Components For Successful Research
I have been a participant in numerous research studies for the past twenty years ranging from straightforward medical clinical trials to psycho social studies where the needs of people living with HIV were investigated. I am a strong advocate for participation in research to advance scientific evidence to help clinicians provide the best services to people living with HIV. I remain committed to being an ongoing participant and am presently enrolled in a research study involving cardio- vascular disease.
As a long term participant many questions have been raised – How accurate is the information gathered in research projects? Do all participants answer questions honestly? Are participants inclined to give partial responses, no responses, tell the researcher what they want to hear rather than the real account of events relating to questions? If I feel somewhat vulnerable as a participant – do other participants feel the same way? Do I completely trust the researchers and their motivations? Do researchers understand how questions may trigger painful emotions and memories? Do researchers have the necessary psycho-social skills to administer the research and respond to participants who are emotionally triggered?
Do I have adequate time to give precise responses? Are the research methods flawed? What happens if the research study does not produce the desired results? Whose fault is it? Needless to say these questions were not keeping me up at night or consuming my thoughts every minute of the day. But after reading articles recently on this very topic, it confirmed how I am not the only person asking questions about research studies.
The VOICE study, which began in 2011 as a clinical trial using ARV-based pre-exposure prophylaxis (PrEP) pills or topical microbicide gel with women in sub-Saharan Africa , supposedly failed because the women lied about taking the medication as prescribed. In attempts to understand why the VOICE study failed questions were raised about motivation to remain in the study with reasons given by the women themselves, including the assurance of quality medical care in a setting which had higher standards than the overcrowded clinics they were accustomed to and regular HIV testing in a respectful environment. Researchers speculated that financial remuneration was a motivating factor for the women to lie and remain in the study. Reasons for not taking the medication as reported by the women included side effects, simple loss of motivation for unknown reasons, while others expressed their basic mistrust and fear of research. Researchers identified the need to prioritize behavioral science as much as biomedical science while conducting clinical trials.
Emily Newman described the findings of research which indicates how microbicides targeting HIV became significantly less effective when semen was introduced “We found that all of the microbicides that target the HIV virus became significantly less effective in the presence of semen—sometimes by greater than 20 fold.” Research is underway to develop combination microbicides using multiple components in the gel to target the HIV virus while targeting the HIV -promoting factors of semen.
After reading about the VOICE study and the suggestions and conjectures about why this clinical trial failed, I continue to reflect on the questions I have been asking myself for a long time. As a participant in research and clinical trials I will not blame myself when I am not able to adhere completely or provide incomplete responses to questions I deem to be confusing, intrusive or emotionally challenging. I will also ask more questions about the role of stigma as a participant in HIV research studies as this may well have been a valid reason for the failure of the VOICE study. The women involved were probably singled out in their community and with their partners and there must have been backlash and stigma as a result in this region of the world where stigma is much worse than here in Canada where we are for the post part protected with privacy policies. However there is subtle stigma which needs further examination in research studies in the developed world.
The ethical lessons learned as a participant include – I will not accept or entertain thoughts of how a participant alone is to blame when they opt to say no to certain procedures in clinical trials or for the failure of research studies. I will continue to be a participant in research studies, listen to my inner voice, ask questions and speak up when flaws in the research methodology are apparent. I will continue to advocate for an inclusive voice of people living with HIV in every stage of research from design to final analysis and implementation.
HIV Disclosure Project Team Member