TB/HIV Co-infection

The incidence and impact of TB/HIV co-infection is significant and growing. TB is the leading causes of death among people living with HIV. Integrating TB and HIV education and research is essential to finding ways to reduce the impact of both epidemics. Increasing and improving knowledge of co-infection among communities that have worked exclusively in one area of research, whether HIV or TB is necessary to combat both epidemics.

 

The Community Research Advisors Group (CRAG), the community advisory board to the U.S. CDC's Tuberculosis Trials Consortium (TBTC) and Community Partners (CP), a group of community representatives working across the five National Institutes of Health (NIH) HIV/AIDS clinical trials networks are interested in hearing your thoughts around the following:

• Thoughts on how to discuss and address TB/HIV co-infection stigma
• Thoughts on how to develop more holistic approaches in engaging households around TB/HIV co-infection

More information on TB Resources for Communities can be found on the Office of HIV/AIDS Network Coordination (HANC) public site.

We look forward to a stimulating discussion around integrating TB/HIV education and research globally.

Please contact Russell Campbell

Recommendation to Adopt "Perinatal"

Hi Friends,

I have come to believe "mother to child" is stigmatizing and that it has just become standard without anyone thinking about its effect.  It is easily substituted by the word “perinatal". We have been using this a long time, but a couple of year ago, I heard another mother say something that has finally broken through to my consciousness.  It is time for the everyone to re-think this.  Community can make that happen!

I serve on the Pediatric Guidelines Panel for the DHHS and we have initiated the change there. I was surprised when I made the suggestion to the Guidelines panel in the context of stigmatizing the mother, it was accepted without hesitation. Now, as we revise those treatment guidelines, we will be removing the term “…MTC” everywhere it occurs in the guidelines.  I am asking the community at IMPAACT and the Community Partners at all networks to consider expanding the effort.  As new protocols are written, we can ask that “perinatal” be used in the title and throughout the document instead of “mother to child”. The Perinatal Guideline panel can change their language, too. It is a huge task since use of MTC is so pervasive, but one step at a time, I’m certain we can do this! 

Dorothy S - Former Community Partners Co-chair

 

Contact: Russell Campbell (rcampbel@fhcrc.org)

 

Feedback from current/past trial volunteers on how best to collect sensitive information on potential HIV exposure and adherence

Dear Past Trial Participant:

We need your advice! 

HIV prevention researchers are trying to find better ways to collect information for future clinical trials. We want to do a better job gathering feedback around risk behaviors for HIV infection and about how consistently people are really using the products that are tested in clinical trials.

The questions below are designed to trigger your memories of clinical trial interviews but please feel free to share other ideas and thoughts you might have.  You do not have to answer all of the questions in order.

We would appreciate your thoughts in the following areas: 

1) GENERAL INFORMATION: How can we explain why the accuracy of reporting of risk behaviors and actual use of trial products is so important?

During the informed consent process, and during the trial itself, you may or may not have been told how important information about HIV risk behaviors and use of the study product is to making sure we correctly understand the results of the study.

·       In your opinion, might a more specific explanation of the critical importance of this information be useful as a standard practice? 

·       Would it help to explain how the science of the study really depends on this information? Would it help to have an explanation of the consequences of inaccurate information?

2) Environment - Internal & External: In your opinion, what type of environment works best to ensure real / accurate information is gathered?

·         What about the outside environment might be significant – for example, does it matter if the setting is a center dedicated to research or a research center combined with a treatment center?

·         What characteristics of the place in which this information is gathered matter – for example, the room location within the clinic, sound proofing, movement of people around the room, or anything else you think is important?

·         What is the single most important thing about the clinic environment that may or may not provide a sense of safety or confidence in talking about private and sensitive information?

3) STAFF: Who is best suited to gather this information?

·         Does it matter what the gender, age, race/tribe, familiarity, professional level, and language/vernacular of the interviewer is? Which aspects do you think are important? Which are not so important?

·         What is the single most important characteristic of the staff which is likely to allow study participants to be as truthful as possible about sexual risk/activity, about being able to follow the study regimen and use the product, or other related private concerns?

·         Would it be best to have two different staff do the following: one staff person to ask about potential exposures to HIV, and another staff person who would provide risk-reduction counseling? Would separating these staff functions potentially allow for more openness and truthful responses? Or might the same person be trusted to do both without influencing how people report their risk behavior and consistence of following the study procedures and using the study product?

