The aim of this review of the argument – based literature was to identify ethical arguments pro and against the Provider Initiated Opt – Out Prenatal HIV screening approach in Sub – Saharan Africa. The World Health Organization (WHO) has specified the minimum package of information to be given to clients during the informed consent process including the tests clinical and prevention benefits, the right to refuse the test, the follow – up services that will be offered and the need to anticipate informing any contacts at risk in case the test turns out positive [9]. These conditions are rarely met in most health care settings. Even in developed countries, many women are still seen in labor rooms with unknown HIV serostatus. For instance, Siemieniuk et al. reported cases from Alberta in Canada who were diagnosed either in the labour room or postpartum [20]. About 32 % of women who give birth in Sub – Saharan Africa do so without ever receiving any prenatal care [4, 8]. The Opt out prenatal screening approach should therefore be coupled with increased efforts to improve prenatal care coverage, which has improved, but remains below expectations in this region of the world. The risk of rendering health care professionals negligent and not able to provide the necessary information as required is a major risk of this approach, especially in a region of the world with very limited human resources in health care. Wanyenze et al. have however proposed that abbreviated counselling models with the Opt – Out approach, if well formulated and implemented could produce similar, and even better results compared to the voluntary time consuming standard HIV counselling and testing approaches [30]. This could be worth experimenting in a Sub – Saharan African context, as this region is seriously challenged with scarcity in health care professionals.
Informed consent, for whom?
For the health care staff or for the patient’s? Informed consent remains a crucial requirement in both healthcare and research settings. However, many scholars have stated that fulfilling its requirements is unrealistic and even mythical [50, 51]. Even in developed countries with generally higher levels of education and more information, most of the patients never fully understand the informed consent form that they do sign [36, 52]. Without written consent, the likelihood that the test becomes compulsory increases [12, 53]. However, Bayer has argued that making it more difficult to say no with regards to taking an HIV test within the opt – out approach can be justified from a public health perspective. He is particularly concerned with the opportunities accrued to treating the infected on time, avoiding treatable and preventable opportunistic infections and reducing transmission to their partners [53]. Dixon-Mueller supports making it more difficult for persons to say no to getting tested from a rights based approach [54]. She argues that labelling the provider initiated opt – out approach as disempowering since some clients may not feel free to say no undermines these same people’s rights to know their HIV status and to make sexual and reproductive decisions based on this information. In settings where the levels of education and awareness with regards to human rights are generally lower, this becomes a serious ethical concern to be tackled more carefully. With this screening approach, clients have been reported to be totally unaware that they were tested for HIV or been directly or indirectly coerced to get tested [16, 17]. Being unaware of an existing option to turn down the test could reduce the provider initiated opt – out HIV screening approach to compulsory HIV screening [23, 27].
In the United Kingdom, Sheer et al. reported over 18 % of the tested pregnant women for HIV believing they could not refuse the test [14]. Njeru et al. have reported limited pre and posttest counseling in Kenya, Tanzania and Zambia as well as neglect of preventive measures with the Provider Initiated Opt – Out HIV screening approach [48]. Considering that these are high HIV prevalence settings, the intended benefits of expanded screening could be blurred by consequences that could result from coercion, test without consent, aggravated stigma, distrust in healthcare staff and non – compliance to recommended treatment regimens even amongst those tested positive [14, 16, 18, 19, 39, 55]. Fields and Kaplan have argued that protecting the best interest of the fetus and enhancing the general good for society (beneficence) through excessive “paternalistic” HIV screening of pregnant woman is ethically unacceptable [23]. They propose a health care model with health care staff being committed to provide the best available care as well as respecting as much as possible the autonomy of the patients. On the other hand, Johansson et al. think that despite the fact that the Opt –Out strategy might become involuntary in the clinical setting, it remains acceptable [12]. They base their arguments on the fact that the increased availability of very effective and inexpensive lifesaving drugs renders ethical concerns raised by an intrusive HIV testing practice less important compared to the child’s hypothetical preferences to be born healthy [12]. Effective drugs for the management of HIV are generally effective, available and affordable in most Sub – Saharan African countries today [2, 4]. Schuklenk and Kleinsmidt are comfortable with the Opt – Out screening approach even if it could turn out to be compulsory HIV screening especially in areas with high prevalence rates like in Sub – Saharan Africa [56]. They however provide key preconditions for this compulsory testing to be ethically justified. These are:
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I.
the women in question would have had voluntarily chosen to carry the fetus to term
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II.
they would have had a reasonable alternative to this course of action (e.g., abortion at least until the point of fetal viability)
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III.
continuing voluntary treatment with HAART would be available to them
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IV.
The confidentiality of the women’s HIV status should ideally be maintained during as well as after their pregnancy (not imperative).
The ethical framework driving their reasoning however was purely consequentialist in nature [56]. They fail to take into account possible serious psychological consequences (stigma and social exclusion) and confidentiality issues could arise if the HIV test becomes practically compulsory in prenatal care settings [18, 27, 37]. The Provider Initiated Opt – Out Prenatal HIV Screening approach runs these risks if it is not implemented with caution.
Empirical research in bioethics has been embraced and its importance has generally been well recognized [57, 58]. Despite concerns raised by empirical research about the disregard or inappropriate practice of the informed consent procedure, coercion or compulsory testing with this testing approach,[15–17, 25, 26, 31], it might be of interest for public health actors to embrace these claims with caution [16, 57, 58]. As Obermeyer et al. have reported in a study from four African countries that based on the type of question asked, coercion can be overestimated especially when the women are questioned retrospectively [16]. With the closed question “could you have said no”, which has generally been used in most empirical research endeavors to evaluate the quality of informed consent, coercion was overestimated at 77 %. In depth analysis however revealed that 60 % of these women actually consented to get tested.
