December 16, 2008

III. Background

HIV/AIDS Treatment for Children

Mother-to-child transmission is the main cause of HIV infections in children. Infection can take place during pregnancy, labor, and delivery, and in 20 to 40 percent of infection cases through breastfeeding.[6] Programs for the prevention of mother-to-child-transmission (PMTCT) greatly reduce infection among newborns: One dose of Nevirapine is given to the woman during labor, and one dose is given to the baby within 72 hours of birth.[7]

If untreated, one in two children born with HIV will die before their second birthday as their bodies succumb to opportunistic infections such as pneumonia, tuberculosis (TB), or diarrhea.[8] In particular, a certain type of pneumonia has been identified as the leading cause of death in infants with HIV.[9]

Antibody tests, which are used to diagnose HIV in adults, are ineffective in children below the age of 18 months because children can carry their mother's antibodies until this time. Polymerase chain reaction (PCR) testing allows for testing of children under 18 months but requires expensive laboratory equipment and specially trained staff. PCR testing is not widely available in Kenya, although dry blood spot testing has been introduced in the past two years (see Chapter VI, below).[10]

Treatment of HIV and of opportunistic diseases-infections that the immune system is unable to prevent due to HIV-in children is also somewhat different from adults. Antiretroviral treatment should be given to all HIV-positive infants, and as needed to other children based on a CD4 cell count and a clinical assessment.[11] A number of different combinations can work effectively in children. A common combination in Kenya is Lamivudine (3TC), Nevirapine, and Stavudine (d4T).[12] Treating HIV in children is more complex than treating HIV in adults. For example, the dosage has to be calculated based on the child's weight or body surface area, and changed frequently as the child grows. Side effects can also be different than in adults.[13]

Many children who test HIV-positive must be given the antibiotic cotrimoxazole to prevent opportunistic infections and hence early death. Cotrimoxazole is inexpensive and reduces mortality of small children by about 43 percent.[14]

Until recently, the absence of pediatric formulations of drugs has been an obstacle in the treatment of children. Pharmaceutical companies have placed little interest into researching drugs that would primarily be consumed by children in developing countries. Those that were developed were late in coming and were much more expensive than adult antiretroviral drugs. Pediatric antiretroviral formulations have become more widely available in Kenya since late 2006, when the Clinton Foundation negotiated price reductions in pediatric drug formulations made by two Indian pharmaceutical companies.[15] For small children who cannot easily swallow pills, liquid formulations (syrups) have been developed. For older children, there are single pills with a lower dosage than the adult formulation. Most recently, a fixed dose combination pill has been developed for children, six years later than the one for adults.[16]

In high-income countries, HIV is very rare in children, partly due to the success of PMTCT programs. For those children who have contracted the virus, ART has turned HIV into a manageable chronic disease with significant numbers of children in good health who go on to live with the infection into adulthood. However, in Africa, HIV still kills children at alarming rates.

The Epidemic in Eastern and Southern Africa

HIV/AIDS is a crisis of unprecedented magnitude across Africa. An estimated 22.5 million people in Sub-Saharan Africa are living with HIV[17]-roughly two-thirds of the world's HIV-positive people. Around 1.8 million children in Sub-Saharan Africa are HIV-positive, nearly 90 percent of the children living with HIV worldwide.[18] More than 12 million children have been orphaned by AIDS in Africa.[19]

Eastern and Southern Africa have been particularly affected by HIV. An estimated 5.3 million people are in need of antiretroviral therapy there, more than half of the total number of people in need of treatment worldwide.[20] In Eastern and Southern Africa, HIV is also the leading cause of death in children under the age of five: The top 10 countries with the highest number of child deaths due to HIV are all in Eastern and Southern Africa.[21]

The case of Kenya

Kenya has a generalized HIV epidemic-that is, an epidemic that affects all segments of society. The country faces many of the same challenges in fighting HIV as other countries in the region. Over 1.5 million people have died of AIDS in Kenya.[22] In 2008 there were an estimated 1.6 to 1.9 million people living with HIV in the country, about 7.4 percent of the adult population.[23] This is a significant increase from the prevalence of about 5 percent in 2006.[24] The impact of HIV on the country has been disastrous. HIV/AIDS has contributed to a downturn in the economy and increased poverty, and has led to the breakdown of community and family structures.[25]

