In-depth: Trials and Tribulations of HIV Prevention Research

SOUTH AFRICA: Clarity sought in microbicides furore

Photo: Zanele Muholi/One in Nine Campaign
Are communities adequately represented in clinical trials?
Johannesburg, 7 February 2007 (PlusNews) - Confusion has erupted over the safety of the microbicide trials, which were halted after preliminary results showed the proposed prophylactic could increase the risk of HIV infection.

South African health minister Manto Tshabalala-Msimang has ordered a probe into the trials involving just over 600 women in KwaZulu-Natal Province, who were part of research being carried out on the microbicide candidate, Ushercell, in Benin (West Africa), India, South Africa and Uganda.

Last week, the US reproductive health research organisation, CONRAD, announced that it would discontinue the trials.

Microbicides include a range of products - such as gels, films and sponges - that could help prevent the transmission of HIV and other sexually transmitted infections. No microbicide has yet been shown to be effective.

There has been public outrage over the latest development, heightened by sensational media coverage depicting the women as 'guinea pigs', alleging that participants in microbicide trials were encouraged to visit bars and other similar places of entertainment, and engage in unprotected sex.

The Medical Research Council (MRC), which led the study, has dismissed the inaccurate media reports, saying its HIV prevention clinical trials were conducted with prior approval of the Biomedical Research Ethics Committee of the University of KwaZulu-Natal.

"As per our [MRC's] memorandum of understanding with participants as well as the Ministry of Health, participants are assisted by MRC researchers in understanding the possible health benefits and risks in trials such as this," the principal MRC investigator in the Ushercell trials, Dr Roshini Govinden, told IRIN PlusNews.

Citing ethical concerns, Tshabalala-Msimang said in a statement: "While we support innovation through health research, the government of South Africa is determined to ensure that the health of our people is not compromised in the process."

The minister has instructed the National Health Research Ethics Council to establish whether prospective participants were given sufficient information to make informed decisions about taking part.

In the past few years, other trials have raised concerns over the treatment of African volunteers: in 2004, a series of articles by news agency Associated Press claimed that American health authorities had covered up information about the potentially negative effects of Nevirapine and alleged there were flaws in the Ugandan study that assessed its safety and efficacy.

South Africa's ruling party, the African National Congress (ANC), subsequently accused American health officials and local AIDS activists of "a conspiracy with a pharmaceutical company to tell lies to promote the sales of Nevirapine", and using Africans as guinea pigs.

In 2005, West African trials of an antiretroviral drug called tenofovir (used in HIV treatment) were terminated after disputes between the researchers and activists over how the trials were being conducted.

ARE COMMUNITIES INVOLVED?

Dawn Cavanagh, a microbicide activist, is sceptical about the outcry over the microbicide trials, as there was little public interest in research into microbicides in South Africa before this week's media coverage.

"Hopefully, all the outrage will be translated into energy and activism, and more people will become involved," she commented, because community participation in current microbicide research has largely consisted of "tokenism".

The MRC's Govinden pointed out: "Although no formal community advisory group had been established, due the size of the research area, partnerships in HIV prevention clinical trials is vital, and community stakeholders were engaged and involved in the research process from inception ... with regular updates on the progress of the trials."

Cavanagh, who works for a local NGO, the Forum for the Empowerment of Women, and has been educating women about microbicides, questioned the systems put in place to ensure that communities were involved in trials.

Most local support mechanisms are not adequately empowered and lack autonomy, having been set up by research agencies. "How can ordinary grassroots people, who have not been exposed to this level of research discourse, be expected to engage [with researchers] as equals?"

Existing standards and guidelines on how to include communities in microbicide research were "not even being properly met", she warned. The public, activists and communities, had also failed. "We failed to stay on top of things, expecting someone else to monitor this," she admitted.

According to Cavanagh, researchers could not afford to leave communities behind in their bid to create an effective HIV prevention method for women.
"Without genuine participation from women in this research process, nobody will use them (microbicides)."

Meanwhile, microbicide trials continue around the globe, and the MRC has successfully recalled 250 Ushercell samples from the trial's respondents.

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