DESCRIPTION (provided by applicant): New HIV prevention methods such as oral pre-exposure prophylaxis (PrEP) may soon be approved for HIV prevention if current clinical trials confirm their effectiveness and safety. Risk compensation among future users is a major concern, as it could seriously undermine the potential public health impact of PrEP once rolled out. Currently risk compensation has only been assessed in clinical trials designed to evaluate the effectiveness of PrEP. But clinical trial data on risk compensation alone is not sufficient to guide PrEP planning given those data are collected in situations of optimal counseling, and where the potential for socially desirable answers is enhanced. The unknown effectiveness of the study drug and the presence of a placebo arm are also substantial threats to data validity. Research outside the clinical trial environment is needed to adequately prepare for PrEP rollout. Conducting the proposed research now, before PrEP is approved for HIV prevention, allows for a quick response to PrEP rollout if current trials demonstrate the effectiveness and safety of PrEP. The proposed research includes three aims and is investigated in two phases. Each phase uses a different methodology but is linked together by an underlying conceptual model - the Information, Motivation, and Behavioral (IMB) Framework. In Phase 1, after hearing messages about PrEP, 600 women from two sites in sub-Saharan Africa - Bondo, Kenya and Pretoria, South Africa - will be randomized to receive one of two factorial-type surveys. Each survey will use the same realistic vignettes, but will vary by PrEP context based on study arm - the participant in vignette taking PrEP or participant in vignette not taking PrEP. Survey data will be used to address Aims 1 and 2 of the research: 1) to assess the effect that the availability of PrEP will have on sexual risk decisions among women at higher risk for HIV infection, and 2) to identify demographic and behavioral correlates of women who are most likely to increase their sexual risk behavior when using PrEP. Phase 2 of the proposed research will address Aim 3, which is to develop risk-reduction counseling guidelines for women who are most likely to increase their sexual risk behavior when using PrEP. In-depth interviews (IDIs) will be conducted with 30 women per site who meet this criterion (as identified from survey data) as well as up to 3 counselors per site. Data from these interviews, as well as survey data, will be used to create risk-reduction counseling guidelines within an IMB framework. Guidelines will include key messages, questions to stimulate discussion on perception of risk, questions to identify those mostly likely to exhibit risk compensation, and behavior skills needed to minimize risk compensation. PUBLIC HEALTH RELEVANCE: Antiretroviral-based products such as oral pre-exposure prophylaxis (PrEP) can have a major public health impact in preventing new HIV infections, but risk compensation can drastically reduce its benefit. Current data on risk compensation from clinical trials are insufficient at predicting risk compensation outside of the clinical trial setting given the artificiality of the clinical trial environment. To maximize the benefit of PrEP once it is rolled out to the public, the proposed research will assess the effect that the availability of PrEP will have on sexual risk decisions among women at higher risk for HIV infection outside of the clinical trial environment. The study outcome will be risk-reduction counseling guidelines for women who are most likely to increase their sexual risk behavior when using PrEP.

Antiretroviral-based products such as oral pre-exposure prophylaxis (PrEP) can have a major public health impact in preventing new HIV infections, but risk compensation can drastically reduce its benefit. Current data on risk compensation from clinical trials are insufficient at predicting risk compensation outside of the clinical trial setting given the artificiality of the clinical trial environment. To maximize the benefit of PrEP once it is rolled out to the public, the proposed research will assess the effect that the availability of PrEP will have on sexual risk decisions among women at higher risk for HIV infection outside of the clinical trial environment. The study outcome will be risk-reduction counseling guidelines for women who are most likely to increase their sexual risk behavior when using PrEP.