Service Delivery Considerations for Introducing New Injectable Contraceptives Lasting 4 and 6 Months in Nigeria and Uganda: A Qualitative Study.

BACKGROUND: New family planning (FP) product introduction requires understanding the target market and support from stakeholders from across the health sector. We aimed to understand the perspectives of FP providers and other stakeholders on the potential introduction of new subcutaneous (SC) depot medroxyprogesterone acetate (DMPA) injectable contraceptives lasting 4 and 6 months in Nigeria and Uganda. METHODS: Between July 2021 and February 2022, we conducted 48 in-depth interviews (IDIs) and 11 focus group discussions (FGDs) with FP providers and other stakeholders involved with service delivery, program management, and policymaking in Lagos and Abuja in Nigeria and Kampala and Luwero in Uganda. IDIs and FGDs explored respondents' reactions to and preferences for the new injectables lasting 4 and 6 months. RESULTS: Most respondents liked the idea of longer-acting DMPA-SC products, noting the potential for reduced facility visits for clients and workloads for providers, cost savings for users and the health system, and potential for improved commodity logistics. Some nonproviders raised concerns about confusion among providers and clients with the availability of multiple injectable products; however, providers did not share this concern. The greatest interest among all groups was for the 6-month injectable, even without the option for self-injection. Several respondents reported that self-injection is not widespread in either context, and some noted that contact with a provider would be important for products with longer durations. Respondents' acceptability of the new injectables assumed that side effects would be no worse than the existing 3-month product. CONCLUSIONS: Family planning stakeholders in Nigeria and Uganda are supportive of expanding the method mix with new injectables, which they see as having the potential to meet the needs of more users. Concerted engagement of health providers, policymakers, and the community will be necessary for successful introduction once these new contraceptive products are available.

Using Human-Centered Design to Explore Potential Users' and Men's Views of New Injectable Contraceptives in Kampala and Lagos.

BACKGROUND: Injectable contraceptives are the most used method in sub-Saharan Africa. We conducted market research to assess potential user attitudes toward 4- and 6-month injectables. We also present user suggestions for marketing these new injectables once they are available. METHODS: We implemented a 2-phase market research study from October through December 2021 in Kampala, Uganda, and Lagos, Nigeria. We conducted 11 focus group discussions (FGDs) with 51 participants in Kampala and 12 FGDs with 67 participants in Lagos. FGDs included current and potential injectable users and men stratified by marital status and age. Next, 23 women in Kampala and 24 in Lagos participated in cocreation workshops using human-centered design methods to explore marketing and communications strategies for each injectable. Data collection teams completed semistructured data extraction tables that were then analyzed thematically. RESULTS: Participants liked both injectable options due to the reduced number of facility visits that would save time and money and increase privacy. Primary concerns included side effects, delayed return to fertility, cost, self-efficacy to self-inject, and stock-outs. Participants in Kampala preferred a shorter reinjection window (or "grace period") because it is easier to remember and they assumed it meant a quicker return to fertility, but participants in Lagos preferred a longer window because it provides extra time for reinjection. Citing norms around women needing to get pregnant quickly after marriage, participants in both sites felt that the 4-month injectable would benefit young people with busy lifestyles or limited access to facilities, whereas the 6-month injectable would benefit women who already had children. CONCLUSIONS: We found that participants in Kampala and Lagos would prefer additional injectable options to meet the wide-ranging needs of users in different stages of their reproductive lives. Family planning program planners can apply the marketing insights we identified when these new injectables become available.

Contraceptive Continuation and Experiences Obtaining Implant and IUD Removal Among Women Randomized to Use Injectable Contraception, Levonorgestrel Implant, and Copper IUD in South Africa and Zambia.

Few longitudinal studies have measured contraceptive continuation past one year in sub-Saharan Africa. We surveyed 674 women who had been randomized to receive the three-month intramuscular contraceptive injectable (DMPA-IM), levonorgestrel (LNG) implant, or copper intrauterine device (IUD) during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial in South Africa and Zambia and were subsequently followed for two additional years to explore method continuation, reasons for discontinuation, and access to implant and IUD removal services. We also conducted in-depth qualitative interviews with 39 participants. We estimated cumulative discontinuation probabilities using Kaplan-Meier estimates and assessed factors associated with discontinuation using Cox-proportional hazards models. The LNG implant continuation rate over the maximum 44-month study period was 60 percent, while rates for the copper IUD and DMPA-IM were 52 percent and 44 percent, respectively. Reasons for method discontinuation included side effects, particularly menstrual changes, and method stock-outs. Most implant and IUD users who sought removal were able to access services; however, room for improvement exists. In this cohort originally randomized to receive a contraceptive method and attend regular study visits, implants and IUDs continued to be highly acceptable over an additional two years, but facilities should continue to ensure that insertions and removals are available as requested.

Optimizing the design of a contraceptive microarray patch: a discrete choice experiment on women's preferences in India and Nigeria.

BACKGROUND: Efforts are underway to develop an easy-to-use contraceptive microarray patch (MAP) that could expand the range of self-administrable methods. This paper presents results from a discrete choice experiment (DCE) designed to support optimal product design. METHODS: We conducted a DCE survey of users and non-users of contraception in New Delhi, India (496 women) and Ibadan, Nigeria (two versions with 530 and 416 women, respectively) to assess stated preferences for up to six potential product attributes: effect on menstruation, duration of effectiveness, application pain, location, rash after application, and patch size. We estimated Hierarchical Bayes coefficients (utilities) for each attribute level and ran simulations comparing women's preferences for hypothetical MAPs with varying attribute combinations. RESULTS: The most important attributes of the MAP were potential for menstrual side effects (55% of preferences in India and 42% in Nigeria) and duration (13% of preferences in India and 24% in Nigeria). Women preferred a regular period over an irregular or no period, and a six-month duration to three or one month. Simulations show that the most ideal design would be a small patch, providing 6 months of protection, that would involve no pain on administration, result in a one-day rash, and be applied to the foot. CONCLUSIONS: To the extent possible, MAP developers should consider method designs and formulations that limit menstrual side effects and provide more than one month of protection.

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.

What About Methods for Men? A Qualitative Analysis of Attitudes Toward Male Contraception in Burkina Faso and Uganda.

CONTEXT: Male contraceptive options are limited; however, product development efforts tend to focus on female methods. Research on attitudes toward methods for men-particularly in regions of low contraceptive prevalence, such as Sub-Saharan Africa-could inform the development of new male methods. METHODS: Qualitative data were taken from focus group discussions with 80 men aged 23-67 and 398 women aged 15-50 conducted in Burkina Faso and Uganda in 2016. Transcripts were analyzed thematically to explore support among men and women for male contraceptive methods, and to extract suggestions about ideal method characteristics. RESULTS: Male and female participants in both countries expressed support for new male contraceptive options; more positive attitudes were expressed in Uganda than in Burkina Faso. Participants of both sexes recognized that male methods could reduce the family planning burden on women and offer men greater control over their fertility; however, some had concerns about side effects and thought that men would not use contraceptives. Relationship characteristics, such as polygamous unions, were cited as possible challenges. In both countries, various delivery methods (e.g., creams or jellies, injections and implants) and durations (from short-acting to permanent) were proposed. CONCLUSIONS: The acceptability of new male methods among most participants in the two countries indicates a potential demand for male contraceptives. Options should include a variety of method characteristics to maximize choice, engage men, and support men and women's contraceptive needs.

