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Introduction of the levonorgestrel intrauterine system inKenya through mobile outreach: review of service statisticsand provider perspectives David Hubacher,a Vitalis Akora,b Rose Masaba,a Mario Chen,a Valentine Veenaa Limited introduction of the LNG IUS through mobile outreach in Kenya, without any special promotion,resulted in good uptake. And providers viewed it positively, particularly because of its noncontraceptivebenefits. Increased provision of the LNG IUS can improve options for women needing highly effectivereversible contraception.
ABSTRACTBackground: The levonorgestrel intrauterine system (LNG IUS) was developed over 30 years ago, but the product iscurrently too expensive for widespread use in many developing countries. In Kenya, one organization has receiveddonated commodities for 5 years, providing an opportunity to assess impact and potential future role of the product.
Methods: We reviewed service statistics on insertions of the LNG IUS, copper intrauterine device (IUD), and subdermalimplant from 15 mobile outreach teams during the 2011 calendar year. To determine the impact of the LNG IUSintroduction, we analyzed changes in uptake and distribution of the copper IUD and subdermal implant by comparingperiods of time when the LNG IUS was available with periods when it was not available. In addition, we interviewed 27clinicians to assess their view of the product and its future role.
Results: When the LNG IUS was not available, intrauterine contraception accounted for 39% of long-acting methodprovision. The addition of the LNG IUS created a slight rise in intrauterine contraception uptake (to 44%) at the expenseof the subdermal implant, but the change was only marginally significant (P5.08) and was largely attributable to thecopper IUD. All interviewed providers felt that the LNG IUS would increase uptake of long-acting methods, and 70% feltthat the noncontraceptive benefits of the product are important to clients.
Conclusions: The LNG IUS was well-received among providers and family planning clients in this population in Kenya.
Advance Access Article published on January 9, 2014 as doi: Although important changes in service statistics were not apparent from this analysis (perhaps due to the small quantityof LNG IUS that was available), provider enthusiasm for the product was high. This finding, above all, suggests that alarger-scale introduction effort would have strong support from providers and thus increase the chances of success.
Adding another proven and highly acceptable long-acting contraceptive technology to the method mix could haveimportant reproductive health impact.
(1992), the vaginal ring (2001), the contraceptivepatch (2002), and the etonogestrel implant (2006).1–3 In many countries, the levonorgestrel intrauterine In resource-poor countries, the commercial LNG IUS product may be available in the private sector, but only reproductive health commodity. The most recent the highest socioeconomic classes can realistically example is from the United States, where it was afford it. In Kenya, for example, the commercial approved 13 years ago. The LNG IUS is now more popular in the United States than any new contra- Cost is not the only consideration when contem- ceptive product introduced since 1992, including the plating the potential role and impact of the LNG IUS.
DMPA (depot medroxyprogesterone acetate) injectable Although the LNG IUS is a form of intrauterine contraception, as is the copper intrauterine device FHI 360, Research Triangle Park, NC, USA.
(IUD), it should not be viewed as simply another IUD.
Correspondence to David Hubacher ([email protected]).
The LNG IUS and the copper IUD have striking TABLE 1. Comparing the LNG IUS and the Copper IUD Treats menorrhagia, increases hemoglobin, and likely alleviates anemia and problems with uterine fibroids Both in the highest tier of contraceptive effectiveness Both have similar, high continuation rates Abbreviations: IUD, intrauterine device; LNG IUS, levonorgestrel intrauterine system.
differences in side effects and noncontraceptive planning.11 Recent introduction of a natural benefits. However, in terms of effectiveness and family planning method resulted in sizeable other factors, the products have important At the family planning program level, it is important to know how a new product might alter rently being introduced on a very limited basis into the pattern of method uptake and services. For some programs in resource-poor countries through example, a new method might attract new clients donations from the International Contraceptive and overburden the service delivery system, Access (ICA) Foundation (a partnership between particularly if the new method requires more time and effort to provide. If a new method becomes Population Council). Since inception in 2003, the popular, a program will need to purchase enough ICA Foundation has donated nearly 50,000 LNG product to satisfy demand, and potentially decrease IUS devices to 19 countries.6 In recipient pro- orders of other products if a contraceptive sub- grams, the LNG IUS is provided free-of-charge alongside established contraceptives so women can have expanded choice. Programs are embra- providers’ opinions are critical. Given their impor- Advance Access Article published on January 9, 2014 as doi: cing the donations so their clients can benefit from tant role in contraceptive counseling,13 providers can help shape the impact of a new product.
