The Effect of Presentation of Pharmacokinetic (PK) Drug Results on Self-reported Study Product Adherence among VOICE Participants in Zimbabwe

MusaraPetina,; MunaiwaOtillia,; MahakaImelda,; MgodiNyaradzo, M; HartmannMiriam,; LevyLisa,; MontgomeryElizabeth, T; GrossmannCynthia, I; Mike, ChirenjeZvavahera; StratenAriane, van der; MenschBarbara,

doi:10.1089/aid.2014.5070.abstract

Cited by 6 publications

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“…The importance of peers in adoption of the contraceptive NuvaRing (N.V. Organon, Oss, The Netherlands) was a key finding in a US study among adolescent girls [33]. By contrast, at the start of ASPIRE, and in other PrEP trials at the same African research sites, negative peer influence – for example rumors and widespread reports of nonadherence in waiting rooms – negatively affected adherence [10,34]. Researchers' efforts to provide individual and peer support may be critical investments of time and energy that ultimately serve multiple overlapping objectives: addressing physical and emotional barriers to product use, educating participants about the research process and their role in a global HIV prevention effort, fostering respect and trust among researchers and participants and ultimately supporting adherence and enhancing product effectiveness.…”

Section: Discussionmentioning

confidence: 99%

Acceptability and use of a dapivirine vaginal ring in a phase III trial

Montgomery¹,

Straten

Chitukuta

et al. 2017

Aids

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107

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Background The MTN-020/ASPIRE trial evaluated the safety and effectiveness of the dapivirine vaginal ring for prevention of HIV-1 infection among African women. A nested qualitative component was conducted at six of 15 study sites in Uganda, Malawi, Zimbabwe and South Africa to evaluate acceptability of and adherence to the ring. Method Qualitative study participants (n = 214) were interviewed with one of three modalities: single in-depth interview, up to three serial interviews or an exit Focus Group Discussion. Using semistructured guides administered in local languages, 280 interviews were audio-recorded, transcribed, translated, coded and analyzed. Results We identified three key findings: first, despite initial fears about the ring's appearance and potential side effects, participants grew to like it and developed a sense of ownership of the ring once they had used it. Second, uptake and sustained adherence challenges were generally overcome with staff and peer support. Participants developed gradual familiarity with ring use through trial progression, and most reported that it was easy to use and integrate into their lives. Using the ring in ASPIRE was akin to joining a team and contributing to a broader, communal good. Third, the actual or perceived dynamics of participants' male partner relationship(s) were the most consistently described influence (which ranged from positive to negative) on participants' acceptability and use of the ring. Conclusion It is critical that demonstration projects address challenges during the early adoption stages of ring diffusion to help achieve its potential public health impact as an effective, long-acting, female-initiated HIV prevention option addressing women's disproportionate HIV burden.

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Section: Discussionmentioning

confidence: 99%

Acceptability and use of a dapivirine vaginal ring in a phase III trial

Montgomery¹,

Straten

Chitukuta

et al. 2017

Aids

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107

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“…In VOICE-C, a qualitative study conducted concurrently with VOICE, women were unwilling to personally acknowledge nonadherence [21]. In VOICE-D, only after provision of PK results did women acknowledge nonuse as well as other socially undesirable behaviors [32]. …”

Section: Discussionmentioning

confidence: 99%

Disclosure of pharmacokinetic drug results to understand nonadherence

Straten

Montgomery²,

Musara

et al. 2015

Aids

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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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“…When combined with in-depth interviews, pharmacokinetic measures are powerful tools to understand the determinants of product use in HIV prevention trials, in particular the aspects of participants' lives and the characteristics of the product and dosing regimen that either facilitate or undermine product use. Indeed, in the VOICE D qualitative sub-study of 127 active arm participants conducted after the trial was completed using interviewers who were not involved in the main trial, only in the second stage (November 2013-April 2014) when participants were retrospectively provided with their plasma drug levels from the trial did they finally disclose nonuse and offer explanations for this [16, 17]. In stage 1 of VOICE D (December 2012 – March 2013, N=88, 44 of whom also participated in stage 2), participants again did not acknowledge non-use; rather, they discussed other women not using [17].…”

Section: Discussionmentioning

confidence: 99%

“…Indeed, in the VOICE D qualitative sub-study of 127 active arm participants conducted after the trial was completed using interviewers who were not involved in the main trial, only in the second stage (November 2013-April 2014) when participants were retrospectively provided with their plasma drug levels from the trial did they finally disclose nonuse and offer explanations for this [16, 17]. In stage 1 of VOICE D (December 2012 – March 2013, N=88, 44 of whom also participated in stage 2), participants again did not acknowledge non-use; rather, they discussed other women not using [17]. So on their own, in-depth interviews, thought to encourage greater rapport between participants and study staff than conventional structured interviews, also failed to encourage disclosure of nonuse.…”

Section: Discussionmentioning

confidence: 99%

Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Nonuse Increase at the Termination Visit?

Mensch¹,

Brown

Liu

et al. 2016

AIDS Behav

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VOICE — a phase 2B, placebo-controlled, randomized trial testing daily use of an antiretroviral tablet (tenofovir or Truvada) or daily use of tenofovir gel in 5029 women from South Africa, Uganda, and Zimbabwe — found none of the drug regimens effective in reducing HIV-1 acquisition in the intent-to-treat analysis. More than half of women assigned to active products in a case cohort sample had no drug detected in any plasma specimens tested during the trial. Yet, in response to questions asked of participants during the trial, ≥90% of doses were reportedly taken. To explore factors associated with low adherence, a behavioral termination visit questionnaire was developed after early closure of the oral tenofovir and vaginal gel arms. We hypothesized that participants would be more forthcoming about nonuse after they exited the trial than during monthly/quarterly follow-up visits. Comparison of adherence reporting at routine follow-up visits with reporting at trial termination, however, indicates that disclosure of product nonadherence did not increase at the termination visit as anticipated. In resource-limited settings where women value the ancillary benefits provided by trial participation and are concerned that disclosure of nonuse may jeopardize trial participation, objective measures of adherence may yield more meaningful data regarding the inability or reluctance to use than measures of product use derived from self-report.

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The Effect of Presentation of Pharmacokinetic (PK) Drug Results on Self-reported Study Product Adherence among VOICE Participants in Zimbabwe

Cited by 6 publications

References 0 publications

Acceptability and use of a dapivirine vaginal ring in a phase III trial

Acceptability and use of a dapivirine vaginal ring in a phase III trial

Disclosure of pharmacokinetic drug results to understand nonadherence

Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Nonuse Increase at the Termination Visit?

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