HIV drugs plus gender inequality equals non-adherence

Initiatives to increase access to essential medicines in developing countries is, of course, a good thing. It is the building of a lifeline. However, in settings challenged by the legacy of colonialism, hampered by unfair trade policies, and marked by poverty and oppression, it is no small feat to get the right drugs to patients and increase the number of patients served. It is a continuous struggle against the obstacles posed by transport and logistics, bureaucratic administrations, weak health care infrastructure, political inertia and the machinations of global pharmaceutical companies. And it is well-known that once the patients finally get the drugs, the struggle is not at all over. There are still problems of 'adherence', which at first sight may look like mere psychological unwillingness or carelessness in regard to compliance with a drug regime. On closer inspection, 'adherence problems' are really problems in integrating the taking of medication within the life-world of the patient. For one or another reason, it does not fit.

I recently saw a striking news item reminding me of the social complexity that stands behind 'non-adherence.' Apparently a significant number of men in Uganda, living with HIV but not open about their status, are taking medications from their HIV-positive female partners. When antiretroviral treatment was first being rolled out in Africa, I recall anecdotal reports of patients sharing their medicines with those without access to treatment. There the motive behind sharing was understandable and admirable -- a matter of human solidarity -- though the practice was dangerous as it meant improper dosing for all involved. The Ugandan case is different: the men probably would have access to treatment if they declared their status and appeared at clinics (apparently this is not just a Ugandan phenomenon). And this is stealing, not sharing, apparently facilitated in some cases by gender-based violence. So this is a new way of being 'non-compliant': having an aggressive partner unable to come to terms with his own HIV diagnosis.  

The ethics of disseminating research results

Article 33 of the Declaration of Helsinki (2008) reads:

At the conclusion of the study, patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it, for example, access to interventions identified as beneficial in the study or to other appropriate care or benefits.

As usual with ethics guidelines, they do not come with practical guidance. So how, in concrete terms, do you best carry out this ethical requirement? What if fulfilling this requirement actually involves risks to participants? And do you have to only disseminate at the conclusion of the study?

There is an interesting recent article in PLoS Medicine on this topic. In part, researchers were provoked to disseminate results back to participants in a longitudinal observational HIV treatment study, when a participant said: "You have been asking me questions and taking my blood for years, but I do not know anything about what you have found." Acting on this remark while the research is still ongoing seems to have taken the research team -- and the participant community -- on a challenging but very positive journey. Dissemination of research means translating them in two ways: from the dominant scientific language (English) into the local language, and translating technical terms into more accessible ones to those without extensive formal education. Bringing HIV positive persons in a research study together at the same event poses potential issues of stigma and loss of confidentiality, and subsequent involvement of ethics committees. And the format of dissemination has to be culturally appropriate: powerpoint slides and handouts are not going to do it. In the dissemination event described in the article, everything seems to have gone as it should among researchers and participants, resulting in a greater understanding of and respect for one another. This is an embodiment of what the 'ethical conduct of research' means far beyond the usual fixation on the contents of consent forms.

The unbearable fragility of HIV treatment access

It has taken a tremendous effort, over the course of many years, to give HIV-positive persons in sub-Saharan Africa access to antiretroviral treatment. On the World Health Organization's latest reckoning, over five million persons are now on treatment worldwide. However, the success is partial: another ten million persons in need of treatment currently do not receive it, and the pool of those who will need treatment in the future is expanding furiously -- over 7000 new HIV infections take place globally every day.

Even the partial success in access to treatment is very, very fragile. The global HIV treatment initiatives are generally bankrolled by the developed world's financial heavyweights who (after debilitating their own economies) are calling for austerity and belt-tightening, and programs supporting the lives of distant others are looking vulnerable.

