Injectable hormonal contraception is an important part of the method mix globally, with depotmedroxyprogesterone acetate (DMPA) the most commonly used injectable product. Many women findinjectables more convenient and discreet than taking a daily birth control pill, and some prefer thismethod to device-based longer-acting reversible methods (e.g., intrauterine devices; implants).Although with ideal use DMPA is over 99% effective, several features have limited compliance andhence effectiveness, including barriers/inconvenience associated with returning to the clinic every threemonths, side effects/menstrual pattern changes, and long/unpredictable return to fertility. In fact, one-year continuation rates can be as low as 40%. Daré Bioscience is developing a long-acting injectable(LAI) that provides extended release of etonogestrel with precise control over drug release rate,targeting windows of protection for six months and 12 months, a rapid return of fertility within twomonths, a steadier hormone dose than currently available therapies, and anticipated side effects similarto Nexplanon® (the currently-approved method of delivering etonogestrel). End-user research is criticalfor designing an LAI that users will find acceptable, to increase the likelihood of future uptake andconsistent use. This R43 study, conducted in partnership with the Population Council, comprises end-user research with US women to understand their preferences for LAI duration in light of other attributes(particularly effect on menstruation, side effects, and return to fertility), acceptability of the LAIs vs.other contraceptive methods, and heterogeneity in duration preferences and acceptability betweendifferent end-user profiles. We will leverage Amazon's Mechanical Turk (MTurk) platform to efficientlysurvey a national sample of 1,000 women ages 18-44 years, stratified by age group, urban/ruralresidence, and ever-use of hormonal contraception. In Aim 1, we will examine women's LAI durationpreferences, considering other product attributes, by implementing a discrete choice experiment (DCE),as well as acceptability of the LAIs compared with currently available contraceptive methods. In Aim 2,we will identify distinct LAI end-user profiles via latent class analyses (LCA), and LAI durationpreferences for each. LCA models will include end users' overall perceived acceptability of the LAIs,socio-demographic characteristics, fertility intentions, reproductive history, and contraceptivehistory/general preferences. Findings from this study will directly inform which LAI duration(s) to pursueand identify the characteristics of US women most likely to be interested in using an LAI. If this R43study is successful, as defined by confirmation of hypotheses that the LAI would fill unmet contraceptiveneeds, we will pursue an evaluation of end-user experiences using our selected LAI prototype(s) withinthe first in-human Phase I trial of an LAI.
Public Health Relevance Statement: PROJECT NARRATIVE
Injectable hormonal contraception is an important part of the method mix globally, but several features
- especially its three-month maximum duration - limit method satisfaction, efficacy, and continuation.
This study entails end-user research to inform the design of a long-acting injectable (LAI) contraceptive
currently under development, that targets windows of protection for six and 12 months, a rapid return
to fertility, and a steadier hormone dose than currently available therapies. In a national (US) survey
with 1,000 18-44 year-old women, we will examine women's preferences regarding LAI duration and
acceptability compared with currently available contraceptive methods, as well as the characteristics of
women most likely to use the LAI.
Project Terms: <3-keto-desogestrel><3-ketodesogestrel><3-oxo desogestrel><3-oxodesogestrel>
