Participant safety and data integrity, critical in trials of new investigational drugs, are achieved through honest participant report and precision in the conduct of procedures. HIV prevention post-trial access studies in middle-income countries potentially offer participants many benefits including access to proven efficacious but unlicensed technologies, ancillary care that often exceeds local standards-of-care, financial reimbursement for participation and possibly unintended benefits if participants choose to share or sell investigational drugs. This case study examines the possibility that this combination of benefits may constitute an undue inducement for some participants in middle-income countries, where economic challenges are prevalent. A case study is presented of a single participant in a cohort of 382 participants who used concealment, fabrication and deception to ensure eligibility for a post-trial access study of an unlicensed HIV prevention technology at potential risk to her health and that of her fetus. A root cause analysis revealed her desire to access HIV prevention during an unplanned pregnancy with a partner whose faithfulness was in question. Researchers should consider implementation of systems to efficiently identify similar cases without inconveniencing the majority of participants
Trial registration number NCT01691768.
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Contributors KTM is the primary author of the paper and worked as the Project Director at the urban site for Centre for the AIDS Programme of Research in South Africa (CAPRISA) 008 and was the overall Safety Officer. JAS has reviewed and provided input to this paper and is the CAPRISA Bioethics Head who reviewed the case and give direction on continued study participation by the participant. LEM is the Principal Investigator of CAPRISA 008, and provided review and input to this paper. DRW has reviewed and made major contributions to this paper based on his expertise in medical ethics.
Funding United States Agency for International Development through CONRAD (grant no. PPA-12-143). MACAIDS Fund through the Tides Foundation (TFR11-01545).
Competing interests One of the coauthors of this paper (DRW) chaired the Research Ethics Committee that reviewed the Centre for the AIDS Programme of Research in South Africa 008.
Patient consent Obtained.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The primary outcome paper is in the process of finalisation for submission for publication and is being authored by LEM.
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