Peruvian FSW Perspectives on Ethics-Relevant Experiences of Participating in an HPV Vaccine Clinical Trial

Aims: This qualitative study examined Peruvian female sex workers’ (FSWs) evaluation of social and health risks/benefits, informed consent, incentives, fair treatment, and post-trial care following their participation in an HPV vaccine phase IV clinical trial (GIRASOL), in which all participants received quadrivalent HPV vaccine.   

Methods: Sixteen FSWs aged 23-29 years from Lima, Peru who previously enrolled in the GIRASOL trial were administered semi-structured interviews to assess perceptions of study participation. Interviews were conducted in Spanish, audio-recorded, transcribed, and translated into English. Transcripts were coded in Atlas.ti using open and axial coding. Codes were collapsed, combined, and developed into concepts and representative quotes.    

Results: Broad themes emerging from content analysis included respect, privacy, absence of stigma, access to healthcare, and abandonment. Most participants reported staff treated them with empathy, fairness, and dignity, that participation provided protection from cancer and an opportunity to privately receive quality sexual health care, they were well prepared by consent procedures, participation was voluntary, and incentives were appropriate. Of note, one participant responded, “If nothing else, they always treated me as a human”. Unexpectedly, some experienced desertion when the study ended.    

Conclusions: Participants were generally content with all aspects of the study and emphasized its protective and non-coercive attributes. They expressed gratitude for the professional treatment despite normalized stigma regarding their FSW status. Further work may be needed to reduce feelings of abandonment.  Researchers may also need to develop navigation plans to properly transition participants out of research projects once studies have ended.