User evaluations offer promise for pod-intravaginal ring as a drug delivery platform: A mixed methods study of acceptability and use experiences

PloS One
Kate Morrow GuthrieKathleen L Vincent

Abstract

Effective HIV prevention requires efficient delivery of safe and efficacious drugs and optimization of user adherence. The user's experiences with the drug, delivery system, and use parameters are critical to product acceptability and adherence. Prevention product developers have the opportunity to directly control a drug delivery system and its impact on acceptability and adherence, as well as product efficacy. Involvement of potential users during preclinical design and development can facilitate this process. We embedded a mixed methods user evaluation study into a safety and pharmacokinetics (PK) trial of a pod-intravaginal ring delivering antiretroviral agents. Women enrolled in two cohorts, ultimately evaluating the safety/PK of a pod-IVRs delivering TDF-alone, TDF-FTC, and/or TDF-FTC-MVC. A 7-day use period was targeted for each pod-IVR, regardless of drug or drug combination. During the clinical study, participants provided both quantitative (i.e., survey) and qualitative (i.e., in-depth interview) data capturing acceptability, perceptibility, and adherence behaviors. Initial sexual and reproductive health history surveys, daily diaries, a final acceptability and willingness to use survey, and a qualitative in-depth int...Continue Reading

References

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Citations

Oct 29, 2019·Current Opinion in HIV and AIDS·Thesla Palanee-Phillips, Jared M Baeten
May 21, 2019·Perspectives on Sexual and Reproductive Health·Sara E VargasUNKNOWN other members of the Project WISH Research Team
Oct 20, 2020·Advanced Materials Technologies·Rima JanusziewiczS Rahima Benhabbour
Jul 20, 2021·Geburtshilfe und Frauenheilkunde·Fojan RafieiKhosrow Mottaghy
Jan 1, 2022·AIDS Research and Human Retroviruses·Imogen HawleyAriane van der Straten

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Methods Mentioned

BETA
contraception
blood draws
biopsy
biopsies

Clinical Trials Mentioned

NCT02431273

Software Mentioned

pod
NVivo

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