Study - Addressing Social Drivers of HIV/AIDS for the Long-Term Response: Conceptual and methodological Considerations

Via MSMGF.

A key component of the shift from an emergency to a long-term response to AIDS is a change in focus from HIV prevention interventions focused on individuals to a comprehensive strategy in which social/structural approaches are core elements. Such approaches aim to modify social conditions by addressing key drivers of HIV vulnerability that affect the ability of individuals to protect themselves and others from HIV. The development and implementation of evidence-based social/structural interventions have been hampered by both scientific and political obstacles that have not been fully explored or redressed. This paper provides a framework, examples, and some guidance for how to conceptualise, operationalise, measure, and evaluate complex social/structural approaches to HIV prevention to help situate them more concretely in a long-term strategy to end AIDS.

Conclusion:

After nearly 30 years of the HIV/AIDS pandemic, there have been woefully few examples of truly successful HIV prevention initiatives conceived and implemented by national policy makers and programme planners. To ensure measurable HIV prevention success by 2031, the 50th anniversary of the epidemic, it will be necessary to move beyond the limited, individualistic, urgency-based approaches of the past. Shifting from an emergency framework and mounting a long-term response to AIDS requires new approaches that engage with underlying social-structural drivers of patterns of practices that influence vulnerability and facilitate the spread of HIV, as part of comprehensive, strategic programming (or ‘combination prevention’).

Patterns of behaviour and practices arise from combinations of drivers, operating in specific social, economic, and political contexts. As such, no single causal pathway can be drawn from a social driver to a set of practices or behaviours; rather, a range of potential outcomes may arise. Making causal inference about correlations between social drivers and HIV burden involves identifying ‘sociologically plausible’ pathways drawn from extant social science and epidemiological data. Engaging with social drivers requires methods and approaches beyond traditional conceptualisations that seek to identify and intervene on single, causal determinants or universal mechanisms of influence. HIV prevention researchers and advocates should reject and resist over-simplified language for social drivers. Statements that particular social-structural factors ‘do’ or ‘do not’ lead to HIV transmission are almost always too simplistic; language should shift to discussing how, in what circumstances, and for whom particular combinations of factors contribute to HIV vulnerability (or, conversely, resilience). In order to be rigorous, design of HIV prevention programmes and interventions aiming to address social-structural factors should:

• Begin with an assessment of the social and structural factors that may be
• increasing HIV vulnerability in targeted populations and settings.
• Identify (hypothesise) sociologically plausible causal chains between distal structural factors and specific individual or group practices.
• Identify levels of possible influence, in line with the HIV prevention programme’s or intervention’s scope and aim.
• Articulate any assumptions about such influences and aims including potential expected and unexpected consequences of the programme or intervention (including other social impacts).
• Build in evaluation mechanisms that are both feasible and appropriate to the aim, level, scope and method of the programme or intervention as a way to enable validation of assumptions, investigation of the mechanisms by which structures affect risk and vulnerability, and appropriate assessment of outcomes and impact.

Find the whole study here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Bacterial Bioshield Could Keep HIV at Bay

Via New Scientist.

A LIVING microbicide reduces HIV-like infection in monkeys, and might one day provide women with long-lasting defence against the virus.

Dean Hamer of the National Institutes of Health in Bethesda, Maryland, and colleagues engineered naturally occurring vaginal bacteria to produce the anti-HIV protein cyanovirin-N.

They applied a gel containing the bacteria to the vaginas of rhesus macaques before infecting them by the same route with a hybrid of SIV and HIV. The engineered bacteria cut the infection rate by 63 per cent (Mucosal Immunology, DOI: 10.1038/mi.2011.30).

Human females have 10 times as much of the bacteria as female macaques, so the engineered bacteria could reduce infection rates even more dramatically, says Hamer. Clinical tests could begin in a few years after safety testing.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Washington D.C.: Public Meeting on Safety Issues in PrEP

An invitation from the Forum for Collaborative HIV Research:

Safety Issues in Pre-exposure Prophylaxis for HIV negative individuals, proposals for management of safety concerns, and pending plans for scale-up

Forum for Collaborative HIV Research

1608 Rhode Island Avenue, NW

Washington, DC 20036

August 19, 2011

8:30am - 4:00pm

The Forum for Collaborative HIV Research has been tasked by our collaborators in the public health community, including the US Food and Drug Administration, to convene an open public meeting to address safety issues that may surround the introduction of biomedical approaches to prevent HIV infection. Recent data from the iPrEx, Partners PrEP and CDC’s TDF2 studies support a conclusion that pre-exposure prophylaxis (PrEP) with antiretrovirals may be effective at preventing transmission of infection in otherwise healthy, vulnerable individuals upon exposure to HIV. This important finding may lead to scale-up, broad use of PrEP and, potentially, approval of a PrEP indication.

