Use of Objective Structured Clinical Examination (OSCE) in a hybrid digital / in-person training for hormonal IUD in Nigeria: findings and applications of the approach.

Background: The hormonal intrauterine device, a long-acting reversible contraceptive method, is being introduced to pilot sites in the private and public sector in Nigeria by the Nigerian Federal Ministry of Health since 2019. To inform training of health care providers, a study was conducted on a hybrid digital and in-person training which utilized Objective Structured Clinical Examination (OSCE) to assess competency of provider trainees. This study represents one of few documented experiences using OSCE to assess the effectiveness of a digital training. Methods: From September - October 2021, in Enugu, Kano and Oyo states of Nigeria, 62 health care providers from public and private sector health facilities were trained in hormonal IUD service provision using a hybrid digital / in-person training approach. Providers, who were skilled in provision of copper IUD, underwent a didactic component using digital modules, followed by an in-person practicum, and finally supervised service provision in the provider trainee's workplace. Skills were assessed using OSCE during the one-day practicum. Results: Use of the OSCE to assess skills provided valuable information to study team. The performance of provider trainees was high (average 94% correct completion of steps in the OSCE). Conclusions: OSCE was used as a research methodology as part of this pilot study; to date, OSCE has not been integrated into the training approach to be scaled up by FMOH. Uniformly high performance of provider trainees was seen on the OSCE, unsurprising since provider trainees were experienced in providing copper IUD. If and when training is rolled out to providers inexperienced with copper IUD, OSCE may have a more important role to assess skills before service provision. The role of OSCE in design of hybrid digital / in-person training approaches should be further explored in rollout of hormonal IUD and other contraceptive technologies.

Use of a hybrid digital training approach for hormonal IUD providers in Nigeria: results from a mixed method study.

BACKGROUND: In Nigeria, in-service trainings for new family planning (FP) methods have typically been conducted using a combination of classroom-based learning, skills labs, and supervised practicums. This mixed-methods study evaluated the feasibility, acceptability, provider competency, and costs associated with a hybrid digital and in-person training model for the hormonal intrauterine device (IUD). METHODS: The study was conducted in Enugu, Kano, and Oyo states, Nigeria, and enrolled FP providers previously trained on non-hormonal IUDs. Participants completed a digital didactic training, an in-person model-based practicum with an Objective Structured Clinical Examination (OSCE), followed by supervised provision of service to clients. Provider knowledge gains and clinical competency were assessed and described descriptively. Data on the feasibility, acceptability, and scalability of the approach were gathered from participating providers, clinical supervisors, and key stakeholders. Training costs were captured using an activity-based approach and used to calculate a cost per provider trained. All analyses were descriptive. RESULTS: Sixty-two providers took the hybrid digital training, of whom 60 (91%) were included in the study (n = 36 from public sector, n = 15 from private sector, and n = 9 both public/private). The average knowledge score increased from 62 to 86% pre- and post-training. Clinical competency was overall very high (mean: 94%), and all providers achieved certification. Providers liked that the digital training could be done at the time/place of their choosing (84%), was self-paced (79%), and reduced risk of COVID-19 exposure (75%). Clinical supervisors and Ministry of Health stakeholders also had positive impressions of the training and its scalability. The hybrid training package cost $316 per provider trained. CONCLUSIONS: We found that a hybrid digital training approach to hormonal IUD service provision in Nigeria was acceptable and feasible. Providers demonstrated increases in knowledge following the training and achieved high levels of clinical competency. Both providers and clinical supervisors felt that the digital training content was of high quality and an acceptable (sometimes preferable) alternative to classroom-based, in-person training. This study provided insights into a hybrid digital training model for a long-acting contraceptive, relevant to scale-up in Nigeria and similar settings.

Defining principles for a choice-based approach to HIV prevention.

