Supporting Participant Adherence through Structured Engagement Activities in the MTN-020 (ASPIRE) Trial

SchwartzKatie,; NdasePatrick,; TorjesenKristine,; MayoAshley,; ScheckterRachel,; StratenAriane, van der; Soto-TorresLydia,; PalaneeThesla,; BaetenJared,

doi:10.1089/aid.2014.5146.abstract

Cited by 5 publications

(4 citation statements)

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“…During extended waiting room periods, already well-documented settings for frustration, the trial environment readily offered the situational time and space for participants to share negative trial and product use experiences. As such, it may be productive for research staff to proactively organize peer and group activities, such as the participant engagement activities in the MTN ASPIRE trial and the FACTS trial ‘adherence clubs’, to offer a forum for participants to interact in a constructive manner that airs concerns, worries, and rumors and directs peer influence towards a more positive direction for protocol outcomes [20]. …”

Section: Discussionmentioning

confidence: 99%

Misreporting of Product Adherence in the MTN-003/VOICE Trial for HIV Prevention in Africa: Participants’ Explanations for Dishonesty

et al. 2016

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Consistent over-reporting of product use limits researchers’ ability to accurately measure adherence and estimate product efficacy in HIV prevention trials. While lying is a universal characteristic of the human condition, growing evidence of a stark discrepancy between self-reported product use and biologic or pharmacokinetic evidence demands examination of the reasons research participants frequently misrepresent product use in order to mitigate this challenge in future research. This study (VOICE-D) was an ancillary post-trial study of the vaginal and oral interventions to control the epidemic (VOICE) phase IIb trial (MTN 003). It was conducted in three African countries to elicit candid accounts from former VOICE trial participants about why actual product use was lower than reported. In total 171 participants were enrolled between December 2012 and March 2014 in South Africa (n = 47), Uganda (n = 59) and Zimbabwe (n = 65). Data suggested that participants understood the importance of daily product use and honest reporting, yet acknowledged that research participants typically lie. Participants cited multiple reasons for misreporting adherence, including human nature, self-presentation with study staff, fear of repercussions (study termination resulting in loss of benefits and experience of HIV-related stigma), a permissive environment in which it was easy to get away with misreporting, and avoiding inconvenient additional counseling. Some participants also reported mistrust of the staff and reciprocal dishonesty about the study products. Many suggested real-time blood-monitoring during trials would encourage greater fidelity to product use and honesty in reporting. Participants at all sites understood the importance of daily product use and honesty, while also acknowledging widespread misreporting of product use. Narratives of dishonesty may suggest a wider social context of hiding products from partners and distrust about research, influenced by rumors circulating in clinic waiting-rooms and surrounding communities. Prevailing power hierarchies between staff and participants may exacerbate misreporting. Participants recognized and suggested that objective, real-time feedback is needed to encourage honest reporting.

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Section: Discussionmentioning

confidence: 99%

Misreporting of Product Adherence in the MTN-003/VOICE Trial for HIV Prevention in Africa: Participants’ Explanations for Dishonesty

et al. 2016

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“…Given the role of peer interactions and social influences on adherence, interventions could be designed to promote a positive social discourse around product use and supportive norms fostering commitment toward the study and its objectives. Initiatives to promote participants’ engagement are being implemented in the next generation of prevention trials [45]. Finally, real-time product use monitoring and feedback to participants should be further evaluated in future trials for improving accuracy of self-reports and motivating high product adherence.…”

Section: Discussionmentioning

confidence: 99%

Disclosure of pharmacokinetic drug results to understand nonadherence

Straten

Montgomery²,

Musara

et al. 2015

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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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“…This was a first step, but we likely missed opportunities to engage others and leverage peer influence, partners, and the community as a whole in supporting product use [18]. Subsequent efforts in ongoing microbicide trials are engaging participants more systematically in group and social activities outside of the counseling session to promote sustained product use [24]. Research exploring contextual factors influencing disclosure, motivations for study participation, and investigational product use is ongoing, and may ultimately provide a more comprehensive understanding of study product adherence behavior [25, 26].…”

Section: Discussionmentioning

confidence: 99%

Perceptions and Experiences with the VOICE Adherence Strengthening Program (VASP) in the MTN-003 Trial

et al. 2014

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The VOICE Adherence Strengthening Program (VASP) was implemented in May 2011 to improve adherence counseling in VOICE (MTN-003), a multisite placebo-controlled trial of daily oral or vaginal tenofovir-based Pre-Exposure Prophylaxis (PrEP). Anonymous baseline (N = 82) and final follow-up (N = 75) surveys were administered to counselors and pharmacists at 15 VOICE sites, and baseline (N = 18) and final (N = 26) qualitative in-depth interviews were conducted with purposively selected counseling staff at 13 VOICE sites. Qualitative interviews with VOICE participants (N = 38) were also analyzed for segments related to counseling. Behavioral and biological measures of product use collected in the 6 months prior to VASP implementation were compared to those collected during the 6 months following implementation. Results show that the majority of staff preferred VASP and thought that participants preferred VASP over the previous education and counseling strategy, although there was no evidence to suggest that participants noticed modifications in the counseling approach. No meaningful changes were observed in pre/post levels of reported use or drug detection. Interpretation of results is complicated by mid-trial implementation of VASP and its proximity to early closure of oral and vaginal tenofovir study arms because of futility.

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Supporting Participant Adherence through Structured Engagement Activities in the MTN-020 (ASPIRE) Trial

Cited by 5 publications

References 0 publications

Misreporting of Product Adherence in the MTN-003/VOICE Trial for HIV Prevention in Africa: Participants’ Explanations for Dishonesty

Misreporting of Product Adherence in the MTN-003/VOICE Trial for HIV Prevention in Africa: Participants’ Explanations for Dishonesty

Disclosure of pharmacokinetic drug results to understand nonadherence

Perceptions and Experiences with the VOICE Adherence Strengthening Program (VASP) in the MTN-003 Trial

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