Another trial of tenofovir as pre-exposure prophylaxis to prevent HIV infection has run into trouble on ethical grounds, this time in Thailand.
The Thai Drug Users’ Network (TDN) and other AIDS advocacy organizations are protesting against the design of a study of tenofovir pre-exposure prophylaxis that is planned to recruit 1600 injecting drug users in Thailand..
The multi-site trial, though with different sponsors, has already been suspended in Cambodia and Cameroon after target group communities expressed similar concerns over community involvement and unethical trial practices.
“Yet again, we drug users are treated as less than human, not worth the same basic dignity and rights as others. Even though the researchers know Thai IDU are at high risk for HIV, they refuse to provide clean injecting equipment in the context of this trial despite using a placebo,” said Paisan Suwannawong, Director of the Thai AIDS Treatment Action Group (TTAG).
TDN and allies are concerned that the same standards are not being followed in Thailand as in other countries where a similar trial is being held. “In the African sites, condoms are offered as a matter of course to the trial participants, who are chosen for their high-risk sexual behavior.”
TDN is also concerned over the standard of care provided in the trial. In a violent drug war started in 2003, people involved with drugs were subjected to numerous human rights violations which pushed them underground and away from essential services, and resulted in nearly 3,000 extra-judicial executions that remain largely uninvestigated.
“Thailand has no harm reduction policy, and drug users are routinely denied care, including anti-retroviral therapy, or made to quit drugs first,” said Seree Jintakanon, chairman of TDN. “Virtually none of the nearly 50,000 people on ARV in Thailand are injecting drug users, yet now we are made to believe that IDU will receive the highest standard of care in this trial. For people who seroconvert during the trial, or are screened out because of their HIV at the start of the trial, we have no evidence that they will receive appropriate care.”
Trial participants will be recruited at their point of service, methadone clinics. The protesters are concerned that this will result in coercion to participate in the trial. Nantapol Cheunchooklin, who was a trial participant in an earlier vaccine trial among IDU in Bangkok, remembers, “I was afraid that if I refused being recruited in the trial, I might displease the clinic staff or that it would have a negative consequence on the methadone I was receiving.”
Earlier this month, TDN and several other AIDS advocacy organizations, using the self-appointed umbrella name, the “Thai Tenofovir Community Working Group,” asked UNAIDS to intervene to try and postpone the commencement of the trial in order to have real community dialogue, mechanisms for involvement, and resolutions of perceived trial design problems. “We 100% support research into new and better options for HIV prevention. But, tenofovir, which would have to be taken every day for the rest of one’s life, costs nearly US$500/month. Trial participants would only get it free for one year. We are not hopeful that this method of prevention would be available for IDU or for ANY Thai person for that matter, ever. If IDU and PLWHA were invited to be part of the process from the beginning, however, we might have negotiated better post-trial access,” said Mr. Jintakanon.