But the challenges to maintaining and expanding HIV treatment programs apparently come from all angles. AllAfrica, that great warehouse of online African news, gives two recent examples. Kenya has been hit by a rise in food prices and a drought. Nearly two and a half million Kenyans are regarded as food-insecure, as prices have risen 15 percent; herders are losing their livestock in the dry north-east of the country, and some are fleeing to Uganda. For those who are food-insecure, HIV-positive and in need of antiretroviral treatment, the situation is grim: even for those who can access treatment, the pills are very hard to tolerate (and less effective) on an empty stomach. Some people would rather go off treatment than deal with the side-effects, though this could lead to resistant strains of HIV; others are reluctant to start treatment, which is likely to lead to poor clinical outcomes. In Tanzania, another twist: a sizable patients taking antiretroviral treatment may fail to adhere to treatment in their quest for the latest miraculous herbal cure. A former Lutheran pastor in the village of Loliondo has concocted something which has stirred a great deal of excitement, as would any substance promising to cure diabetes, tuberculosis and HIV. The ingredients are unknown, but the Tanzanian Drugs and Food Authority, the National Institute for Medical Research and the Muhimbili National Hospital endorse the herb as fit for human consumption. But there is no proof of its efficacy. No matter: people with HIV are flocking there by the thousands, some persons literally dying to get there. The Tanzanian authorities are struggling to convince people to continue taking their drugs, and not succumb to the siren song of an HIV/AIDS cure. (It is always more pleasant to imagine an indigenous cure than deal with the reality of depending on products of foreign multinational pharmaceutical companies.) With all these pressures -- economic crises, natural disasters, rising new infections, strange cultural manifestations -- is it reasonable to expect the pool of those accessing HIV treatment to continue to expand? What is the plan B if the bubble bursts?

Scale up and follow up: the struggle to stay on AIDS treatment in Africa

Not so long ago, the number of HIV-positive persons in Africa who had access to antiretroviral drugs was painfully low. Through important initiatives such as the US President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis and Malaria, millions have been put on AIDS treatment in the past few years. Available graphs on treatment access show a healthy upward trajectory, flatter in some parts of the developing world, and steeper in others, but nevertheless going up. And up is good.

A recent report in the New York Times shows another side of the story. Getting people started on antiretroviral drugs is one thing, keeping them on the treatment is another. HIV treatment, as it currently stands, is lifelong. Once you start, there is no stopping: or rather, there is stopping, but with disasterous consequences for the health of individuals and potentially for the community (if expensive to treat resistant strains of HIV thereby emerge). But keeping people -- increasingly vast numbers of them -- from defaulting on their treatment is a tremendous challenge with many obstacles. It is hard to know how many are 'lost to follow up', but if it is as the report states (between 15-40%), then we are talking about millions.

The agencies that are to be praised for efforts to increase treatment access may also shoulder some of the blame for the current situation. For years, 'numbers of persons on treatment' were the stuff of progress reports, the ultimate marker of program success, and where efforts and funding were to be largely concentrated. The focus was not on keeping people on their treatment regimes. If hell is not to be paved with good intentions, attention is going to have to subtly shift, the causes of loss to follow-up will have to be thoroughly explored, and support will have to provide to those tracing treatment defaulters and coaxing them to take their drugs.

Two cheers for microbicides

This year's biggest success in HIV prevention research was undoubtedly the CAPRISA 004 study on pre-exposure prophylaxis (PrEP) microbicides gel for women. The unveiling of the study results at the recent International AIDS conference in Vienna made it the toast of the town and raised the spirits of HIV/AIDS researchers, policy-makers and advocates everywhere, given the sad string of serious pitfalls and setbacks -- scientific, economic, and political -- endured over the last years. Against that dismal backdrop, a gel that over a 30-month period, used before and after sex, protected women from getting HIV by 39% sounds like manna from heaven. Colleen Farrell over at the Bioethics Forum has a good brief description of the CAPRISA study and some of its implications and limitations.

