Wednesday, December 8, 2010

Call To Action - Women and HIV Research Blog Comments Needed


As you may already know The National Institute of Allergy and Infectious Diseases (NIAID) has developed a series of blog posts on the 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.


• Go to 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.


• 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.


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.

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.


Friday, October 8, 2010

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?