CDC Offers Free AIDS Tests at Drugstores

via washingtontimes.com, via Mike Stobbe

ATLANTA (AP) - Getting an AIDS test at the drugstore could become as common as a flu shot or blood pressure check, if a new pilot program takes off.

The $1.2 million program will offer the free rapid HIV tests at pharmacies and in-store clinics in 24 cities and rural communities, the Centers for Disease Control and Prevention announced Tuesday.

“We believe we can reach more people by making testing more accessible and reduce the stigma associated with HIV,” Dr. Kevin Fenton, who oversees the agency’s HIV prevention programs, said in a statement.

The tests are already available at seven places, including Washington, D.C., Oakland, Calif., and an Indian health service clinic in Montana. The CDC will soon pick 17 more locations.

The HIV test is a swab inside the mouth; it takes about 20 minutes for a preliminary result. The test maker says it’s correct 99 percent of the time. If the test is positive for the AIDS virus, pharmacy employees will refer customers to a local health department or other health care providers for a lab blood test to confirm the results, counseling and treatment. The workers are expected to deliver the news face-to-face and give customers privacy, the CDC said.

An estimated 1.1 million Americans are infected with HIV, but as many as 20 percent of them don’t know they carry the virus, according to the CDC. It can take a decade or more for an infection to cause symptoms and illness.

Since 2006, the CDC has recommended that all Americans ages 13 to 64 get tested at least once, not just those considered at highest risk: gay men and intravenous drug users. But fewer than half of adults younger than 65 have been tested, according to the agency’s most recent statistics.

It’s important to know about infection not only for treating the condition but also to take steps to prevent spreading it to others. An HIV diagnosis used to be a death sentence, but medications now allow those infected to live longer and healthier lives.

Read the rest.


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IAPAC Summit - If people who need HIV drugs aren’t getting them now, why should the prevention benefit of treatment be the reason that the drugs become available?

via Aidsmap, by Roger Pebody

The issue of ‘treatment as prevention’ raises a number of ethical issues, Richard Ashcroft, professor of bioethics at Queen Mary University of London told the IAPAC Controlling the HIV Pandemic with Antiretrovirals Evidence Summit in London this week.

He reminded the audience that it is rare for a doctor to give a patient a medicine that will primarily benefit a third party. He went on to highlight situations in which, at present, antiretroviral treatment is not universally available to all people who need it for their own health. In such circumstances, why should treatment’s prevention benefit be “the clincher” that convinces funders and policy makers to make the drugs more widely available?

At the same meeting, Kevin Fisher of AVAC noted that the ethical concerns tended to differ in different parts of the world. In settings where there is already good access to HIV treatment, the concerns are often related to individuals experiencing external pressure or compulsion to take treatment. In resource-limited settings, the concerns focused more on the cost of and access to treatment.

Read the rest.

And check out the Mapping Pathways slides that were presented at the same meeting, on the issue of PrEP.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position. Please look for us on Facebook here www.facebook.com/MappingPathways and you can follow us on Twitter @mappingpathways as well.]

Microbicides 2012 Conference: “Someday, our ARV-prevention tools will be as sexy as the I-Phone!”

Original content from the Mapping Pathways blog team

This is the second part of a two-part blog series on highlights and discussions from the Microbicides 2012 conference that recently concluded in Sydney. Here, Jim Pickett re-emphasizes the importance of adherence in clinical trials (a big topic of discussion at the conference) and his optimism about the future of the HIV prevention and treatment landscape. Read Part I here.

MP: Can you give us some examples that illustrate the issues surrounding adherence?

JP: The Partners PrEP trial and the FEM-PrEP trial are good case studies to illustrate the issues surrounding adherence in an HIV prevention clinical trial. Partners PrEP reported very high levels of adherence while the FEM-PrEP trial had to be stopped in April 2011 due to “futility.” Studies later indicated that while many of the FEM-PrEP participants said they adhered to the medication schedule, blood tests indicated that many did not.

A built-in support system and the risk perception of participants are the key here. In Partners PrEP, serodiscordant couples were enrolled together into the trial. One partner was HIV positive while the other was negative. The HIV risk of the HIV-negative partner was not theoretical; it was real. HIV was in their life and they were in it together.