However, even one assumes that the study results will be replicated and confirmed, it is still hard not to be somewhat pessimistic about the challenges of implementing this HIV prevention strategy in the field. On paper, it has fine feminist credentials: it is female-controlled way of preventing women from getting HIV from (all-too-often-wayward) men. In reality, there are bound to be challenges to adherence, when women are not repeatedly reminded to use the gel, and particularly if men dictate when sex occurs (not an hour from now, but now). This blogger does not personally have a vagina, but can imagine that inserting gel into it before and after sex is not a particularly erotic or pleasant experience, even if doing so might be lifesaving, particularly in high HIV-prevalence settings. (Fortunately pill and other forms of PrEP are currently being tested.) In addition, I am not sure anyone knows what the long-term health effects of intermittent use of antiretroviral drugs for HIV prevention purposes are, since this is (as Ferrell puts it) a new frontier. And we are not even talking yet about the usual problems of distributive justice in developing countries -- universal access to PrEP for safe sex purposes will be a long time coming, in countries where there is still no universal access for drugs for prevention of mother-to-child transmission or for antiretroviral treatment.

Of course, we already have a pretty vivid idea of what doing nothing in the face of the HIV/AIDS epidemic amounts to. Pessimism can and only should go so far. So researchers have to soldier on, even if they come up with interventions that provide spotty protection and whose implementation raises ethical problems right, left and center. CAPRISA 004 seems to have provided an important weapon for the long and ugly battle ahead.

Ethics, Zuma and the shield of culture

The controversy regarding President Zuma and his extramarital (and unprotected) sexual capers heated up significantly today. I was greeted this morning with the Cape Times headline: ZUMA DEFENDS LOVE CHILD. The growing media coverage, some speculative, provoked the President to react in the form of a press release. In the press release, the President decries the invasion of his privacy while admitting that he fathered a baby with Ms. Sonomo Khoza. Then he says something very strange:

I said during World AIDS Day that we must all take personal responsibility for our actions. I have done the necessary cultural imperatives in a situation of this nature, for example the formal acknowledgment of paternity and responsibility, including the payment of inhlawulo to the family.

That is certainly a new twist on the concept of personal responsibility. Translated into a new HIV prevention message, it runs something like this: when you have unprotected extramarital sex, and your sexual partner then has your child, do remember to pay compensation to the family. It's the right thing to do! This slogan should be all the rage on the international AIDS conference scene this year. Though perhaps a catchier version would be: clean up your fuck up. In a culturally appropriate way, of course.

Then the press release goes in an even murkier direction:

The media is also in essence questioning the right of the child to exist and fundamentally, her right to life. It is unfortunate that the matter has been handled in this way. I sincerely hope that the media will protect the rights of children.

When I read this, I couldn't get the image out of my mind of Arnold Schwarzenegger in Total Recall, in the scene where he picks up people and uses them as shields to protect himself from gunfire. In Zuma's case, he picks up a child (and its associated rights) in an attempt to shield himself from criticism: don't shoot the baby! In any case, the media has not focused on the right of the child to exist, if only because that boring issue does not sell papers. How the child came to exist is far more interesting.

The press release includes a statement about the possible impact of this revelation to HIV prevention efforts. The President assures us that intensified efforts in prevention, treatment and research will continue. The idea that his personal behavior could act as a template of rationalization for sexual waywardness in local communities ... that does not come into play. Nor his obvious personal dislike of condoms that he and his government promotes. Now you could argue that President Clinton had his affairs, so why shouldn't Zuma be allowed his Presidential flings? One answer is: that Clinton was not allowed, he was nearly impeached, besides being roasted in the press. But the better answer is: Clinton's actions did not take place during a heterosexually-driven HIV epidemic responsible for hundreds of lives every single day.

South African presidents and HIV prevention: the madness never stops

Former South African president Thabo Mbeki famously denied that HIV causes AIDS, and affirmed that the HIV/AIDS epidemic was really just a ploy by pharmaceutical companies to squeeze money out of African countries. He supported 'rogue scientists' who tried to support this unorthodox view with scientific evidence, though the larger scientific community was profoundly unimpressed. When it became obvious that his position on the subject was untenable, he kept hush on the whole epidemic, while sending out his minions to discretely and not-so-discretely enact his viewpoint in health policy. It led to lukewarm HIV prevention efforts, right when a real show of force and determination was needed to save lives. There are still calls, in some quarters of South African society, for Mbeki to stand trial for this episode.