The situation regarding children is also indicative of the challenges in the sub-region. HIV is a leading cause of death in children in Kenya: according to UNICEF, 15 percent of all child deaths are attributable to HIV.[26] Around 20,000 infants were infected through their mothers in 2006.[27] While this was the most common mode of transmission, children have also become infected through sex,[28] and more rarely through drug use[29] and unsafe circumcision.[30] Treatment coverage of adults is almost double that of children: according to government figures, about 54 percent of adults (177,000 persons) who need treatment receive it,[31] compared with only 27 to 30 percent of children (20,000).[32]

Despite this, and the recent increase in HIV prevalence, Kenya is seen as a relative success and a leader of strong HIV policies within the region. The country has been hailed for reducing the prevalence of HIV due to changes in sexual behavior among young people. In its recent HIV/AIDS "Epidemic Update," UNAIDS named Kenya as one of the countries in which "prevention efforts are having an impact."[33]

The Global Fight against HIV/AIDS

In the past decade, the international community has made concerted efforts to stem the HIV epidemic. In 2001, UN member states adopted the Millennium Development Goals (MDGs), which set ambitious targets in the area of health. Goal 4 aims to reduce the under-five child mortality rate by two-thirds between 1990 and 2015. Goal 6 aims to halt and begin to reverse the spread of HIV by 2015, and to achieve, by 2010, universal access to treatment for HIV/AIDS for all those who need it.[34]

In 2003 the World Health Organization (WHO) initiated a program to get three million people in developing countries on ART by the end of 2005.[35] The Global Fund to Fight AIDS, Tuberculosis and Malaria prioritized treatment access in Africa and started concerted efforts to place the drugs within reach of the ordinary population. This was partly due to pressure from activists and people living with HIV, who demanded access to the drugs in poor countries, and who helped change international rules to allow distribution of generic drugs in those countries.[36] While this has been an enormous step forward, many medicines, in particular those that are still relatively new, are still too expensive for use in poor countries. Patent protection has increased in developing countries, and this pushes prices up.[37]

On the regional level, the African Union (AU) has committed itself to fighting HIV/AIDS on the continent. In particular, the May 2006 Abuja Call for Accelerated Action Towards Universal Access to HIV and AIDS, Tuberculosis and Malaria Services in Africa reiterates the importance of access to treatment.[38]

However, the global roll-out of antiretroviral drugs has largely focused on adults. It was only in 2005 that a coalition of international actors came together to call for increased attention to treatment of children. Under the leadership of UNICEF, the "Unite for Children Unite Against AIDS" initiative was launched. The campaign aims to provide either antiretroviral treatment or cotrimoxazole (an antibiotic), or both, to 80 percent of children in need by 2010.[39]

Fighting HIV/AIDS in Kenya

In 1999 the Kenyan government declared HIV/AIDS a national disaster and a public health emergency. At that point, the national prevalence rate was about 14 percent among adults; Nyanza province in western Kenya had a prevalence rate of about 29 percent.[40] Shortly after, the National Aids Control Council (NACC) was established as part of the Office of the President to provide a stronger response to HIV/AIDS.[41]  In May 2003 the government of President Mwai Kibaki proclaimed a "total war on AIDS," and the following year started providing antiretroviral drugs in public hospitals, but to a limited number of patients.[42] Generic drugs were initially imported from Brazil and are now coming mostly from India.[43]

Current HIV/AIDS policies are defined in the Kenya National HIV/AIDS Strategic Plan 2005-2010 by the NACC. The Plan emphasizes the need to target vulnerable groups, including orphans and vulnerable children, and to focus on women and youth. The Strategic Plan refers directly to the MDGs and defines specific targets for 2010 such as: lowering the prevalence rate to 5.5 percent; reaching at least 50 percent of infected pregnant women with PMTCT treatment; reaching at least 75 percent of patients in need of ART; reaching all patients with affordable opportunistic infection drugs; and informing 75 percent of people living with HIV a   bout their treatment and their rights.[44]

In order to implement policies and provide guidance to health workers and others involved in HIV/AIDS-related work, the government has also developed guidelines on a variety of issues, including testing,[45] antiretroviral drug therapy,[46] nutrition and HIV/AIDS,[47] and many other topics.

