Feasibility and Acceptability of LNG 1.5 mg as an On-Demand Pericoital Contraceptive in Ghana.

Globally, there is a need for more family planning method options as currently, available options do not adequately meet the needs of women, specifically those who have infrequent sex. Levonorgestrel (LNG) 1.5 mg is widely available as emergency contraception pills (ECP), and recent research has shown that certain women take it as their main form of contraception. Furthermore, limited studies have found repeat, on-demand use safe and efficacious. This 12-month prospective, single-arm, interventional study in Ghana tested whether a single LNG 1.5 mg on-demand or pericoital ("around the time of sex") dose contraceptive was acceptable to women who have infrequent sex and if pharmacy provision was feasible. The study sample (1,890) comprised women of reproductive age recruited from urban areas, having infrequent sex (i.e., coital frequency ≤ 6× per month), and not using any other modern methods except condoms or ECP at the time of study inclusion. Results indicated that there is demand and acceptability for a pericoital pill and that pharmacy provision is feasible. Furthermore, precoital use of the pill had high levels of satisfaction and was popular with new users. Adding LNG 1.5 mg for pericoital use to the family planning method mix has the potential to address an important segment of the population currently underserved, decrease unwanted pregnancies, and increase modern contraceptive prevalence rates.

Feasibility of e-commerce pharmacy provision and acceptability of levonorgestrel 1.5 mg for pericoital use in urban and peri-urban settings in Kenya: a prospective cohort study.

INTRODUCTION: An 'on-demand' contraceptive pill may suit women having infrequent sex. We assessed the feasibility of e-commerce pharmacy provision and acceptability of levonorgestrel (LNG) 1.5 mg for pericoital use in Kenya. METHODS: A 12-month prospective, single-arm, open-label, interventional study conducted from August 2020 to August 2021. A total of 897 women aged 18-49 years at risk of pregnancy and having infrequent sex (ie, six times or fewer coital frequency/month) were screened and enrolled. We undertook univariate and bivariate analysis on multiple data points: enrolment dataset, bimonthly surveys, extended survey around 6-month follow-up, and e-commerce pharmacy sales log. RESULTS: A total of 2291 pericoital LNG 1.5 mg pill doses were dispensed to 300 women over a 12-month period mainly via the USSD (Unstructured Supplementary Service Data) platform. Of the 266 women who obtained the pill and completed the survey, most (83%) were satisfied/very satisfied with e-commerce platform services, citing convenience and ease of use. The pill was also acceptable. Of the 266 women who used it at least once, 94% were satisfied/very satisfied, likely to continue using and would recommend it to others; 86% used it within 24 hours before/after sex as recommended and most of the time they had sex; and 147 (55%) experienced side effects, mainly nausea, headache, changes in menstrual pattern, cramps and dizziness that were mild and tolerable. CONCLUSIONS: E-commerce pharmacy provision of LNG 1.5 mg for pericoital use is feasible. In addition, a pericoital LNG 1.5 mg pill is acceptable among women having infrequent sex and could potentially address their unmet family planning needs.

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.

Quality of care in abortion in the era of technological and medical advancements and self-care.

BACKGROUND: Discussions around quality of abortion care have been focused mainly on service-delivery aspects inside healthcare facilities. More recently, with availability of medical abortion (MA), increase in its self-use, and emergence of other delivery platforms such as telemedicine, the responsibility of quality care has broadened to actors outside of facilities. BODY OF TEXT: This commentary discusses the meaning of quality of abortion care with the paradigm shift brought by medical and technological advancement in abortions, and raises questions on the role of the state in ensuring quality in abortion management-especially in settings where abortion is decriminalized, but also in countries where abortion is permitted under certain circumstances. It consolidates the experience gained thus far in the provision of safe abortion services and also serves as a forward-thinking tool to keep pace with the uptake of newer health technologies (e.g., availability of medical abortion drugs), service delivery platforms (e.g., telemedicine, online pharmacies), and abortion care providers (e.g., community based pharmacists). CONCLUSIONS: This commentary provides context and rationale, and identifies areas for action that different stakeholders, including health advocates, policymakers, program managers, and women themselves, can adopt to fit into an alternative regime of abortion care.

Husbands' concerns and experiences with the progesterone vaginal ring in three sub-Saharan African countries: a mixed methods study.