The HIV prevention landscape is on the cusp of an unprecedented era of multiple biomedical prevention products available for distribution. Several HIV prevention options, such as oral pre-exposure prophylaxis (PrEP), dapivirine vaginal rings, and injectable cabotegravir for PrEP, are becoming more widely available. Although the future HIV prevention market promises to be rich in options, it would benefit from a core set of principles that uphold choice in all phases of product development, assessment, and introduction. These principles, as presented in this Viewpoint, show the applicability, opportunities, and challenges of choice in different contexts of HIV prevention and provide checkpoints of accountability. By committing to these principles, stakeholders at national and global levels can advance choice across all phases of the HIV prevention market, thereby ensuring that individuals can realise their right to choose when and how to prevent HIV in their own lives.

Demand Forecasting Approaches for New Contraceptive Technologies: A Landscape Review and Recommendations for Alignment.

INTRODUCTION: Market size estimations and demand forecasts use a variety of methodological approaches to inform decision-making around new (and lesser-used) contraceptive methods. For contraceptive products already available at scale in a market, historical procurement and consumption data can help to inform these forecasts. However, little published guidance is available on appropriate approaches to estimating contraceptive demand in the absence of historical data. METHODS: This landscape review aimed to describe the variety of approaches for modeling demand for new contraceptive methods, highlight opportunities for alignment around forecasting practices, and make recommendations to support more accurate forecasting and sound decision-making based on forecasts. We used the published scientific and gray literature to inform the development of a semistructured guide for key informant interviews. We conducted interviews with 29 experts representing a spectrum of interests in market size estimation and demand forecasting for new contraceptive methods (e.g., ministries of health, donors, manufacturers, technical assistance providers, and demand forecasting specialists). We coded notes from the interviews using thematic content analysis. RESULTS: The purposes of market size estimation and demand forecasting for new contraceptive methods vary widely, as do associated model inputs and outputs. Key informants revealed a need for more standardized language around market size estimation and demand forecasting and highlighted key recommendations: select models that are fit-for-purpose, clearly articulate assumptions and uncertainty in model outputs, consider a broad range of contraceptive options in a forecast to capture the complete contraceptive supply environment, and perform a reality check of results and refresh assumptions. CONCLUSION: We recommend following a simple decision pathway to ensure that forecasts are fit-for-purpose, with appropriate inputs, outputs, and assumptions clearly articulated. Common pitfalls around overestimating demand should be avoided. Incorporating best practices into forecasting exercises will ensure that models are useful for the stakeholders.

A Field Test of the NORMAL Job Aid With Community Health Workers in Kenya to Address Contraceptive-Induced Menstrual Changes.

INTRODUCTION: Concerns about contraceptive-induced menstrual changes (CIMCs) contribute to nonuse and discontinuation of family planning (FP). Current counseling materials inadequately address these concerns. After obtaining initial feedback, we field-tested an adapted version of the NORMAL job aid that guides community health workers on how to counsel women about CIMCs. The field test aimed to help understand how the job aid was used, the challenges faced in using it, and recommendations to improve the job aid. METHODS: Sixteen community health volunteers (CHVs) from 2 subcounties in Kenya were trained on the 2-page job aid and given copies of the job aid to use with clients. Six to 8 weeks after the training, we interviewed the CHVs about their experiences using the job aid. The interviews were audio-recorded, transcribed, and analyzed to identify qualitative themes. RESULTS: All 16 CHVs reported using the job aid each time they counseled. All liked it and said they used it because it gave them new information and made counseling easier. All reported offering the job aid to most clients and that most clients accepted a copy. CHVs noted clients referred their friends and family to them after counseling using the job aid. CHVs said the job aid reduced clients' and their male partners' concerns about CIMCs and helped clients select or switch FP methods. Most CHVs did not have suggestions for improving the job aid. CONCLUSION: The job aid was highly acceptable to the CHVs who participated in this small assessment. According to the CHVs, it increased counseling effectiveness and may help increase uptake and continued use of FP methods directly through counseling or indirectly through diffusion in the community. Though further research is needed in other settings and to quantify its impact, we recommend this promising job aid be adapted for wider use.

