Ethical Challenges: Microbicide Trials

From our blogger-scholar friend Sean Philpott. He is the Policy and Ethics Director of the Global Campaign for Microbicides, a broad-based, international effort to build support among policymakers, opinion leaders, and the general public for increased investment into microbicides and other user-controlled prevention methods. Dr. Philpott shares his thoughts on the recent microbicides trials:

Interventional studies designed to test new methods of preventing HIV transmission, such as microbicides, present a variety of ethical challenges. Researchers must ensure that locally acceptable means of preventing HIV and other STDs are available to all people who are screened or enrolled. Researchers also have a moral responsibility to ensure access to high quality care to all participants who seroconvert during the course of a trial.

When an prevention trial fails, as recently happened with Phase III trials of the candidate microbicide Cellulose Sulfate (Ushercell), researchers and trial sponsors are often accused of treating volunteers as guinea pigs. Worse yet, researchers may have to combat such rumors as the long-lived myth that participants are encouraged to have unprotected sex or deliberately exposed to HIV. At least two South African politicians have suggested precisely that. If anything, however, these two microbicide trials appear to be models of how transnational HIV prevention research should be conducted, through transparency and prioritization of participants’ rights.

In the CONRAD-sponsored Ushercell trial, 35 of 1,333 participants in both the experimental and the control groups seroconverted before the trial was discontinued. The rate of seroconversion was no greater than expected for at-risk women in these countries (48% of South African volunteers were found to already be HIV positive). There was, however, a slight increase in the rate of seroconversion in the experimental group. Although not statistically significant, researchers decided to stop the trial out of concern that Ushercell might increase risk of HIV infection. A second study, conducted at two sites in Nigeria by Family Health International, was also halted even though there was no evidence of increased risk. In all HIV prevention trials some volunteers will become infected despite the intensive counseling and support services they receive to help minimize their risk.

Contrary to what is being claimed by some politicians and journalists, however all study participants went through comprehensive informed consent procedures in their own languages, with key messages reinforced at every visit (including the fact that they should not count on the gel for protection and should always use condoms). All participants received monthly counseling, free condoms, and prompt diagnosis and treatment for any curable STIs. Trial sponsors also developed written agreements with local providers to assure that any women who seroconverted would get care, including antiretroviral drugs as needed; the CONRAD trial included a ”set-aside” in the research budget to support long-term care and treatment for participants.

Although disappointed by the results, leading microbicide and community activists like the Global Campaign for Microbicides and the African Microbicide Advocacy Group (AMAG) have been unanimous in their support of the Ushercell researchers, and continued microbicide research. These groups have been following the conduct of these studies, and have been directly engaged in the design, oversight and review of these and other microbicide trials.

The Campaign and AMAG have also been a resource for those seeking answers from site investigators, sponsors, microbicide experts and information publicly available about the trials at http://www.global-campaign.org/cellulose-sulfate.htm).