Presentation on theme: "The Tenofovir Trial in Cambodia In 2004 a randomized trial by investigators from the United States and Australia was planned to assess the safety and efficacy."— Presentation transcript:
The Tenofovir Trial in Cambodia In 2004 a randomized trial by investigators from the United States and Australia was planned to assess the safety and efficacy of Tenofovir as pre exposure prophylaxis for HIV in HIV negative female sex workers in Cambodia. The trial was to recruit 960 women but in July 2004 protests led by sex workers in Cambodia and activists at the XV International AIDS Society conference in Bangkok, brought worldwide media attention to claims that the trial was unethical in several ways. Lack of ongoing health care for participants was a particular focus. As a result of the protests the Cambodian Prime Minister closed the trial early, 400 participants had been recruited.
Everyone agrees that … Trial volunteers who are recruited because they are seen as likely to practice a particular risk behaviour should receive the best proven measures to help them reduce their risk of acquiring HIV infection from that behaviour BUT What are the best proven HIV prevention measures ? Were they already in place in Cambodia - and if not why not ? If they are in place does it mean the researchers don’t have to provide anything extra ? Informed Consent should be obtained from every participant. BUT What is informed consent ?
“ We were told that we can contribute to saving humanity, why should we do that, what has humanity done for us ? … sold us…discriminated against us …raped us…kept us powerless. Humanity has denied our humanity, why are we asked to contribute. ” There are HUMAN RIGHTS in the USA, how about ours in CAMBODIA? Violations of sex workers human rights : potholes on the road to a vaccine ?
Listening for Researchers “ I am not worried about HIV.I use condoms. What if my arm drops off or I have a kid with two heads ? So you will encourage condom use, even provide them, but to get results you need us to have unprotected sex ….run that by me again What is being done to give HIV + sex workers access to what all HIV citizens are already entitled to ? You turned up to talk to us with the very people that run other corrupt, violent abusive HIV programs here - 100% CUP and “rescues” of alleged trafficking victims - why would we trust you ? ” The 100% Condom use program - HIV prevention for sex workers in Cambodia ?
The key questions Should people that become HIV infected while enrolled in a trial as a result of risky behaviour or exposures that they cannot avoid should HIV treatment be provided. If so, at what level, for how long ? If trial participants are physically harmed by the product being tested should they receive care and compensation? Through what process ? If the product is proved effective should trial participants or their communities receive that product even if their government or health insurer won’t pay for it ?
Community People were arguing about different things, all of them with broader implications for health research. One issue is the ambiguous definition of the word “community.” Is it people enrolling in a trial, the surrounding population, NGOs in the region or nation, activists 4000 miles away? How are all those voices to be heard and responded to in a meaningful way? AIDS VACCINE ADVOCACY COALITION
Recommendations Better coordination between the disparate trials their multiple sponsors, trial participants and their communities Protections and benefits for trial participants at all trial sites that include treatment for HIV infection high quality prevention interventions compensation for physical harm caused by participation in research. Capacity building for researchers, trial sponsors and sex worker communities to build understanding of the issues Renewed systems for ethical approval and monitoring of trials.