Methodological Challenges in Biomedical HIV Prevention Trials (2008) / Chapter Skim
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3 Design Considerations: Risk-Reduction Counseling
3 Design Considerations: Risk-Reduction Counseling
Pages 88-103
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From page 88... ...
Two main reasons are the uncertainties about the effectiveness of specific behavioral interventions in reducing HIV infection risk in areas where many HIV prevention trials are conducted, and the uncertainties associated with adapting behavioral interventions that have been shown to reduce risky behaviors or specific sexually transmitted infections (STIs) from one geographical or cultural setting to another.
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From page 89... ...
First, they argue that investigators must attempt to counterbalance any increased risk that participants will become HIV infected owing to disinhibition: that is, that they may engage in more risky behavior if they erroneously believe they are protected by the test intervention. Thus the duty to minimize risks in clinical trials dictates that investigators provide counseling on methods to prevent HIV infection (Lie et al., 2006)
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From page 90... ...
Finally, there is uncertainty about the effectiveness of behavioral intervention strategies in reducing the risk of HIV infection. The next section reviews the evidence on the effectiveness of behavioral risk-reduction interventions in reducing risk behaviors, with an emphasis on sexual behaviors, the incidence of STIs, and incidence of HIV infection.
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From page 91... ...
The investigators found no evidence that more intensive VCT (rapid testing and counseling provided onsite) reduced HIV infection rates compared with standard VCT (providing participants with prepaid vouchers for use with an external provider)
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From page 92... ...
Lyles and colleagues (2007) recently conducted a systematic review of randomized and nonrandomized U.S.-based research from 2000 to 2004 on behavioral risk-reduction interventions, to identify those with the best evidence of efficacy in reducing HIV risk behaviors.
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From page 93... ...
(2004) conducted a randomized comparison of an intervention emphasizing ethnic and gender pride, HIV knowledge, communication, condom skills, and healthy relationships with a control emphasizing exercise and nutrition in 522 sexually experienced African American girls aged 14 to 18 in the U.S.
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From page 94... ...
. Several behavioral intervention HIV prevention trials done outside the United States were designed and powered to assess HIV infection as an endpoint.
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From page 95... ...
First, the National Institute of Mental Health (NIMH) Collaborative HIV/STD Prevention Trial is a community-level HIV prevention intervention study conducted in international settings, using behavioral outcomes and HIV infection as the primary study endpoints.
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From page 96... ...
. A number of studies have adapted behavioral HIV risk-reduction interventions shown to be efficacious in developed countries to developing country settings.
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From page 97... ...
Evaluating Behavioral Risk-Reduction Interventions in the Context of a Biomedical Intervention Trial If definitive evidence on the effectiveness of behavioral risk-reduction interventions in settings where biomedical HIV prevention trials are planned were to become available, investigators would face questions on the cost and sustainability of integrating behavioral risk-reduction interventions into such trials. Unfortunately, as noted, researchers face considerable uncertainty about which behavioral risk-reduction interventions are most effective in many settings where biomedical HIV prevention trials occur.
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From page 98... ...
• Can the trial ethically limit the counseling in a control group to the level already (nominally) provided in a particular community, when more intensive behavioral interventions have not been shown to be effective in reducing HIV infection risk in that context?
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From page 99... ...
SUMMARY In late-stage HIV prevention trials of biomedical interventions, investigators and donors also have an excellent and unique opportunity to evaluate and compare different behavioral risk-reduction interventions as part of the trial's research objectives (see Chapter 10 for specific study designs)
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From page 100... ...
2007. The efficacy of behavioral interventions in reducing HIV risk sex behaviors and incident sexually transmitted disease in black and Hispanic sexually transmitted disease clinic patients in the United States: A meta-analytic review.
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2005. A meta-analytic review of HIV behavioral interventions for reducing sexual risk behavior of men who have sex with men.
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From page 102... ...
2007. Ethical considerations in biomedical HIV prevention trials.
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From page 103... ...
2004. A randomized controlled trial to reduce HIV transmission risk behaviors and sexually transmitted diseases among women living with HIV: The WILLOW program.
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