Sample HIV Vaccine Research Education Presentation

CDC Interim Guidelines on PrEP

Dear Advocates,

Today the US Centers for Disease Control and Prevention issued interim guidance on pre-exposure prophylaxis (PrEP) as an HIV prevention strategy for gay men and other men who have sex with men (MSM). These interim guidelines address key considerations for health care providers considering daily oral TDF/FTC as PrEP for their MSM clients. With this interim guidance in place, US agencies and organizations should now move swiftly to design and implement demonstration projects in key high-incidence settings. These projects would gather additional needed data on PrEP for HIV prevention and lay the groundwork for eventual introduction of PrEP as an additional HIV prevention strategy.

This update summarizes some of the key points of the CDC interim guidance which includes this important statement: “PrEP has the potential to contribute to effective and safe HIV prevention for MSM if 1) it is targeted to MSM at high risk for HIV acquisition; 2) it is delivered as part of a comprehensive set of prevention services, including risk-reduction and PrEP medication adherence counseling, ready access to condoms, and diagnosis and treatment of sexually transmitted infections; and 3) it is accompanied by monitoring of HIV status, side effects, adherence, and risk behaviors at regular intervals.”

Advocates’ input is needed to map out next steps in the US and to discuss the relevance of these interim guidelines for other countries. We hope you will join us for a teleconference on “Translating PrEP Research into Practice”. The call will feature debate and discussion with brief remarks from key discussants on what needs to happen next to translate the iPrEx trial results outside of clinical trial settings. Please join us on Tuesday, February 8 from 10 to 11am US Eastern time (visit www.timeanddate.com to confirm the time in your area).

Click here to register for the call.

As we provide this update on an important biomedical advance, AVAC also offers condolences and steadfast support to Ugandan gays and lesbians who lost a leader and shining light with the brutal and senseless murder of David Kato. There will be no end to AIDS without an end to homophobia, stigmatization and human rights abuses worldwide.

Key statements in the MMWR include:

• 
  “Until the safety and efficacy of PrEP is determined in trials now under way with populations at high risk for HIV acquisition by other routes of transmission, PrEP should be considered only for MSM.” Details on other trials available here.
  
• 
  “The iPrEX trial results provide strong evidence that support for adherence to the prescribed medication regimen must be a routine component of any PrEP program.” The guidelines also specify the need for “PrEP medication adherence counseling” and the “support [of] PrEP medication at each follow-up visit, more often if inconsistent adherence is identified.”
  
• 
  PrEP is an HIV prevention intervention and should only be given to individuals who are HIV-negative. “To minimize the risk for drug resistance, PrEP should not be started in persons with signs or symptoms of acute viral infection unless HIV-uninfected status is confirmed by HIV RNA testing or a repeat antibody test performed after the viral syndrome resolves.” And guidelines indicate the need to “document negative HIV antibody test(s) immediately before starting PrEP medication.”
  
• 
  PrEP is not meant for everyone. The CDC’s interim guidance states, “For MSM whose behaviors place them at high risk for HIV infection and who do not use other effective prevention methods consistently, PrEP might reduce their risk for HIV infection.”
  
• 
  The effects of long-term use of TDF/FTC as PrEP is still unknown, so regular monitoring is critical. CDC notes, “Health-care providers and patients should be aware that HIV prevention is not a labeled indication for the use of Truvada and that its long-term safety in HIV-uninfected persons is not yet known. Health-care providers should report any serious adverse events resulting from prescribed TDF/FTC for PrEP to the Food and Drug Administration’s MedWatch.”
  

This teleconference is the first in a series of calls that AVAC has planned in the coming weeks and months. These calls will build on the current issue of Px Wire, which outlines some of the important questions and next steps in biomedical HIV prevention research.

Please join us! If you have any questions in advance, please send them to avac@avac.org.

Best,
AVAC

Advocate’s Guide to Statistical Terms

Source: AVAC (http://www.avac.org/ht/a/GetDocumentAction/i/4255)
No study can produce a simple “yes” or “no” on whether or not a product “worked”. To decipher the headlines and discussions regarding the data from this or any trial, it is useful to understand some statistical terms used to describe a trial result. For the MDP 301 study, the data analysis will include comparisons of rates of infections in participants enrolled in the PRO 2000 and placebo groups.

One key term is statistical significance. If a result is described as statistically significant, it means that an observed difference (for example, between two arms of a microbicide trial) is very likely due to the product itself and is not a coincidence. Significance is always given with a confidence level. A 95 percent confidence level, which is standard for many trials, means that there is at most a 5 percent likelihood of a statistically significant result having occurred solely by chance.

The trial team will also report on the confidence intervals associated with its findings. A confidence interval is a way of describing the reliability of the finding, which is given as a point estimate – such as a 35 percent reduction in risk of infection. The narrower the confidence interval around the point estimate, the more likely it is that the result is accurate and would be seen again if the trial was repeated.

