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Many Ghanaian women seeking implant removal are able to obtain services, but knowledge and access gaps exist., Key Findings Although most contraceptive implant users in Ghana are able to access removal services, barriers, including cost, provider reluctance to remove, and difficult removals, exist.Providers express confidence in removing implants, but many are less confident in their ability to perform difficult removals., Key Implications Family planning programs should review and strengthen potential gaps in removal service provision including access to removals for outreach clients, financial disincentives for removal, and provider training and referral systems for difficult removals.More research is needed to assess the prevalence and consequences of difficult implant removals in different settings., Background: Access to quality removal services is a key component of informed choice in contraceptive implant use; however, limited data exist on users’ access to removal services. In Ghana, implants are available across the country and are the most commonly used contraceptive method among married women. Methods: From October 2017 and January 2018, we conducted a phone survey with a stratified random sample of 1,159 women who had obtained an implant from a public-sector Ghana Health Service clinic in 2 regions and 1,073 women who had an implant inserted through Marie Stopes International Ghana (MSIG) mobile outreach in 2 other regions. We also interviewed 50 women just after receiving an implant removal from MSIG. We conducted follow-up in-depth interviews with 20 implant acceptors and 15 implant providers across the 4 study regions. Results: More than four-fifths of women in both service delivery contexts knew that their implant could be removed before its labeled duration. Nearly half of public sector clients and one-third of outreach clients reported that their provider only told them of removal access at the place of insertion. Among women obtaining their implant in the public and outreach sectors, respectively, 32% and 21% reported ever wanting it removed and 61% and 55% who attempted removal obtained a removal on the first attempt. An additional 17% in each context were successful in having their implant removed within 1 week of the first attempt. Most women obtained removal from the same place they received their insertion (81% public, 70% outreach). Most women reported their overall removal experience was very or somewhat easy (74% public, 68% outreach). Challenges included cost, provider availability, interactions with providers, and difficult removals. Conclusions: Access to implant removal is not universal in Ghana. Strengthening removal services in both the public and outreach sectors is needed to ensure comprehensive access.

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.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.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.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.

An effervescent microneedle patch has been designed for rapid separation of drug-loaded microneedles and long-term contraception., 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.

Objective To describe medroxyprogesterone acetate (MPA) levels among Kenyan depot medroxyprogesterone acetate (DMPA) users in the FEM-PrEP HIV prevention trial, and to compare MPA levels between ARV for HIV prevention (treatment) and placebo groups. Study Design We measured MPA in previously collected plasma samples from 63 Kenyan trial participants who used DMPA for one or two complete intervals. We separately assessed MPA levels among the nine DMPA users who became pregnant at this site. Results Mean MPA levels at the end of each 12 week injection interval were 0.37 ng/ml (95% CI: 0.25, 1.99) and 0.28 ng/ml (95% CI: 0.19, 1.22) among participants assigned TDF/FTC and 0.49 (95% CI: 0.40, 1.27) and 0.39 (95% CI: 0.31, 1.17) among those assigned placebo. The difference between groups was not statistically significant overall, or in an analysis which adjusted for the observed low adherence to TDF/FTC. Unanticipated findings of this analysis were low 12-week MPA levels among DMPA users in both study arms. Of 61 women who contributed data for the first DMPA injection interval, 26.2% had MPA levels

Background Use of contraception lowers a woman's risk of experiencing an ectopic pregnancy. In the case of method failure, however, progestin-only contraceptives may be more likely to result in ectopic pregnancies than some other methods such as combined hormonal and barrier contraceptives. Objective To describe ectopic pregnancy risk associated with use of implants and progestin-only injectable contraceptives through a systematic review of published studies. Data sources We searched electronic databases for articles in any language published through May 2015 describing studies of progestin-only injectables and implants. We also searched bibliographies and review articles for additional studies. Study selection and extraction Studies that reported any pregnancies were included in the review. Independent data extraction was performed by two authors based on predefined data fields, and where possible, we calculated the proportion of pregnancies that were ectopic and the ectopic pregnancy incidence rate per 1000 woman-years. Results Fifty-three studies of implants and 28 studies of injectables were identified; 79% reported pregnancy location. The proportion of ectopic pregnancy ranged from 0 to 100% with an incidence of 0-2.9 per 1000 woman-years in studies of marketed levonorgestrel implants. Studies of etonogestrel implants and the injectables, depot-medroxyprogesterone acetate and norethisterone enanthate, reported few ectopic pregnancies. Conclusion Progestin-only contraceptive implants and injectables protect against ectopic pregnancy by being highly effective in preventing pregnancy overall; however, the absolute risk of ectopic pregnancy varies by type of progestin. Risk of ectopic pregnancy should not be a deterrent for use or provision of these methods.

