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Cure Research Ethics, Risks for Participants
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Study Risks Not Understand, did participants get adequate explanations & discussions of risks?
from Jules: below is study just published that I believe had been previously presented at conference, I think at July 2016 IAC. There has been only recently more discussion about the ethics of HIV cure research. I said years ago at the early stages of HIV cure research that the ethics are very problematic, potential study participants even more back then but still now all too often do not understand the studies, do not understand the risks for themselves by participating in these studies, in particular the potential side & adverse events of the drugs researched, the adverse events of stopping ART are of particular note that researchers often & certainly many proponents of this research do not understand or appreciate - what are the risks of repopulating reservoirs & key areas of the body like the brain, what is affect on kidney, etc after having < 50 c/ml of HIV for a prolonged time - what are the risks for patients who early on had low nadir CD4 & clinical or even worse subclinical diseases or conditions that once ART is lifted & viral load increases that these conditions or diseases can return - we saw this when similarly treatment interruptions were thought to be risk free & patients experienced onset of diseases or conditions while they interrupted therapy AND is THIS EVER communicated as a risk to potential study participants - I doubt it very much. Potential cure research participants are usually doing well on HAART, with undetectable viral load & likely at least reasonable CD4 counts. Are they explained, do they truly understand, that a cure may be found, may never be found, that if found it could be a decade or longer - maybe 2 decades to find, are older patients explained that even if a cure is found & if they have had HIV for 30 years the damage to organs are such that a cure may not or is not likely to prevent accelerated aging syndrome with earlier onset for comorbidities & multiple comorbidities because the 30 years of damage that has been done? Sure HIV cure research is important and should be conducted, but it should be put into a proper context, which I do not think it has, it has become political & almost a political ideology perhaps. In a larger context 80% of people with HIV in the USA are 45 years or older, 50% are over 50, and 20% are over 60-65; in a broader context the importance of adequately dealing with the many aging issues, many that are not understood, for patients is relatively ignored compared to cure & PrEP, but the many problems faced by aging HIV+ individuals deserves as much maybe more discussion & policy and programs investments as cure & PrEP, but does not get it, politics.
I have often said over the years and still to this day there really is very poor if any sometimes true / real informed consent in general for studies, patients all to often do not understand or get adequate explanations of the risks of participating in any studies. These long word informed consent documents patients are asked to sign are all too often too difficult & lengthy to read or understand and are not adequately explained all too often.
HERE ARE recent reports from NATAP regarding this topic of HIV cure research ethics, including published papers
HIV Cure Research Ethics: "Such early trials may pose serious risks while initially producing little individual or social benefit.....Cure studies may be marked by a curative misconception among those who are HIV-infected and who hope to permanently rid their bodies of the virus."http://www.natap.org/2016/HIV/090916_01.htm
Social and ethical implications of HIV cure research:
"Curing HIV has become a strategic priority of the International AIDS Society and the National Institute of Allergy and Infectious Diseases at the US National Institutes of Health.......curing HIV...... a social intervention......Cure studies may be marked by a curative misconception among those who are HIV-infected and who hope to permanently rid their bodies of the virus......HIV organizations that have exclusively provided HIV services without integration into local health systems may resist the growing momentum to consider curing HIV. Although HIV is increasingly perceived as just another disease, many jobs, careers and identities are tightly linked with the service structures and research spawned by HIV".....At the institutional level, implementation structures that establish a false dichotomy between treatment and cure, similar to the false dichotomy between HIV treatment and prevention in the 1990s [24], could pit these potentially complementary approaches against each other. HIV cure implementation structures that identify individuals with acute HIV infection have inherent public health benefits, but HIV cure research and programmes that depend on newly HIV-infected babies could introduce perverse incentives that are misaligned with global expectations regarding the elimination of mother-to-child HIV transmission.http://www.natap.org/2014/HIV/060114_02.htm
Willingness to participate and take risks in HIV cure research: survey results from 400 people living with HIV in the US
Jan 2017 Jnl of Virus Eradication
Pdf attached
Descriptive results revealed potential misperceptions about clinical benefits. While people may be willing to participate in HIV cure research, they may be largely unaware of the potential risks and lack of direct clinical benefits in early HIV cure research and this has ethical implications for informed consent. For example, people living with HIV may expect to gain knowledge about their health but HIV cure research results are most often compiled and published in the aggregate and not returned to study participants. Hope that health will improve was also a strong motivator factor, yet there is a real possibility of individual harm while advancing scientific HIV cure knowledge. Reducing the HIV reservoir was perceived as a clinical benefit by potential participants, although a reservoir decrease may not confer direct clinical benefit. Thus, HIV cure research implementers need to be careful how knowledge of results, risk of harms, lack of direct clinical benefits and reservoir reductions are discussed in informed consent forms to avoid misperceptions around clinical benefits (or lack thereof). True informed consent and knowledge around clinical risks should be assured using tests of understanding in order to avoid underestimating risks and overestimating expectations for personal benefits. Furthermore, the risk of transmitting HIV to others (in the case of an unsuspected viral rebound) was a real possible demotivator (28% very likely to be discouraged). This result was reminiscent of similar prior surveys that showed the importance placed on reducing HIV transmission risk [ 6 , 10 ].
Although early HIV cure studies confer little to no clinical benefit [ 3 , 11 ], it is possible that study participants still perceive the likelihood of benefits when deciding to join studies, either through therapeutic misconception or other tendencies to overstate the potential for benefits whilst simultaneously discounting potential risks to self.
We found >50% willingness to participate in 14 different types of HIV cure studies. Perceived clinical benefits and social benefits were important motivators, while personal clinical risks appeared to deter potential participation. Roughly two-thirds of survey respondents (68%) indicated that they were somewhat willing to stop treatment as part of HIV cure research. In the bivariate models, females, African Americans/blacks, Hispanics, individuals in the lowest income bracket, people living with HIV for longer periods of their lives, and people who were self-perceived 'very healthy' were less willing to participate in certain types of HIV cure studies than others. Multivariate results showed the perceived benefits (adjusted odds ratios >1) and perceived risks (adjusted odds ratios <1) acted as potential motivators and deterrents to participation, respectively.
More than 50% of survey respondents indicated that they would be willing to participate in all types of HIV cure-related studies. The high apparent willingness to participate in HIV cure research and the belief that a cure for HIV was already available by a minority of respondents underscores the need to better educate potential study candidates about the different types of HIV cure studies and their potential risks in order to prevent therapeutic or curative misconception [ 9 ]
Respondents were 78% men and ranged in ages between 19 and 74 years of age (median age 51). The sample was ethnically diverse: 65% Caucasians/whites, 17% African Americans/black, 12% Hispanic/Hispanic descent and 4% mixed race. Virtually all survey respondents had at least a high school degree or equivalent and nearly half had a 4-year degree or higher. More than one-third (37%) of survey respondents earned less than $25,000 annually and another third (35%) earned more than $50,000 (Table ).
Of the survey respondents, 8% thought a cure for HIV infection was presently available and 3% thought a cure would never materialise; the majority of respondents was evenly split across a perceived time to cure. In open-ended responses, participants most commonly defined HIV cure as 'not transmitting HIV to others' (68%), 'completely eliminating HIV from the body' (68%), and 'no more HIV treatment needed' (65%), above 'no longer testing positive on the antibody HIV test' (31%).

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