A Qualitative Study of Provider Thoughts on Implementing Pre-Exposure Prophylaxis (PrEP) in Clinical Settings to Prevent HIV Infection

via PLoS ONE, by Emily A. Arnold, Patrick Hazelton, Tim Lane, Katerina A. Christopoulos, Gabriel R. Galindo, Wayne T. Steward, Stephen F. Morin

ABSTRAST

Background

A recent clinical trial demonstrated that a daily dose tenofovir disoproxil fumarate and emtricitabrine (TDF-FTC) can reduce HIV acquisition among men who have sex with men (MSM) and transgender (TG) women by 44%, and up to 90% if taken daily. We explored how medical and service providers understand research results and plan to develop clinical protocols to prescribe, support and monitor adherence for patients on PrEP in the United States.

Methods

Using referrals from our community collaborators and snowball sampling, we recruited 22 healthcare providers in San Francisco, Oakland, and Los Angeles for in-depth interviews from May-December 2011. The providers included primary care physicians seeing high numbers of MSM and TG women, HIV specialists, community health clinic providers, and public health officials. We analyzed interviews thematically to produce recommendations for setting policy around implementing PrEP. Interview topics included: assessing clinician impressions of PrEP and CDC guidance, considerations of cost, office capacity, dosing schedules, and following patients over time.

Results

Little or no demand for PrEP from patients was reported at the time of the interviews. Providers did not agree on the most appropriate patients for PrEP and believed that current models of care, which do not involve routine frequent office visits, were not well suited for prescribing PrEP. Providers detailed the need to build capacity and were concerned about monitoring side effects and adherence. PrEP was seen as potentially having impact on the epidemic but providers also noted that community education campaigns needed to be tailored to effectively reach specific vulnerable populations.

Conclusions

While PrEP may be a novel and clinically compelling prevention intervention for MSM and TG women, it raises a number of important implementation challenges that would need to be addressed. Nonetheless, most providers expressed optimism that they eventually could prescribe and monitor PrEP in their practice.

Read the full text here.


[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.]

HIV and the Law

via the Global Commission on HIV and the Law

The end of the global AIDS epidemic is within our reach. This will only be possible if science and action are accompanied by a tangible commitment to respecting human dignity and ending injustice.

Law prohibits or permits specific behaviours, and in so doing, it shapes politics, economics and society. The law can be a human good that makes a material diff erence in people’s lives. It is therefore not surprising that law has the power to bridge the gap between vulnerability and resilience to HIV.

We came together as a group of individuals from diverse backgrounds, experiences and continents to examine the role of the law in eff ective HIV responses. What we share is our abiding commitment to public health and social justice. We have listened with humility to hundreds of accounts describing the eff ects of law on HIV. In many instances, we have been overwhelmed by how archaic, insensitive laws are violating human rights, challenging rational public health responses and eroding social fabric. At other times, we have been moved by those who demonstrate courage and conviction to protect those most vulnerable in
our societies.

Many would say that the law can be complex and challenging and is best left alone. Our experience during this Commission has shown us a very different perspective. We have been encouraged by how frank and constructive dialogue on controversial issues can sometimes quickly lead to progressive law reform, the eff ective defence of legislation or better enforcement of existing laws. Even in environments where formal legal change is a slow and arduous process, we have witnessed countries taking action to strengthen access to justice and challenge stigma and discrimination.

Click here for the full report.


[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.]

CROI 2012: Researchers Compare Differences in Progession to AIDS Between Races

via POZ Treatment News, by Tim Horn

Some sobering news from the Women’s Interagency HIV Study (WIHS): Black women living with HIV are more likely to progress to AIDS and twice as likely to die of its complications compared with white women living with HIV, according to new results from the cohort presented Tuesday, March 6, at the 19th Conference on Retroviruses and Opportunistic Infections in Seattle. Though black women were significantly less likely to adherence to antiretroviral (ARV) therapy in the analysis, their risk of AIDS-related deaths were still significantly higher after accounting for this.

Eighty percent of HIV infections globally occur in women and people of African descent, but the majority of studies on antiretroviral (ARV) therapy have been conducted in men of European descent, Kerry Murphy, MD, of Albert Einstein College of Medicine in New York and her WIHS colleagues explained in their introduction comments.

Though previous data from the WIHS—one of the largest and longest cohort studies following women living with HIV in the United States—pointed to better survival among white women in the United States, the finding was not statistically significant, at least not when the results were published in 2005. The study has been under way since 1993, with sites in Brooklyn, the Bronx, Chicago, Los Angeles, Northern California and Washington, DC.