Following political conflict and post-election violence in late 2007 and early 2008, a new government was formed in April 2008 under President Kibaki and Prime Minister Raila Odinga. While the new government has not made any major changes to HIV/AIDS policies, its reorganization of ministries has created some confusion. The former Ministry of Health is now called Ministry of Public Health and Sanitation, and headed by Minister Beth Mugo. In addition, a new Ministry for Medical Services has been created, under Minister Peter Anyang' Nyong'o.[48] The division of labor between these two has remained unclear to observers.[49]

Funding for health and HIV/AIDS

The overall health budget for the years 2007-2008 is 34 billion Kenyan shillings (KSh) (about US$442 million).[50] This represents about 7 percent of total government expenditure,[51] far below the government's commitment to allocate 15 percent of the government's budget to the health sector, in accordance with the Abuja Declaration of African governments.[52]

Within health funding, a considerable amount of money goes to HIV/AIDS programs. At present, about KSh20 billion (approximately US$260 million)-over 50 percent of Kenya's health budget-goes toward HIV/AIDS treatment and care.[53] HIV/AIDS services have often been funded through vertical programs that circumvent the regular health system and create separate, HIV-specific structures. But for HIV goals to be met, broader health systems must also be strengthened.[54]

Donors have funded much of Kenya's fight against HIV. In 2006, based on conservative estimates, about 34 percent of Kenya's HIV/AIDS-related funding came from external sources[55] (several analysts estimate the percentage of donor funding in HIV services to be significantly higher[56]). The most important donor in Kenya for health is the United States, through the President's Emergency Plan for AIDS Relief(PEPFAR). During 2007 PEPFAR funding was over US$368 million,[57] exceeding the government's own contributions toward HIV/AIDS of about US$282 million in 2007.

Another important donor is the Global Fund to Fight AIDS, Tuberculosis and Malaria. It has approved HIV grants totaling nearly US$130 million[58] and in November 2007 disbursed US$70 million to Kenya. Before that, Kenya had failed to obtain approved Global Fund aid because of delays and mismanagement.[59] Corruption has also been a major problem within the NACC, whose first director had to step down as a result.[60]

Other important donors include the United Kingdom, Japan, Germany, and several multilateral agencies, such as UNICEF, the World Bank, and the European Union (EU).[61] There are also two important private US donors, the Clinton Foundation-which almost exclusively funds pediatric HIV interventions-and the Bill and Melinda Gates Foundation.

[6] The German HIV Peer Review Group, "Prevention of Mother-to-Child-Transmission of HIV in Kenya, Tanzania and Uganda," November 2007, (accessed September 16, 2008).

[7] PMTCT services also consist of HIV counseling and testing, obstetric practices to avoid transmission during delivery (if the mother gives birth in a health facility), and advice in feeding practices and family planning. Ministry of Health, "Interventions to prevent mother-to-child transmission," website of the ministry at, under Health Programmes, page on HIV/AIDS in Kenya, subheading "Interventions for preventing the spread of HIV," (accessed August 22, 2008); USAID/Horizons, "Strengthening PMTCT Programs. Studies explore strategies to promote adherence and follow-up care," June 2007, (accessed September 16, 2008), p. 6.

[8] Marie-Louise Newell et al., "Mortality of infected and uninfected infants born to HIV-infected mothers in Africa: A pooled analysis," Lancet, vol. 364, October 2004, pp. 1236–1243.

[9] This type of pneumonia is called PCP, or Pneumocystis jirovecipneumonia. World Health Organization, "New WHO Guidelines on Co-Trimoxazole Prophylaxis for HIV-related Infections among Children, Adolescents and Adults," (accessed October 13, 2008).

