I. Executive Summary

Experts estimate that fewer than 2 in 10 people in sub-Saharan Africa know their HIV status. Even fewer know the HIV status of their partner. Not knowing your–or your partner's–HIV status can have devastating consequences. It puts millions of people who have HIV at risk of premature death by delaying initiation of treatment and unknowingly exposing others to the virus. Those who are found to be HIV-negative need the knowledge to continue to protect themselves against HIV infection. Ignorance of HIV status is particularly problematic for sero-discordant couples-people in relationships where one person is HIV-infected while the other is not-where, according to some studies, a significant percentage of new infections in sub-Saharan Africa occurs.

There is broad international consensus that HIV testing must be expanded urgently so that more people can protect their health, but the question of how to do this has been the subject of heated debate. As treatment has become more available in resource-constrained settings, some medical and public health officials have argued that the scale of the epidemic in high prevalence regions such as southern and eastern Africa requires a more aggressive response, in which certain human rights protections should be suspended or restricted for the benefit of the greater good. These officials have pitted a "rights-based" approach against a "public health" approach.

Good public health and human rights practices generally go hand-in-hand, though: The right to make a decision based on informed consent is not only protected by human rights law, but is also crucial from a public health perspective, as it enables people to act on the knowledge they obtain through the test; confidentiality, another aspect of the right to health and privacy, is also crucial for maintaining public trust in the health care system.

One of the new HIV counseling and testing approaches that has proliferated across sub-Saharan Africa in the last few years is large scale community-based testing. In contrast to provider-initiated testing in healthcare settings, this type of testing has received little attention or scrutiny. By bringing HIV testing into communities, these testing programs seek to reach people who are unlikely to access voluntary testing and counseling services and who are not in touch with the healthcare system. While these programs have real potential, their impact may be limited if they result in, or contribute to-intentionally or unintentionally-violations of basic human rights. To date, no international guidelines exist to help countries implement this testing model in a way that both contributes to public health goals and is respectful of human rights.

Lesotho, a country of about 1.9 million people with the third highest HIV prevalence in the world and a severely overstretched healthcare system, is one of the countries implementing this testing model. With the encouragement of the World Health Organization (WHO), it developed a highly ambitious community-based HIV testing program in 2005 in which thousands of lay counselors from villages all over the country were to offer HIV counseling and testing to everyone twelve years and older. The "Know Your Status" (KYS) testing campaign, as it was called, which was launched on December 1, 2005, planned to offer 1.3 million people an HIV test within two years.[1]The then-Director of WHO's HIV/AIDS program lauded the campaign as a model for other high prevalence countries to follow, with the potential to dramatically reduce HIV prevalence.[2]

By harnessing the potential of community-based lay counselors, the campaign sought to overcome a major hurdle to expanding HIV testing that is characteristic not just to Lesotho but to many other high-prevalence countries: the healthcare system's crippling capacity problems and inability to reach those who are the least likely to seek HIV-testing or be in contact with the healthcare system, including those who live in remote locations. The campaign's approach to expanding testing, though, also posed considerable challenges to Lesotho's overstretched healthcare system. How would it ensure proper training and oversight of such a large number of lay counselors? How would it ensure that the campaign did not merely test people but also inspired people to change their sexual behaviors and linked those testing positive to care, support, and treatment?

The unprecedented scope and ambition of the program, combined with the lack of capacity of Lesotho's healthcare system meant that there was a real risk that the KYS campaign would fail to enable people to act on the knowledge of their status and to respect and protect the basic human rights of those that it was targeting. Infringements on rights could arise through testing without informed consent, failure to provide the information individuals needed to make an informed decision on an HIV test, breaches in confidentiality, and ineffective accountability mechanisms. The under capacitated health system meant that there was also a risk of poor access to prevention, care and treatment services.

The campaign's Operational Plan, a detailed 48-page plan of action, recognized these various risks and challenges. It stated:

While filled with promise for helping Basotho [the people of Lesotho], the "Know Your Status" campaign may also yield damaging effects-unintentional or intentional-to the people of Lesotho.[3]

Yet, the Operational Plan expressed confidence that the campaign would overcome these challenges and would-ultimately-significantly contribute to HIV prevention efforts, help enroll many more people into care and treatment, and reduce stigma.