With additional follow-up data now available, the WIHS researchers again revisited potential associations between race, AIDS-related deaths, non-AIDS related deaths and the new AIDS-related illnesses in the cohort.

Included in the analysis reported by Murphy and her colleagues at CROI were 1,471 women living with HIV on continuous ARV therapy.

Compared with white women in the cohort, black women were twice as likely to die of an AIDS-related complication. This finding was statistically significant and accounted for other known predictors of AIDS death, including high depression scores, high pre-treatment viral loads, low pre-treatment CD4 cell counts, hepatitis C coinfection and a history of illicit drug use.

Read the Rest.


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

In Conversation with Nomita Chandhiok: Exploring the ‘tool box’ of HIV prevention strategies

Original content from the Mapping Pathways blog team

“If a woman, for whatever reason, is unable to negotiate the use of a condom during sex, at least she can have something else to protect herself with – something that can help put her in control.”

Doctor Nomita Chandhiok is one smart lady. A gynaecologist by training, she is a scientist and researcher in the Division of Reproductive Health at the Indian Council of Medical Research (ICMR), the premiere research body of the government of India. Her job is to identify issues related to women’s health, sexual reproductive health, women’s infection, and HIV prevention that are relevant to India, and then conduct and coordinate studies that push forward research on these issues.

“HIV is a high priority for the Council,” says Dr. Chandhiok. “ARVs as prevention have really evolved.” She explains that all HIV prevention and treatment policies fall under the Indian government’s NACO programme. “As part of this programme, we would promote HIV prevention strategies such as PrEP or microbicides. Our focus so far has been on promoting condom use and safe sex practices, but now there could possibly be these new tools as well.”

Creating the toolbox
In particular, the ICMR is currently running a number of pre-clinical trials for product development and screening for microbicides. The organisation recently finished a Phase 1 trial that looked at an indigenously produced microbicide called Basant (the product is curcumin/turmeric based). The product was tested on 30 women and was found to be safe, says Dr. Chandhiok. Further studies would explore the post-coital efficacy of Basant and its male tolerability in 30-40 men. A study is also ongoing to identify and prepare six sites in the country for phase III microbicide trials. Dr. Chandhiok explains that these sites are located in three high-prevalence Indian states – Maharashtra, Andhra Pradesh, and Karnataka. The ICMR is seeking to determine the HIV incidence and prevalence rate amongst 9000 commercial sex workers in six districts in these areas. “Once we know the incidence rate, and if it is high enough (say 3-4% or more), we will then develop these sites for future HIV prevention trials.”

An empowerment tool for Indian women
Dr. Chandhiok has been working in this area for almost a decade. In 2003, she received a Fogarty Fellowship at Brown University, where she was exposed to research on microbicides as an HIV prevention tool.  “In early 2000, people thought HIV was going to spread like wildfire in India,” explains Dr. Chandhiok. As a result, the ICMR was looking ahead to find new prevention tools that they could possibly add to the government’s existing arsenal of HIV prevention strategies. As it turns out, the epidemic did not spread as imagined. “HIV is still a big issue in our country, but our numbers are better now… We don’t have a general epidemic. So, given the nature of the epidemic in India, any tools we develop will be for specific populations.”

Dr. Chandhiok explains further, “We talk in terms of a prevention toolbox. We don’t talk about one general tool. The aim is to provide several options that a person could  use through their entire sexual life. So, for example, you have a choice – if you can use a condom, great; if not, then you have the option of using a microbicide also.”

Dr. Chandhiok feels that prevention tools such as microbicides, once their efficacy has been proven and effective products created, could serve to empower Indian women. “As an empowerment tool for women these prevention tools need to be developed.” She explains, “These are very important for us to look at because if a woman, for whatever reason, is unable to negotiate the use of a condom during sex, at least she can have something else to protect herself with—something that can help put her in control.”

Concerns and challenges
Dr. Chandhiok is quick to point out that a lot of this discussion, though, is still theoretical. “At this point, we don’t have enough data to roll out tomorrow. There are still questions to be answered. We’re not at the point of saying we are ready to roll.”

For instance, she explains that oral PrEP, even were its efficacy to be proven, would still run into a huge implementation challenge in India. “In India, we don’t have strong regulation. You could be able to buy an ARV without prescription. So for something like PrEP, which is pill based, you don’t want people using it just like that without a proper prescription or a trained professional administering it and providing proper information and counselling.”