[10] Avert, "Children, HIV and AIDS," September 5, 2008, (accessed October 6, 2008), section "Children infected with HIV."

[11] WHO, Antiretroviral Therapy for HIV Infection in Infants and Children: Towards Universal Access. Recommendations for a public health approach (Geneva: WHO, 2006), (accessed October 6, 2008); Avert, "HIV treatment in children," (accessed October 13, 2008).

[12] Clinton Foundation dosing wheel, provided by the Clinton Foundation to Human Rights Watch in August 2008; Human Rights Watch telephone interview with James Kamau, Kenya Treatment Access Movement (KETAM), October 13, 2008.

[13] American Academy of Pediatrics, "Increasing Antiretroviral Drug Access for Children With HIV Infection," 2007,;119/4/838.pdf (accessed October 13, 2008).

[14]Newell et al., "Mortality of infected and uninfected infants." Cotrimoxazole costs about US$0.04 per pediatric tablet, and a child needs a maximum of two per day, according to the Ministry of Health. See "Summary Report October 2007," MMePA (Monitoring Medicine Prices and Availability) Quarterly, p. 2. This regular publication is produced by the Ministry of Health in conjunction with international NGOs and agencies, including Health Action International (HAI).

[15] Avert, "HIV Treatment and Children: The Problems," (accessed October 19, 2008).

[16] Human Rights Watch interview with Prof. Olago, head of the National AIDS Council (NACC), Nairobi, August 10, 2008; Medecins Sans Frontieres (MSF), "Affordability, Availability and Adaptability of AIDS Drugs in Developing Countries: An On-going Challenge," August 1, 2008, ums/2008/aids/news/?id=2877 (accessed October 13, 2008).

[17]  UNAIDS/WHO, "AIDS epidemic update 2007," December 2007, (accessed October 6, 2008), p.4.

[18] UNAIDS, 2008 Report on the Global HIV Epidemic (Geneva: UNAIDS, 2008), (accessed October 6, 2008), p. 33.

[19] Avert, "Sub Saharan Africa HIV & AIDS Statistics," September 29, 2008, (accessed October 6, 2008).

[20] WHO, UNAIDS, UNICEF, Towards Universal Access: Scaling up priority HIV/AIDS interventions in the health sector - Progress Report 2008, (accessed October 6, 2008), p. 16.

[21] UNICEF, "HIV attributable deaths in children aged under 5 in ESAR," August 2008, unpublished statistics, on file with Human Rights Watch.

[22] WHO, "Kenya: Summary country profile for HIV/AIDS scale-up," December 2005, (accessed October 6, 2008), p. 1. On the spread of AIDS in Kenya, see John Iliffe, The African AIDS Epidemic. A History (Oxford: James Currey, 2006), pp. 27-29.

[23] Ministry of Health, "Kenya AIDS Indicator Survey, preliminary report," July 2007, (accessed October 6, 2008). This prevalence rate is for ages 15-49. According to UNAIDS the prevalence is between 7.1 and 8.3 percent. UNAIDS/WHO, "Epidemiological Fact Sheet on HIV and AIDS, Kenya," July 2008, (accessed October 6, 2008).

[24]UNAIDS/WHO, "AIDS epidemic update 2007," pp. 11-14, 18. The Kenya AIDS Indicator Survey is the first population-based survey of the HIV epidemic in Kenya since the 2003 Kenya Demographic and Health Survey. It is possible that earlier surveys were inaccurate. "Kenya: Shocking Rise in HIV Prevalence,", July 29, 2008, (accessed October 27, 2008).

[25]Human Rights Watch, In the Shadow of Death: HIV/AIDS and Children's Rights in Kenya, vol. 13, no.5(A), June 2001,

[26] UNICEF, "HIV attributable deaths in children aged under 5 in ESAR," August 2008.

[27] National AIDS Control Council, UNGASS 2008: United Nations General Assembly Special Session on HIV and AIDS, Country Report - Kenya, 2008, (accessed October 6, 2008), p. 12.