FEM-PrEP involved women recruited on their own, with no consideration whether they were in a serodiscordant relationship – or any relationship for that matter. The risk of HIV was not present in the form of a partner who already had it, but it was, in fact, present in their environment where there was very high HIV incidenceIV HIV . It is interesting that many of these women did not believe themselves to be at a high risk of HIV, despite this high incidence.

Human beings are very good at rationalizing risks and saying “it can never happen to us.” I can drive fast and will never get into a car accident. If I feel a certain behavior is not risky, or that I can “get away with it”, I will not take steps to protect myself.

We don’t want to create tools where only people who are married or in a relationship are able to use the tools successfully. That would be crazy. But we do have to think about how important those social relationships are and use the lessons learned to devise new tools and new trials that give us answers – and develop things that work for all kinds of people, regardless of relationship status, sexual orientation, or whether their potential HIV exposure comes from unprotected vaginal intercourse, unprotected anal intercourse, or from the sharing of syringes during injection drug use.

MP: Are there any trials coming up that you are excited about?

JP: I’m very excited by the upcoming MTN-017 rectal microbicide safety and acceptability trial that will enroll approximately 186 gay men, other men who have sex with men, and transgender women at trial sites in South Africa, Peru, Thailand, and the United States. Participants will go through three eight-week cycles: One cycle of having a daily Truvada tablet, another cycle of applying a “rectal friendly” reformulated tenofovir gel every day, and a cycle of applying the gel before and after having sex.

What impresses me is the level of community involvement sought and obtained to help design this trial. The trial team, and advocates such as myself, visited each of the sites mentioned, had day-long meetings with community members, captured all their observations, and made adjustments to the trial design from the input received. We have to listen to the voices of the communities. We can’t just show up and conduct trials.

MP: What are your other thoughts on the HIV prevention and treatment landscape?

JP: I always like to compare the HIV prevention and treatment landscape to the evolution of computers and phones. Years ago, computers were the size of a house. It took time for the computer to evolve from its clunky beginnings to its current look where we can carry it around in our pocket and it can do more things than we ever could have imagined. Now we have phones and computers that are completely intuitive and easy to use.

Similarly, the HIV landscape has evolved over the years. Before 1996, we had a handful of drugs that didn’t always work great. They were toxic and had to be taken multiple times a day. When protease inhibitors came out in 1996, people near death’s door were brought back to life. But they also had to suffer through a whole host of side effects like nausea, diarrhea, and body disfigurements.

Now, new-age ARV medication can combine three drugs into one pill that has to be taken just once a day. The side effects are minimal and you don’t have to worry about requirements like eating it on a full or empty stomach, or having it refrigerated.

We are now in the clunky computer stage of ARV-based prevention. But, things will keep getting better. We can’t get to the streamlined phase before going through the clunky phase. We have to learn to crawl before we can run. Someday, our ARV prevention tools will be as sexy as the iPhone.

Jim Pickett is the Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago. He is chair of IRMA (International Rectal Microbicide Advocates), and a member of the Mapping Pathways team. Read Part I of Jim’s interview here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Microbicides 2012 Conference: Adherence – the A-word on everyone’s lips

Original content from the Mapping Pathways blog team

In part I of this two-part blog series, Jim Pickett talks about his experiences at the recently concluded Microbicides 2012 conference in Sydney and the buzz among advocates and trial designers today.

MP: What were some of the highlights for you from the conference?

JP: The conference in itself was great with many interesting and informative presentations. A highlight for me was that conversations about rectal microbicides were integrated throughout the conference and not just in one or two presentations. Rectal microbicides got a lot of attention.

From a Mapping Pathways perspective, we submitted an oral abstract that was accepted and I think the presentation I did was well received. We generated a lot of conversations about the work we have been doing and are planning to do in the upcoming year.

A Canadian colleague presented on their country’s plans for integrating ARV-based prevention into their national prevention plan and one of their planned activities is to develop a Canadian version of Mapping Pathways. This stems from a consultation in Ottawa I participated in last year – so it was gratifying to see Mapping Pathways being picked up by others – and presented at an international conference.

