Law and Pediatric HIV Testing

Abstract

Realization of the right to health occurs along a continuum including national ratification of international treaties such as the Convention on the Rights of the Child, passage of domestic laws and policies that may specify modes of implementation and enforcement such as Kenya’s Constitution and HIV and AIDS Prevention and Control Act, and actual implementation of domestic laws and policies such as through the regulation and delivery of health services. The stages heuristic theoretical framework describes the public policy continuum as consisting of marked stages: agenda setting, policy formulation, policy implementation, and evaluation. This case study illustrates the continuum in Kenya with regard to pediatric HIV testing. Kenya has made progress applying law, policy, and science to reduce vertical transmission of HIV and increase HIV testing of infants, although several challenges remain. Progress in policy implementation may reduce mother-to-child transmission and increase pediatric HIV testing.

Introduction

By law, children around the world are protected from preventable disease and death. International, national, and subnational laws and policies provide this protection. In Kenya, for example, every child is guaranteed the right to health by virtue of the country’s acceptance of international treaties, its new constitution, ¹ and the national Children Act. ² And yet, in Kenya as in other low-income countries, children routinely die of various preventable causes such as pneumonia, diarrhea, and HIV/AIDS. Although the law tells us children are protected, science reminds us of their continued vulnerability through objective yet startling statistics.

Over three million children, the vast majority of whom live in sub-Saharan Africa, are infected with HIV. ³ The pediatric HIV/AIDS crisis is particularly acute in 3 countries that are home to one-third of the world’s HIV-positive children—Kenya, Nigeria, and South Africa (see Table I). ⁴ Without testing and treatment, half of HIV-positive infants die by age 2 years and three-fourths by age 5 years. ^5,6 In 2011 alone, 330 000 children acquired HIV and 230 000 died of AIDS, despite the virtual elimination of pediatric HIV/AIDS in high-income countries. ³

Each of these pediatric deaths is evidence that the global community and its constituent nations are far from fully realizing their commitments to children’s health under international and domestic law. Opportunely, the existence of proven and increasingly accessible clinical interventions to prevent, diagnose, and treat pediatric HIV/AIDS sets the stage for further progress. Clinical trials throughout the world have consistently found that interventions including HIV testing and providing HIV-positive pregnant and breastfeeding women with antiretroviral (ARV) treatment can lower the risk of mother-to-child transmission of HIV from around 40% to less than 5%. ⁷ For those children who have already acquired HIV through vertical transmission or through other means such as unsafe blood transfusions, the best remaining defense against dying from AIDS is HIV testing and diagnosis followed by ARV treatment, as recommended by the World Health Organization (WHO). ⁸

Clinical services like HIV testing and treatment are essential for the survival of these children. However, these services do not exist in a vacuum. Laws, regulations, policies, and guidelines play a critical role in shaping the structural environment for clinical service delivery. The example of pediatric HIV testing and counseling in Kenya makes this clear.

Table 1.

One-Third of HIV-Positive Children Live in 3 Countries.^a

Country	HIV-Positive Children (Aged 0-14, y)	Orphans Due to AIDS
Kenya	220 000	1 100 000
Nigeria	440 000	2 200 000
South Africa	460 000	2 100 000
Global Total	3 300 000	16 600 000

^aUNAIDS (2011). Country Responses. www.unaids.org. UNAIDS (2010). Global Report Fact Sheet. www.unaids.org. UNAIDS (2012) Global Report Fact Sheet. www.unaids.org.

The Kenyan Case

Kenya is among those nations in which significant progress has been made, both in preventing mother-to-child transmission (PMTCT) and in testing and treating infants and other children. By 2011, 69% of the pregnant women with HIV received ARV drugs to prevent mother-to-child transmission, 2 340 health facilities provided early infant diagnosis for HIV, and 31.1% of children needing antiretroviral treatment were receiving it. ⁹ Kenya’s case is illustrative of how international law, national policy, and public health programs can mutually reinforce the realization of the right to health.

Methods

In order to clarify the status of pediatric HIV Testing and Counselling policy in Kenya, online legal research was conducted using Kenya Law Reports, an online legal database. Laws (ie, acts and subsidiary legislation) reviewed included, but were not limited to, the Children Act, ² the Kenya National Commission on Human Rights Act, ¹⁰ the HIV and AIDS Prevention and Control Act, ¹¹ Legal Notice 34, ¹² Legal Notice 180, ¹³ and the Constitution of Kenya. ¹ The National Guidelines for HIV Testing and Counselling in Kenya ¹⁴ were also reviewed, as were relevant international treaties to which Kenya is a State Party.

The following research questions were addressed: (1) which cadres of health workers are authorized to conduct HIV testing and counseling? (2) When should HIV testing and counseling be offered? (3) Who can provide consent for pediatric HIV testing? (4) Should HIV status be disclosed to pediatric patients? Findings were synthesized into a desk review that was revised and finalized with input from HIV/AIDS lawyers, program leaders, and scientists in Kenya.

