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Published in: AIDS and Behavior 2/2017

01-02-2017 | Original Paper

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

Authors: Elizabeth T. Montgomery, B. Mensch, P. Musara, M. Hartmann, K. Woeber, J. Etima, A. van der Straten

Published in: AIDS and Behavior | Issue 2/2017

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Abstract

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.
Literature
1.
go back to reference DiMatteo MR. Variations in patients’ adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004;42(3):200.CrossRefPubMed DiMatteo MR. Variations in patients’ adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004;42(3):200.CrossRefPubMed
2.
go back to reference Marrazzo JM, Ramjee G, Richardson BA, et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015;372(6):509–18.CrossRefPubMedPubMedCentral Marrazzo JM, Ramjee G, Richardson BA, et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015;372(6):509–18.CrossRefPubMedPubMedCentral
4.
go back to reference van der Straten A, Montgomery ET, Hartmann M, Minnis A. Methodological lessons from clinical trials and the future of microbicide research. Curr HIV/AIDS Rep. 2013;10(1):89–102.CrossRefPubMed van der Straten A, Montgomery ET, Hartmann M, Minnis A. Methodological lessons from clinical trials and the future of microbicide research. Curr HIV/AIDS Rep. 2013;10(1):89–102.CrossRefPubMed
5.
go back to reference van der Straten A, Van Damme L, Haberer JE, Bangsberg DR. Unraveling the divergent results of pre-exposure prophylaxis trials for HIV prevention. AIDS. 2012;26(7):F13–9.CrossRefPubMed van der Straten A, Van Damme L, Haberer JE, Bangsberg DR. Unraveling the divergent results of pre-exposure prophylaxis trials for HIV prevention. AIDS. 2012;26(7):F13–9.CrossRefPubMed
6.
go back to reference Rees H, Delany-Morelwe S, Lombard C. FACTS 001 phase III trial of pericoital tenofovir 1% gel for HIV prevention in women. In: Conference on retroviruses and opportunistic infections (CROI); 2015. pp. 23–6. Rees H, Delany-Morelwe S, Lombard C. FACTS 001 phase III trial of pericoital tenofovir 1% gel for HIV prevention in women. In: Conference on retroviruses and opportunistic infections (CROI); 2015. pp. 23–6.
7.
go back to reference Corneli AL, Deese J, Wang M, et al. FEM-PrEP: adherence patterns and factors associated with adherence to a daily oral study product for pre-exposure prophylaxis. J Acquir Immune Defic Syndr. 2014;66(3):324–31.CrossRefPubMedPubMedCentral Corneli AL, Deese J, Wang M, et al. FEM-PrEP: adherence patterns and factors associated with adherence to a daily oral study product for pre-exposure prophylaxis. J Acquir Immune Defic Syndr. 2014;66(3):324–31.CrossRefPubMedPubMedCentral
8.
go back to reference van der Straten A, Brown ER, Marrazzo JM, et al. Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study. J Int AIDS Soc. 2016;19(1):20642.PubMedPubMedCentral van der Straten A, Brown ER, Marrazzo JM, et al. Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study. J Int AIDS Soc. 2016;19(1):20642.PubMedPubMedCentral
9.
go back to reference Corneli AL, McKenna K, Perry B, et al. The science of being a study participant: FEM-PrEP participants’ explanations for over-reporting adherence to the study pills and for the whereabouts of unused pills. J Acquir Immune Defic Syndr. 2015;68(5):578–84.CrossRefPubMed Corneli AL, McKenna K, Perry B, et al. The science of being a study participant: FEM-PrEP participants’ explanations for over-reporting adherence to the study pills and for the whereabouts of unused pills. J Acquir Immune Defic Syndr. 2015;68(5):578–84.CrossRefPubMed
10.
go back to reference Mazar N, Ariely D. Dishonesty in everyday life and its policy implications. J Public Policy Mark. 2006;25(1):117–26.CrossRef Mazar N, Ariely D. Dishonesty in everyday life and its policy implications. J Public Policy Mark. 2006;25(1):117–26.CrossRef
11.
go back to reference Oosterbeek H, Sloof R, van de Kuilen G. Cultural differences in ultimatum game experiments: evidence from a meta-analysis. Exp Econ. 2004;7(2):171–88.CrossRef Oosterbeek H, Sloof R, van de Kuilen G. Cultural differences in ultimatum game experiments: evidence from a meta-analysis. Exp Econ. 2004;7(2):171–88.CrossRef
12.