RESUMEN Contexto: Las opciones de anticonceptivos masculinos son limitadas; sin embargo, los esfuerzos de desarrollo de productos tienden a enfocarse en los métodos femeninos. La investigación sobre las actitudes hacia los métodos para hombres, ­ particularmente en las regiones de baja prevalencia de anticoncepción, como el África subsahariana­ podría dar sustento al desarrollo de nuevos métodos masculinos. Métodos: Se tomaron datos cualitativos a partir de discusiones de grupos focales que se llevaron a cabo en Burkina Faso y Uganda en 2016, con la participación de 80 hombres de 23 a 67 años y de 398 mujeres de 15 a 50 años. Las transcripciones se analizaron temáticamente para explorar el apoyo de hombres y mujeres a los métodos anticonceptivos masculinos, así como para extraer sugerencias sobre las características ideales del método. Resultados: Los participantes masculinos y femeninos en ambos países expresaron su apoyo a las nuevas opciones de anticonceptivos masculinos; se expresaron más actitudes positivas en Uganda que en Burkina Faso. Los participantes de ambos sexos reconocieron que los métodos masculinos podrían reducir la carga de planificación familiar para las mujeres y ofrecer a los hombres un mayor control sobre su fecundidad; sin embargo, algunos participantes plantearon sus preocupaciones sobre los efectos secundarios y consideraron que los hombres no usarían anticonceptivos. Las características de la relación, como las uniones polígamas, se mencionaron como posibles desafíos. En ambos países, se propusieron varios tipos de métodos anticonceptivos (por ejemplo, cremas o jaleas, la inyección y el implante) y de distintas duraciones (de acción corta a permanente). Conclusiones: La aceptabilidad de los nuevos métodos masculinos en la mayoría de los participantes en los dos países indica una demanda potencial de anticoncepción masculina. Las opciones deberían incluir una variedad de características del método para maximizar la elección, involucrar a los hombres y apoyar las necesidades de anticonceptivos de hombres y mujeres.

RÉSUMÉ Contexte: Les options contraceptives masculines ne sont guère nombreuses. Le fait est, cependant, que les efforts de développement de produits se concentrent généralement sur les méthodes féminines. L'étude des attitudes à l'égard des méthodes masculines ­ en particulier dans les régions à faible prévalence contraceptive telles que l'Afrique subsaharienne ­ permettrait d'éclairer le développement de nouvelles méthodes pour les hommes. Méthodes: Les données qualitatives requises ont été extraites de discussions de groupe menées en 2016 avec 80 hommes âgés de 23 à 67 ans et 398 femmes âgées de 15 à 50 ans au Burkina Faso et en Ouganda. Elles ont été transcrites et analy-sées thématiquement pour examiner le soutien des hommes et des femmes à l'égard des méthodes contraceptives masculines et en dégager les suggestions possibles sur les caractéristiques des méthodes idéales. Résultats: Dans les deux pays, les participants et participantes ont exprimé leur appui de nouvelles options de contraception masculine; plus d'attitudes positives ont été exprimées en Ouganda qu'au Burkina Faso. Les participants des deux sexes ont reconnu que les méthodes masculines pourraient alléger la charge de la planification familiale portée par les femmes et offrir aux hommes un meilleur contrôle de leur fécondité. Certains s'inquiétaient cependant des effets secondaires et pensaient que les hommes n'utiliseraient pas les contraceptifs. Les caractéristiques de relation, telles que les unions polygames, ont été citées comme difficultés possibles. Dans les deux pays, différentes méthodes (par exemple, crèmes ou gels, injection ou implant) et durées (de courte à permanente) ont été proposées. Conclusions: L'acceptabilité de nouvelles méthodes masculines aux yeux de la plupart des participants dans les deux pays révèle une demande potentielle de contraception masculine. Les options proposées doivent inclure diverses caractéristiques de méthode pour maximiser le choix, engager les hommes et soutenir les hommes et les femmes dans leurs besoins contraceptifs.

The new contraceptive revolution: developing innovative products outside of industry†,‡.