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

In 2015, a global learning agenda for the hormonal intrauterine device (IUD) was developed with priority research questions regarding use of the method in low- and middle-income countries. In addition, members of the Hormonal IUD Access Group aligned on a strategy to expand access in the context of volunteerism and contraceptive method choice. This article synthesizes evidence generated since then and describes steps taken to address demand- and supply-side barriers to access. Findings demonstrated high continuation rates and satisfaction among hormonal IUD users that are comparable to other long-acting reversible contraceptives (LARCs). Across studies, a sizable number of users reported they would have chosen a short-acting method or no method at all if the hormonal IUD were not an option, which suggests that women did not see the hormonal IUD as interchangeable with other LARC options and thus it may fill an important niche in the market. With several countries now poised to scale up the method, resource mobilization will be key. On the demand side, investments in implementation research will be critical to understanding how best to launch and scale the method, while ensuring the sustainability of multiple quality-assured suppliers with affordable public-sector pricing will be necessary on the supply side.

What are the prospects for the hormonal IUD in the public sector? A mixed-method study of the user population in Zambia.

BACKGROUND: The levonorgestrel-releasing intrauterine device (IUD)-also known as the hormonal IUD-is a highly effective contraceptive method that has not been widely available in the public sector in Zambia. Early introduction efforts can provide critical insights into the characteristics of users, reasons for method choice, and experiences getting their method. METHODS: We conducted a survey with 710 public sector clients who received a hormonal IUD, copper IUD, implant or injectable in two provinces of Zambia, and additional in-depth interviews with 29 women. We performed descriptive analyses of survey data and fitted multivariable logistic regression models to assess factors associated with hormonal IUD use. Qualitative interviews were analyzed thematically. RESULTS: Factors associated with hormonal IUD use included full-time or self-employment (relative to both implant and copper IUD use), as well as being older, wealthier, and partner not being aware of method use (relative to implant use only). Common reasons for choosing long-acting methods were duration, perception that the method was "right for my body," and convenience. In addition, a portion of hormonal IUD acceptors mentioned effectiveness, potential for discreet use, few or manageable side effects, and treatment for heavy or painful periods. Between 83 and 95% of women said that they were counseled about menstrual changes and/or non-bleeding side effects; however, more hormonal IUD acceptors recalled being counseled on the possibility of experiencing reduced bleeding (88%) than amenorrhea (43%). Qualitative interviews indicate that women seek methods with minimal or tolerable side effects. While most women reported their partner was aware of method use, men may be more consistently involved in the decision to use contraception rather than in the choice of a particular method. Qualitative results show an appreciation of the lifestyle benefits of reduced bleeding (especially lighter bleeding), although amenorrhea can be cause for concern. CONCLUSIONS: Initial efforts to introduce the hormonal IUD can provide valuable learnings that can inform broader method introduction to expand choice and better suit women's needs in Zambia and elsewhere. Scale-up plans should include emphasis on high quality counseling and demand generation. The government of Zambia is committed to increasing access to high-quality contraception and making more choices available to users. To date, the hormonal IUD, a highly effective, long-lasting contraceptive has not been widely available in the country. A study in pilot introduction settings provided insights into why women chose the methods, their characteristics, and their experiences getting their methods. The 710 women in the study received family planning services in public sector settings in two provinces in Zambia. Women in the study who received a hormonal IUD, copper IUD, implant, or injectable completed a quantitative survey; in-depth interviews were also conducted with 29 women. Results showed common reasons for choosing the long-acting methods (hormonal IUD, copper IUD or implants) were their duration, perception that the method was "right for my body," and convenience. In addition, some hormonal IUD acceptors indicated that they were attracted to the method's effectiveness, potential for discreet use, few or manageable side effects, and treatment for heavy or painful periods. Qualitative interviews with women also showed that women want contraceptive methods that lead to minimal or tolerable side effects. Male partners were typically aware of contraceptive use; however, men were less involved with decisions about the particular method women selected. Use of the hormonal IUD can lead to reduced menstrual bleeding, and in the interviews, women indicated that they liked reduced bleeding (especially lighter bleeding), although amenorrhea (paused bleeding) can be cause for concern. The results can help inform broader method introduction.

Global research and learning agenda for building evidence on contraceptive-induced menstrual changes for research, product development, policies, and programs.