The introduction of progesterone vaginal ring (PVR) in sub-Saharan Africa calls for insights on the product's role in promoting women's autonomy regarding their reproductive decision-making and behaviour. Such insights could inform the positioning of the method within family planning programmes in the region. In this paper, we explore husbands' experiences with PVR as perceived by their wives and as reported by husbands of a subset of women users in Kenya, Nigeria, and Senegal. We discuss how such experiences might influence women's rights and autonomy regarding their reproductive decisions and contraceptive behaviour. We use a mixed-methods approach drawing on data from quantitative interviews with 174 women and qualitative in-depth interviews with 10 husbands of a subset of the women in the three countries. The findings show that husbands appreciated PVR's attributes relating to user-control (women could insert and remove the method themselves), ease of use, and non-interference with sex and flow of breast milk. Wives' perceptions of their husbands' experiences regarding PVR's non-interference with sex were consistent with the husbands' own reports. In addition, health care providers played important roles in supporting sustainable use of the method through giving information, counselling, and assisting women who experienced ring slippage to manage those challenges. The findings suggest that self-managed health technologies such as PVR could expand women's choices and control over their reproductive decisions. The findings further suggest that sustainable use of such products could require linkages with appropriate health systems structures to address challenges with use if and when they arise.

Commentary: Does Twitter have a role in improving Family Planning messages and services in Low-and-Middle-Income Countries (LMICs)?

Stakeholders are coming together to develop a vision for increasing access to family planning (FP) by 2030. Of the 923 million women in the developing world who wish to avoid a pregnancy, 218 million women are not using a modern contraceptive (Guttmacher Institute, 2020). In 2016, over 3.4 billion people were using the internet (https://ourworldindata.org/internet 2016). Moreover, internet users in the developing world use social media more frequently than Internet users in the U.S. and Europe. Of the many proposed actions to accelerate progress in family planning, the use of Twitter should be a key component. In this commentary, we describe the use of Twitter in a select group of low-and-middle-income countries that have made commitments to the family planning 2020 initiative (FP2020 countries and have the potential to leverage Twitter with current and potential family planning users. We examine Twitter feeds in eight key FP2020 countries, and we look at the content of Tweets issued by the ministries of health in most of these same countries. Our view is that it is feasible and easy to access Twitter feeds in low-and -middle income countries. We base our view on the types of reproductive health and family planning terms discussed in a public forum such as Twitter by current and potential users and their partners and ministries of health. We highlight two broad considerations that merit discussion among interested stakeholders, including policy makers, program designers, and health advocates. The first relates to the use of Twitter within family planning programs, and the second relates to themes that require more significant research. Data coupled with analytical capacity will help policy makers and program designers to effectively leverage Twitter for expanding the reach of family planning services and influencing social media policy. Our aim is to not only to contribute to the body of knowledge but also to spur greater engagement by program personnel, researchers, health advocates and contraceptive users.

Addressing contraceptive needs exacerbated by COVID-19: A call for increasing choice and access to self-managed methods.

The COVID-19 pandemic has exposed the vulnerability of global contraception provision, exacerbating the barriers to access reproductive health services, leading to suspension of clinical services and disruption of supply chains. Critical to combatting this crisis is the expansion of healthcare to include self-care approaches to de-medicalize contraception and increase an individual's agency in determining what method they use, when they use it, and where they obtain it. Expanding the mix of self-administered contraceptives is essential for ensuring choice, access, and availability. We highlight advances in the self-care movement and actions needed to strengthen self-management approaches to maximize our chances of preventing a reproductive health crisis.

Abortion Self-Care: A Forward-Looking Solution To Inequitable Access.

Following the World Health Organization's (WHO) definition of self-care, abortion self-care is the ability of pregnant individuals to manage their unwanted pregnancies with or without the support of health care providers-particularly, in the early weeks of pregnancy (up to 12 weeks' gestation). The advent of medication abortion (MA) has made this possible, as early self-managed MA at home is a safe, acceptable and cost-effective method of pregnancy termination. The drugs currently available for MA are mifepristone and misoprostol, as well as the two packaged together (also known as the combipack), which is more efficacious than misoprostol alone in evacuating the uterus and is considered the first-line medication for MA. Regardless of the legality of abortion where they live, women worldwide are using these medications to self-manage pregnancy termination inside or outside clinical settings-in conjunction with telemedicine services, peer-led support groups, hotlines and online information sources-which has contributed significantly to reducing maternal mortality and morbidity from unsafe procedures.