[28] According to the 2006 UNGASS report, 14 percent of women and 29 percent of men had sex before the age of 15. National AIDS Control, UNGASS 2006: United Nations General Assembly Special Session on HIV and AIDS, Country Report - Kenya," 2006, (accessed October 15, 2008), p. 25. According to a study in Nyanza province, the average age at first sex is 12 among boys and 13 among girls. Population Council/Constella Futures, "Situation Analysis of the Sexual and Reproductive Health and HIV Risks and Prevention Needs of Older Orphaned and Vulnerable Children in Nyanza Province, Kenya," March 2007, (accessed November 10, 2008).

[29] "Deadly Cocktail: HIV and Drug Use," PlusNews, November 2007, (accessed October 15, 2008).

[30] D. Brewer, "Male and Female Circumcision Associated with Prevalent HIV Infection in Virgins and Adolescents in Kenya, Lesotho and Tansania," AEP, vol.17, no.3, March 2007, pp. 217-226. More recently it has been recognized that medically performed male circumcision reduces the risk of HIV transmission.

[31] Dr. I. Mohamed, head of National AIDS and STD Control Programme (NASCOP), "2007 Kenya AIDS Indicator Survey Preliminary Results," July 29, 2008, (accessed September 25, 2008).

[32] Human Rights Watch interviews with Dr. Lyndon Marani, ART program manager, NASCOP, Ministry of Health, Nairobi, August 13, 2008; and Gerald Macharia, country director of the Clinton Foundation, Nairobi, August 20, 2008.

[33] UNAIDS/WHO, "AIDS epidemic update 2007," pp. 11-14, 18.

[34] United Nations, "End Poverty. Millennium Development Goals 2015," (accessed October 13, 2008). In the 2001 UNGASS Declaration of Commitment on HIV/AIDS, world leaders further spelt out their commitments to fighting HIV. United Nations General Assembly Special Session on HIV/AIDS, "Declaration of Commitment on HIV/AIDS," June 25-27, 2001, (accessed October 13, 2008).

[35] This report uses the term antiretroviral treatment (ART). In Kenya, many refer to ARV or ARVs meaning the drugs and the treatment. In quoting from interviews we have left this term as it was used by the interviewees.

[36] Avert, "Providing drug treatment for millions," (accessed September 26, 2007).

[37] Avert, "AIDS, drug prices and generic drugs," (accessed October 19, 2008); MSF, "Campaign for Access to Essential Medicines," (accessed October 19, 2008).

[38] African Union, "Abuja Call for Accelerated Action Towards Universal Access to HIV and AIDS, Tuberculosis and Malaria Services in Africa," Special Summit of the African Union on HIV and AIDS, Tuberculosis and Malaria,  Abuja, Nigeria, May 2-4, 2006, (accessed October 13, 2008).

[39] UNICEF/UNAIDS, Children: The Missing Face of AIDS. A Call For Action (New York: UNICEF, 2005), (accessed October 13, 2008).

[40]Human Rights Watch, In the Shadow of Death, pp. 10-13.

[41]NACC, "About Us," (accessed September 9, 2008). NACC is the government's coordinating body on HIV/AIDS policies; it is now part of the Ministry of State for Special Programs. The National AIDS and STD Control Programme (NASCOP) in the Ministry of Health is the key actor implementing governmental HIV/AIDS policies.

[42] "Kenya: Feature – Help for HIV/AIDS patients," IRINnews, (accessed October 13, 2008); "New Kenyan President Declares 'Total War On AIDS,' Urges Religious Leaders To Support 'ABC' Prevention Model," Kaiser Daily HIV/AIDS Report, May 21, 2003, (accessed September 9, 2008).

[43] Human Rights Watch interviews with Protus Lumiti, manager, Nyumbani orphanage, Nairobi, August 7, 2007; and James Kamau, KETAM, October 13, 2008. See also the website of Ranbaxy, a manufacturer of generic drugs in India: (accessed October 15, 2008).

