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

• Published in: PloS one 2018-05, Vol.13 (5), p.e0197269
• Main Authors: Guthrie, Kate M, Rosen, Rochelle K, Vargas, Sara E, Getz, Melissa L, Dawson, Lauren, Guillen, Melissa, Ramirez, Jaime J, Baum, Marc M, Vincent, Kathleen L
• Format: Article
• Language: English
• Subjects: Acceptability; Adhesion; Administration, Intravaginal; Adolescent; Adult; Anti-HIV Agents - administration & dosage; Anti-HIV Agents - adverse effects; Anti-HIV Agents - pharmacokinetics; Antiretroviral agents; Behavior; Biology and Life Sciences; Birth control; Clinical trials; Contraception; Data analysis; Diaries; Disease prevention; Dosage and administration; Drug delivery; Drug delivery systems; Drug dosages; Evaluation; Exercise; Female; Gynecology; Health care; HIV; HIV Infections - prevention & control; HIV Infections - psychology; Hospitals; Human immunodeficiency virus; Humans; Management; Medical diagnosis; Medicine and Health Sciences; Menstrual Cycle; Methods; Middle Aged; Mixed methods research; Obstetrics; Optimization; Patient Compliance; Patient Satisfaction; Pharmaceutical research; Pharmacokinetics; Pharmacology; Polls & surveys; Prevention; Preventive medicine; Product development; Public health; Qualitative analysis; Qualitative Research; Reproduction; Reproductive health; Reproductive systems; Safety; Sexual Behavior; Sexually transmitted diseases; Social sciences; STD; Surveys; Technology Acceptance Model; Testing; User experience; User friendly products; Young Adult
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0197269

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 interview comprised the user evaluation data for each pod-IVR experienced by the participants. Overall, the majority of participants (N = 10) reported being willing to use the pod-IVR platform for HIV prevention should it advance to market. Confidence to use the pod-IVR (e.g., insertion, removal) was high. There were no differences noted in the user experience of the pod-IVR platform; that is, whether the ring delivered TDF-alone, TDF-FTC, or TDF-FTC-MVC, users' experiences of the ring were similar and acceptable. Participants did report specific experiences, both sensory and behavioral, that impacted their use behaviors with respect to the ring, and which could ultimately impact acceptability and adherence. These experiences, and user evaluations elicited by them, could both challenge use or be used to leverage use in future trials and product rollout once fully articulated. High willingness-to-use data and lack of salient differences in user experiences related to use of the pod-IVR platform (regardless of agents delivered) suggests that the pod-IVR is a feasible and acceptable drug delivery device in and of itself. This finding holds promise both for an anti-HIV pod-IVR and, potentially, a multipurpose prevention pod-IVR that could d