Disclosure of pharmacokinetic drug results to understand nonadherence. (23rd October 2015)

• Record Type: Journal Article
• Authors: van der Straten, Ariane; Montgomery, Elizabeth T.; Musara, Petina; Etima, Juliane; Naidoo, Sarita; Laborde, Nicole; Hartmann, Miriam; Levy, Lisa; Bennie, Thola; Cheng, Helen; Piper, Jeanna; Grossman, Cynthia I.; Marrazzo, Jeanne; Mensch, Barbara
• Is Part Of: AIDS. Volume 29:Number 16(2015)
• Publication Date: 2015-10-23
• Subjects: adherence -- HIV preexposure prophylaxis -- microbicide -- pharmacokinetic drug detection -- VOICE-D Study -- women; AIDS (Disease) -- Periodicals; Acquired Immunodeficiency Syndrome; AIDS (Disease); Periodicals; Periodicals; 616.9792005
• DOI: 10.1097/QAD.0000000000000801
• Languages: English
• ISSNs: 0269-9370

Abstract

Abstract : Objectives: In VOICE, a phase IIB trial of daily oral and vaginal tenofovir for HIV prevention, at least 50% of women receiving active products had undetectable tenofovir in all plasma samples tested. MTN-003D, an ancillary study using in-depth interviews (IDIs) and focus group discussions (FGDs), together with retrospective disclosure of plasma tenofovir pharmacokinetic results, explored adherence challenges during VOICE. Methods: We systematically recruited participants with pharmacokinetic data (median six plasma samples), categorized as low (0%, N = 79), inconsistent (1–74%, N = 28) or high (≥75%; N = 20) on the basis of frequency of tenofovir detection. Following disclosure of pharmacokinetic results, reactions were captured and adherence challenges systematically elicited; IDIs and FGDs were audio-recorded, transcribed, coded and thematically analysed. Results: We interviewed 127 participants from South Africa, Uganda and Zimbabwe. The most common reactions to pharmacokinetic results included surprise (41%; low pharmacokinetic), acceptance (39%; inconsistent pharmacokinetic) and happiness (65%; high pharmacokinetic). On the basis of participants' explanations, we developed a typology of adherence patterns: noninitiation, discontinuation, misimplementation (resulting from visit-driven use, variable taking, modified dosing or regimen) and adherence. Fear of product side effects/harm was a frequent concern, fuelled by stories shared among participants. Although women with high pharmacokinetic levels reported similar concerns, several described strategies to overcome challenges. Women at all pharmacokinetic levels suggested real-time drug monitoring and feedback to improve adherence and reporting. Conclusion: Retrospective provision of pharmacokinetic results seemingly promoted candid discussions around nonadherence and study participation. The effect of real-time drug monitoring and feedback on adherence and accuracy of reporting should be evaluated in trials. Abstract : Supplemental Digital Content is available in the text