4) METHODS/TOOLS: There are different ways in which information about sensitive behaviors is collected during a trial. These include:  self-administered surveys (the participant fills it out directly); face-to-face interviews (an interviewer asks questions and the participant responds); computer assisted (ACASI) (the participants listens to questions over headphones and enters answers into a computer); or sometimes a combination of methods are used.

·         What is your opinion on which method (or combination of methods) is best suited to have volunteers report the most real and accurate sensitive information on risk behaviors for HIV and actual use of the study product (adherence)?

·         The accuracy of some information about human behavior depends on memory. Might it be helpful to provide a question in which participants could report how confident they feel in their ability to remember these pieces of information?

5) Barriers: Based on your experiences and understanding of your community, what are the things we should avoid doing? For example,

·         In your opinion, what are the biggest obstacles to volunteers in reporting sensitive information related to risk behaviors and possible HIV exposure? What might make volunteers comfortable sharing their true experiences?

·         If you ever reported information that wasn’t accurate because of your discomfort with the way  questions were asked about your risk behaviors to HIV or about your consistent use of (adherence to) the study intervention?

6) ANYTHING ELSE?

·         Is there anything else you would like to share that might help us improve the quality of the sensitive information we collect from volunteers on HIV risk behaviors or adherence to product use in clinical trials?

Please share your experiences and suggestions below. If you feel comfortable, please let us know if you have even been a trial participant. Providing your name and contact information are completely optional.  You can also click here to share your thoughts in an email to HANC.   

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QR Codes and Mobile Advertising Get Big

In case you haven't noticed, Americans are obsessed with our phones—we can't stop looking at them! The growth of mobile technology has been nothing short of phenomenal. During an Internet advertising conference on February 27, 2011, Eric Schmidt, CEO of Google stated that mobile use is growing faster than all of Google's internal predictions, with YouTube seeing 200 million mobile playbacks a day. Responding to this trend, web designers at HVTN are focusing heavily on mobile marketing. In November 2010, we started placing QR codes into our print advertisements. Currently, nearly 10% of visitors to our outreach website, www.hopetakesaction.org are coming from a mobile device.

Perhaps you've seen these black and white maze-like squares in magazines, billboards and catalogs and wondered what they were. QR or quick response codes were first invented in Japan in 1994 to track parts in vehicle manufacturing. The technology is now used in a broader context, including advertisements aimed at smartphone users. QR codes can be scanned by smartphones to bring up a website for more information.

How to Use QR Codes in Advertising

1. There are many sites that can help you create QR codes for free or a small cost. Check out Kaywa.com, Qreateandtrack.com or Qrstuff.com. These are just a few sites; many others offer similar features.
   
   
2. Once the QR code is generated, place it on a print ad. Make sure that the QR code is at least 1 inch by 1 inch. Smaller codes may not be scannable.
   
   
3. To scan the code, smartphone users first need to download a QR reader. Many readers are available for free or a small charge in the app store.
   
   
4. Measure how many people are scanning your QR code. Most sites that generate the codes will offer tracking for a monthly fee.
   

Examples of QR Codes in Advertising

In February, I went to New York City and spotted many QR codes on billboards. I saw some very innovative ways that designers are incorporating the codes into the ads.


Ad for the Grammy awards, spotted in subway station.

Ad for JetBlue Getaways, spotted inside a subway train.

I love how this design makes the QR code a primary element of the ad. If you look closely, you can see that each square of the enlarged code includes a picture of people on vacation. The actual scannable code is included in the lower-left corner.

By far the most stunning example of QR code advertising. The code accesses the website discoverthemaster.com, featuring 15 pieces of Picasso's art, and a link to buy tickets to the exhibit, which is currently at the Virgina Museum of Fine Arts. A large mural of this can be seen in New York's Soho district, near Wooster and Grand. When I was in NY, I only saw the beginnings of the mural. I would love to see the finished version; it's truly a work of art.

Picasso mural in development in New York's Soho neighborhood.

Written by Soyon Im, Manager of Internet Strategies at the HIV Vaccine Trials Network, Fred Hutchinson Cancer Research Center, sim@fhcrc.org.

Call To Action - Women and HIV Research Blog Comments Needed

Greetings,

As you may already know The National Institute of Allergy and Infectious Diseases (NIAID) has developed a series of blog posts on the AIDS.gov website related to planning for the future of NIAID’s HIV/AIDS clinical trial networks. NIAID is seeking input from the broader research and HIV/AIDS communities on specific aspects of the restructuring of NIAID’s research networks. They are specifically seeking comments about the treatment and prevention research priorities that should be addressed during the coming years.