The plan addressed most of the risks and challenges in detail. It indicated that all testing should be voluntary and that test results should be confidential. It called for proper training and supervision of lay counselors. It also described quality control, monitoring and evaluation, and independent oversight mechanisms that were to be put in place. Finally, it stressed the key importance of expanding care and treatment in parallel to the campaign, invoking the Ministry of Health's intention to make antiretroviral drugs available at all local healthcare clinics.

Human Rights Watch and the AIDS and Rights Alliance for Southern Africa (ARASA) jointly conducted research in Lesotho in October 2007 and February 2008 to examine how well the principles and protections identified in the operational plan were implemented in the roll-out of the KYS campaign. We conducted dozens of interviews with key informants, including KYS staff, counselors, healthcare workers and others, as well as some KYS clients, in five towns and ten villages in five districts of Lesotho.

We focused our research on five aspects of the country's HIV counseling and testing campaign with direct relevance to international human rights principles and public health norms and standards. We examined: 1) informed consent and counseling; 2) confidentiality; 3) linkages between HIV testing and prevention, care and treatment services; 4) accountability mechanisms; and 5) the adequacy of the policy and legal framework for protecting the rights of people living with HIV.

Our research in Lesotho revealed both positive and negative aspects of the KYS campaign. On the positive side, we found no evidence of involuntary testing and heard only a few allegations of breaches of confidentiality. We also found that some efforts were made to ensure that testing was linked to HIV treatment and care services, and that there was a great commitment among counselors to bringing HIV counseling and testing to communities. On the negative side, we found a failure to ensure that the human rights safeguards included in the Operational Plan were properly implemented in practice, which resulted in the campaign failing to intervene when it became clear that many counselors in Mafeteng district were ill-equipped to conduct HIV counseling and testing. There was a clear disconnect between the planning on paper and the capacity to implement what was planned. All those involved in the planning of the campaign, the Lesotho government, and the WHO, bear responsibility for not recognizing this disconnect and responding to it from the outset. The KYS campaign's implementation was fraught with problems, resulting in poor training and supervision of counselors; poor linkages, at times, to other services after testing; and insufficient mechanisms to ensure respect for human rights and the accountability of government efforts. In places where the campaign was conducted most intensively, human rights protections, as well as the integrity of the counseling and testing provided, seemed most endangered. Human rights protections should be an integral part of any testing campaign, not an optional element that can be added or left out depending on availability of resources.

To be sure, many of the KYS counselors we interviewed were deeply committed to the concept of bringing HIV education and testing into communities. Many told us of hours-long walks to remote villages to speak to villagers about HIV and AIDS. Others explained to us how they went beyond the call of duty to accommodate the concerns of their clients by inviting them to their own homes to test or returning to their homes repeatedly to counsel clients testing positive. We also encountered nurses at local healthcare centers who had invested considerable time and energy-on top of their already grueling schedules-in training and supervising KYS counselors, and offering people who tested not just referrals but integrated HIV-related health services.

The KYS campaign, though, has not been the quick-fix that policy makers had hoped for. From day one, the campaign was in trouble. While the Operational Plan had provided a detailed script for a highly disciplined and systematic testing campaign, in practice KYS' overall implementation was chaotic, uneven, lackluster, and fraught with problems. Many of the elements of the campaign that the Operational Plan described-a media campaign, quality assurance, monitoring and oversight for potential abuses-were either never implemented or implemented only after a long delay. Although by late August 2007-21 months after its launch-the campaign had trained about 3,590 lay people-of the 7,200 planned-in many parts of the country, it failed to meet its targets by wide margins.[4] While HIV testing at healthcare clinics increased significantly, by late August 2007, fewer than 25,000 people had been tested through KYS, just 2% of the 1.3 million target that had been set for the end of 2007.[5] An April 2008 press release by WHO in Lesotho stated that "while only 50,000 people in Lesotho knew their status in 2004, by the end of 2007, over 240,000 Basotho tested for HIV" and that 30 percent of HIV tests were conducted in community-based settings.[6] However, it does not estimate how many people had actually been tested by KYS counselors.

In response to the sluggish performance of KYS, the government organized a three-week long intensive testing drive in Mafeteng district in August 2007. As part of the drive, KYS program managers sent 318 counselors into villages in Mafeteng district to conduct HIV counseling and testing. This resulted in more people being tested than in any other three-week period during the two-year campaign-13,342, with 1,468 (11%) testing positive.[7]Our research found that in its eagerness to test as many people as possible, the KYS campaign sent dozens of KYS counselors who had never received any practical training into villages; some had never even seen a test kit before. The lack of adequate training poses a clear risk of violations of informed consent and confidentiality.

Indeed, we found that counseling provided by KYS counselors was often substandard, raising concern about whether people's consent to test-or their decision not to test-was actually informed. In some cases, women did not get tested because they were not permitted to consent or felt that they could not consent without their husband's permission. Although we did not document specific cases of breaches of confidentiality, the KYS counselors we interviewed had varying degrees of understanding of the importance of confidentiality and attitudes towards it.

Several nurses from Mafeteng district complained that the influx of KYS referrals after the drive had caused real strains on their clinics and laboratories, as well as on their ability to ensure linkages between testing and care. We were told that KYS had not coordinated with local clinics or labs to ensure that the healthcare system in Mafeteng district could absorb the considerable influx of people testing positive and although the Operational Plan stated that people who tested negative would be referred to prevention services, this has not happened in practice. In other parts of the country, it appears health clinics were able to absorb new patients referred by KYS because the pace of KYS testing was very low.

Lack of accountability mechanisms also meant, according to several supervisors and nurses interviewed by Human Rights Watch, that multiple individuals were wrongly told that they were HIV-infected because counselors did not know how to operate or read test kits. Some of these cases came to light when laboratory technicians became suspicious that immune level tests came back showing no abnormality and decided to retest the blood samples for HIV. It is not known how many such cases went unnoticed. Although the Operational Plan provided for various mechanisms, such as supervision for counselors, quality assurance procedures and internal and outside monitoring, aimed at ensuring that the government could detect problems caused by the KYS campaign and intervene when needed, most of these accountability measures were not actually implemented. Quality assurance procedures aimed at ensuring that the results of rapid tests were accurate were not followed, leaving the KYS campaign with no way of identifying problems with either batches of test kits or their administration by counselors. The KYS campaign has also failed to put in place a system to track uptake of referrals to healthcare centers for follow-up services. It thus had no way of signaling a problem should uptake of referrals be unacceptably low.

The Operational Plan called for the establishment of various KYS and independent monitoring mechanisms to collect information on the implementation of the campaign and potential problems it caused. However, as of October 2007, two months before the KYS campaign was supposed to end, these mechanisms were not functional. The independent monitoring mechanisms that were supposed to collect information about potential problems related to breaches of consent, confidentiality, the quality of counseling and testing, potential post-disclosure problems for women, or problems with linkages to treatment, were never even created. The authorities failed to seize the important opportunity KYS offered to engage civil society networks of people living with HIV and support groups, in providing oversight over the campaign. As a result, people were deprived of an accessible mechanism to raise potential concerns about the KYS campaign.

Although Lesotho has made considerable progress in recent years in adopting a legal and policy framework that protects the rights of people living with HIV, major gaps remain. In 2006, Lesotho adopted a landmark law granting women legal capacity, which means that women can now own property, maintain bank accounts, and make their own decisions about medical procedures. The law is an important first step toward breaking the almost complete dependence of women on their male partners, which had made them vulnerable to human rights abuses ranging from property grabbing to domestic violence. Yet, Lesotho still does not have a law on domestic violence, meaning that women remain extremely vulnerable to violence from male partners when disclosing their HIV status. Lesotho's laws protect employees with HIV and AIDS in the private but not the public sector. The country is in the process of adopting a new law on HIV and AIDS, but the draft legislation does not fully protect the rights of people living with HIV and AIDS, reduce vulnerability, or provide protection from infection.

Community-based testing campaigns have real potential. They offer a real chance to reach out to populations that are otherwise unlikely to test, but they also entail risks that must be addressed head-on through the implementation of robust human rights safeguards. While such safeguards were part of the plan for Lesotho's KYS campaign, they were not implemented. The government of Lesotho and international organizations such as WHO and UNAIDS can and must learn important lessons from the KYS campaign. These campaigns need careful planning, sufficient funding, good training, ample coordination, proper oversight, and the involvement of civil society which can play a critical role in ensuring accountability and reporting potential human rights abuses. Without these elements, these programs risk failing to achieve their ambitious goals-as happened in Lesotho-or worse, damaging the cause they were intended to serve.