Ethical issues surrounding the provider initiated opt – Out prenatal HIV screening practice in Sub – Saharan Africa: a literature review

Autonomy

Fulfilling the conditions for a proper counselling could be very challenging, and most of the times unrealistic. Improvement in the quality of antenatal care services offered could permit HIV counselling and screening under this approach to more or less respect the autonomy of the clients.

In the Provider Initiated Opt – Out screening approach, a relatively small amount of time is spent between the health care provider and the client for counselling [9, 10]. Although this may be considered a drawback, Wanyenze et al. argue that abbreviated counselling if properly carried out produces similar, and at times better levels of understanding amongst clients [30]. Although with an inherent opportunity for the client to turn down the test if she so wishes, this approach will be ethically justified on grounds that the client receives the required and complete information package [9, 10, 27], that the health care provider has the required expertize in communicating appropriately generally within a limited amount of time and that the health provider herself has the required knowledge. With these preconditions generally unmet in most health care settings, the question of how informed the informed consent is under this approach remains troublesome. Obermeyer et al. in a study in four African countries (Burkina Faso, Kenya, Malawi and Uganda) reported that 7 % of clients were tested without any consent. With this provider initiated opt out HIV screening strategy, many clients from most recent studies in Sub – Saharan Africa have reported that they were not aware they could have an opportunity to decline the test if they wanted to and that they were coerced to undertake the test as a precondition to continue receiving health care in their respective health facilities [16, 25, 26, 31, 32].

Another argument in favour of the Provider Initiated Opt – Out approach has been that the extensive pre-test counselling and written consent that were inherent to the opt – in approach and voluntary testing and counselling deterred clients from being tested [33]. Hanssens has highlighted that this approach might not appropriately take into consideration consequences like labelling, psychological distress and post-test discrimination by health care providers with patients that turn out to be HIV positive [13].

Beneficence

Most authors argue that knowing one’s HIV status permits a timely initiation of appropriate therapies, generally affordable and effective today to decrease HIV associated morbidity and mortality [2, 4]. Provision of treatment today is amongst the most important benefits if getting an HIV test done [2, 18]. This is especially important for pregnant women as this could help them in making informed reproductive choices [23]. Liddicoat et al. found in a retrospective analysis of the charts of 221 HIV positive patients who had encountered a health care provider in the previous year, that the risk and need to carry out an HIV test amongst these clients were not properly addressed and the HIV test was only proposed to 27 % of these persons [34]. This suggests that when the responsibility is left in the hands of health care providers to recommend an HIV test on a case by case basis, more missed HIV test opportunities can be recorded [23]. Knowing one’s status ideally enables early initiation of treatment, which reduces the spread of the infection [2]. Massive detection might require health systems to be prepared to treat all HIV infected mothers. However, it might be difficult to ascertain if health systems in Sub – Saharan Africa could accommodate and appropriately manage larger numbers of pregnant women infected with HIV. April [18], Wocial and Cox [27] have proposed that the sustainability and guaranteeing of proper medical care to all women who shall test positive as recommended by the WHO [9] need to be properly evaluated before vulgarizing the Opt – Out screening practice in high HIV prevalence settings like Sub – Saharan Africa. If not, the negative social and psychological consequences that could arise might instead outweigh the benefits from knowing their HIV status (e.g. stigma, social exclusion).

Stigma

The Provider Initiated Opt –Out prenatal screening approach has been embraced as a less stigmatizing approach, compared to the usual voluntary testing and counseling or opt – in approaches [9, 23, 33, 35]. The reason given for this is that, as part of routine medical care, HIV becomes treated like all other “normal” or usual diseases [9, 10]. However, some authors fear that vulgarizing prenatal HIV screening as with the Opt – Out approach if not well considered could worsen HIV associated stigma [18, 27, 35, 36]. Inadequate and inappropriate counseling, disregard of sociocultural peculiarities and lack of sustainability of the medical care package before and after the test have been identified as key action areas deserving amelioration. In Sub – Saharan Africa where gender bias and HIV associated stigma are still serious concerns, expanded HIV testing risks resulting in other consequences like discrimination, domestic violence and abandonment [37–39]. Csete et al. have proposed incorporation of measures to fight against gender violence and abuse within the package of the Opt – Out screening approach [37]. These include: emergency helplines, training of police and social service staff on issues of AIDS related violence against women, criminalization of marital rape and school based awareness programmes for girls and boys. Rennie and Behets have argued that in settings characterized by extreme poverty, weak health care and civil society capacities, gender inequality and high levels of stigma against HIV – AIDS patients, the Opt – Out HIV screening approach might divert from its initial human rights motivations of offering universal access to HIV – AIDS management [40]. They recommend continuous empirical research to assess the effects of this approach on individuals and communities, from both ethical and human rights perspective, especially when implemented in resource limited settings.

Coverage and acceptability

The Provider Initiated Opt – Out Prenatal HIV Screening approach has been reported to be associated with an increase in the uptake of the HIV test [9, 41–44]. Research from most studies in Sub Saharan Africa have described this approach is being generally more acceptable to clients compared to the former Opt - In approach. The acceptability rates range from 80 % to 97 % in most prenatal care clinics [11, 12, 41–45]. With the voluntary counselling and testing approach (Opt – In), acceptability rates have generally been low rarely going over 80 % [2, 9]. True and informed acceptability of the opt - out approach has however been put to question [14, 15, 17, 25]. Empirical research findings have been increasingly revealing that the HIV test options presented to pregnant women are biased: no true voluntary options to accept or turn down the test, most clients directly or indirectly coerced to take the test and the quality of the informed consent process described generally as poor [17, 25, 46], 41]. Most clients have reported that the test was presented to them as compulsory by health care providers and many did not know they had an option to turn down the test if they wanted to [39, 46–49]. Johansson et al. also highlight the risk of the Opt - Out approach becoming an involuntary testing strategy if implemented in a real setting without caution [12]. Larsson et al. have recommended active monitoring and evaluation as key components of the Opt – Out prenatal HIV screening practice [39].

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].

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.