FP, family planning; IUD, intrauterine device; LARCs, long-acting reversible contraceptives; LEAP, Learning about Expanded Access and Potential; MCSP, Maternal and Child Survival Program; MSI, Marie Stopes International; PAC, postabortion care; PP, postpartum; PSI, Population Services International; SIFPO-2, Support for International Family Planning and Health Organizations; WLHIV, women living with HIV.
↵a This table is intended to summarize evidence collected across countries and projects, but not all results are reflected in this synthesis paper. For additional results, refer to the Hormonal IUD Access Portal website at www.hormonaliud.org.
↵b X = data available.
↵c (x) = Some data collected but quantity/quality limited. Assessment of the current status of evidence based on review and assessment of existing data from each country and project.

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TABLE 4.
Overview of Hormonal IUD Products Approved by a Stringent Regulatory Authority and Available in Low-Income Countries^a
Supplier Quality-Assured Hormonal IUD Product Containing 52 mg LNG
Bayer AG^b Mirena
International Contraceptive Access Foundation Unbranded LNG IUS product
Medicines360 Avibela^c
Abbreviation: IUD, intrauterine device; LNG, levonorgestrel; SRA, stringent regulatory authority.
↵a In addition to the products listed in the table, several hormonal IUD products are being introduced in a limited number of FP2020/FP2030 countries that are not currently approved by an SRA. In 2022, Mirena was the first hormonal IUD product to be prequalified by the World Health Organization.
↵b Bayer AG also manufactures the lower-dose hormonal IUD products Skyla and Kyleena. However, these products are not yet available in low- and middle-income countries, and therefore are not discussed in this paper.
↵c The Medicines360 product is sold in the United States under trade name Liletta; the product is sold in FP2020/FP2030 countries under the trade name Avibela.

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TABLE 5.

Demographics for Hormonal IUD Adopters

Project (N at baseline)	EECO (N=242)	EECO (N=166)^a	SIFPO-2 (MSI) (N=286)^b	SIFPO-2 (PSI) (N=208)	MCSP (N=289)^c	MCSP (N=359)^c	LEAP (N=266)^d	LEAP (N=153)^d
	Madagascar	Zambia	Nigeria	Nigeria	Kenya	Zambia	Nigeria	Zambia
Age, years, %
<25	30.0	17.0	See below^e	6.0	41.0	21.0	8.0	22.0
25+	70.0	82.0	See below^e	94.0	55.0	72.0	92.0	78.0
Married, %	79.0	84.0	93.8	95.0	85.8	83.0	97.0	78.0
Mean parity	1.7	3.3	4.4	3.3	N/A^f	4.1	3.3	3.0
Secondary education or higher, %	82.0	52.0	69.5	89.0	57.0	45.0	86.0	50.0
Timing of insertion, %^g
Postpartum (<48 hours)					8.7	27.9
Postpartum (48 hours to 1 year)					52.6	30.1
Postabortion					0.4	4.3
Not post-pregnancy					37.4	36.2
Missing					1.0	1.5

Abbreviations: EECO, Expanding Effective Contraceptive Options; IUD, intrauterine device; LEAP, Learning about Expanded Access and Potential; MCSP, Maternal and Child Survival Program; MSI, Marie Stopes International; PSI, Population Services International; SIFPO-2, Support for International Family Planning and Health Organizations.
↵a While 166 respondents participated in the baseline and 155 respondents participated in the follow-up, not all respondents answered all survey questions. As a result, in Zambia proportions will not always equal 100%.
↵b Sociodemographic data available for 30% of hormonal IUD clients (n=286) although not all women answered all of the related questions.
↵c Study includes hormonal and copper IUD adopters, but table only includes hormonal IUD adopters.
↵d Study includes hormonal, copper IUD, and implant adopters, but table only includes hormonal IUD adopters.
↵e Of the available sociodemographic data for hormonal IUD adopters, the mean age was 34 years.
↵f Parity collected as categorical variable so mean parity not available. 49% of hormonal IUD adopters had parity 1–2, 30% had parity of 3–4, 15% had parity of 5+, and 4% had parity of 0.
↵g Data for “timing of insertion” for Kenya came from 289 hormonal IUD adopters; for Zambia, it came from 395 hormonal IUD adopters.

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TABLE 6.

Continuation Rates for Those Studies That Followed Clients Over Time

Time Frame	6 Months		12 Months
Project	LEAP		EECO		SIFPO-2 (PSI)	LEAP
	Nigeria, % (95% CI)	Zambia, % (95% CI)	Madagascar, % (95% CI)	Zambia, % (95% CI)	Nigeria, % (95% CI)	Nigeria, % (95% CI)	Zambia, % (95% CI)
Hormonal IUD	n=266	n=140	n=242	n=166	n=208	n=266	n=140
Hormonal IUD	94.3 (90.7, 96.5)	96.3 (91.3, 98.4)	84.0 (76.0, 90.0)	81.8 (74.7, 87.1)	90.0 (80.7, 94.9)	86.8 (82.1, 90.4)	94.7 (89.2, 97.4)
Copper IUD	n=274	n=149				n=274	n=149
Copper IUD	92.4 (88.5, 95.0)	94.0 (88.4, 97.0)				86.9 (82.1, 90.4)	89.1 (82.3, 93.4)
Implant	n=295	n=78				n=295	n=78
Implant	91.6 (87.7, 94.3)	90.4 (80.9, 95.3)				85.0 (80.2, 88.7)	83.1 (72.2–90.1)

Abbreviations: CI, confidence interval; EECO, Expanding Effective Contraceptive Options; IUD, intrauterine device; LEAP, Learning about Expanded Access and Potential; PSI, Population Services International; SIFPO-2, Support for International Family Planning and Health Organizations.