Despite the availability of a variety of contraceptive methods, millions of women still have an unmet need for contraceptive choices. Short-acting methods are plagued by issues with adherence, leading to imperfect or inconsistent use and subsequent unintended pregnancy. Long-acting contraceptive methods such as intrauterine devices and contraceptive implants, while providing highly effective and safe contraception, do not meet the needs of all women, often due to cost, access or acceptability issues. Several new methods are in various stages of development and are designed to address the shortcomings of current methods. Providers should be aware of these future options and how they might better meet women's needs.

Background: Pregnancy among study participants remains a challenge for trials of new HIV prevention agents despite promotion and provision of contraception. We evaluated contraceptive use, pregnancy incidence, and study drug adherence by contraceptive method among women enrolled in the FEM-PrEP trial of once-daily oral tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) for HIV prevention. Methods: We required women to be using effective non-barrier contraception at enrollment. At each monthly follow-up visit, women were counseled on contraceptive use and tested for pregnancy. TDF-FTC adherence was determined by measuring plasma drug concentrations at 4-week intervals. We used Cox proportional hazards models to assess factors associated with incident pregnancy and multivariate logistic regression to examine the relationship between contraceptive method used at enrollment and TDF-FTC adherence. Results: More than half of women were not using effective contraception before enrollment. Ninety-eight percent of these women adopted either injectable (55%) or oral (43%) contraceptives. The overall pregnancy rate was 9.6 per 100 woman-years. Among injectable users and new users of combined oral contraceptives (COCs), the rates were 1.6 and 35.1, respectively. New users of injectables had significantly greater odds of adhering to TDF-FTC than new COC users [odds ratio (95% confidence interval): 4.4 (1.7 to 11.6), P = 0.002], existing COC users [3.1 (1.3 to 7.3), P = 0.01], and existing injectable users [2.4 (1.1 to 5.6), P = 0.04]. Conclusions: Women using COCs during FEM-PrEP, particularly new adopters, were more likely to become pregnant and less likely to adhere to study product than injectable users. HIV prevention trials should consider requiring long-acting methods, including injectables, for study participation.

Use of contraceptive implants has surged in recent years, yet emerging data show a deficit of service delivery capacity and coverage for implant removals. The number of projected removals needed in the 69 FP2020 focus countries in 2018 (4.9–5.8 million) is more than twice that estimated for 2015 (2.2 million). We must proactively plan and execute high-quality implant removal services in order to fulfill the exceptional promise of implants in meeting client needs and advancing toward FP2020 goals.

CONTEXT: Unmet need for contraception has become a central concept in the family planning field and one of the most important indicators for program planning and evaluation. The measure has faced criticism however for not taking into account women’s stated intention to use contraceptives. METHODS: Using longitudinal data on more than 2500 rural Bangladeshi women in 128 villages this study links women’s contraceptive adoption and experience of unwanted pregnancy between 2006 and 2009 to their unmet need status and their stated intention to use contraceptives in 2006. RESULTS: Intention to use a method was predictive of subsequent use for both women with and without an unmet need. Three-quarters of the unintended pregnancies reported between 2006 and 2009 occurred among women without an unmet need in 2006. In addition nearly half of women without an unmet need who were pregnant or postpartum in 2006 had experienced an unwanted pregnancy compared with 30% of all women classified as having an unmet need. CONCLUSION: To adequately meet population family planning needs programs must look beyond unmet need and focus on the total demand for acceptable and effective methods.

BackgroundA 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.MethodsWe 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.ResultsMany 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.ConclusionStudy findings indicate that a contraceptive MAP is of potential interest to women and that specific MAP attributes will be important to acceptability.

Objective: Sino-implant (II) is a contraceptive implant that had a commodity price one-third of the competing products a decade ago. To make Sino-implant (II) more widely available, we conducted a trial to collect safety and efficacy data required for World Health Organization (WHO) prequalification, a quality standard allowing global donors to procure a pharmaceutical product. Study design: This was a randomized controlled trial allocating 650 participants to either Sino-implant (II) or Jadelle®. Participants were seen at 1 and 6 months, and then semiannually. The primary efficacy measure was the pregnancy Pearl Index [number of pregnancies per 100 women-years (WY) of follow-up] in the Sino-implant (II) group during up to 4 years of implant use. Results: For the primary outcome, Sino-implant (II) had a 4-year Pearl Index of 0.74 (95% confidence interval, 0.36–1.37) compared to 0.00 (95% confidence interval, 0.00–1.04) for Jadelle®. The Sino-implant (II) pregnancy rate was significantly higher in the fourth year (3.54 per 100 WY) than in the first 3 years combined (0.18 per 100 WY; p

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

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, f 2 , 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.