Background: Contraceptive-induced menstrual changes (CIMCs) can affect family planning (FP) users' lives in both positive and negative ways, resulting in both opportunities and consequences. Despite this, and despite the important links between FP and menstrual health (MH), neither field adequately addresses CIMCs, including in research, product development, policies, and programs globally. Methods: In November 2020, a convening of both MH and FP experts reviewed the existing evidence on CIMCs and identified significant gaps in key areas. Results: These gaps led to the establishment of a CIMC Task Force in April 2021 and the development of the Global Research and Learning Agenda: Building Evidence on Contraceptive-Induced Menstrual Changes in Research, Product Development, Policies, and Programs Globally (the CIMC RLA) , which includes four research agendas for (1) measurement, (2) contraceptive research and development (R&D) and biomedical research, (3) social-behavioral and user preferences research, and (4) programmatic research. Conclusions: Guided by the CIMC RLA, researchers, product developers, health care providers, program implementers, advocates, policymakers, and funders are urged to conduct research and implement strategies to address the beneficial and negative effects of CIMCs and support the integration of FP and MH. CIMCs need to be addressed to improve the health and well-being of women, girls, and other people who menstruate and use contraceptives globally. Disclaimer : The views expressed in this article are those of the authors. Publication in Gates Open Research does not imply endorsement by the Gates Foundation.

Factors affecting uptake of the levonorgestrel-releasing intrauterine device: A mixed-method study of social franchise clients in Nigeria.

BACKGROUND: Despite the positive characteristics of the levonorgestrel-releasing intrauterine device (IUD)-a long-acting, highly effective contraceptive with important non-contraceptive attributes-the method has not been widely available in low- and middle-income countries. This study of hormonal IUD, copper IUD, implant and injectable users in Nigeria compares their characteristics, reasons for method choice, and experiences obtaining their method. METHODS: We conducted a phone survey with 888 women who received a hormonal IUD, copper IUD, contraceptive implant or injectable from 40 social franchise clinics across 18 states in Nigeria. We analyzed survey data descriptively by method and assessed factors associated with hormonal IUD use through multivariate logistic regression models. Follow-up in-depth interviews conducted with 32 women were analyzed thematically. RESULTS: There were few differences by method used in the socio-demographic profiles and contraceptive history of participants. Among users choosing a long-acting, reversible method, the top reasons for method choice included perceptions that the method was "right for my body," long duration, recommended by provider, recommended by friends/family, few or manageable side effects, and high effectiveness. Among hormonal IUD users, 17% mentioned reduced bleeding (inclusive of lighter, shorter, or no period), and 16% mentioned treatment of heavy or painful periods. Qualitative data supported these findings. Among survey respondents, between 25% and 33% said they would have chosen no method if the method they received had not been available. Both quantitative and qualitative data indicated that partner support can affect contraceptive use, with in-depth interviews revealing that women typically needed partner permission to use contraception, but men were less influential in method choice. CONCLUSIONS: Expanding access to the hormonal IUD as part of a full method mix provides an opportunity to expand contraceptive choice for women in Nigeria. Findings are timely as the government is poised to introduce the method on a wider scale.

Expanding long-acting contraceptive options: a prospective cohort study of the hormonal intrauterine device, copper intrauterine device, and implants in Nigeria and Zambia.