[44] National AIDS Control Council, "Kenya National HIV/AIDS Strategic Plan 2005/6 – 2009/10. A Call to Action," June 2005, (accessed November 11, 2008).

[45] NASCOP, Ministry of Health, "National Guidelines for Voluntary Counseling and Testing," 2001; NASCOP, Guidelines for HIV Testing in Clinical Settings (Nairobi: Ministry of Health, 2004).

[46] NASCOP, Ministry of Health, "Guidelines for antiretroviral drug therapy in Kenya," third edition, 2005.

[47] NASCOP, Ministry of Health, "Kenyan National Guidelines on Nutrition and HIV/AIDS," 2006.

[48] "Speech by His Excellency Hon. Mwai Kibaki, C.G.H., M.P., President and Commander-In-Chief of the Armed Forces of the Republic of Kenya during the announcement of the Grand Coalition Government at State House, Nairobi," April 13, 2008, (accessed September 10, 2008).

[49] Human Rights Watch interview with representatives of Health Rights Advocacy Forum (HERAF), Nairobi, August 12, 2008.

[50] Hon. Amos Kimunya, E.G.H., M.P., Minister for Finance, "Budget Speech for the Fiscal Year 2007/2008," June 14, 2007, (accessed November 11, 2008). Among those, about 20 billion KSh are budgeted for HIV/AIDS treatment and care. Human Rights Watch interview with Dr. Lyndon Marani, ART program manager, NASCOP, Ministry of Health, Nairobi, August 13, 2008.

[51] Ministry of Health, "Public Expenditure Review," 2007, and "Allocation Projections," 2008. This is a rise from 2006, when the government allocated 5.1 percent to health. Veloshnee Govender, Di McIntyre, and Rene Loewenson, "Progress towards the Abuja target for government spending on health care in East and Southern Africa," EQUINET Discussion Paper 60, April 2008, (accessed November 11, 2008), p. 13.

[52] Organization of African Unity (OAU), "Abuja Declaration on HIV/AIDS, Tuberculosis and Other Related Infectious Diseases," African Summit on HIV/AIDS, Tuberculosis and Other related Infectious Diseases, Abuja, April 24-27, 2001, (accessed October 19, 2008).

[53] Human Rights Watch interview with Dr. Lyndon Marani, ART program manager, NASCOP, Ministry of Health, Nairobi, August 13, 2008.

[54]Gorik Ooms et al., "The 'diagonal' approach to Global Fund financing: a cure for the broader malaise of health systems?" Globalization and Health, 2008, vol 4:6, (accessed November 11, 2008); Dongbao Yu et al., "Investment in HIV/AIDS programs: Does it help strengthen health systems in developing countries?" Globalization and Health, 2008, vol 4:8, (accessed November 11, 2008).

[55] Govender, McIntyre, and Loewenson, "Progress towards the Abuja target for government spending on health care in East and Southern Africa," p. 15.

[56] Human Rights Watch interview with James Kamau, KETAM, August 6, 2007; "Kenya's Dependency on Donor Funding Affecting Fight Against HIV/AIDS, NGO Consortium Head Says," The Body: The Complete HIV/AIDS Resource, (accessed November 11, 2008); John Kamigwi et al., "Scaling Up the Response to HIV and AIDS in Kenya: Mainstreaming through the Government Budget Process," Constella Futures, March 2006, (accessed October 15, 2008).

[57] United States President's Emergency Fund for AIDS Relief (PEPFAR), "Kenya FY 2007 Country Operational Plan (COP)," (accessed September 15, 2008).

[58] Ibid.

[59] Kenya had failed to submit audited accounts for past grants or delayed grant reports. See Wairagala Wakabi, "Kenya's mixed HIV/AIDS response," The Lancet, vol. 369, issue 9555, January 6, 2007, pp. 17-18.

[60] Transparency International, Global Corruption report 2006. Corruption and Health (London/Ann Arbor: Pluto Press, 2006), pp. 112-115.

[61] USAID, "Kenya," (accessed September 15, 2008); Embassy of Japan in Kenya, "Japan's ODA to Kenya," (accessed September 15, 2008).