A significant global unmet need for new contraceptive options for both women and men remains due to side effect profiles, medical concerns, and inconvenience of many currently available products. The pharmaceutical industry has largely abandoned early research and development for contraception and will not likely engage to bring new products to the market unless they have been significantly de-risked by showing promise in early phase clinical trials. This lack of interest by big pharma comes at a time when scientific and technological advances in biology and medicine are creating more opportunities than ever for the development of new and innovative drug products. Novel partnerships between the academic sector, small biotechnology companies, foundations, non-government organizations (NGOs), and the federal government could accelerate the development of new contraceptive products. We discuss the challenges and opportunities that we have encountered as an NGO with a mission to develop novel contraceptive products for low- and middle-income countries and how it differs from developing products for higher-income markets. We hope that our experiences and "lessons learned" will be of value to others as they proceed down the product development path, be it for female or male or for hormonal or nonhormonal contraceptives.

Women's Perspectives on Contraceptive-Induced Amenorrhea in Burkina Faso and Uganda.

CONTEXT: Women's concerns about contraceptive-induced menstrual changes can lead to method discontinuation and nonuse, contributing to unmet need for contraception. Research on women's perceptions of amenorrhea related to longer acting methods and in low-income countries is limited. METHODS: Data were from nationally representative household surveys and focus group discussions with women of reproductive age conducted in Burkina Faso and Uganda in 2016-2017. Bivariate cross-tabulations and multivariate logistic regression analyses were used to examine sociodemographic and reproductive characteristics associated with women's attitudes about contraceptive-induced amenorrhea (n=2,673 for Burkina Faso and 2,281 for Uganda); menstrual health determinants were also examined for Burkina Faso. Qualitative data from focus group discussions were analyzed to understand reasons behind women's attitudes and how they influence contraceptive decision making. RESULTS: Sixty-five percent of women in Burkina Faso and 40% in Uganda reported they would choose a method that caused amenorrhea during use. In Burkina Faso, the predicted probability of accepting amenorrhea was higher for women aged 15-19 (compared with older women), living in rural areas, married and cohabiting (compared with never married), currently using a contraceptive method (compared with never users) and from Mossi households (compared with Gourmantché); menstrual health practices were not associated with amenorrhea acceptability. In Uganda, the least wealthy women had the highest predicted probability of accepting amenorrhea (51%). Qualitative analysis revealed a variety of reasons for women's attitudes about amenorrhea and differences by country, but the relationship between these attitudes and contraceptive decision making was similar across countries. CONCLUSIONS: Addressing misconceptions about contraception and menstruation may result in more informed method decision making.

Contexto: Las preocupaciones de las mujeres acerca de los cambios menstruales inducidos por los anticonceptivos pueden conducir a la interrupción y el abandono del método, lo cual contribuye a la necesidad insatisfecha de anticoncepción. La investigación sobre la percepción de la amenorrea por parte de las mujeres sobre los métodos de acción más prolongada y en los países de bajos ingresos es limitada. Métodos: Los datos provienen de encuestas representativas de hogares a nivel nacional y discusiones de grupos focales con mujeres en edad reproductiva realizadas en Burkina Faso y Uganda entre 2016 y 2017. Se utilizaron tabulaciones cruzadas bivariadas y análisis de regresión logística multivariada para examinar las características sociodemográficas y reproductivas asociadas con las actitudes de las mujeres con respecto a la amenorrea inducida por anticonceptivos (n = 2,673 para Burkina Faso y 2,281 para Uganda); también se examinaron los determinantes de la salud menstrual en Burkina Faso. Se analizaron datos cualitativos de discusiones de los grupos focales para comprender las razones que determinan las actitudes de las mujeres y cómo influyen en la toma de decisiones sobre anticonceptivos. Resultados: El 65% de las mujeres en Burkina Faso y el 40% en Uganda informaron que elegirían un método que les causara amenorrea durante su uso. En Burkina Faso, la probabilidad predicha de aceptar la amenorrea fue mayor para las mujeres de 15 a 19 años (en comparación con las mujeres mayores), que vivían en zonas rurales, que estaban casadas y cohabitaban (en comparación con las que nunca se habían casado), que actualmente usaban un método anticonceptivo (en comparación con las mujeres que nunca lo habían usado) y de hogares Mossi (en comparación con Gourmantché). Las prácticas de salud menstrual no se asociaron con la aceptabilidad de la amenorrea. En Uganda, las mujeres menos ricas tuvieron la probabilidad más alta de aceptar amenorrea (51%). El análisis cualitativo reveló una variedad de razones con respecto a las actitudes de las mujeres sobre la amenorrea y las diferencias por país, pero la relación entre estas actitudes y la toma de decisiones sobre anticonceptivos fue similar en todos los países. Conclusiones: El abordaje de los conceptos erróneos sobre la anticoncepción y la menstruación podría resultar en una toma de decisiones más informada sobre los métodos anticonceptivos.