Choosing and Using the Progesterone Vaginal Ring: Women's Lived Experiences in Three African Cities.

PURPOSE: This study explored experiences of selecting and utilizing a newly introduced contraceptive - the progesterone vaginal ring (PVR) - among women seeking a contraceptive method in 3 African capital cities (Abuja, Nairobi, and Senegal). The study explored women's perceptions of, and lived experiences with, using the new product to better understand their reception of a new contraceptive. This understanding will help inform the design of programs to support women in their adoption and continued use of the PVR and other new contraceptives. PATIENTS AND METHODS: This longitudinal, qualitative study drew on an interpretive phenomenological approach, involving multiple in-depth interviews (IDIs) with 9 study participants over a 6-month period. Participants involved in the study were postpartum women seeking contraceptive services at participating clinics. A total of 25 IDIs were conducted, and a detailed "within-case" and "cross-case" analysis of participants' accounts was carried out to identify similar and dissimilar themes along descriptive, linguistic, and conceptual lines. RESULTS: Four overarching themes emerged from the analysis. These themes circulated around the unconventionality of the PVR, which heightened its desirability among participants; the sense of comfort that women gained from opting to use the PVR over other FP methods; narratives of consideration that centered on women's partners, and that were important for ensuring the sustainability of women's PVR use; and the conundrums that women grappled with as they prepared to disengage from the PVR after two cycles of use. CONCLUSION: The PVR is an acceptable contraceptive method to postpartum women in urban African settings. However, prior to its introduction into new country contexts, formative data on women's perceptions of, and reactions to, the product need to inform country preparation processes. Such information would be useful for tailoring counseling around this contraceptive, as well as for product marketing and robust uptake of the method.

The inclusion of sexual and reproductive health services within universal health care through intentional design.

In this paper, we argue that how sexual and reproductive health (SRH) services are included in UHC and health financing matters, and that this has implications for universality and equity. This is a matter of rights, given the differential health risks that women face, including unwanted pregnancy. How traditional vertical SRH services are compensated under UHC also matters and should balance incentives for efficiency with incentives for appropriate provision using the rights-based approach to user-centred care so that risks of sub-optimal outcomes are mitigated. This suggests that as UHC benefits packages are designed, there is need for the SRH community to advocate for more than simple "SRH inclusion". This paper describes a practical approach to integrate quality of SRH care within the UHC agenda using a framework called the "5Ps". The framework emphasises a "systems" and "design" lens as important steps to quality. The framework can be applied at different scales, from the health system to the individual user level. It also pays attention to how financing and resource policies intended to promote UHC may support or undermine the respect, protection and fulfilment of SRH and rights. The framework was originally developed with a specific emphasis on quality provision of family planning. In this paper, we have extended it to cover other SRH services.

Contraceptive technologies for global health: ethically getting to safe, effective and acceptable options for women and men.

While the contributions of science, biomedicine, and engineering to contraceptive development offer wonder and promise to the community, what inspires many of us in the not-for-profit sector about the process of contraceptive product development is the integration of consultations with users, providers and policy makers, good clinical and manufacturing practice in product design and development, and the delivery of approved products at affordable prices to those in greatest need. The commitment to have an impact on the reproductive lives of women and men along with the ethical principles embedded in this process of achieving safe, effective, and acceptable options include the respect for persons, i.e., eventual users, beneficence for those using the product and justice in ensuring that it is available to those who are most vulnerable, including those in developing countries. It is the inspiration that drives the scientists and developers to produce public benefit and additional social value.

Post-use ring weight and residual drug content as potential objective measures of user adherence to a contraceptive progesterone vaginal ring.

