Abstract

Between 1995 and 2005, injectable use doubled worldwide. However, discontinuation rates remain high, partly because of side effects but also because of missed appointments for reinjection. A longer-acting injectable (LAI) may improve compliance by reducing the required number of reinjection visits, thereby reducing unintentional discontinuation. This study examined acceptability of LAI characteristics comprising the target product profile (TPP). In 2012, we conducted qualitative case studies in Kenya and Rwanda, consisting of 19 focus group discussions (FGDs) with 177 current, previous, or never users of injectables and 46 in-depth interviews (IDIs) with providers, program implementers, and policy makers. FGDs and IDIs assessed current injectable experiences; attitudes toward potential LAI products; and perceptions of TPP attributes, including ranking preferences for the most and least important characteristics. In addition, we obtained completed electronic surveys from 28 international family planning opinion leaders about the perceived need for an LAI, important product characteristics, and challenges to LAI development or introduction. Many FGD participants and interviewees spontaneously expressed strong interest in an LAI, but there was some variation in TPP preferences. The majority of participants ranked effectiveness as the most important TPP attribute. Providers were generally more concerned about side effects than potential users; some potential users suggested that side effects were related less to the product than to their own body chemistry and that side effects were acceptable as long as they did not last a long time or disrupt daily activities. Women and providers, especially in Kenya, preferred a method with a predictable return to fertility. Some participants associated amenorrhea with delayed or reduced fertility. Most women and providers preferred delivery of the LAI in a single, prepackaged, disposable injection system to facilitate injections by providers and to reduce the risk of pain or discomfort for women. While providers and policy makers ranked cost as one of the most important issues, it was among the least important issues for most potential users. Many Kenyan, but few Rwandan, participants appeared willing to pay for an LAI, with some presuming cost savings from reduced menstruation and fewer clinic visits. Some TPP preferences for an LAI have implications for product development decisions about formulation, delivery mechanism, or presentation, while others point to the need for tailored communication and counseling approaches to ensure acceptability and adherence within clinical trials and beyond.

Highlights

  • Between 1995 and 2005, injectable use doubled worldwide

  • Preferences for a potential longer-acting injectable contraceptive www.ghspjournal.org product administered through a single intramuscular injection in the upper arm or buttocks that lasts for 3 months

  • This research aimed to inform the development process of an longer-acting injectable (LAI) by providing a more in-depth understanding of the perspectives of potential users, providers, and opinion leaders on the target product profile (TPP), which identifies desired and minimally acceptable product characteristics related to such aspects as effectiveness and side effect profile

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Summary

Introduction

Between 1995 and 2005, injectable use doubled worldwide. discontinuation rates remain high, partly because of side effects and because of missed appointments for reinjection. Between 1995 and 2005, injectable contraceptive use doubled worldwide.[3] In sub-Saharan Africa, more than one-third of modern contraceptive users currently rely on injectable contraceptives.[4] Dramatic increases in injectable uptake have occurred in several African countries, including Kenya and Rwanda.[5,6] injectable discontinuation is high, due in part to women experiencing menstrual and weight changes or other side effects.[7,8,9,10,11,12] as many as 40% of injectable users unintentionally discontinue due to missed appointments for reinjection.[13,14] Injectable users who are late for a reinjection are often asked to return to the clinic during their menses, increasing the likelihood of pregnancy before the injection.[15]

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