Contexte: Les inquiétudes des femmes à l'égard des changements menstruels induits par la contraception peuvent conduire à l'arrêt ou à la non-utilisation de la méthode et contribuer ainsi au besoin non satisfait de contraception. La recherche sur les perceptions des femmes de l'aménorrhée liée aux méthodes à durée d'action prolongée et dans les pays à revenu faible est limitée. Méthodes: Les données sont extraites d'enquêtes de ménage nationalement représentatives et de discussions de groupe avec des femmes en âge de procréer, menées au Burkina Faso et en Ouganda en 2016-2017. Les caractéristiques sociodémographiques et reproductives associées aux attitudes des femmes concernant l'aménorrhée induite par la contraception (n=2 673 pour le Burkina Faso et 2 281 pour l'Ouganda) ont été examinées en tableaux croisés bivariés et par analyses de régression logistique multivariée. Les déterminants de la santé menstruelle ont aussi été examinés pour le Burkina Faso. L'analyse des données qualitatives obtenues des discussions de groupe a permis de cerner les raisons à la base des attitudes des femmes et leur influence sur les décisions contraceptives prises. Résultats: Soixante-cinq pour cent des femmes burkinabè et 40% de leurs homologues ougandaises ont déclaré qu'elles choisiraient une méthode dont la pratique causerait l'aménorrhée. Au Burkina Faso, la probabilité prédite d'acceptation de l'aménorrhée s'est avérée supérieure pour les femmes âgées de 15 à 19 ans (par rapport à leurs aînées), vivant en milieu rural, mariées ou en union (par rapport à celles qui n'avaient jamais été mariées), pratiquant actuellement la contraception (par rapport à celles qui ne l'avaient jamais pratiquée) et d'origine Mossi (par rapport à Gourmantché). Les pratiques de santé menstruelle n'étaient pas associées à l'acceptabilité de l'aménorrhée. En Ouganda, les femmes les moins riches sont associées à la plus haute probabilité prédite d'acceptation de l'aménorrhée (51%). L'analyse qualitative a révélé diverses raisons à la base des attitudes des femmes à l'égard de l'aménorrhée ainsi que certaines différences suivant le pays, mais la relation entre ces attitudes et la décision contraceptive s'est avérée similaire dans les deux pays. Conclusions: La résolution des idées fausses concernant la contraception et la menstruation pourrait conduire à une prise de décision mieux éclairée dans le choix des méthodes.

Long-acting reversible contraception by effervescent microneedle patch.