Results and Discussion

International and Domestic Laws and Policy in Existence in Kenya

Treaties are the clearest expression of binding international law. Kenya and 159 other nations have agreed to be bound by a treaty known as the International Covenant on Economic, Social, and Cultural Rights, article 12 of which recognizes “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health” and calls for action to realize this right by reducing infant mortality and ensuring healthy child development. ¹⁵ Children’s right to health is underscored by the Convention on the Rights of the Child, a treaty to which Kenya and 192 other nations are bound and under which every child has a right to “the enjoyment of the highest attainable standard of health.” ¹⁶ These 2 treaties, along with the Universal Declaration of Human Rights ¹⁷ and United Nations General Assembly Declarations on Millennium Development Goals ¹⁸ and HIV/AIDS ¹⁹ provide the global community and individual nations like Kenya with an international legal foundation on which to build a successful global, national, and local response to HIV/AIDS and other diseases. However, many challenges persist when it comes to translating the noble principles of international agreements into improved child health. National, and often subnational, laws and policies are needed to help make international commitments and principles specific and enforceable where it matters most—on the ground as reflected by adequate services in health facilities and communities.

At the national level, Kenya’s new Constitution—the country’s supreme law—states that “Every person has the right … to the highest attainable standard of health … .” ¹ The Government of Kenya has passed and begun to implement various laws and policies to realize its constitutional and international commitments to improved child health. Of particular relevance to pediatric HIV testing and counseling are the Children Act, ² the HIV and AIDS Prevention and Control Act, ¹¹ and the National Guidelines for HIV Testing and Counselling in Kenya. ¹⁴ Together, they provide answers to the 4 previously mentioned research questions. Clarifying the answers and codifying them in enforceable law and policy are essential steps toward fulfillment of every Kenyan child’s right to health. Without clarification from national or subnational policymakers on these and other questions, health workers may develop answers that may well vary from clinic to clinic and from patient to patient. Furthermore, patients may not know what to expect in the way of health services, thereby reducing their power to hold public and private sector providers accountable.

Who Has the Authority to Conduct HIV Tests?

If authority to offer or conduct HIV tests is restricted to certain health workers of which there is a relative scarcity (eg, physicians and laboratory technologists), then supply of HIV testing may fall short of demand. On the other hand, standards must be maintained. Kenya’s answer to this quandary is to require doctors, clinical officers, nurses, laboratory technicians, and counselors to undergo training conducted in line with national standards in order to receive the required certification to conduct HIV testing and counseling. The Kenyan approach exemplifies “task shifting” of HIV testing and counseling from relying solely on physicians to including other more plentiful health workers and counselors, as recommended by the WHO. ²⁰ Kenyan policy aims to maintain high-quality standards by requiring training and certification of all HIV testing and counseling service providers, as well as registration of all private sector organizations that conduct HIV testing and counseling outside of health facilities. ¹⁴

Should HIV Tests Be Routinely Offered?

Kenyan policy also provides a clear answer to when HIV testing must be offered to pediatric and adult patients. The answer aligns with guidance issued by the WHO and the Joint United Nations Programme on HIV/AIDS calling for provider-initiated, routine HIV testing and counseling in health facilities of countries with generalized HIV epidemics. ²¹ Kenya’s HIV prevalence is about 7%, consistent with a generalized, predominantly heterosexual epidemic. ²² According to Kenyan policy, it is considered “unacceptable” and “negligent” not to offer HIV testing and counseling in maternal and child health services, pediatric inpatient facilities, and general outpatient settings, among others. Kenya’s National Guidelines for HIV Testing and Counselling clearly state that “HTC [HIV testing and counseling] should be offered to all clients or patients attending any health facility as part of routine care.” In sum, the Government of Kenya has adopted a provider-initiated model of testing meant to increase service coverage while preserving the autonomy of individuals to opt out. This national policy, if vigorously implemented and enforced, may lead to increased uptake of HTC services with corresponding prevention and treatment benefits. ^23,24

Who Can Provide Consent for Children to Be Tested?

Under Kenya’s HIV testing and counseling guidelines, ¹⁴ the Children Act, ² and the HIV and AIDS Prevention and Control Act, ¹¹ parents clearly have authority to consent to HIV testing and counseling for their children. Guardians also have such authority, yet the question of what kind of guardian has the authority to consent for the child has arisen. Under Kenyan law, there are 2 types of guardians. Actual guardians are persons with care and control over a minor. For example, family members caring for AIDS orphans would be considered actual guardians. Legal guardians have care and control over a minor and official legal custody granted by court order.² In Kenya, relatively few actual guardians may have legal custody of children for whom they care, given the generally limited access to the legal system and its official products. ²⁵

Whether actual guardians without a court order granting legal custody are able to consent on behalf of children under their care and control is not entirely clear. This is so because Legal Notice 180¹³ commenced Section 14 of the HIV/AIDS Prevention and Control Act of 2006 that would appear to require consent from either a parent or a legal guardian for pediatric testing. However, the Statute Law (Miscellaneous Amendments) Act of 2009 amended the HIV/AIDS Prevention and Control Act by removing the word “legal” prior to the word “guardian” in various instances. These amendments may imply intent on the part of Kenyan legislators to allow all guardians to consent for pediatric HIV testing as well as disclosure, rather than restricting this authority to only legal guardians. Furthermore, this 2009 legislation broadly defined a “guardian” as “any person having custody of such child … by reason of the death, illness, absence or inability of the parent of such child … or for any other cause.” Whether all persons and institutional guardians (eg, orphanages) with a child under their care and control can consent to pediatric HIV testing is an important question, given the answer’s potential implications for access to pediatric HIV testing.