When new contraceptives become available, Previous research has shown that family planning they generally improve reproductive health in the counselors are more likely to recommend methods affected population. In a multicountry analysis, that they use themselves,14 and client uptake of Jain found that overall contraceptive use rises methods is also linked to providers’ personal with increased method choice,7 and a review of method use.15 Similar patterns have been seen international data over 27 years showed that as in the use of hormone replacement therapy.16 each additional contraceptive method became In many settings, decades can pass before available to most of the population, overall initial introduction leads to widespread national modern contraceptive use rose.8 A systematic review found that increased choice raises contra- Since 2008, the Marie Stopes affiliate in ceptive uptake, improves health outcomes, and improves adherence.9 In contrast, Sutherland services to approximately 5,000 women. Thus, et al., analyzed data from 13 countries and found during this time, some clients had one addi- that the rise in injectable use was partially offset by declines in use of other methods,10 whereas (LARC) choice, which also includes subdermal Ross found macro-level evidence that expansion implants and all types of intrauterine devices.
of injectables attracted new users to family We undertook this project at MSK to better understand the impact of the LNG IUS intro-duction efforts.
TABLE 2. LARC Insertions Performed by 11 Outreach Teams of We used anonymous MSK service statistics andinterviews with MSK providers to evaluate the LNG IUS introduction activity. This research wasapproved by the Protection of Human Subjects Committee (of FHI 360) and the Kenya Medical Research Institute’s Ethical Review Committee.
Abbreviations: IUD, intrauterine device; LARC, long-acting reversible The MSK providers voluntarily agreed to be contraceptive; LNG IUS, levonorgestrel intrauterine system.
interviewed through an informed consent pro- cess that was approved by these committees.
outreach program, which consists of 15 teams indifferent geographic regions of Kenya. Each team LARCs: 39% chose the copper IUD, 60%, the has 2 clinicians (1 medical doctor and 1 nurse) and 2 care assistants; the teams visit catchment public-sector health facilities on a rotating basis teams provided a total of 1,030 LNG IUS. On a to provide family planning services.
monthly basis, the mean number of insertions We reviewed MSK’s existing (internal) report- per team varied considerably for each product: ing systems to tabulate the monthly number of 201 for the copper IUD, 309 for the subdermal contraceptive method insertion procedures for each of the 15 outreach teams during the 2011 calendar year. We developed an electronic data- available, IUD services accounted for an average base and entered into a spreadsheet the number of insertions for the LNG IUS, copper IUD, and average proportion of women selecting an IUD The average subdermal implant. Of the 15 teams, 4 did not (copper IUD or LNG IUS) rose slightly (to 44.3%) proportion of receive any LNG IUS in the study period and were when the LNG IUS was available, but the change women selecting excluded from the analysis. Of the possible 132 was only marginally significant (P 5.08). The either a copper IUD total available months across the 11 teams, 2 modest increase was largely attributable to the or LNG IUS rose months with no LARC insertions (all 3 methods high volume of copper IUDs relative to the slightly when the combined) were excluded from the calculations.
volume of the LNG IUS. The relative importance LNG IUS was Thus, a total of 130 months of data were included of the IUD versus the implant varied consider- Advance Access Article published on January 9, 2014 as doi: ably across the different teams, regardless of number of monthly product insertions. In some months and in some teams, the LNG IUS was not available. Thus, we examined how the average proportions of total IUD (copper IUD plus LNG providers inserted 51 or more LNG IUS while IUS) versus subdermal implant insertions varied 11% had not inserted even 1 device. About half of per month, by whether or not the LNG IUS was providers felt equally comfortable describing and available. We used a t test to determine whether providing all 3 long-acting methods (the implant, availability of the LNG IUS increased total IUD the copper IUD, and the LNG IUS). For the half insertions, relative to the subdermal implant.
who were not equally comfortable with describ- ing/providing all 3 long-acting methods, they were most comfortable with the subdermal All interviewed variety of questions to characterize their views implant and least comfortable with the LNG providers felt that and their clients’ views on the new product.