This can all be confusing because all these values are inter-related, but to fully understand the strength of a result, one must know: (1) the point value; (2) whether or not the result is statistically significant; (3) the confidence level, which may be expressed as a percent (95% of more) or a p-value (.05 or less); and (4) the confidence interval.

Other terms that might be used in discussion of initial results are per-protocol (PP) and intent-to-treat (ITT) analyses of results. Per-protocol results only include infection that occurred in those participants who received the full intervention. With a user-controlled product, where use in a trial is measured through self-reporting, it is very difficult if not impossible to determine a per-protocol result. Intent-to-treat counts every infection after trial enrollment, regardless of whether a participant used the product, the placebo, or condoms. ITT is considered a gold standard because it considers every randomized participant. ITT analyses remove the risk that dropouts or subgroups may have unbalanced the two arms to any degree. In general, the safest route is to report both PP and ITT and to analyze any difference.

In a microbicide trial, an approximation of a “per protocol” result would be a sub-group analysis of participants who reported high gel use and low condom use. This is controversial in microbicide trials for several reasons: it is not known whether this group differs in other ways from the rest of the trial population (thereby undermining randomization); it is not clear how accurate the self reporting of gel and condom use is; and the numbers in any sub-group analysis are unlikely to be large enough to allow for a statistically significant result.

Advocates’ take-home message: No matter what the headlines say, a single number is not the full result.

PX Wire – January-March 2011

Source: AVAC (http://www.avac.org/ht/d/sp/a/GetDocumentAction/i/31966)
PX Wire is AVAC’s quarterly update on biomedical HIV prevention research. Each quarterly issue is posted on AVAC’s website (http://www.avac.org/ht/d/sp/i/346/pid/346) and can be viewed for free.

Grant Sources

During your partnership with NHVREI you have incorporated messages about HIV vaccine research within the overall HIV/AIDS education/prevention activities and programs of your organization. As you consider submitting future applications to CDC and other potential funders for other HIV/AIDS related projects, we hope that you will continue to include messages in support of HIV vaccine research as part of your sustainability efforts.

To assist you in identifying potential sources of funding for HIV/AIDS programs, we have included two essential links that will provide you with useful information on potential funders and federal grants that may or may not specifically support HIV/AIDS initiatives or educational efforts related to HIV vaccine research. We hope that this information will help you enhance your organizational capacity as you move forward in the fight of HIV/AIDS.

The Foundation Center is the leading source of information about philanthropy worldwide. Through data, analysis, and training, it connects people who want to change the world to the resources they need to succeed. The Center maintains the most comprehensive database on U.S. and, increasingly, global grantmakers and their grants — a robust, accessible knowledge bank for the sector. It also operates research, education, and training programs designed to advance knowledge of philanthropy at every level. Thousands of people visit the Center's web site http://foundationcenter.org/ each day and are served in its five regional library/learning centers and its network of 450 funding information centers located in public libraries, community foundations, and educational institutions nationwide and beyond.

Grants.gov is your source to FIND and APPLY for federal grants. The U.S. Department of Health and Human Services is the managing partner for Grants.gov, an initiative that is having an unparalleled impact on the grant community. Visit http://grants.gov/ to learn more about Grants.gov and determine if you are eligible for grant opportunities offered on this site.

Grant Writing Assistance

Online Grant-writing Tutorial - Offered by The National Minority AIDS Council Click on this link to access NMAC's grant-writing tutorial A grant-writing tutorial, geared primarily toward beginner proposal writers, is now available on the National Minority AIDS Council web site. The tutorial, which was developed as part of NMAC's cooperative agreement with the Health Resources and Services Administration HIV/AIDS Bureau contains information for responding to requests for grant proposals for HIV-related services. http://www.TGCIgrantproposals.com

Winning Grant Proposals Online - This new site from The Grantsmanship Center is a brand new resource designed to help nonprofit organizations and government agencies write better grant proposals and develop better programs. It provides a wealth of useful information, examples, and insights. You may also read, browse, or search the entire collection of over 600 proposal abstracts absolutely FREE! Of course, to actually READ the proposals, you will need to purchase a disk but a good deal of information can be gleaned from the free site. http://www.tgcigrantproposals.com/minorities.htm

Directory: sites -> default -> files -> attachments
attachments -> Manifesto! Version: 16 December 2008 a green New Deal for Europe Europe needs a new direction
attachments -> For immedate release
attachments -> For immedate release
attachments -> 2. I have almost 200 remote sites which I have to configure by using the same topology
attachments -> Sponsored by: Michigan Association of Community
attachments -> Classes that use Transcender & Certification that can be earned
attachments -> Log File: 2015-02-03-09-20-28 b unitycxn connection messages unitymbxdb1 messages log
attachments -> From: Hisham Ahmed, Chair
attachments -> Short-Team Faculty Led Third-Party Providers
attachments -> Topic: Adding Analytics Concentration to the pmba program

Download 177.8 Kb.

Share with your friends: