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Participating in Microbicide TrialsResearchers use multiple strategies to protect participants. |
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Since 1996, more than 20,000 women have participated in clinical trials to help identify a safe and effective vaginal microbicide. All of the women volunteered for the trials, knowing they were going to help answer a question about the safety, acceptability, and in some cases effectiveness of a study product. They agreed to return to their study sites every three months, or even monthly, to receive counseling, supplies of gel and condoms, and an HIV test. Study staff also made a commitment to the women. In their study protocols, counseling messages, and educational materials, the staff outlined how they would protect the safety, confidentiality, and human rights of each study participant. Their experiences have shown just how complex — and critical — that commitment can be. Truly informing women The women must understand that the researchers do not know whether the study product works, that a portion of the participants may be randomly assigned to use a placebo that contains no microbicide, and that all participants need to continue using condoms and other HIV-prevention measures throughout the study. Explaining technical terms and research concepts such as randomization and placebos to potential participants can be difficult. As a result, researchers have developed creative materials such as illustrated booklets, videos, and interactive computer-based educational programs to help explain them. Many trials also use a questionnaire to assess a woman's understanding of a study before she signs an informed consent form agreeing to participate in the study. However, researchers also recognize that informed consent should be a continuing process rather than a one-time event. In the two Phase III cellulose sulfate trials that have been conducted, for instance, the study staff administered this type of questionnaire both before and during the trials. Involving communities
These community representatives help ensure that the trials are designed and implemented in an acceptable, relevant, and ethical way. The representatives review study protocols and informed consent forms, evaluate draft educational materials, relay community concerns to the study staff, refute rumors, and help disseminate study results. Such community involvement generates support for microbicide research and reduces the likelihood that a woman will be stigmatized because of her participation in a trial. Ensuring access to care Funding for microbicide trials does not always include support for antiretroviral therapy (ART) or other services for people living with HIV. However, cost is not the only barrier to treatment. The complexity of ensuring continuity of care over a person's lifetime is also a challenge for research organizations conducting short-term studies. A 2006 study by the Global Campaign for Microbicides found that the standard of HIV care for participants who seroconvert during microbicide trials has varied. One trial set aside funds to support five years of ART for every woman who seroconverted during the trial. Others offered to enroll seroconverters into trials of ART regimens. Most referred the women to the closest source of HIV care, and many were able to establish written agreements with programs that provide free ART.1 A study by FHI suggests that such referrals are acceptable to study participants.2 The Global Campaign for Microbicides recommends that microbicide trials be conducted at or in partnership with local HIV care centers, and that researchers use their trials as opportunities to strengthen local standards of care for people living with HIV. References
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