To increase access to long-acting contraception, we developed a reversible contraceptive microneedle patch that is simple-to-administer, slowly releases contraceptive hormone (levonorgestrel) for >1 month, and generates no biohazardous sharps waste. After manually pressing the patch to skin for 1 min, microneedles rapidly separate from the patch within the skin due to effervescence triggered by contact with skin's interstitial fluid, as demonstrated in rats and human participants. Long-acting contraception is achieved by formulating microneedles with a biodegradable polymer [poly(lactic-co-glycolic) acid] that slowly releases levonorgestrel for ~1 month in vitro. In rats, the patch maintained levonorgestrel concentration above the human contraceptive threshold level for >1 month, and a placebo microneedle patch was well-tolerated in human participants. Women of reproductive age in three continents demonstrated interest in and preference for long-acting contraception by microneedle patch. These studies indicate that an effervescent microneedle patch could facilitate greater access to long-acting contraception.

User preferences for a contraceptive microarray patch in India and Nigeria: Qualitative research on what women want.

BACKGROUND: A new contraceptive microarray patch (MAP) for women is in development. Input on this method from potential end-users early in the product development process is important to guide design decisions. This paper presents the qualitative component of a broader study exploring initial acceptability of the MAP and selected product features. The qualitative research was intended to identify product features that are most salient to end-users and to contextualize preferences around them with subsequent research planned to assess quantitatively the relative importance of those features. METHODS: We conducted 16 focus group discussions and 20 in-depth interviews with women and 20 IDIs with family planning providers in New Delhi, India, and Ibadan, Nigeria. Input from the MAP developer served to identify plausible features of the MAP to include in the focus group discussions and in-depth interviews. Interviews were audio-recorded, transcribed into English, coded, and analyzed to examine key dimensions of MAP features. RESULTS: Many participants viewed the MAP as potentially easy to use. Interest in self-application after learning correct use was high, especially in India. Participants favored formulations affording protection from pregnancy for three or six months, if not longer. Interest in a shorter-acting MAP was particularly low in Nigeria. Non-desirable MAP features included a potential localized skin rash and pain at application. Views on patch size and location of application were related to the potential for rash and pain, with a desire to permit discreet use and minimize pain. Results indicate that the side effect profile, effectiveness, and pricing are also important factors for acceptability and uptake of a future product. CONCLUSION: Study findings indicate that a contraceptive MAP is of potential interest to women and that specific MAP attributes will be important to acceptability.

Potential user interest in new long-acting contraceptives: Results from a mixed methods study in Burkina Faso and Uganda.

Method-related concerns represent an important cause of contraceptive non-use and discontinuation. User preferences must be incorporated into the design of new contraceptive technologies to ensure product success and improve family planning outcomes. We assessed preferences among potential users in Burkina Faso and Uganda for six contraceptive methods currently under development or ready for introduction: a new copper intra-uterine device (IUD), a levonorgestrel intra-uterine system, a new single-rod implant, a biodegradable implant, a longer-acting injectable, and a method of non-surgical permanent contraception. Questions were added to nationally-representative PMA2020 household surveys that asked 2,743 and 2,403 women in Burkina Faso and Uganda, respectively, their interest in using each new method. We assessed factors associated with interest through multivariable logistic regression models. We conducted qualitative interviews and focus groups with 398 women, 78 men, and 52 family planning providers and key informants to explore perceived advantages and disadvantages of the methods. Respondents expressed interest in using all new methods, with greatest interest in the longer-acting injectable (77% in Burkina Faso, 61% in Uganda), followed by a new single-rod implant. Least interest was expressed in a new copper IUD (26% Burkina Faso, 15% in Uganda). In both countries, women with less education had higher odds of interest in a longer-acting injectable. Interest in most new methods was associated with desiring a method lasting longer than one year and acceptance of lack of menstrual bleeding as a contraceptive side effect. Perceived advantages and disadvantages were similar between countries, including concerns about menstrual side effects and fear of the biodegradable nature of the biodegradable implant. Potential users, their partners, and providers are interested in new longer-acting methods, however, familiar forms including the injectable and implant may be the most immediately acceptable. A biodegradable implant will require clear counseling messages to allay potential fears.

Developing acceptable contraceptive methods: Mixed-method findings on preferred method characteristics from Burkina Faso and Uganda.