BACKGROUND: 30 years after the introduction of the levonorgestrel-releasing intrauterine device in Europe, several sub-Saharan African countries are seeking to broaden access to this contraceptive method. In this study, we aimed to assess 12-month continuation of the hormonal intrauterine device, copper intrauterine device, and implants, as well as to assess women's experiences and satisfaction using these methods in the private sector in Nigeria and the public sector in Zambia. METHODS: We did a prospective cohort study of long-acting reversible contraceptive users across 40 private sector clinics in Nigeria and 21 public sector clinics in Zambia. Eligible women were aged 18-49 years in Nigeria and 16-49 years in Zambia, had chosen to receive the hormonal intrauterine device, copper intrauterine device, or implant (either a 5-year levonorgestrel-releasing subdermal implant or a 3-year etonogestrel-releasing subdermal implant), and, in Nigeria only, had access to a telephone. Women were interviewed within 100 days of receiving their contraceptive method either via telephone in Nigeria or in person in Zambia, with follow-up surveys at 6 months and 12 months. The primary outcomes were method-specific, 12-month continuation rates-ie, continuation rates of the hormonal intrauterine device, copper intrauterine device, and implant across Nigeria and Zambia. We used Kaplan-Meier methods to estimate the cumulative probabilities of method-specific continuation and a log-rank test to compare contraceptive methods. We analysed self-reported satisfaction and experiences as a secondary outcome. FINDINGS: Between June 25 and Nov 22, 2018, we enrolled a total of 1542 women (n=860 in Nigeria and n=682 in Zambia) receiving a long-acting reversible contraceptive. In total, 835 women (266 [32%] hormonal intrauterine device users, 274 [33%] copper intrauterine device users, and 295 [35%] implant users) in Nigeria and 367 (140 [38%] hormonal intrauterine device users, 149 [40%] copper intrauterine device users, and 78 [21%] implant users) in Zambia were included in the study analysis. The 12-month cumulative continuation rates were 86·8% (95% CI 82·1-90·4) for the hormonal intrauterine device, 86·9% (82·1-90·4) for the copper intrauterine device, and 85·0% (80·2-88·7) for implants in Nigeria. In Zambia, the 12-month cumulative continuation rates were 94·7% (89·2-97·4) for the hormonal intrauterine device, 89·1% (82·3-93·4) for the copper intrauterine device, and 83·1% (72·2-90·1) for implants. At least 71% of respondents across the timepoints were very satisfied with their method, and at least 55 (79%) of 70 reported having recommended their contraceptive method to someone else. Across the methods, the most commonly self-reported positive aspect of long-acting reversible contraceptive use at 12 months was effectiveness in Nigeria (range 93-94%) and long-lasting duration in Zambia (48-60%). Between 124 (50%) of 248 and 136 (59%) of 230 Nigerian participants and 26 (42%) of 62 and 66 (57%) of 117 Zambian participants reported nothing negative about their contraceptive method. INTERPRETATION: Our study showed high continuation rates and satisfaction across long-acting reversible contraceptives, including the hormonal intrauterine device, a method that has been largely underused in sub-Saharan Africa. This finding supports the inclusion of the hormonal intrauterine device as a valuable addition to the mix of contraceptive methods in Nigeria and Zambia. FUNDING: Bill & Melinda Gates Foundation.

Seeking synergies: understanding the evidence that links menstrual health and sexual and reproductive health and rights.

Global efforts to improve menstrual health and sexual and reproductive health and rights (SRHR) are fundamentally intertwined and share similar goals for improving health and well-being and increasing gender equality. Historically, however, the two fields have operated independently and missed opportunities to build upon their biological and sociocultural linkages. Biological touchpoints connecting the two fields include genital tract infections, menstrual disorders, contraception, and menopause. From a sociocultural perspective, intersections occur in relation to the experience of puberty and menarche, gender norms and equity, education, gender-based violence, and transactional sex. We describe evidence linking menstrual health and SRHR and offer recommendations for integration that could strengthen the impact of both fields.

Provision of the levonorgestrel intrauterine system in Nigeria: Provider perspectives and service delivery costs.

Background: Several organizations in Nigeria are leading pilot introduction programs of the levonorgestrel intrauterine system (LNG-IUS). We conducted a qualitative assessment of providers' experiences across the five programs and an analysis of service delivery costs in one program. Methods: We conducted 20 in-depth interviews (IDIs) with providers. We used project expenditure records to estimate incremental direct service delivery costs of introducing the LNG-IUS in 40 social franchise clinics supported by the Society for Family Health (SFH). We then compared the direct service delivery costs per couple years of protection (CYP) for the LNG-IUS to other family planning methods. Results: Providers appreciated the therapeutic benefits of the LNG-IUS, especially reduction of heavy bleeding. They said that women generally accepted bleeding changes with counseling but noted complaints about spotting and mixed acceptability of amenorrhea. Providers indicated being comfortable with both the insertion and removal process and believed their equipment and infection prevention protocols were adequate. Lack of awareness among women, limited availability, current pricing, and resistance to uterine placement among some women were perceived as barriers. The estimated direct service delivery cost of introducing the LNG-IUS in pilot settings, inclusive of up-front provider training costs, was USD 34 per insertion. Direct service delivery costs at a 'steady state' (i.e., without training costs included for any method) of the LNG-IUS per CYP was similar to that of other contraceptive methods distributed in Nigeria. Conclusion: Providers' positive experiences with the LNG-IUS and direct service delivery costs per CYP that align with those for other methods suggest that the LNG-IUS could be an important addition to the method mix in Nigeria. Product introduction strategies will need to address both the supply and the demand sides, as well as consider appropriate pricing of the LNG-IUS relative to other methods and particularly the copper IUD.

