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.
A case study
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.
In her article Blame Research Design For Failed HIV Study, Ida Susser offers some insight into why the Voice study failed and suggests essential inclusive elements to ensure studies achieve desired goals. It included the need to focus on behavioral and social elements including an understanding of the daily routine of women and their coping mechanisms in daily stressful challenges, re-examining why methods are not used and finding alternative approaches, building trust with participants, the crucial need for involvement of the community in what she referred to as a bottom up approach, confronting cultural challenges and learning from similar clinical trials which were successful.
"The moral of the story – 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."
According to PositiveLite.com's Marc André Leblanc most women in the study were not able to use the prescribed medication consistently to make an impact and this indicates how women, African women in particular, must be offered a range of options. Leblanc explained how the ability of women to use microbicide gels consistently for long durations is varied. He referred to the use of products for anal sex which are common for some individuals and therefore could make adherence easier, depending on the participants and their practices.
Zeda Rosenberg and Sharon Hillier explain how deep rooted gender inequalities, economic inequalities and being biologically more susceptible to contracting the virus are factors that must be considered. They emphasized the need for female initiated options while recognizing different needs at different times over the lifespan of girls and women. Using a daily gel before and after sex is challenging for women and is not the right approach.
Fortunately as mentioned by the authors, scientists around the world continue to develop a range of new products that are easier to use as the research community waits for results early next year from two late stage clinical trials using a monthly vaginal gel which may be more suitable to meet the needs of the daily lives of women as it is a discreet method of protection and women will have more options about choosing or not to discuss its use with their partners. A range of products and options are needed as there is no single solution.
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 HI -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 most part protected with privacy policies. However there is subtle stigma which needs further examination in research studies in the developed world.
The moral of the story – 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 of results.
This article previously appeared on the HIV Disclosure Project website here.