In addition to authorizing parents and guardians to consent to pediatric HIV testing, Kenya’s policy as set out in the HTC guidelines allows children to consent for themselves if they are pregnant, married, themselves a parent, symptomatic for HIV, or are engaged in behavior that puts them at risk of HIV (ie, “emancipated minors”).

Furthermore, health care workers may be able to provide consent in cases where a parent or a guardian is unavailable or unwilling to provide consent. This is so given the Children Act’s mandate that the “right to health and medical care … shall be the responsibility of the parents and the Government,” and the stated need to act “in the best interests of the child.”

Should HIV Status Be Disclosed to the Pediatric Patient?

The answer in Kenya’s HTC guidelines varies depending upon to which of the 3 categories the child pertains. Children who are emancipated minors and who therefore can consent independently to HIV testing should have their results disclosed directly to them. For “youth and adolescents” who are not emancipated minors, disclosure of HIV test results should occur with their parents, guardians, or caretakers and post test counseling “should be offered to both parties together, after which the youth or adolescent should be offered individual post test counseling.” Although age ranges for the terms “youth” and “adolescent” are not defined in any of the documents reviewed, the WHO’s provider-initiated testing and counseling guidance suggests adolescence as beginning at age 10 years. For children who are neither youths or adolescents nor emancipated minors, “Parents, guardians, and caretakers must use their own judgment to determine when a child can safely receive knowledge of their HIV status.” ¹⁴

Implementation of Domestic Laws and Policy in Kenya

Universally, laws and policies exist at 2 levels (1) as written in official government documents and (2) in practice through interpretation, implementation, and enforcement. The 2—policy and practice—are often not aligned. ²⁶ Kenya’s HTC guidelines explicitly seek to prevent such misalignment by delineating an “implementation framework” involving various groups and officials including the National AIDS Control Council, the Ministry of Public Health and Sanitation’s National AIDS and Sexually Transmitted Infection (STI) Control Program, the National HTC Taskforce, Provincial Medical Officers, Provincial AIDS/STI Coordinators, District Medical Officers of Health, District AIDS/STI Coordinators, and service delivery organizations including the Government of Kenya, nongovernmental, community-based, and faith-based organizations.

Kenya has clearly made progress in PMTCT and pediatric HIV testing and treatment. Nevertheless, Kenya like many other nations faces several challenges to continued progress in pediatric HTC such as sustaining national and donor financing, addressing human resources shortages, strengthening laboratory capacity, and fully implementing the move from a client-initiated opt-in model to a provider-initiated opt-out model of testing. Furthermore, ensuring that health care workers are aware of and comply with existing laws and policy governing pediatric HTC is essential and should not be assumed. A 2005 study found that 0 of 58 health facilities surveyed throughout Kenya had a copy of the then current national guidelines for HIV testing in clinical settings, and that none of these facilities had “in house policy guidelines on HIV counseling and testing for children.” ²⁷ A study in South Africa also identified a lack of clear written policies to guide health workers in addressing HIV/AIDS with pediatric patients. ²⁸ Health workers themselves have asked for clearer policy guidance. ²⁹

Conclusion

In theory, strengthening implementation of Kenya’s existing laws and policy governing HIV testing should lead to improvements in service delivery and ultimately to far fewer cases of Kenyan children acquiring HIV and dying as a result of it. Along these lines, the well-accepted stages heuristic theoretical framework notes the importance of not only agenda setting and policy formulation, but also implementation and evaluation. ²⁶ The Government of Kenya, private sector organizations, Kenyan civil society, UN agencies such as WHO and Joint United Nations Programme on HIV/AIDS, and international donors and providers of technical assistance (such as the US President's Emergency Plan for AIDS Relief and the multilateral Global Fund to Fight AIDS, tuberculosis, and malaria) all have important roles to play in this regard. There are many facets to implementing laws and policies, including sharing them with those whose rights and duties are affected (eg, health workers and patients), training health workers on how to put policies into practice, supportive supervision that recognizes and attempts to overcome barriers to practical implementation of policies, and the application of penalties and remedies provided for in Kenyan law. The latter include criminal liability for negligent infringement of a child’s right to health under Kenya’s Children Act, ² awards of civil damages to those whose rights under Kenya’s HIV and AIDS Prevention and Control Act ¹¹ have been violated, and remedial orders issued under the Kenya National Commission on Human Rights Act. ¹⁰

In Kenya, as elsewhere, people desire a society where children do not die of preventable causes such as AIDS, and where no child acquires HIV in the first place. Law, together with medicine and public health, can help progressively turn this desire and right into reality. Key approaches include establishing new evidence-based laws and policies where necessary, amending laws or policies, and improving implementation of existing laws and policies.