MP: Are there any major themes that emerged from this conference?

JP: Adherence, the A-word, was a very big topic throughout the entire conference. We realized that we have to make HIV-prevention or treatment products people like and will want to adhere to. We have to figure out how tools like PrEP and microbicides fit in people’s lives, and funding should be put in place to better understand what people want, how they have sex, and the role of pleasure, love and intimacy, among many other “real world” realities. Right now, only about two percent of the budget of any study is used for the socio-behavioral aspect – that is, understanding participants’ motivations, documenting adherence, and exploring the communities they are a part of.

Adherence is especially crucial for PrEP to move into the real world. Participants in trials come to the clinic for monthly visits that include a host of prevention services and counseling on condom use and adherence to the study product. If adherence is an issue in such a controlled environment, how big of an issue will it be in the real world where they are not getting that level of intensive support?

A scenario where a trial has to be stopped because people did not take the drug is a major concern because it leaves us more questions than answers. We get no answers on the efficacy of the drug – we are left thinking “what if the person had taken it as instructed?”  We cannot afford to spend millions on trial after trial where we find out finally that people did not take the drug as instructed.

Sure, the lack of adherence could be telling us about acceptability – and if we are making products that people are having a hard time adhering to, is this product really acceptable? By the same token, this is an iterative process – what we have is what we have right now, and the only way to determine if the drug works is if people take it. We can’t improve on the delivery if we can’t answer that question. It is a bit of a conundrum.

MP: What are some of the strategies discussed to tackle the issue of low adherence?

JP: The first step, as mentioned, is to increase funding for the socio-behavioral components of the trial. We need to do better at finding the “right” trial participants. Imagine a case where two people are being recruited for an HIV study trial. One is a person who wants to do the study to the best of his or her abilities and is motivated by the aims of the study. The other person is motivated by the access to healthcare and the little monetary incentive provided by participation in the study. Would both their levels of adherence be the same? This isn’t to cast judgment on anyone – but really, we need to answer the study question – and we can’t do that if people don’t follow the study protocol.

Another interesting strategy being discussed more and more is separating the people who counsel the participants during the trial (adherence counseling) from the people who record user experiences taking, or not taking, the study product. If the same person performs these two functions, participants who form a bond with their adherence counselors during the course of the trial may be unwilling to disclose exactly how well they adhered to the program. The end goal is to find better ways to capture the data and make participants feel completely relaxed about being honest about their user experience. If they did not take the drugs as instructed, that’s ok. But we want to know why.

Jim Pickett is the Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago. He is chair of IRMA (International Rectal Microbicide Advocates), and a member of the Mapping Pathways team. Stay tuned for part II of the blog.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Model shows excellent prognosis for UK gay men with HIV

via aidsmap, by Michael Carter

New UK research provides further evidence of the dramatic impact of antiretroviral therapy on the prognosis of HIV-positive patients. Published in the online edition of AIDS, a simulated model showed that a non-smoking, 30-year-old gay man, whose HIV is diagnosed promptly, could expect to live until he is 78 years of age. A gay man who smoked, but whose HIV was detected early, had a life expectancy of 75 years.

The model also showed that late diagnosis of HIV cut life expectancy. Nevertheless, it showed the clear benefits of HIV therapy in these circumstances. A gay man whose HIV was detected when his CD4 cell count was just 140 cells/mm3 could still expect to live until he was 71.5 years old.

“Predicted life expectancy in people with HIV is high in settings with access to multiple antiretroviral drugs,” comment the investigators. “Delays in diagnosis pose the greatest risk of excess mortality for people with HIV.”

It is now well established that modern antiretroviral therapy significantly improves the life expectancy of patients with HIV. However, investigators from the UK were concerned that studies attempting to quantify prognosis may have underestimated the benefits of treatment because they did not take into account improvements in HIV therapy and care.

They therefore developed their own prognostic model. It was based on 10,000 theoretical gay men whose HIV was diagnosed in 2010. They selected this group because factors other than HIV impact on the prognosis of the other main groups affected by HIV in the UK.