In the quest for efficiency or adequacy?
Efficiency must be clearly differentiated from adequacy. Considerations regarding the former most of the time compels health care staff to offer the HIV test simply as part of their job, or to take specific precautions not to get infected when caring for the pregnant women during delivery. Under such circumstances, the responsibility of health care staff as moral agents is eroded [27]. From an ethical perspective, the concept of adequacy possesses an internal morality and should normally generate a moral impulse that the patient receives during the informed consent process. Sherr et al. have underscored the importance of the quality of information given to pregnant women in antenatal clinics and that of a proper process of obtaining informed consent [14]. If not appropriately acted upon, they highlight how counterproductive this could turn out by reducing the HIV test uptake rates and consequently decreasing the chances for preventing the transmission of HIV from the mother to the child. Eyal has argued this constitutes the bases of trust which is key for compliance to proposed behavioral and biomedical regimes in case the mother is infected [19]. He also argues that Coercion, deception, manipulation and other violations of standard informed consent requirements seriously jeopardize the trust, which remains a key requirement for people to seek medical advice, comply with it, and participate in medical research. The success of the Highly Active Anti-Retroviral Therapy used today in managing patients with HIV – AIDS is almost dependent on compliance [2]. Non – compliance does not only lead to poor outcomes in persons infected, but could also predispose to the development and spread of drug resistant strains of the virus. This is already a growing challenge for public health actors in this region of the world [2, 59, 60]. It is rare and most of the time almost inexistent to find skilled staff (Clinical/psychologists, counselors and social workers) being implicated in the diagnosis and care process of mothers infected with HIV. Despite the reported decrease in levels of stigma associated with HIV – AIDS, the condition still remains a very stigmatization condition and it shall take time for this to reduce to expected and enviable levels [1, 2, 9]. Adequate HIV counseling and screening could guarantee a better understanding of the prevention and treatment options, their effectiveness, available alternatives, dispel false beliefs (reduce stigma) and strengthen trust between the health care staff and society [19]. Challenging the knowledge and beliefs of clients with regards to HIV is a sign of respect for her and renders her decisions to be truly well informed (strengthening her autonomy) [24].
Chandisarewa et al. have reported more infant/mother pairs receiving antiretroviral prophylaxis and follow up in clinics with the opt – out approach compared to the opt – in screening approach (p <0.01) [11]. Tudor Car et al. have reported in a recent systematic review a high uptake (96 %) of the current opt – out HIV screening approach in prenatal care services [5]. They also paradoxically report a less than expected (17 %) retention rate on current HIV prevention programs of the infected mothers and children at risk. This could be indicative of the fact the testing is not done under optimal conditions to ensure compliance to the available HIV management protocols in this population. There is some skepticism of an inappropriate application of this approach which can instead deter clients from seeking care and lead to loss to follow up [19, 55]. Becker and collaborators have argued that uncoordinated and non-comprehensive aggressive testing could lead to stigmatization and could deter patients from meeting health care providers for the management, not only of HIV, but other diseases [55]. De Zulueta and Boulton have also reported how health care staff indirectly coerce clients to accept HIV testing. In their study, only two out of thirty-two (32) women were aware of the possibility of a woman, HIV positive, giving birth to an uninfected child [46]. This could depict some degree of lack of information and inadequate counseling skills on the part of the health care staff, or purposeful selective retention of certain pieces of information to coerce the pregnant women to accept the test [46].
HIV with the growing availability and affordability of the treatment for sure has become a chronic condition with most persons leading a normal quality of life as the uninfected [2]. However, we argue that the most important purpose of getting an HIV test is not getting to know one’s status. The behavior after obtaining the test results remains capital for prevention and care purpose. An HIV test done under inappropriate conditions could be a guarantee for clients to flee from coming for follow up after results, many not even turning up for the test results and non – compliance [19, 26]. Sub Saharan Africa is facing a growing epidemic of non – compliance to HAART in most areas and associated HIV resistance [59, 60]. April suggests that the potential gains of this approach if appropriate measures to fight against loss to follow up of patient tested positive are not taken will be negligible [18]. He thinks that the lack of mechanisms to track, educate and monitor diagnosed patients risk eroding the expected gains from the Opt – Out HIV screening approach. As the world and scientific community enviably awaits a vaccine or complete cure medications for HIV, securing the effectiveness of available medications through avoidance of non-adherence to treatment and drug resistance remains critical. The quality of the counseling, consent and screening process could be useful avenues to enhance healthy health care provider – client relationships, foster trust and consequently posttest compliance to recommended treatment (prevention) options [19, 40, 55].
The Provider Initiated Opt – Out Prenatal HIV Screening approach might not necessarily clash with client autonomy if appropriately implemented. From a public health perspective, good quality counseling (void of direct or indirect coercion) using an appropriate, pretested and validated abbreviated model could still allow pregnant women to voluntarily decide on whether to take the test or not. More women will come to know their status, receive early treatment and appropriate interventions to reduce the transmission of HIV from mother to child. It is unclear if the Opt – In approach actually enhances the autonomy of the tested parties, since clients at times still feel pressured to undertake the test [9, 18, 27]. Anticipated stigma and discrimination if one turn’s down the test could deter clients from taking the test [61]. An atmosphere of trust and confidence remains a key determinant of test uptake and compliance to evidence based recommendations given to these patients by health care providers. Third party interests in infectious disease scenarios might compel some degree of compulsion to protect third parties. With HIV in pregnancy, it might be argued that some degree of soft compulsion (soft paternalism) is ethically justified to protect the interest of the baby who has a high potential of being born HIV free today.