OBJECTIVES: The primary aim was to investigate post-use ring weight as a potential measure of cumulative adherence to a progesterone-releasing vaginal ring. STUDY DESIGN: We weighed and quantified residual progesterone in 115 vaginal rings following 90-day use by participants in an acceptability trial conducted in Nigeria, Senegal and Kenya. The primary objective was to correlate residual progesterone content with post-use ring weight. Secondary objectives included correlating ring weight with putative duration of ring use, and, where participants used two rings consecutively in the study, correlating residual content between these paired rings. RESULTS: Mean ring weight and progesterone content of used rings was 8.62±0.24 g and 1245±245 mg respectively, versus 9.37±0.02 and 2058±21 mg for control rings. Most used rings (90.4%) had residual progesterone levels less than 85% of the nominal loading. Linear regression showed a strong positive linear trend between residual progesterone content and post-use ring weight for all rings (r2=0.82). Duration of ring use was inversely associated (p=.00020) with ring weight. CONCLUSIONS: Post-use ring weight is highly correlated with residual progesterone content, a benchmark objective cumulative measure of adherence, and thus potentially useful as a surrogate objective measure of cumulative adherence to a progesterone-releasing vaginal ring. IMPLICATION STATEMENT: For vaginal rings containing a high initial drug loading and releasing a relatively large fraction of the initial loading during clinical use, post-use ring weight may offer a simple and inexpensive alternative to residual content testing for accurate monitoring of user adherence.

Introducing the Progesterone Vaginal Ring (PVR) as a New Option for Postpartum Family Planning in Sub-Saharan Africa: Insights from Engagements with Stakeholders.

The progesterone vaginal ring (PVR) is a ring-shaped device designed for use by women in the postpartum period to regulate fertility by complementing and extending the contraceptive effectiveness of lactational amenorrhea to suppress ovulation.1 It is available in eight Latin American countries for use by breastfeeding women who want more effective modern contraceptives in addition to contraceptive benefits provided by lactational amenorrhea alone.1 The PVR is a method that can be suitable to women in sub-Saharan Africa, given the near-universal practice of breastfeeding and the current level of unmet need for contraception in the postpartum period. Efforts are currently underway to introduce the PVR in Africa and south Asia. To ensure a seamless introduction, scale up and sustainability of the PVR in the region, the Population Council conducted pre-introductory activities with stakeholders in Kenya, Nigeria and Senegal to determine the level of interest in the ring, potential facilitating and mitigating factors and identify solutions to address challenges. The research team combined three approaches: in-depth interviews with family planning stakeholders; desk review of reports and policy guidelines; and in-group meetings. The stakeholders reached included public sector officials including policy makers and program managers, implementing partners, regulators, women and religious networks. All three countries had a promising policy and programmatic context that was supportive to PVR introduction. The exercise provided insights on socio-cultural and religious factors that could potentially impact how the PVR is perceived within communities and identified possible remedies to address misperceptions. It also paved the way for the conduct of an acceptability study of the PVR among breastfeeding women in these countries. The high acceptability rate in each country and the support expressed by government and other stakeholders have provided impetus for registration of the product in each country. Learning from this process could also direct how other family planning and reproductive health commodities would be introduced in the future.

Do Women Find the Progesterone Vaginal Ring Acceptable? Findings from Kenya, Nigeria, and Senegal.

The progesterone vaginal ring (PVR) is a contraceptive designed for use by breastfeeding women in the first year postpartum. This Report presents results of an acceptability study of the PVR in Kenya, Nigeria, and Senegal. Women seeking postpartum family planning services were offered various contraceptive options including the PVR. Of the 174 participating women, 110 (63 percent) used one ring and 94 (54 percent) completed the study by using two rings over a six-month period. Women were interviewed up to three times: at the time they entered the study, at 3 months (the end of the first ring cycle), and at 6 months (the end of the second ring cycle or when they exited if they had discontinued earlier). Many participants found the ring to be acceptable, with over three-quarters reporting that it was easy to insert, remove, and reinsert. While a small proportion of women experienced ring expulsion, the majority did not. These findings suggest that even in countries with little or no use of vaginal health products, contraceptive vaginal rings offer women a new option that they are able and willing to use.

Assessing the validity of indicators of the quality of maternal and newborn health care in Kenya.

BACKGROUND: The measurement of progress in maternal and newborn health often relies on data provided by women in surveys on the quality of care they received. The majority of these indicators, however, including the widely tracked "skilled attendance at birth" indicator, have not been validated. We assess the validity of a large set of maternal and newborn health indicators that are included or have the potential to be included in population-based surveys. METHODS: We compare women's reports of care received during labor and delivery in two Kenyan hospitals prior to discharge against a reference standard of direct observations by a trained third party (n = 662). We assessed individual-level reporting accuracy by quantifying the area under the receiver operating curve (AUC) and estimated population-level accuracy using the inflation factor (IF) for each indicator with sufficient numbers for analysis. FINDINGS: Four of 41 indicators performed well on both validation criteria (AUC>0.70 and 0.75

Aligning goals, intents, and performance indicators in family planning service delivery.