Rates of HIV testing currently observed in UK gay men were incorporated into the model. These show that HIV is generally detected early, with median CD4 cell count at the time of diagnosis being 410 cells/mm3. It assumed that the patients had fully drug-sensitive HIV, had a 40% chance of being a smoker for life, were not co-infected with hepatitis and were never lost to follow-up. HIV treatment was started when the patients’ CD4 cell count fell to 350 cells/mm3 and the patients were fully adherent to this.

Higher rates of some non-HIV-related illnesses have been observed in patients with HIV. Therefore, the investigators assumed that their simulated patients were 50% more likely to die of such diseases than individuals in the general population.

The same scenario was considered for patients whose HIV was diagnosed late.

In ideal conditions, with timely diagnosis of HIV, the life expectancy of patients was 75 years (range, 63 to 83 years). This increased to 78 years if the patient did not smoke (range, 66 to 86 years).

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Mobile testing units show success in linking people to HIV care and treatment

via aidsmap, by Carole Leach-Lemens

Linkage to facility-based HIV care from a mobile testing unit is feasible, South African researchers report in the advance online edition of the Journal of Acquired Immune Deficiency Syndromes.

In a stratified random sample of 192 newly diagnosed individuals who had received CD4 test results, linkage to care was best among those who were ART eligible, Darshini Govindasamy and colleagues found.

The lower the CD4 cell count the greater the linkage to care: all of those with CD4 counts at or under 200 cells/mm3, two-thirds of those with CD4 counts of 201-350 cells/mm3 and a third of those with CD4 counts over 350 cells/mm3 linked to care.

An estimated two million people died as a result of HIV/AIDS in sub-Saharan Africa in 2008. South Africa now has the largest ART programme in the world, yet half of those in need of treatment do not get it. And a large number of those who do present for care, present late with low CD4 cell counts increasing their risk of early death.

In South Africa traditional HIV counselling and testing (HCT) sites at stationary facilities have increased and consequently so have the numbers tested. Yet this has not resulted in increased numbers on treatment and in care.

Transport costs, being male and having a low CD4 cell count have been well documented as the primary barriers of non-linkage to care.

Successful early diagnosis of HIV has to be accompanied by strategies that assure timely linkage to care and treatment so improving health outcomes.

Mobile testing units offer several advantages: people are often tested at an earlier stage of HIV; it is easier for hard-to-reach and high-risk populations to test; and they are cost-effective. However, maintaining on-going HIV care may prove difficult, requiring referral to stationery facilities.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

HPTN 052: Responses, benefits and challenges

The HPTN 052 study's compelling interim results on "treatment as prevention" are eliciting strong reactions from various players in the HIV/AIDS prevention community. According to UNAIDS, "the breakthrough is a serious game-changer", and AVAC has stated that "the upcoming UN High Level Meeting on AIDS should set treatment and prevention targets that take the HPTN 052 results into account." Other have voiced concerns that the evidence may not be compelling enough for some segments; for instance, in Sub-Saharan Africa, where most people remain untested, the methodology used in the HPTN 052 study may not be as effective as hoped.

There are other critical questions as well: How will we improve rates of diagnosis without coercion? How will governments and communities build the capacity to treat people with HIV promptly and effectively? What are the cost implications?

A few days ago, aidsmap published an excellent article, tackling these issues and concerns. To read more about the reactions, the possible benefits, the challenges and proposed solutions, and the dollars-and-cents issues, click here.

Also, folks from the US, South Africa and India who are interested in new ways to prevent transmission of HIV – and want to help shape our project goals and deliverables – are highly encouraged to take a few minutes and fill in our survey.

Your efforts will be greatly appreciated!

Take the survey now.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

In the Pipeline: Lab-on-a-Chip that Could Diagnose HIV in Minutes

Last month brought a potentially path-breaking announcement from an international team of researchers. The team has developed a self-powered blood-analysis chip (see Ivan Dimov's photograph on the left), which can process blood without the assistance of external tubing and other components. This means that it could be used to detect diseases like HIV and TB within minutes, revolutionizing the way these diseases are tested for.

The implications are exciting: The portable nature of the device would make it easy for field workers to it use for diagnosis, and the fact that it is made of plastic components means it could be manufactured in bulk at comparatively low prices.

Read more about this recent development here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]