Background: Unmet need remains high in developing regions. New contraceptive technologies may improve uptake and use. This study examines desirable product characteristics. Methods: We added a module to the female questionnaire of the PMA2020 surveys in Burkina Faso and Uganda and conducted 50 focus group discussions (FGDs) with women, 10 FGDs with men, and 37 in-depth interviews (IDIs) with providers across the two countries. FGDs with women and IDIs with providers included a semi-structured ranking exercise on pre-selected product characteristics. Results: Effectiveness, duration, few side effects, cost, and access were the characteristics most commonly reported as important in choosing a method by survey respondents across both countries. Half or more of women surveyed in each country would like a method that lasts at least one year, while 65% in Burkina Faso and 40% in Uganda said they would use a method causing amenorrhea. Qualitative findings show that women want methods with minimal and predictable side effects. Reactions to increased bleeding were negative, especially in Burkina Faso, but perspectives on reduced bleeding were more mixed. Women and providers preferred methods that are discreet and not user-dependent, and associate duration with convenience of use. Some women in Uganda expressed concerns about the invasive nature of long-acting methods, and cost was an important consideration in both countries. In the ranking exercise, discreet use and few side effects often ranked high, while causing amenorrhea and not requiring a pelvic exam often ranked low. Conclusion: Product development should consider user preferences for success in these settings.

In vivo release of levonorgestrel from Sino-implant (II) ­ an innovative comparison of explant data.

OBJECTIVES: Measuring the amount of progestin remaining in contraceptive implants used for different lengths of time provides useful information on in vivo release kinetics including change over time. We compared estimated in vivo levonorgestrel (LNG) release rates derived from Sino-implant (II) explants with similar data from removed Jadelle. STUDY DESIGN: We measured LNG remaining in 44 sets of Sino-implant (II) used for up to 7 years and removed in four Chinese clinics. Results were compared with published data for Jadelle explants used for up to 36 months. We estimated and compared monthly and daily LNG release rates for the two products using prediction models for drug release. We also estimated the dissolution profile similarity factor, f2, for LNG release. RESULTS: Both Sino-implant (II) and Jadelle release approximately 30% of total LNG load after 3 years. Results of fitting the data to a biologically plausible modified Higuchi prediction model indicate comparable release through 3 years. An estimated similarity factor of 80.6 (90% confidence interval: 70.8-85.7) indicates similarity in the dissolution profiles of the two implants. CONCLUSIONS: LNG release in vivo measured through explant analysis suggest that Sino-implant (II) and Jadelle may perform similarly through 3 years of use and could remain highly effective beyond this time point. These results align with published data for Jadelle and Sino-implant (II) showing high effectiveness for 5 years. Ongoing clinical studies comparing the products over 5 years present an opportunity to verify this supportive measure of clinical effectiveness. IMPLICATIONS: This innovative approach provides evidence that Sino-implant (II) may perform clinically similarly to Jadelle over 3 years and remain a highly effective contraceptive beyond this time point. Data from explant analyses show promise for investigating the equivalence of elusion profiles of contraceptive implants.

The reliability of calendar data for reporting contraceptive use: evidence from rural Bangladesh.

Collecting contraceptive-use data by means of calendar methods has become standard practice in large-scale population surveys, yet the reliability of these methods for capturing accurate contraceptive histories over time remains largely unknown. Using data from overlapping contraceptive calendars included in a longitudinal study of 3,080 rural Bangladeshi women, we assessed the consistency of reports from the baseline interview month in 2006 with reports from the same month in a follow-up survey three years later, and examined predictors of reliable reporting. More than one-third of women were discordant in their reports for the reference month in the two surveys. Among women reporting use of any contraceptive method for the reference month in both surveys, 25 percent reported different methods at the two time points. Women using condoms or traditional methods and those with more complex reproductive histories, including more births and more episodes of contraceptive use, were least likely to report reliably. (STUDIES IN FAMILY PLANNING