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Introduction
Pages 27-36

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From page 27...
... Key methodological challenges include the lack of a surrogate marker for HIV infection, the choice of a control group and type of trial design, the loss of study power due to lower than expected incidence rates and higher than expected pregnancy rates, high rates of participant attrition, suboptimal adherence among participants to the product being tested, and challenges in measuring participants' adherence to the product and risk behavior. Although not discussed in this report, trials also face major ethical and regulatory challenges.
From page 28...
... countries to approve products, and complex requirements for licensing products with multiple active compounds -- further complicate biomedical prevention trials. These challenges underscore the need for well-conceived and conducted late-stage intervention trials of biomedical HIV preventive interventions, using the best available methodologies, that can identify different (combinations of)
From page 29...
... Issues to be addressed include but are not limited to • loss of study power through lower-than-expected incidence and high pregnancy rates, • other design considerations such as choice of endpoints and control groups, • methods for monitoring the interim results of trials (including adjustments to trial size and duration) , • pooling of data from trials testing the same product, • methods for improving adherence to study regimens and the quality of self-reported behavioral data, and • optimizing retention of trial participants.
From page 30...
... Issues to be addressed include but are not limited to loss of study power through lower-than-expected incidence and high pregnancy rates, other design considerations such as choice of endpoints and control groups, methods for monitoring the interim results of trials (including adjustments to trial size/duration) , pooling of data from trials testing the same product, methods for improving adherence to study regimens and the quality of self-reported behavioral data, and optimizing retention of trial participants.
From page 31...
... Ideally, substantial evidence from basic research and animal models on an intervention's potential for preventing HIV transmission would be available before initiation of late-stage clinical trials. Although the committee did not assess the biological plausibility or implausibility of various biomedical prevention interventions, it believes that funders and investigators need to carefully consider biological plausibility during preclinical testing and when prioritizing interventions.
From page 32...
... This underscores the need for multidisciplinary research expertise, including a strong behavioral and social science component, in designing, conducting, and analyzing clinical trials, to ensure that they are feasible, ethical, relevant, and efficient. • Although biomedical HIV prevention trials must provide risk reduction counseling to all participants, these trials are typically not designed to evaluate the effectiveness of the behavioral risk reduction intervention(s)
From page 33...
... • Finally, although this report focuses specifically on non-vaccine biomedical HIV prevention interventions, a comprehensive approach to prevention is needed to control the HIV pandemic. Components of such an approach include effective behavioral and biomedical HIV prevention interventions, widespread access to treatment, destigmatization of HIV, care for vulnerable populations, policy environments supportive of change, and structural interventions targeting poverty, gender equity, nutritional status, living conditions, education, and health care infrastructure in developing countries.
From page 34...
... Chapter 9 discusses the importance of interim monitoring of trial results and best practices for analyzing interim and well as final results. In conclusion, Chapter 10 proposes alternative study designs that can sometimes offer advantages over the current two-arm superiority design used in most biomedical HIV prevention trials.
From page 35...
... Social Science and Medicine 50(4)


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