In an online survey and personal interviews, researchers, policy makers and potential trial volunteers with HIV infection underlined different perceived risks in HIV cure research. Potential participants were the only group to stress the possible social, emotional and financial risks, according to the study poster presented at AIDS 2016.
With HIV cure research reflecting diverse interventions soon entering clinical trials, understanding the perceived risks of that research assumes growing importance for efforts to recruit and inform volunteers. Researchers from AIDS service organizations conducted an online survey of 400 HIV-positive U.S. adults focusing on perceived risks that would discourage them from entering HIV cure studies. The researchers also conducted interviews with 36 HIV-positive people and with researchers, bioethicists and members of institutional review boards and regulatory agencies.
The 400 HIV-positive respondents completing online surveys in September and October 2015 represented 38 U.S. states. Most respondents (77%) were men, 65% were white, 17% black, 12% Hispanic, 4% mixed race/ethnicity and 2% Asian. The survey asked respondents to rate diverse factors for their likelihood to discourage participation in an HIV cure study. Response categories were very likely to discourage participation, somewhat likely, barely likely, not likely and don't know/not sure. The researchers did not detail how they recruited respondents.
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Potential personal clinical risks more often rated very likely to discourage study participation were activation of genes that could cause cancer (49%), possibility of developing resistance to drugs (37%), toxicities or adverse negative effects of drugs (30%) and known risks of stopping HIV medications (30%). Symptoms or side effects more often rated very likely to discourage participation were hair loss (32%) and vomiting (23%). The social risk most often rated very likely to discourage participation was risk of transmitting HIV to a sex partner (28%). The study procedures more often cited as very likely to discourage study participation were spinal tap (26%), bone marrow biopsy (22%) and lymph node or rectal biopsy (13% each). Fewer than half of respondents believed practical burdens such as transportation, parking or time away from work or school were very likely or somewhat likely to keep them from enrolling in HIV cure studies.
Interviews disclosed differing perceptions of HIV cure research risks among clinician-researchers, policy makers/regulators and people with HIV who might volunteer for studies. Researchers spoke strongly about reducing or mitigating risks and about the importance of carefully interpreting risk information. Policy makers and regulators weighed differences in risk categories, such as known versus unknown risks, short-term versus long-term risks and real versus theoretical risks. Potential study participants with HIV were the only group to point out possible social, emotional and financial risks including (1) maintaining disability insurance or income including Social Security and (2) maintaining current health care or insurance coverage. Interview respondents believed the riskier cure research interventions are stem cell transplants and gene therapy, latency-reversing agents and combination approaches.
The researchers who conducted the study recommended that cure investigators minimize risks to study participants "to prevent crises of confidence in the HIV cure clinical research enterprise, because this could set the field back for several years." They stressed that potential volunteers' perceptions of cure research risks may differ from "expert scientific opinions" and underlined the need for "sustained education efforts" for potential volunteers.