Recently, the drug development paradigm has also shifted with more focus on safeguarding individuals on medications. Premarket studies can miss important safety signals, either because the patient population is different and limited by enrollment criteria, too small to see low incidence events, or exposure is not long enough to identify latent effects. Compensatory behavioral issues may also be a concern upon scale-up. Appropriate communication strategies to reach the intended healthcare provider and the intended vulnerable populations must be identified and formulated. Mechanisms to anticipate and/or control the development of resistant HIV are also important. Finally, public focus as a result of our meeting may identify additional public health issues that should be addressed as well.

The Forum meeting will follow our usual format of panel discussions featuring stakeholders, including academics, trialists, clinicians, community advocates, public health professionals, and others. Each will be asked by a moderator to address a set of pre-prepared questions. Four panels are planned: (1) What are the safety issues of concern with pre-exposure prophylaxis?; (2) what are potential remedies to control safety risks and their pros and cons?; (3) what are the public health implications?; and (4) finally, a panel will summarize and identify next step.

Because of limited space, public participation in the meeting room will be limited to one participant per organization. An overflow room will be available for attendees on an as-needed basis. The meeting will be webcast to enhance national dissemination. Written supplementary questions can be directed to the panels. Webcast attendees can also submit written questions via instant messaging.

Registration: Register online at http://prep-reg.com/ to attend the public meeting or to view the live webcast.

Location: 1608 Rhode Island Avenue NW, Washington, DC 20036
Date and Time: August 19, 2011 8:30 AM-4:00 PM

________________________________________
Forum Announcements

Studies show new progress in HIV testing in emergency departments

July 29

A CDC sponsored supplement released in the Annals of Emergency Medicine details new HIV testing efforts in Emergency Departments. "Emergency departments play a critical role in helping people learn their HIV status, connecting them to life-prolonging care, and helping them avoid transmitting the virus to others"said Jonathan Mermin, MD, Director of CDC's Division of HIV/AIDS Prevention. Click here to read more

Controlling the HIV Epidemic - The Promise of ARV-Based Prevention: Presentations now available

July 28

Presentations made at the Forum co-sponsored IAS Satellite Symposium "Controlling the HIV Epidemic - The Promise of ARV-Based Prevention" are now available. Click here to read more

Statistical Methods for Causal Inference in Observational and Randomized Studies: Course fees increase on August 1

7/26/11 This course concerns statistical methods for causal inference using observational and experimental longitudinal data. The course will focus on the application of methodological advances in statistical and causal research to improve the design and interpretation of safety analyses. These analyses will become increasingly important in the post-marketing safety environment for new drugs.

Dates: September 26-28, 2011.
Location: UC Washington Center, Washington, DC.

To register, please use the following link: www.hivforum.org/stats2011

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

New, Long-Term PrEP Study Announced

Via Now Chelsea, by Sam Spokony.

Few methods of HIV prevention have been as promising, or as controversial, as pre-exposure prophylaxis (PrEP). After a history of underground practice and off-label prescriptions, the approach has recently begun to receive serious attention from researchers, policy makers and health care advocates.

An outgrowth of post-exposure prophylaxis (or PEP, a short-term antiretroviral treatment that has been used since the early 90s to decrease the likelihood of HIV infection after exposure to the virus, either occupationally or through sex), PrEP is a similar antiretroviral that can be taken by HIV-negative individuals in order to help prevent them from seroconverting (being infected).

The results of a Phase III clinical study known as iPrEx were published in the New England Journal of Medicine on November 23, 2010. The study showed that, in a group of 2,499 gay men, PrEP — in the form of a combination of drugs under the brand name Truvada — was 44 percent effective in preventing HIV seroconversion.

Under the guidance of Dr. Roy Gulick (director of the Weill Cornell Medical College HIV Clinical Trials Unit), a new experiment called the NEXT (Novel Explorations of Therapeutics) PrEP Study will begin this fall. It will include 400 at-risk, HIV-negative gay men, and will take place over 48 weeks at 12 sites across the U.S. and Puerto Rico.

The NEXT PrEP Study will differ from iPrEx in that its primary experimental group will receive a daily regimen of the drug maraviroc (brand name Selzentry). The control group will receive Truvada, and two other experimental groups will receive combinations of maraviroc and either tenofovir or FTC (the two individual drugs that make up Truvada). A major goal of the study, along with testing the HIV-prevention efficacy of maraviroc, will be to gauge the side effects of the drug on participants.

“The longest any HIV-negative person has taken PrEP in a clinical study is 12 weeks,” Gulick told Chelsea Now in a July 23 phone interview [This is actually a major factual error. For example, the average follow-up in iPrEx was 14 months - IRMA]. “Now, since this is a drug we’re giving to healthy people, the next step is exploring further to prove that it is both safe and tolerable for them.”

Read the rest here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]