go back to reference Gino F, Ayal S, Ariely D. Contagion and differentiation in unethical behavior: the effect of one bad apple on the barrel. Psychol Sci. 2009;20(3):393–8.CrossRefPubMed Gino F, Ayal S, Ariely D. Contagion and differentiation in unethical behavior: the effect of one bad apple on the barrel. Psychol Sci. 2009;20(3):393–8.CrossRefPubMed
13.
go back to reference Gino F, Ariely D. Dishonesty explained: what leads moral people to act immorally. In: Miller AG, editor. The social psychology of good and evil. New York: Guilford Press; 2015. Gino F, Ariely D. Dishonesty explained: what leads moral people to act immorally. In: Miller AG, editor. The social psychology of good and evil. New York: Guilford Press; 2015.
14.
go back to reference Ekman P. Telling lies: clues to deceit in the marketplace, politics and marriage. London: W.W. Norton and Company; 2009. Ekman P. Telling lies: clues to deceit in the marketplace, politics and marriage. London: W.W. Norton and Company; 2009.
16.
go back to reference van der Straten A, Montgomery ET, Musara P, et al. Disclosure of pharmacokinetic drug results to understand nonadherence. AIDS. 2015;29(16):2161–71.CrossRefPubMed van der Straten A, Montgomery ET, Musara P, et al. Disclosure of pharmacokinetic drug results to understand nonadherence. AIDS. 2015;29(16):2161–71.CrossRefPubMed
17.
go back to reference van der Straten A, Mayo A, Brown E, et al. Perceptions and experiences with the VOICE adherence strengthening program (VASP) in the MTN-003 trial. AIDS Behav. 2015;19(5):770–83.CrossRefPubMedPubMedCentral van der Straten A, Mayo A, Brown E, et al. Perceptions and experiences with the VOICE adherence strengthening program (VASP) in the MTN-003 trial. AIDS Behav. 2015;19(5):770–83.CrossRefPubMedPubMedCentral
18.
go back to reference Mazar N, Amir O, Ariely D. The dishonesty of honesty people: a theory of self concept maintenance. J Mark Res. 2008;45:633–44.CrossRef Mazar N, Amir O, Ariely D. The dishonesty of honesty people: a theory of self concept maintenance. J Mark Res. 2008;45:633–44.CrossRef
19.
go back to reference van der Straten A, Stadler J, Montgomery E, et al. Women’s experiences with oral and vaginal pre-exposure prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa. PLoS ONE. 2014;9(2):e89118.CrossRefPubMedPubMedCentral van der Straten A, Stadler J, Montgomery E, et al. Women’s experiences with oral and vaginal pre-exposure prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa. PLoS ONE. 2014;9(2):e89118.CrossRefPubMedPubMedCentral
20.
go back to reference Schwartz K, Ndase P, Torjesen K, et al. Supporting participant adherence through structured engagement activities in the MTN-020 (aspire) trial. AIDS Res Hum Retrovir. 2014;30(S1):A–80. Schwartz K, Ndase P, Torjesen K, et al. Supporting participant adherence through structured engagement activities in the MTN-020 (aspire) trial. AIDS Res Hum Retrovir. 2014;30(S1):A–80.
21.
go back to reference Mensch BS, Brown E, Liu K, et al. Reporting of adherence in the VOICE trial: did disclosure of product nonuse increase at the termination visit? AIDS Behav. 2016;20(11):2654–61.CrossRefPubMed Mensch BS, Brown E, Liu K, et al. Reporting of adherence in the VOICE trial: did disclosure of product nonuse increase at the termination visit? AIDS Behav. 2016;20(11):2654–61.CrossRefPubMed
22.
go back to reference Musara P, Munaiwa O, Mahaka I, et al. The effect of presentation of pharmacokinetic (PK) drug results on self-reported study product adherence among voice participants in Zimbabwe. AIDS Res Hum Retrovir. 2014;30(S1):A42.CrossRef Musara P, Munaiwa O, Mahaka I, et al. The effect of presentation of pharmacokinetic (PK) drug results on self-reported study product adherence among voice participants in Zimbabwe. AIDS Res Hum Retrovir. 2014;30(S1):A42.CrossRef
Metadata
Title
Misreporting of Product Adherence in the MTN-003/VOICE Trial for HIV Prevention in Africa: Participants’ Explanations for Dishonesty
Authors
Elizabeth T. Montgomery
B. Mensch
P. Musara
M. Hartmann
K. Woeber
J. Etima
A. van der Straten
Publication date
01-02-2017
Publisher
Springer US
Published in
AIDS and Behavior / Issue 2/2017
Print ISSN: 1090-7165
Electronic ISSN: 1573-3254
DOI
https://doi.org/10.1007/s10461-016-1609-1

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