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PrEP: Roadmap to the Real World

Establishing the Real-World Effectiveness of PrEP Through Demonstration Projects

August 2011

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Unanswered Questions

We believe that the results of iPrEx, along with the recent CDC incidence data, call for moving ahead immediately with demonstration projects to study the implementation of PrEP primarily for G/MSM and transgender women in the United States. As promising as PrEP may be, significant questions remain unanswered, chief among them being whether the efficacy that was demonstrated within the confines of a clinical trial -- where people were not certain whether they were taking drug or placebo, were told that the safety and efficacy of PrEP was unknown, and in which they received extensive monitoring and support -- can be translated into effectiveness in practice. Such clinical translation efforts are not unique to PrEP and can be expected with the introduction of any new biomedical advance for any disease. But, in particular, this translation effort is needed now in order to achieve the public health benefit for which PrEP is so promisingly suited -- progress in reducing HIV infections as directed by the National HIV/AIDS Strategy.6

There are other promising prevention options still under investigation, including the potential benefits of scaling up testing and early care and treatment (TLC+) for people found to be HIVpositive, the possibility of both vaginal and rectal microbicides, and development of an AIDS vaccine. It will take significant time and resources to validate and scale up these interventions, even in the United States. Moreover, none of these approaches -- nor PrEP -- will be sufficient on their own to completely halt new infections; those at risk for HIV need a range of options. It is the comprehensive nature of these multiple options that urges us forward to improve our understanding of the roles this new intervention may play.

We must, therefore, understand as quickly as possible who will benefit most from PrEP, and how best to provide it in an effective, safe, sustainable, and cost-effective manner.

To facilitate and maximize our ability to answer these questions through demonstration projects, it is also important to support the FDA review and potential approval of a prevention indication for TDF/FTC, so that marketing of these drugs for this new prevention use is conducted and monitored in a responsible fashion that complements and serves to support further implementation studies.

Designing the Demonstration Projects

Over and above the key research questions that must be addressed by the demonstration projects, which are detailed below, there is a set of overarching issues that we hope researchers, funders, and other stakeholders take into account:

PrEP Project Participants

As the recent CDC statistics make clear, there are no communities in the United States more urgently in need of effective new prevention options than African American and Latino G/MSM. Moreover, other studies have documented the exceptionally high rates of new HIV infections in transgender females.7 There are also geographic areas that have been particularly hard hit by the epidemic. As such, every effort should be made to ensure that demonstration projects are prioritized in these communities and populations and that the projects are able to document the effects of race, ethnicity, primary language, and health literacy on effectiveness.

Project Venues

Ideally, demonstration projects should evaluate offering PrEP in the types of venues where people most likely to benefit from this intervention are also most likely to obtain sexual health services after a demonstration project concludes. This will be especially critical in regions where an infrastructure for sexual health services is weak or nonexistent, and should take into account the social, language, and practical needs of potential PrEP users. These include publicly funded neighborhood health and sexually transmitted infection (STI) clinics, mobile HIV and/or STI testing services or local community-based organizations (each with links to medical providers), and clinics within hospitals and academic settings. The selection of research sites should emphasize health care service providers that can sustainably continue offering (either solely or through strong partnerships) the full roster of HIV prevention services, including HIV and STI testing and treatment, condom and lube provision, and HIV counseling and behavioral interventions.

Coordination of Data Selection and Collection

It is critical that a single entity is identified that can assure sufficient coordination of PrEP demonstration projects to guarantee that certain core data are collected across all of the projects and that can be compared over time. Also, the leaders of the various demonstration projects should come together regularly to share their experiences and their data.

Community Engagement

International research principles and ethics demand that people who are to be the participants in research should ideally be involved in every step of the research process in some manner. This ensures that the research is ethical and that informed consent is meaningful to a range of participant concerns. It has also been demonstrated in a number of cases to improve the acceptability and conduct of such research. Given the marginalization of many at-risk individuals, the lack of culturally competent health services, and the stigma attached to seeking out HIV testing and care, it will be critical that members of those communities targeted for a PrEP intervention are consulted at every step of the process as laid out in the Good Participatory Practice Guidelines published by the Joint United Nations Programme on HIV/AIDS (UNAIDS) and AVAC.8

Resource Allocation

PrEP is emerging at a time of great economic hardship in the United States. HIV prevention budgets have been slashed at both state and federal levels, and there are currently more than 9,000 HIV-positive people on waiting lists for ARV medications covered by ADAP. As such, conversations must commence now, while the demonstration projects are in their formative stages, about how PrEP will fit into the overall package of prevention methods that we strive to make available to at-risk individuals and to HIV-positive individuals. Though the future of the Affordable Care Act is also uncertain, policy analysis should begin now to determine how the implementation of health care reform might alter the HIV prevention landscape, specifically in regards to PrEP.

What's more, we fully support the goal of the National HIV/AIDS Strategy to bring equitable care and treatment to all people living with HIV as well as prevention services to those who are at risk of becoming HIV infected. Some have begun to express concern that resources allocated for PrEP will potentially diminish those available to ensure access to treatment for all who chose it. We believe, however, that with sufficient advocacy on the part of the community and the support of all stakeholders, we can accomplish both treatment and prevention in the United States at levels sufficient to eventually end the epidemic.

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This article was provided by Project Inform. Visit Project Inform's website to find out more about their activities, publications and services.
See Also
More News and Research on HIV Medications for HIV Prevention

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