Dr. Chandhiok also feels that because HIV isn’t seen as such a priority issue amongst the majority of the population, adherence issues are another challenge, “Prevention is different from treatment. Only if I perceive myself at risk, only then will I think of preventing it.” And, as Dr. Chandhiok explains, in India most people do not perceive themselves as being at risk – HIV is perceived as a problem relegated to those at the margins of society, commercial sex workers or men who have sex with men. “Basically, for us to be able to roll out something like PrEP, we need government commitment, we need the funds to procure it, and we need a system to reach all the people who require it.” And, as it stands now, all three of these factors remain unclear.

The first and most important hurdle, however, is to prove the efficacy of these new prevention tools, says Dr. Chandhiok. “Only once efficacy is proven, can we even begin to think of all the implementation issues. And as it stands now, the trial results are contradictory; so we are still not too certain about how to proceed.” (Learn more about the various HIV prevention trials here).

Particularly disappointing was the closure of the VOICE trial’s study arm testing tenofovir gel last November, says Dr. Chandhiok. “I’m a little confused because of all the conflicting results. There is no one direction as yet, so we don’t know the clear path ahead. We can’t move forward until we have clear-cut evidence that these tools work.”

Note: The VOICE trial announced on November 25, 2011 the closure of its study arm testing tenofovir gel. The decision was made due to futility – while tenofovir gel was found to be safe, the trial was not able to prove the gel worked to prevent HIV. See the statement from the Microbicide Trials Network  for more information. Previously, the trial had to drop its tenofovir tablet arm due to futility as well. The Truvada tablet arm in the trial is continuing.

Nomita Chandhiok is the Deputy Director General in the Division of Reproductive Health at the Indian Council of Medical Research, the premiere research body of the government of India.



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

In Conversation with Kate Morrow: Of Microbicides, Sensations, and Adherence (Part 2)

Original content from the Mapping Pathways blog team

Kathleen (Kate) Morrow is a staff psychologist at the Miriam Hospital and an associate professor (research) of Psychiatry and Human Behavior at the Alpert Medical School of Brown University. She is driving two innovative microbicide projects – Project LINK and Project MIST. Kate is also a member of the IRMA Steering Committee.

(In Part 1 of this interview, Kate talked about Project LINK and how she got started down this career path.)

MP: Could you describe your work with Project MIST? How does it broaden the scope of your earlier work with Project LINK?

KM: Like Project LINK, Project MIST is also part of the Microbicides Innovation Program. I’m doing the acceptability piece on that project, whose Principal Investigator is Robert Buckheit at ImQuest BioSciences. Out of Project LINK, we understood that women could feel the differences among various gels well enough to discern, with their ratings, one product from another. The women finally had a choice to make at the end of the study. Their experiences impacted the product they chose – different women chose different experiences.

We’re in the process of completing LINK analyses now, and one of the things we feel like we don’t have a handle on is how gel volume would play into, and impact, a woman’s perception and experience with a product. So, if we had the exact same gel, but in different volumes, would she experience different things? That’s a question in the field as well – how much gel do we need to apply? That depends on the dosage, the amount of drugs in each measure of gel. That’s still an open question – and we decided we needed to answer that question from the perspective of the user, so that, if we could, we could optimize the volume for drug delivery, as well as the user experience.

And for me, the big question hanging out there was – what do the guys think? From LINK, we now know what women feel and what they think about those feelings and sensations, but we don’t have any understanding of what their male partners feel and how that will drive their preferences for gels.

Last but not least, MIST also gave us the opportunity to try a quick-dissolving film developed by Lisa Rohan at the University of Pittsburgh. So, we’re looking at those three issues in Project MIST: volume and the difference between a gel and a film with respect to user experiences, and exploring male sexual partners’ sensory perceptions and experiences. Like LINK, it’s a mix method study: this time we’re incorporating the male partners into the qualitative data mix to understand their experiences.  We’ll continue to use the validated scales from LINK.

MP: What inspires you?

KM: Well, to begin with, there’s the work itself. I mean, I do this work because I think it’s really important – I think it’s a piece that’s missing otherwise from the field. There are some of us who focus on things like sexual pleasure (Anne Philpott among them), but we have to understand the mechanisms of sexual pleasure – how do we help with that process? These projects, LINK and MIST, uniquely do that. We’re very unique in the fact that what we are trying to understand is which sensory perceptions and experiences impact willingness to use a product and hopefully, down the line, adherence to product use. That way, we can better create a formula that will not only deliver the drug well, but also will make the sexual experience one that people will want to have – so they’ll continue to use the product. What gets me excited every day is trying to figure out that puzzle, and hoping that in the long run this work will have a beneficial impact on the field and our ability to end the HIV epidemic.