IUS. All respondents felt that the LNG IUS would the LNG IUS would attract new clients to long-acting methods, and70% believed that the noncontraceptive benefits to long-acting During the 2011 calendar year, the outreach of the product were very important to their methods.
TABLE 3. Mean Number of Monthly LARC Insertions and Proportion of IUD Insertions per Marie Stopes/Kenya Outreach Team, by LNG IUS Availability,a 2011 Abbreviations: IUD, intrauterine device; LARC, long-acting reversible contraceptive; LNG IUS, levonorgestrel intrauterine system.
a P value5.08 for testing whether the relative monthly distribution of IUD vs. implants is different depending on availability of the LNG IUS.
b Mean of the proportion of women receiving IUDs per month.
c Total IUD is the sum of copper IUD and LNG IUS insertions.
as a whole and for most of the outreach teams copper IUD, providers cited these main features: Advance Access Article published on January 9, 2014 as doi: providers unanimously believed the LNG IUS would attract new clients to long-acting meth- ods, at least partly due to the important and tion in menstrual bleeding as a key ‘‘attractive’’ unique noncontraceptive benefits that the tech- attribute for clients. Forty-four percent of provi- nology offers. The high volume of copper IUD ders reported that the hormonal content of the services (typical for this program) demonstrated product is a feature that clients find unattractive.
high acceptability of this product among both providers can help Reduction of menstrual blood loss was the providers and clients. Thus, this is another improve access to primary noncontraceptive benefit reported by example of how dedicated LARC providers are successful at making important technologies A previous introduction assessment of the LNG IUS in Ghana had similar results to ours.17 Introduction of the LNG IUS through the Marie For example, availability of the product did not Stopes/Kenya outreach program had a mixed significantly alter provision of other methods.
impact. On the one hand, availability of the LNG (However, the small quantity of product may IUS did not appear to alter provision of standard have made this difficult to assess adequately.) long-acting reversible methods (the subdermal Another similarity was found in terms of positive implant and the copper IUD); the pattern of service statistics did not change for the program Ghanaian providers found the product easy to TABLE 4. Experiences With the LNG IUS Among Marie Stopes/Kenya Providers (N527) Number of LNG IUS insertions performed since completing training Method most comfortable describing and providing Method least comfortable describing and providing Do you think clients easily understand the difference Is the 10+ years duration of use for the copper IUD a significant reason women will choose it instead of the LNG IUS that only lasts for 5 years? Advance Access Article published on January 9, 2014 as doi: Did you ever have a stockout of the LNG IUS? If the LNG IUS is not available, what method do women choose instead? Will the LNG IUS attract new clients to long-acting contraception? How important are noncontraceptive benefits of the LNG IUS to your clients? Abbreviations: IUD, intrauterine device; LNG IUS, levonorgestrel intrauterine system.
TABLE 5. Main Attributes of LNG IUS Cited by Marie Stopes/Kenya Providers (N527) Key information provided to clients to distinguish the LNG IUS from the copper IUDa Aspects of the LNG IUS that are attractive to clientsa Reduction of excessive menstrual bleeding Aspects of the LNG IUS are unattractive to clientsa What are the most important noncontraceptive benefits of the LNG IUS?a Advance Access Article published on January 9, 2014 as doi: Abbreviations: IUD, intrauterine device; LNG IUS, levonorgestrel intrauterine system.
a Multiple responses allowed; only responses garnering at least 15% (n54) are shown.