As members of HANC Legacy’s Women and HIV Research Collaborative we have noticed that very few comments that have been submitted to date on any of the NIAID blogs have placed an emphasis on the urgent need for ongoing domestic prevention and treatment research that focuses on HIV/AIDS and women. We are therefore issuing this call to action.

PLEASE:

• Go to http://bit.ly/NIAID_Blogs and select one or more of the NIAID blogs.

• Add your comments (or see the sample below that you may use and/or edit) about the need for a renewed focus on HIV research with women in the United States. To help in that process we have provided a sample comment post that includes some talking points that you can cut and paste into a blog posting. Please write your own response, or simply submit some or all of the points provided below.

And

• Forward this email or the link to this post to everyone you know who would be willing to make sure that HIV research for Women in the United States remains a priority.

TO ENSURE THAT YOUR IMPORTANT COMMENTS ARE INCLUDED IN NIAIDS PLANNING PLEASE POST YOUR COMMENTS BY DECEMBER 31, 2010.

Thank you for using a minute of your time to take this action to ensure women are part of the future of HIV/AIDS research in the United States.

Sincerely,
WHRC Members
_____________________________________________

[SAMPLE BLOG COMMENTS: Please Modify These Comments or Create Your Own Comments
In Support of HIV Research and Women]


I am concerned about the health of women in the United States, particularly as it has been disproportionately impacted by HIV. I wish to support the following areas discussed and prioritized by the HANC Legacy Project during a first-time-ever Consultation on HIV Research and Women on June 11th and 12th, 2010. Their review reflects key concerns such as sensitivity to culture, quality of life, and the changing needs of women across the lifespan.

I respectfully ask that NIAID includes the following priorities related to HIV prevention and treatment for United States’ women:

Epidemiological data must continue to drive research priorities. Awareness of the impact that HIV has had on women in the United States has been heightened through the use of epidemiological data from the Centers for Disease Control and Prevention. The CDC guidance mandates prioritizing HIV prevention efforts for those populations who are most burdened by infection.

HIV treatment research for women continues to be an urgent priority. Prior to the availability of HIV treatment women were 10% less likely than men to die from AIDS defined illnesses. In today’s HIV treatment era, however, women are 20% more likely than men to die from AIDS. While research has answered key questions and has provided specific strategies and treatments to reduce mother-to-child transmission, research must now seek to gain greater insight into gender disparities in treatment successes.

There is a critical need for research that seeks to understand the relationship between women’s reproductive health, gender and economic inequalities and HIV prevention and treatment. United States’ health policies and programs that are designed to reduce the risk of HIV and other sexually-transmitted infections must be improved to explicitly address overall economic disempowerment among women, as well as disparities in poverty among ethnic populations. Research is needed that will help provide the data necessary to make those improvements.

There is a critical need for increased involvement of women in the design and implementation of research. It is understood that HIV prevention and treatment research must include growing numbers of adolescent and adult women. Low retention rates for women in HIV research studies are believed to be influenced by study designs intended for men, but were later altered to accommodate women.
There is a critical need for research involving men who report primarily having sex with women (MSW). The majority of HIV positive women report being infected through heterosexual intercourse or through intravenous drug use. Few studies have focused on the prevention and linkage to healthcare needs of men who primarily identify as having sex with women.

There is a critical need for research in genetics, pathogenesis, and pharmacology of HIV positive and negative women. Understanding women’s physiologic risk; resilience; genetics; drug efficacy; dosing requirements and variables such as pharmacogenomics, is key to enabling adherence, improvements in health and quality of life, and the specific, gender-based care women need and deserve.

Sincerely,
INSERT NAME AND ORGANIZATION

What are your thoughts on the Community Partners Research Priorities?

Community Partners (CP) is a cross-Network body charged by the Network Leadership and the Division of AIDS (DAIDS) with promoting effective representation of the many communities within which the NIH/NIAID-sponsored HIV Clinical Trials Networks conduct research. CP conducts activities regularly through conference calls and online tools such as email and a web portal system that allows for document collaboration and discussion boards.

Community Partners is made up of community representatives from the DAIDS Networks community groups and Network staff, including representatives from the AIDS Clinical Trials Group (ACTG), the HIV Prevention Trials Network (HPTN), the HIV Vaccine Trials Network (HVTN), the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT), the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), and the Microbicide Trials Network (MTN).

