To Give or Not to Give PK Results: An Ethical Dilemma for Researchers &amp; Regulators in Uganda

EtimaJuliane,; NakabiitoClemensia,; AkelloCarolyne, A; KabwiguSamuel,; NakyanziTeopista,; NabukeeraJosephine,; HartmannMiriam,; MontgomeryElizabeth,; MenschBarbara,; StratenAriane, van der

doi:10.1089/aid.2014.5069.abstract

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“…During the design and ethical review of this study, discussion focused on how to present women with their PK results in a clear and neutral manner, how women might feel and respond when presented with objective information about product nonuse [31]. Although women’s reactions to receiving PK results varied, few were negative, and the majority who initially disagreed with or denied their results ultimately accepted them, implying that provision of adherence results was acceptable and understood.…”

Section: Discussionmentioning

confidence: 99%

Disclosure of pharmacokinetic drug results to understand nonadherence

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Montgomery²,

Musara

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Objectives In VOICE, a phase IIB trial of daily oral and vaginal tenofovir for HIV prevention, ≥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 (PK) results, explored adherence challenges during VOICE. Methods We systematically recruited participants with PK data (median 6 plasma samples), categorized as low (0%, N=79), inconsistent (1%-74%, N=28), or high (≥75%; N=20) based on frequency of tenofovir detection. Following disclosure of PK results, reactions were captured and adherence challenges systematically elicited; IDIs and FGDs were audio-recorded, transcribed, coded, and thematically analyzed. Results We interviewed 127 participants from South Africa, Uganda, and Zimbabwe. The most common reactions to PK results included surprise (41%; low PK), acceptance (39%; inconsistent PK), and happiness (65%; high PK). Based on 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, fueled by stories shared among participants. Although women with high PK levels reported similar concerns, several described strategies to overcome challenges. Women at all PK levels suggested real-time drug monitoring and feedback to improve adherence and reporting. Conclusions Retrospective provision of PK 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.

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Section: Discussionmentioning

confidence: 99%