insert, and all stated that their clients were function of higher client demand and thus more satisfied with it. A more general assessment of frequent counseling about and insertion of the global LNG IUS donation activities high- implants. However, if providers are reluctant to lighted the importance of working with in- offer intrauterine contraception, due to perceived country ‘‘product champions’’ and committed lack of expertise or for other reasons, a feedback service-delivery counterparts with IUD insertion loop of diminished contraceptive choices could develop. Although there is certainly no evidence Providers in our study candidly reported being that this is occurring at MSK, it is critical that most comfortable describing and providing the providers maintain skills and confidence with all subdermal implant; this finding exposes some of the challenges for wider provision of intrauterine A larger contemporary concern across sub- contraception. Reasons for being more comforta- Saharan Africa is widespread absence of LARC ble with subdermal implants could simply be a services in public-sector settings, where providers and health systems as a whole typically rely on provision of short-acting methods. Providers are provider support and enthusiasm, which in turn subject to many personal and external influences can improve options for women needing highly that can ultimately limit contraceptive choice for Acknowledgments: FHI 360 thanks Marie Stopes International(London) and the efforts of Tania Boler, Adrienne Testa, and Cristin Gordon-Maclean for supporting this collaboration. We also Our study in Kenya had important limitations.
appreciate Edward Kubai and Raphael Oketch of the ResearchMonitoring & Evaluation Unit of MSK for their efforts in Kenya.
First, this introduction of the LNG IUS was not Funding for this project was provided to FHI 360 by the U.S. Agency conducted in a promotional or scientifically for International Development (USAID) (GPO-A-00-08-00001-00,Program Research for Strengthening Services [PROGRESS]). Many rigorous way to measure the impact. For exam- thanks to the ICA Foundation for promoting women’s health around ple, clients were probably not aware of the the world. The views expressed in this publication do not necessarilyreflect those of FHI 360, Marie Stopes/Kenya, or USAID.
product until they spoke to the provider; thus,it is not possible to conclude anything about true Competing Interests: David Hubacher has served on Advisory Boards demand for the LNG IUS. However, it is feasible for Bayer HealthCare and Teva Pharmaceuticals.
that unmeasured word-of-mouth could haveprompted some women to visit the clinic on MSK outreach days. Second, we did not conduct 1. Hubacher D, Finer LB, Espey E. Renewed interest in intrauterine an experiment on the impact of the product contraception in the United States: evidence and explanation.
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8. Ross J, Stover J. Use of modern contraception increases when more methods become available: analysis of evidence from1982–2009. Glob Health Sci Pract. 2013;1(2):203–212.
9. Gray AL, Smit JA, Manzini N, Beksinska M. Systematic review of The LNG IUS was developed in the 1970s and is contraceptive medicines: ‘‘Does choice make a difference?’’ long overdue for introduction into resource-poor Johannesburg: Reproductive Health & HIV Research Unit of the settings. High product cost is the current barrier University of Witwatersrand, South Africa; 2006. Availablefrom: to more widespread use. New LNG IUS products made by Indian companies are currently avail- 10. Sutherland EG, Otterness C, Janowitz B. What happens to able in India,20,21 and a U.S.-based company is contraceptive use after injectables are introduced? An analysis of currently seeking approval from the U.S. Food 13 countries. Int Perspect Sex Reprod Health. 2011;37(04):202–208. . and Drug Administration for its version of theLNG IUS technology.22 These products hopefully 11. Ross JA, Agwanda AT. Increased use of injectable contraception in sub-Saharan Africa. Afr J Reprod Health. 2012;16(4):68–80.
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22. Medicines360 [Internet]. San Francisco: Medicines360; c2012 17. Nyarko P, Adohinzin C, Tapsoba P, Esantsi S, Townsend J, Kanlisi N, et al. Acceptability and promotion strategies for ______________________________________________________________________________________________________________________________________________Peer Reviewed Received: 2013 Sep 19; Accepted: 2013 Nov 26 ß Hubacher et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permitsunrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly cited. To view a copy of thelicense, visit http://creativecommons.org/licenses/by/3.0/ ______________________________________________________________________________________________________________________________________________ Advance Access Article published on January 9, 2014 as doi:

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CURRICULUM VITAE Rafael A. Rivas-Vazquez, Psy.D. Office Address NeuroScience Home Address 749 Date of Birth January Place of Birth Miami, Education Master’s of Science in Clinical Psychopharmacology Pre-doctoral and Post-doctoral Training Harvard Medical School/Massachusetts General Hospital Licensure Florida Board of Psychology, License #PY000

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