Experiences With the Levonorgestrel Intrauterine System Among Clients, Providers, and Key Opinion Leaders: A Mixed-Methods Study in Nigeria.

BACKGROUND: The levonorgestrel intrauterine system (LNG IUS) is one of the most effective contraceptive methods, and it has noncontraceptive health benefits, including treatment for women with heavy menstrual bleeding. In 2016, Marie Stopes International Organisation Nigeria (MSION) expanded LNG IUS provision through training and support to 9 mobile outreach teams, 105 social franchise clinics, and 20 public-sector providers in 17 states. Information about the LNG IUS was added to awareness-raising materials, and community mobilizers provided information on the LNG IUS alongside other voluntary family planning methods. METHODS: In 2016, Marie Stopes International, MSION, and FHI 360 examined clients' and providers' experiences with the LNG IUS to assess the potential for further scale-up of the method as part of a comprehensive approach to family planning in Nigeria. A mixed-methods approach was used including analysis of routine service data, supplemental data specific to LNG IUS clients, and in-depth interviews with LNG IUS clients, providers, and key opinion leaders. RESULTS: Just under 1,000 LNG IUS were inserted from September 2016 to December 2017 in 16 states in channels supported by MSION, representing 0.4% of all long-acting and reversible contraceptive (LARC) services provided by the participating providers during this time frame. The vast majority (82%) of LARCs provided were implants. A small pool of providers was responsible for providing almost half of the LNG IUS services. Common reasons for women choosing the LNG IUS were reduced menstrual bleeding (61%), long-acting duration (52%), effectiveness (49%), and discreetness (42%). Almost 80% of the users first heard about the method from a provider. Almost all users and providers reported positive experiences with the method, noting the noncontraceptive benefits and fewer side effects compared with other methods. All providers who were interviewed said they would continue offering the LNG IUS. Several key opinion leaders mentioned a total market approach incorporating both public and private sectors would be needed to successfully scale up the LNG IUS. CONCLUSION: Reduced menstrual bleeding and fewer side effects compared with other methods were identified as important attributes of the LNG IUS by clients, providers, and key opinion leaders. Challenges to uptake of the LNG IUS include difficulty with introducing a new method within a busy service delivery infrastructure and limited awareness and demand-generation activities on the LNG IUS specifically. A comprehensive product introduction approach with coordinated demand- and supply-side activities may be required for this method to reach its full potential.

Experiences with the levonorgestrel-releasing intrauterine system in Kenya: qualitative interviews with users and their partners.

OBJECTIVES: The levonorgestrel-releasing intrauterine system (LNG-IUS) is an underused contraceptive method in sub-Saharan Africa. A recent market assessment in Kenya found that if a more affordable version of the method were available it may increase demand and uptake of the method. We therefore aimed to examine attitudes and perceptions around the LNG-IUS and experiences of method use, including exploring attributes such as bleeding changes, contraceptive-related amenorrhoea and perceived non-contraceptive benefits. METHODS: Qualitative interviews were conducted among 29 women who were current or recent users of the LNG-IUS, and among a subset (n = 9) of their husbands/partners. RESULTS: Our findings indicate that women's main reason for choosing the LNG-IUS for contraception was their perception that the method had fewer side effects compared with other contraceptive methods. Women had favourable attitudes towards using the LNG-IUS. Husbands were also very positive about their partner's use of the method. CONCLUSION: Understanding the motivations and experiences of early adopters of the LNG-IUS can help inform the development of demand creation and communication strategies to influence uptake and continuation of the LNG-IUS both in Kenya and perhaps more broadly. Communication efforts that emphasise the positive attributes of the LNG-IUS could help promote wider use of the method, especially if new, more affordable product(s) become available.

