Informed consent in microbicides testing

Friedland, Barbara; Magwaza, Sphindile; Coetzee, Nicol; McGrory, Elizabeth

doi:10.1097/00002030-200102001-00091

Cited by 2 publications

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“…Microbicide research has stimulated additional discussion and work on the definition and evaluation of informed consent. This work highlights the challenges of conducting complex clinical trials among vulnerable populations (32).…”

Section: Ethical Considerations For Research On Hiv/std Prevention Technologiesmentioning

confidence: 99%

Female Condoms and Microbicides

Esu-Williams¹,

Blanchard²

AIDS in Africa

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Prevention of HIV infection is a key component in the global response to the AIDS epidemic. This is particularly true in Africa where infection rates are still rising, and access to treatment and care for infected individuals is likely to remain limited to the wealthy for some time to come. In Africa in particular, and increasingly around the world, women are becoming infected with HIV at higher rates than men. This is due, in large part, to the fact that current strategies to prevent HIV and other sexually transmitted diseases (STDs) do not work or are not appropriate for many women. There are four a Horizons is an HIV/AIDS operations research program supported by the United States Agency for International Development.

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Section: Ethical Considerations For Research On Hiv/std Prevention Technologiesmentioning

confidence: 99%

Female Condoms and Microbicides

Esu-Williams¹,

Blanchard²

AIDS in Africa

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Microbicide trials for preventing HIV/AIDS in South Africa: Phase II trial participants' experiences and psychological needs

Pistorius¹,

Wijgert²,

Sebola³

et al. 2004

SAHARA-J: Journal of Social Aspects of HIV/AIDS

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The Microbicide Division of the Department of Medical Microbiology at MEDUNSA, South Africa, recently completed a phase II expanded safety trial of the candidate microbicide Carraguard. A microbicide is a vaginal product that women might use, if proven safe and effective, to protect themselves from HIV and possibly other sexually transmitted infections (STIs). The study participants were from Ga-Rankuwa and its neighbouring areas, an historically disadvantaged residential township near Pretoria. We conducted six focus group discussions with phase II trial participants to evaluate their experiences with trial participation and their psychological needs. Participants spontaneously talked about their experiences with the study gel and speculum examinations. They felt that they had received high quality medical care. They indicated that their personal hygiene and knowledge of the female reproductive system, HIV and other STIs had improved, which helped their familie and empowered them as women. Participants valued being able to discuss their anxiety about HIV/AIDS wit study staff. They felt that the study provided them with a supportive environment in which their personal problems (not necessarily restricted to HIV/AIDS) could be addressed. Some recommended that the study staf improve their professionalism and punctuality. They suggested the formation of participant support groups, an expressed a preference to remain involved in the trial. Some participants appeared to have become dependent o services provided during the trial. We have taken the results of these focus group discussions into account during planning for a phase III efficacy trial of Carraguard to be conducted in the same and other similar communities.

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Informed consent in microbicides testing

Cited by 2 publications

References 0 publications

Female Condoms and Microbicides

Female Condoms and Microbicides

Microbicide trials for preventing HIV/AIDS in South Africa: Phase II trial participants' experiences and psychological needs

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