A flurry of policy initiatives in the fields of both population and development and reproductive health, many addressing the provision of family planning services, are currently underway: FP2020, the ICPD Beyond 2014, and the post-2015 development agenda, among others. This is an opportune time, therefore, to reflect upon and take into consideration what five decades of family planning programs can teach us about ensuring that policies and programs integrate their underlying intents, concrete goals, and performance indicators. The family planning field has encountered instances in its history when inconsistencies between goals, intents, and indicators arose and adversely affected the delivery of services. This commentary presents our observations concerning potential misalignments that may arise within the many promising initiatives underway. We examine the relationship between the intent, goal, and indicators of FP2020 as a case study highlighting the need for ensuring a tight alignment. We offer suggestions for ensuring that this and other initiatives use carefully calibrated indicators to guide the achievement of explicit program goals without undermining their underlying intent--namely, promoting well-being and reproductive rights.

Emergency contraception in Senegal: challenges and opportunities.

OBJECTIVES: This paper highlights lessons from introductory efforts and presents new data on community, provider and key opinion leader perspectives to support expanded use of emergency contraception (EC) in Senegal. SOURCES OF INFORMATION: The paper draws on four data sources: (i) a literature review; (ii) a secondary analysis of a household survey conducted by the Urban Reproductive Health Initiative; (iii) in-depth interviews with key opinion leaders; and (iv) a quantitative survey of healthcare providers from a range of service delivery points. ANALYSIS OF DATA: Knowledge of EC among women is low in urban areas, with only 20% of women having heard of the method and 4% having ever used it. There were serious gaps in providers' technical knowledge about EC; only 57% knew its mode of action and 34% were aware of the need for timely use (within 120 h). Moreover, nearly half reported reluctance to provide EC to married women and even fewer were willing to provide it to youths, particularly to adolescent girls. Responses from key opinion leaders were mixed, demonstrating ambivalence about EC and how it could be offered. CONCLUSION: In Senegal, the current positive political climate for family planning provides a good opportunity for strengthening EC programming to address knowledge and attitudinal barriers among providers, key opinion leaders and communities.

Enhancing contraceptive choice for postpartum women in sub-Saharan Africa with the progesterone vaginal ring: a review of the evidence.

It is increasingly recognized that women who have just given birth have a high unmet need and require contraceptive protection in the first year postpartum. A majority of women in developing countries do breastfeed exclusively but for short durations, hence they may be sometimes unknowingly exposed to the risk of pregnancy if they are relying on nursing for contraceptive protection. The WHO's Medical Eligibility Criteria for Contraceptive Use recommends the use of different contraceptives in the first year postpartum depending on whether the woman is nursing or not and the time since delivery. Some of the options available for breastfeeding women include implants, IUDs and injectables, which can be obtained only from a trained family planning provider. Since 2013, Population Council has been carrying out a study in Senegal, Nigeria, and Kenya to assess the acceptability of progesterone vaginal ring (PVR) as a new contraceptive option designed specifically for use by breastfeeding women to extend the period of lactational amenorrhea and promote birth spacing. Breastfeeding in sub-Saharan Africa is near universal with fairly long durations, a situation that increases the effectiveness of PVR. Each ring delivers a daily dose of 10 mg of progesterone and can be used continuously up to 3 months with a woman being able to continue with its use up to 1 year (four rings used consecutively). Preliminary results indicate that many women who had used the method found it acceptable and their partners supported its use. Activities aimed at having PVR registered and made available in focal countries are ongoing. Integration of family planning and immunization services for mothers and their newborns will be a key strategy in introducing PVR into targeted health care markets. Given that the use of PVR does not require extensive clinical training, it will be easier to integrate it at all levels of the health system from tertiary health facilities to community-based services. The PVR has been recently included in the WHO Model List of Essential Medicines and the WHO's fifth edition of the Medical Eligibility Criteria for Contraceptive Use which should facilitate its introduction into the public and private sectors.