Use of Model-Informed Drug Development to Streamline Development of Long-Acting Products: Can These Successes Be Translated to Long-Acting Hormonal Contraceptives?

Long-acting contraceptives are the most effective reversible contraceptive methods. Increasing patients’ access to these contraceptives may translate into fewer unintended pregnancies and lead to substantial individual and public health benefits. However, development of long-acting products can be complex and challenging. This review provides ( a) an overview of representative development programs for long-acting antipsychotics as cases for conceptual translation to long-acting contraceptives, ( b) several case examples on how modeling and simulation have been used to streamline the development of long-acting products, and ( c) examples of challenges andopportunities in developing long-acting contraceptives and information on how exposure-response relationships of commonly used progestins may enable regulators and developers to rely on prior findings of effectiveness and safety from an approved contraceptive to streamline the development of long-acting contraceptives. The US Food and Drug Administration is seeking assistance from stakeholders to provide data from studies in which pharmacokinetic and pharmacodynamic or clinical outcomes of hormonal contraceptives were evaluated and not previously submitted.

Assessing the Usability of a Task-Shifting Device for Inserting Subcutaneous Contraceptive Implants for Use in Low-Income Countries

Women in low- and middle-income countries (LMICs) have limited access to long-acting contraceptives. Access to long-acting contraceptives, such as subcutaneous contraceptive implants, could be increased by task-shifting implant administration from advanced to minimally trained healthcare providers. The objective of this study was to investigate the usability of a task-shifting device for administering subcutaneous contraceptive implants. Healthcare providers (n = 128) from multiple health centers in Ethiopia were trained to administer implants on an arm simulator with the traditional method and a method using the device. Participants were observed while inserting implants into the arm simulator, and procedural error rates were calculated. Observations were analyzed using an iterative inductive coding methodology. For the device-assisted method, minimally trained healthcare providers had larger procedural error rates than other professions (p = 0.002). For the traditional method, physicians had larger procedural error rates than nurses and midwives (p = 0.03). Several procedural errors were identified such as participants inserting and removing the trocar and plunger completely or inserting and/or removing the trocar too far or not enough. These findings reinforce the importance of performing formative usability testing during the early phases of a medical device design process, considering users' mental models, and avoiding assumptions about healthcare providers' abilities.

Method Shifting from Long to Short Term Contraceptives and its Associated Factors among Reproductive Age Women, Northwest Ethiopia, 2018

Objective: Even if long term contraceptives are more effective, cost efficient and tolerable choices, method shifting from long to short term contraceptives continued as a global issue. Therefore this study assessed the proportion and associated factors of method shifting from long term to short term contraceptives in Gondar city administration, northwest Ethiopia. Result: A total of 390 women participated in the study that made the response rate of the current study as 96%. The overall proportion of method shifting from long to short term contraceptives was 48.5% with (95% CI: 43.8, 53.3). Had secondary level educational status (AOR=0.18, 95%CI 0.07, 0.51), had information about long acting contraceptives from friends (AOR=6.67, 95%CI 1.89, 23.52), use of long acting contraceptives for limiting purposes (AOR=0.26, 95%CI 0.11, 0.60), and had enough counseling on long acting contraceptives during ANC visits (AOR=0.20, 95% CI 0.08, 0.50) were found to have statistically significant association with method shifting.

Prevalence of Long-acting Reversible Contraceptive Methods and Factors Affecting their Use among Married Women in Akasta Town, North-East Ethiopia

Background: Long acting contraception is a human right and is essential to women’s empowerment. It is essential to reduce poverty, promote economic growth, raise female productivity, lower fertility and improve child survival and maternal health. Even though some long acting reversible contraceptive methods are the world’s most prevalent form of reversible contraception, the utilization is very low in sub-Saharan Africa. Study Aim: To assess the prevalence and factors affecting use of long acting contraceptive methods in Akasta Town, North East Ethiopia. Methods: A community based cross-sectional study was conducted on 422 women of reproductive age between March and May 2016 to achieve study aim. The actual respondents were selected by systematic sampling method at household level. Pretested and structured questionnaires were used to collect data. Result: The prevalence of use of long acting contraceptives in the study area was found to be 33.6% and implants were the most commonly used methods. One hundred thirty one (46.8%) of respondents did not use these methods because of inadequate information provided for them. Two hundred eighty one (66.6%) of respondents said that they knew at least one type of long acting methods and implants were widely known which accounts 139 (49.5%) of respondents. Age, husband’s educational status, knowledge of long acting reversible contraceptives and attitude towards these methods were significantly associated with use of these contraceptives. Conclusions: The study showed that the prevalence of long acting reversible contraceptives in the study area was low. Only 33.6% of respondents ever used any type of these methods in their life time and implants were the most commonly used method. In this study, age of women, husband’s educational status, knowledge of long acting reversible contraceptives and attitude were found to be independent determinants for long acting reversible family planning use. As knowledge and practice of long acting contraceptives was low, extensive health information should be provided.

Determinants of long-acting contraceptives use among reproductive-age couples in Tanjung Karang Public Health Centre Mataram City, West Nusa Tenggara

Background and purpose: The national family planning program prioritises the use of long-acting contraceptives which include intrauterine devices (IUD), tubectomy, vasectomy, and implant. However, the coverage of long-acting contraceptives in Indonesia remains low. This study aims to identify the determinants of long-acting contraceptives uptake among reproductive-age couples in Tanjung Karang Public Health Centre (PHC) Mataram City.Methods: A cross-sectional study was conducted involving 169 reproductive age couples in Tanjung Karang PHC in 2016. Samples were selected from six sub-villages (dusun) in two villages using systematic random sampling. We selected 85 samples from coastal and 84 samples from non-coastal areas. Data on sociodemographic characteristics, perception, husband support, access to service, and information regarding long-acting contraceptives were collected through home interview. Analysis with logistic regression was applied to determine the factors influencing long-acting contraceptives uptake.Results: The majority of respondents aged 20–35 years-old, and most of them have a lower level of education and knowledge regarding long-acting contraceptives. Among all current users, as many as 37.0% use long-acting contraceptive methods. The respondents refused to use long-acting contraceptives due to prohibited by the husband (92.8%) and desire to have more children (38.7%). Multivariate analysis using logistic regression showed that the uptake of long-acting contraceptives was significantly associated with area of residence (non-coastal) with an adjusted odds ratio (AOR)=2.89 (95%CI; 1.39-6.01), employment status with AOR=0.40 (95%CI; 0.18-0.90), income at minimum wages and above with AOR=2.47 (95%CI; 1.16-5.26), and husband support with AOR=2.19 (95%CI; 1.18-3.41).Conclusions: The use of long-acting contraceptives are associated with husband support, living in non-coastal areas, and having a higher-income. Ongoing support from the husband, especially among those who live in coastal areas and from the lower socioeconomic background, is required to improve the coverage of long-acting contraceptives.