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Accurate estimates of study product use are critical to understanding and addressing adherence challenges in HIV prevention trials. The VOICE trial exposed a significant gap between self-reported adherence and drug detection. The VOICE-D qualitative study was designed to better understand non-adherence during VOICE, and was conducted in 2 stages: before (stage 1) and after (stage 2) drug detection results were provided to participants. Transcripts from 44 women who participated in both stages were analysed to understand the effect of presenting drug detection data on narratives of product use. Thirty-six women reported high adherence in stage 1, yet admitted non-use in stage 2, three reported high adherence in both stages (contrary to their drug detection results) and five had consistent responses across both stages and drug results. Presenting objective measures of use may facilitate more accurate product use reporting and should be evaluated in future prevention trials. [ABSTRACT FROM AUTHOR]

Several formulations of HIV pre-exposure prophylaxis (PrEP) have shown varying levels of effectiveness in women. Little information is known about preference across formulations, especially among product experienced women. Seventy-one women (48% married; median age 26; range 18-45) who were participating in a vaginal ring trial for HIV prevention in Malawi, South Africa, Uganda, and Zimbabwe underwent an in-depth interview at their last study visit, during which they were presented with pictures and descriptions of nine possible product formulations (male and female condoms, oral tablets, injectables, implants, and a vaginal gel, ring, insert, and film). Each formulation was discussed, highlighting salient attribute(s) and contextual factors that may have informed stated preferences. Participants expressed most interest for long-acting PrEP formulations (rings, 94%; implants, 39%; injections, 34%), which were generally favored over short-acting ones. Participants appreciated the continuous protection offered, discreet usage, and the advantage of 'peace of mind' imparted by simplified use and infrequent dosing, alleviating worries around forgetting doses. Preferred attributes of short-acting formulations included reversibility, user control, ease of administration, and low toxicity. Participants were least interested in the oral tablets (due to the daily dosing, difficulty swallowing pills, and HIV-related stigma), and the vaginal gel and film (due to vaginal insertion, coital dosing, effect on sex. and unfamiliarity with the method). Dislike for vaginally administered products was more pronounced among young women. Multiple factors played into potential users' considerations for preferred formulations, emphasizing how a suite of options for prevention might best respond to women's needs and wants. [ABSTRACT FROM AUTHOR]

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.