Sex partners as bystanders in HIV prevention trials: Two test cases for research ethics

2019 ◽  
Vol 16 (5) ◽  
pp. 455-457
Author(s):  
Till Bärnighausen

Research involving human subjects can impose risk on some ‘bystanders’– people who are not themselves research subjects but whom the study may affect. We examine the consequences of research for a particular category of bystanders – research subjects’ sex partners – in trials testing interventions to reduce (1) HIV transmission (HIV treatment-as-prevention trials) and (2) HIV acquisition (HIV pre-exposure prophylaxis trials). Both types of trials provide useful test cases for assessing whether bystanders to research deserve special consideration in ethics reviews, and potentially some of the benefits and protections that research subjects receive. In HIV treatment-as-prevention trials, there are two groups of people who are alike in many important respects but treated very differently by research ethics: research subjects who contribute data on the primary endpoint of the trial (because some of them have sex with the people receiving the treatment conditions of the trials) – and bystanders who are not enrolled in the trials but who could have contributed primary endpoint data in the same way as the first group. In pre-exposure trials, the sex partners of people participating in pre-exposure prophylaxis trials are bystanders, even though they are necessary for the success of the trial. Research subjects’ autonomy is fiercely protected by trial enrolment processes. Bystanders, by contrast, often have no choice but to be affected by the study, because of their relationship to a research subject. In HIV prevention trials, standing by can come with important risks, including the same ones on which the success of the research hinges. It is thus important to consider the ethical obligations to protect bystanders, and the related procedural responsibilities.

Sexual Health ◽  
2014 ◽  
Vol 11 (2) ◽  
pp. 166 ◽  
Author(s):  
Martin Holt

This review assesses acceptability research for HIV pre-exposure prophylaxis (PrEP) and treatment as prevention (TasP) among men who have sex with men (MSM) in the Asia-Pacific region and the Americas, evaluating awareness and attitudes. There has been limited research on the acceptability of PrEP outside the United States and no research to date evaluating the acceptability of TasP since the findings of the HIV Prevention Trials Network 052 trial were released. Existing research suggests that PrEP is reasonably acceptable to MSM, but few men are likely to perceive the need for it. Studies of HIV treatment optimism suggest that MSM are likely to be sceptical of TasP.


2019 ◽  
Vol 70 (1) ◽  
pp. 673-701 ◽  
Author(s):  
Andrew C. Cortopassi ◽  
Redd Driver ◽  
Lisa A. Eaton ◽  
Seth C. Kalichman

HIV is transmitted in social and sexual relationships, and HIV transmission risks, as well as protective actions, are evolving as HIV epidemics unfold. The current focus of HIV prevention is centered on antiretroviral medications used to reduce HIV infectiousness in persons already infected with HIV [treatment as prevention (TasP)]. The same medications used to treat infected persons can also be used by uninfected persons as pre-exposure prophylaxis (PrEP) to reduce the infectivity of HIV. Both PrEP and TasP are effective when adherence is high and individuals do not have co-occurring sexually transmitted infections. HIV prevention is most effective and efficient when delivered within sexual networks with high HIV prevalence. Specific network characteristics are recognized as important facilitators of HIV transmission; these characteristics include the degree of similarity among network members (homophily), gender role norms, and belief systems. Since 2011, HIV risk has been redefined based on infectiousness and infectivity, ushering in a new era of HIV prevention with the potential to end HIV epidemics.


Sexual Health ◽  
2014 ◽  
Vol 11 (2) ◽  
pp. 155 ◽  
Author(s):  
K. Rivet Amico

Remarkable advances have been made in the last few years in biomedical strategies to prevent onward transmission of HIV (treatment as prevention (TasP)) and prevent infection among at-risk populations through pre-exposure prophylaxis (PrEP). Numerous issues remain heavily debated, primarily concerning the feasibility of leveraging resources for both widespread access to antiretroviral therapy (ART) for those living with HIV and access to effective prevention antiretrovirals (ARVs) among those at risk for infection. Even with consistent and wide-spread access to ARVs, the behavioural pathway from ARV access to successful rapid and durable suppression or reaching levels of PrEP adherence that confer high rates of protection is increasingly well recognised. For either ‘biobehavioural’ strategy to have maximal individual and community benefit, individuals accessing them must actually use them. In this review, the unique and overlapping factors influencing adherence to ART and PrEP are identified, with an emphasis on the behavioural, social and structural facilitators and barriers to TasP and PrEP success. The implications of the current research base and evidence generated specifically within the Asia-Pacific region are discussed.


2019 ◽  
Vol 16 (5) ◽  
pp. 458-460
Author(s):  
Nir Eyal ◽  
Daniel Wikler

Till Bärnighausen points out the medical risks that two categories of contemporary HIV prevention trials, for “treatment-as-prevention” and for “pre-exposure prophylaxis,” pose to people who are not study participants. Bärnighausen’s compelling case forces reconsideration of the absence of bystanders in the law governing ethical review of health research. It raises the intriguing question: to what legal protection are bystanders morally entitled? The remedy might seem to be to accord bystanders the rights and protections currently accorded to human study participants. We counsel against that remedy on three grounds, inviting colleagues to suggest alternatives.


2013 ◽  
Vol 9 (4) ◽  
pp. 520-534 ◽  
Author(s):  
John G. Francis ◽  
Leslie P. Francis

AbstractHIV prevention and treatment are undergoing impressive technological and practice changes. In-home rapid testing, prophylaxis before risky sex, and treatment as prevention give cause for remarkable optimism and suggest the possibility of an AIDS-free generation. These changes in HIV prevention and treatment might affect HIV policy in several different directions. One direction would be further entrenchment of the currently prevailing punitive approach. A different direction would be a shift away from use of the criminal law as a method for discouraging risky behaviour and towards a strategy aimed to encourage the use of the new treatment and prevention possibilities. When such abrupt technological changes are accompanied by sharp changes in regulatory regimes, they are identified in the public policy literature as a ‘punctuated equilibrium’. A shift away from criminalisation in HIV policy, if sufficiently widespread and transformative, could reach the level of a punctuated equilibrium. This paper presents a critical assessment of the implications of the changes in available forms of treatment and prevention for the continued appeal of criminalisation as an approach to HIV policy. We conclude that criminalisation is less justifiable in the light of what might be circumstances ripe for a punctuated equilibrium.


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