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

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.

Acceptability of and Adherence to an Antiretroviral-Based Vaginal Microbicide among Pregnant Women in the United States

“…While some of this difference could be related to dilutional effects of pregnancy (potentially both increased plasma volume and increased vaginal secretions), the PK parameters on Day 0, 8 h after observed dosing, were observed to be similar between this pregnant cohort and nonpregnant comparators [11]. The challenges of suboptimal adherence and accurate product use reporting in HIV prevention method research have been well documented in other recent microbicide studies [12–15]. In the VOICE trial, as with other microbicide studies, a variety of social and contextual factors influenced women’s ability and willingness to consistently use products on a daily basis [16].…”

Self-administered Versus Directly Observed Once-Weekly Isoniazid and Rifapentine Treatment of Latent Tuberculosis Infection

“…Patients in other prevention studies have also reported good adherence despite objective evidence to the contrary (29, 30). Finally, although the local institutional review boards approved reimbursement for study-related expenses as appropriate, this could have influenced patients to report good adherence (31). …”

Hair levels of preexposure prophylaxis drugs measure adherence and are associated with renal decline among men/transwomen

“…Of importance in this study was that only 1% of participants were concerned about providing a sample that could reveal their adherence level and other studies have suggested that provision of drug levels could improve subsequent drug-taking. [35, 36] However, both DBS and hair require expensive liquid chromatography/ tandem mass spectrometry equipment for analyses and are performed in high-level research laboratories in the U.S. Lower-cost methods that can be applied to real-world implementation in the field and to assess drug taking using point-of-care technology will be the next advances in the field.…”