When Jacob Zuma came to power, there were misgivings. Here was a man who was accused (and eventually acquitted) of rape, and who during the trial affirmed that he had unprotected extramarital sex with a HIV-positive woman, and in addition, believed that a post-coital shower was sufficient to protect himself from the virus. It was not looking good. However, President Zuma did seem to take a more progressive stance on HIV/AIDS than his predecessor in the first year of office. There seemed to be more committment in regard to provision of anti-retroviral treatment and HIV prevention campaigns.

And now this. The news this week is that President Zuma has recently fathered a 'love child' with the daughter of the owner of the Orlando Pirates, a local professional soccer team. From which one can reasonably gather, another case of unprotected extramarital sex -- from a man with three wives, one fiance and 20 children already.

I was listening on the radio today to various condemnations and defenses of the president. The condemnations were predictable, and so were some of the defenses (especially opportunistic appeals to cultural relativism). But one defense struck me: that the sexual behavior of the president will not have an effect on HIV prevention in the country, because studies have shown that a person's sexual behavior is more likely to be influenced by his or her own peers than by his or her president. No need to worry.

Perhaps that is true, though more research is needed. What seems true is that South Africa is back to failed leadership again, in the most personal way: the president apparently cannot restrict himself to only five sexual partners, and when he breaks out, he can't locate a condom dispenser. And when he is sitting there at the next World Aids conference, with his red ribbon on, promoting the use of condoms, what are we supposed to think?

Ugandan government takes dead aim at HIV positive gays

Many Africans seem to believe that men having sex with men, or women having sex with women, is unAfrican. It is as if such sexual behavior never took place on the continent during its very long history, and if it has appeared recently, this is due to external, non-African influences -- as if it were a new fashion craze helicoptered in from San Francisco. In this way, gays in Africa are doubly marginalized: they not only deviate from heterosexual norms, they aren't 'real Africans.' And being stripped of cultural identity is often a prelude to (and justification for) exclusion, humiliation or physical violence. Not everyone in Africa sees things this way, of course, but it is a real and strong tendency.

The tendency is strongly manifest in a provisional bill ("The Anti-Homosexuality Bill") currently being proposed and discussed by the Ugandan government. There already are anti-homosexual laws in Uganda, harking back to colonial times, but members of the government are seeking to beef them up, and how. Among its provisions, single gay sex acts could be punished by life sentences; repeated gay sex acts could lead to the death penalty; gays who test HIV positive could be executed; members of organizations who engage in the 'promotion of homosexuality' (i.e. gay rights groups) would be outlawed; even an attempt to commit a homosexual act would be considered a felony and a conviction would lead to a seven year prison sentence.

The proposal bill is worth reading in the original. It starts off with a number of unargued assertions: that homosexuality is not innate (hence mutable, or 'curable'), and that the bill aims to protect the traditional family values of Ugandans, apparently under serious threat by sexual rights activists hell bent on imposing their agenda of promiscuity and adoption of children by gay couples. One of the last provisions in the proposed bill is aimed to deflect any and all criticism from a human rights point of view: "Any International legal instrument whose provisions are contradictory to the spirit and provisions enshrined in this Act, are null and void to the extent of their inconsistency." A lot like saying: this is the way we intend to treat our gay Ugandan citizens, and outsiders, if they don't like it, can go to straight to hell. Highly reminiscent of Zimbabwean president Robert Mugabe's old trick: use a lot of nationalist and anti-colonial rhetoric against outsiders to justify abuses on the enemies within.

Ugandan government officials generally don't mind listening to right-wing religious groups from the United States (or taking their money) as long as the latter says what the former wants to hear or already believes in. But US anti-gay groups are pulling back (a bit) from this one publicly, even if they are happy with its spirit of the proposed laws. The Ugandans, it seems, are on their own. Or maybe not. Given the extent of gay hatred on the continent, the bill if approved could function as a template for similar legislation in neighboring countries. So it is important to see how this situation evolves.

It is also important from the perspective of HIV prevention. Plenty of men have sex with men in Africa, if you bother to look closely enough, and these men have a disproportionally higher incidence of HIV. Reaching this population with HIV prevention messages and strategies is already difficult enough, without laws that treat them as sub-human.