Expanding Access to a New, More Affordable Levonorgestrel Intrauterine System in Kenya: Service Delivery Costs Compared With Other Contraceptive Methods and Perspectives of Key Opinion Leaders.

BACKGROUND: The levonorgestrel intrauterine system (LNG IUS) is one of the most effective forms of contraception and offers important non-contraceptive health benefits. However, it is not widely available in developing countries, largely due to the high price of existing products. Medicines360 plans to introduce its new, more affordable LNG IUS in Kenya. The public-sector transfer price will vary by volume between US$12 to US$16 per unit; for an order of 100,000 units, the public-sector transfer price will be approximately US$15 per unit. METHODS: We calculated the direct service delivery cost per couple-years of protection (CYP) of various family planning methods. The model includes the costs of contraceptive commodities, consumable supplies, instruments per client visit, and direct labor for counseling, insertion, removal, and resupply, if required. The model does not include costs of demand creation or training. We conducted interviews with key opinion leaders in Kenya to identify considerations for scale-up of a new LNG IUS, including strategies to overcome barriers that have contributed to low uptake of the copper intrauterine device. RESULTS: The direct service delivery cost of Medicines360's LNG IUS per CYP compares favorably with other contraceptive methods commonly procured for public-sector distribution in Kenya. The cost is slightly lower than that of the 3-month contraceptive injectable, which is currently the most popular method in Kenya. Almost all key opinion leaders agreed that introducing a more affordable LNG IUS could increase demand and uptake of the method. They thought that women seeking the product's non-contraceptive health benefits would be a key market segment, and most agreed that the reduced menstrual bleeding associated with the method would likely be viewed as an advantage. The key opinion leaders indicated that myths and misconceptions among providers and clients about IUDs must be addressed, and that demand creation and provider training should be prioritized. CONCLUSION: Introducing a new, more affordable LNG IUS product could help expand choice for women in Kenya and increase use of long-acting reversible contraception. Further evaluation is needed to identify the full costs required for introduction-including the cost of demand creation-as well as research among potential and actual LNG IUS users, their partners, and health care providers to help inform scale-up of the method.

Meeting Postpartum Women's Family Planning Needs Through Integrated Family Planning and Immunization Services: Results of a Cluster-Randomized Controlled Trial in Rwanda.

OBJECTIVE: The primary objective of this study was to test the effectiveness of integrating family planning service components into infant immunization services to increase modern contraceptive method use among postpartum women. METHODS: The study was a separate sample, parallel, cluster-randomized controlled trial. Fourteen randomly selected primary health facilities were equally allocated to intervention (integrated family planning and immunization services at the same time and location) and control groups (standard immunization services only). At baseline (May-June 2010), we interviewed postpartum women attending immunization services for their infant aged 6 to 12 months using a structured questionnaire. A separate sample of postpartum women was interviewed 16 months later after implementation of the experimental health service intervention. We used linear mixed regression models to test the study hypothesis that postpartum women attending immunization services for their infants aged 6-12 months in the intervention facilities will be more likely to use a modern contraceptive method than postpartum women attending immunization services for their infants aged 6-12 months in control group facilities. RESULTS: We interviewed and analyzed data for 825 women from the intervention group and 829 women from the control group. Results showed the intervention had a statistically significant, positive effect on modern contraceptive method use among intervention group participants compared with control group participants (regression coefficient, 0.15; 90% confidence interval [CI], 0.04 to 0.26). Although we conducted a 1-sided significance test, this effect was also significant at the 2-sided test with alpha = .05. Among those women who did not initiate a contraceptive method, awaiting the return of menses was the most common reason cited for non-use of a method. Women in both study groups overwhelmingly supported the concept of integrating family planning service components into infant immunization services (97.9% in each group), and service data collected during the intervention period did not indicate that the intervention had any negative effect on infant immunization service uptake. CONCLUSION: Integrating family planning service components into infant immunization services can be an acceptable and effective strategy to increase contraceptive use among postpartum women. Additional research is needed to examine the extent to which this integration strategy can be replicated in other health care settings. Future research should also explore persistent misconceptions regarding the relationship between return of menses and return to fertility during the postpartum period.