Community Partners represents community research needs and priorities to the HIV/AIDS Clinical Trials Network Leadership Operations Group (NLOG) and Strategic Working Group (SWG) and other advisory groups or committees as needed/requested. CP provides input to DAIDS research plans as they relate to scientific agendas, ethical conduct of clinical trials, community education, community training and communication/information dissemination in a manner that ensures respect for community priorities and continued community participation.

The Office of HIV/AIDS Network Coordination (HANC) works with the six HIV/AIDS clinical trials networks funded by DAIDS with the intent of creating a more integrated, collaborative and flexible research structure. HANC is based at the Fred Hutchinson Cancer Research Center in Seattle, Washington and provides a framework for collaboration and improved communication among network leadership, DAIDS staff, Community Partners, research site staff, SDMCs, core/operation centers, network laboratories and the many partners and research groups engaged in the NIAID research agenda.

Community Partners Priorities

As part of its mandate Community Partners has been charged with identifying and developing programs to meet the training and support requirements of local Community Advisory Boards, increasing the representation and participation of community members from resource-limited settings and vulnerable populations, identifying and addressing challenges to participation in clinical trials, and articulating the scientific priorities of the community to the Network leadership and DAIDS.

In the spirit of this mandate, as well as keeping in line with the vision of Community Partners and its guiding principles Community Partners would like for DAIDS and the Network Leadership to consider the following recommendations as part of the upcoming network recompetition and restructuring:

•Address and improve areas where site-level CAB funding and support mechanisms are problematic based on the results of the Community Partners Site-Level CAB & Staff Survey results

•In collaboration with Community Partners, address, improve and if possible, standardize management of pregnancy and contraception while on study and in the informed consent process

•More effective promotion and dissemination of new or standardized training materials (“Understanding the clinical research process and principles of clinical research” and “The role of a CAB and principles of community involvement” and “Recommendations for Community Involvement in NIAID HIV/AIDS Clinical Trials Research”)and assessing the value of such trainings

Community must be involved at all stages of clinical research from study design to implementation and start of study, DSMB meetings and study evaluation. “Nothing about us without us!”

The following are four priorities that are at the top of everyone’s list, but were not specific enough to be included as specific research topics:
•Develop a cure for HIV infection.
•Develop an effective and safe HIV preventative vaccine.
•Develop effective and safe pre- and post- HIV exposure prophylaxis, including microbicides.
•Develop ethical prevention strategies for those who choose not to, or cannot, be vaccinated.

The research priorities presented by Community Partners is best understood as a list of recommendations to guide future HIV/AIDS research as it continues to seek answers leading to prevention and treatment, eventual cure and eradication of HIV/AIDS. All of these recommendations are important and Community Partners will continue to seek input from the community and work on their behalf to provide answers and insight to their various concerns and issues.

Some items presented are better defined as calls for further resources, such as additional funds for anti-HIV medicines. These items were not included in the priority list. However, they are valid requests and must be addressed.

All studies should proportionately enroll people representative of the population impacted by HIV. This is critical to ensure that prevention and therapeutic trial results can be applied to the people most affected by HIV. Extra measures should be taken to obtain representative enrollment of at-risk or infected populations to provide subgroup analyses where necessary.

While reviewing the research priorities, it is important to remember that the community wants solutions, not research. The issue of the lag time between clinical proof of efficacy and the ability of the community to access the product must be addressed throughout the research process. The ability to rapidly provide communities in need with new products is critical.

Community Partners Research Top Priorities:

1 What can be done to effectively clear HIV from the body through flushing HIV reservoirs?

2 What are safe, effective, acceptable and accessible options for pre-exposure prophylaxis (PrEP)?

3 What are the best ARVs for 1st regimen/subsequent optimal ARV sequencing? What are the best ARVs for different populations?

4 What are innovative and effective strategies to get more people tested?

5 What are the long term effects of HAART Treatment toxicities with regards to: learning disabilities; metabolic disorders/body habitus changes; cardiac health; reproductive health; bone density deterioration; and how to treat neurocognitive and neurological disorders across all disease stages?

6 What are possible resistance issues involving ART based HIV microbicides both on an individual and a community level?

7 When to start HAART treatment?

8 What influences adherence? How can we optimize adherence? What are effective strategies for disguising ARV taste for children?

9 Do different vulnerable groups, e.g. men, women, racial/ethnic groups, have different treatment complications and outcomes?

10 What can be done to reduce inflammation/immune activation in the body and especially the central nervous system?

11 What is the impact of common co-infections on HIV and vice versa, e.g. TB, malaria, hepatitis, Dengue fever?