Experts hash out guidelines for HIV trials involving men who have sex with men

Published: July 20, 2011

ROME — Last week’s encouraging results from two trials showing that prophylactic use of AIDS drugs in HIV-negative people can help prevent infection has underscored the value of studying new preventative treatments, particularly in high-risk groups. And one of the highest risk groups remains men who have sex with men — a term used to include men who might not self-identify as gay.

In the US, for example, men who have sex with men (MSM) represent about 2% of the population, but they accounted for 59% of new HIV diagnoses in 2009. Strikingly, a global review estimated that only 3.3% of HIV prevention spending goes to address the needs of the MSM community in parts of the world where the epidemic is concentrated.

In hopes of facilitating more work in this area, experts from groups such as the Foundation for AIDS Research (amfAR) and the International AIDS Vaccine Initiative held a session at the International AIDS Society meeting here this week to discuss a draft set of guidelines. Although the World Medical Association and UNAIDS have published research principles for biomedical trials in the past, the authors of the newly drafted guidance say it’s the first of its kind to specifically advise on HIV research among individuals who fall into the MSM and LGBT (gay, lesbian, bisexual, transgender) categories.

The draft guidance stresses that consensual same sex practices are illegal in some countries and stigmatized, sometimes by the findings of HIV research itself. “That is a real obstacle to the response,” says Chris Beyrer, director of the Johns Hopkins Center for Public Health & Human Rights in Baltimore, Maryland, an institute involved in drafting the document. He adds that the problem is “really troubling” in former Soviet states such as Uzbekistan and Ukraine where the epidemic is intensifying.

Clinical staff themselves sometimes face coercion. For instance, as many as nine AIDS workers were imprisoned briefly in Senegal in 2009. To help trial investigators and volunteers avoid dangerous or difficult situations, the document sets out a checklist for researchers, encouraging them to reach out to MSM and LGBT community leaders at the early planning stages of each clinical trial and to involve them in communicating the findings once the experiment is complete. It also encourages scientists to institute emergency plans in case participants or staff face threats.

In addition to advising researchers, the draft guidance also provides tips for MSM and LGBT individuals. This includes a sample list of questions that they might ask the scientists, such as: “How will the research team protect our confidentiality and safety before, during and after the research?”

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