But, you know, research can get drab, it can drag along…you meet your small goals often but the big end points don’t come, I think, as often as we’d like them to! So it’s the little things every day that keep us going. I think the thing that inspires me the most in that sense is my participants. Personally, they’re not getting any benefit out of doing these studies with my team – they know it’s a placebo study. But they come in, they try the products, they give us their opinions… To me, they’re the experts, they’re the ones that are the key to my success and my ability to get the data in this field.

Since we started LINK, we’ve seen more than 400 women walk through our doors saying, “I want to help you do this.” They tried all the different products – and I know they weren’t all pleasant! Yet, our retention rate in the studies is well over 90% – it’s a group of women who really want this to happen. They’re dedicated, they try to be as honest as they can…you know, frankly, we ask them some difficult questions. In the qualitative interviews, they’re sitting across from us telling us the story of their experience – and that can’t be easy to do. At some level it’s got to be a little uncomfortable to talk about your sexual experiences in such detail. And now their male partners are also on board. They all understand the medical necessity of the study. They understand that a pleasurable sexual experience is important to microbicides and their ultimate use. I am constantly amazed by our participants.

MP: As a behavioral scientist, what is your role in this process?

KM: Well, it’s possible (in fact, it’s probable) that we will not be able to make one, single ideal microbicide for women. Everybody likes different things in sex, and people like different characteristics. What we’d like to do is raise the floor – get rid of the absolute bad characteristics and make the properties and performances of these gels good enough for people to use them.

Once we end up with a tolerable gel and begin to move into uptake and access and use, what we can then do as behavioral scientists is educate women and their partners about the not-so-great characteristics that might remain but that have to be there in order for the drug to be efficacious. It’s a balancing act between the experience of the user and the efficacy of the product. At some point, we’re likely to run into “we need it to be like this for the efficacy, we can’t change that”. So then, as a behavioral scientist, I have to say, “Okay, if you can’t change that, what impact is it going to have on the user and how can I help the user to cope with that?”

So, there are two things going on for me: on one hand, let’s make the best one possible to begin with. Then, if there are things we can’t change due to efficacy, how do I help people deal with those remaining issues? Even though it’s not going to be perfect, there are still things we can do as behavioral and social scientists to help deal with those imperfections.

MP: What’s the hardest part about your job?

KM: Not having enough time in the day! There’s just so much to do. I’d like it to move a whole lot faster than it can – but that’s just what it is. Obviously, I wish that we were there already. But day in and day out, I love my work. I love the science. I’m very appreciative of my participants and the efforts that they put in. My team is amazing and I think we’re doing good work and that we’ll be able to contribute, ultimately, to a better microbicide.

MP: What are you most excited about for 2012?

KM: Finishing up the LINK data and figuring out which of our scales are most useful to us in the process of evaluating candidate gels. And, of course, continuing with and finishing MIST and incorporating the male partner experience into the mix. Down the road, I’m hoping that we start a project to do similar kinds of science around rectal microbicides both with men who have sex with men (MSM) and women. I’m keeping my fingers crossed that it will get funded and take off this year. I’m just really excited about moving forward and trying to keep all of us moving forward.


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

Empowering Women to Fight HIV: An Interview with South African Dr. Sengeziwe Sibeko

via AllAfrica.com, interview with Dr. Sengeziwe Sibeko

What makes a young African doctor decide to devote her career to helping women fight HIV? Dr. Sengeziwe Sibeko is a 37-year-old medical researcher with a degree in obstetrics and gynecology from the University of KwaZulu Natal (UKZN) in South Africa, an MSc in epidemiology from Columbia University in the United States, and is about to take up a fellowship to study for her PhD at Oxford University in the United Kingdom. AllAfrica's Julie Frederikse interviewed Dr. Sibeko at the community women's reproductive health clinic run by the Centre for the Aids Program of Research in South Africa (Caprisa) in Durban.

When I did my internship back in 1998, I went to the rural northern part of KwaZulu Natal (the South African province where she lives and works) and I was really looking forward to saving lives - yet that was not what was happening at the time. People were dying. You came in each morning to see people die rather than to be able to save lives. But when I went on to do my community service (a two-year requirement for all South African medical students), I really enjoyed obstetrics and gynecology, so when I had the opportunity to specialise I knew that was what I wanted to do.

But over the five years of my specialisation, that changed too. It was no longer just about babies being born - women were coming in because they were sick and babies were dying. I found it to be a depressing situation, and this was further compounded by staff shortages due to people leaving the health system.

Given the depressing effects of Aids that you witnessed, how did you develop your passion around protecting African women from HIV?

My actual turning point came when I went overseas. I got a fellowship in 2006 (from the Fogarty International Clinical Research Scholars and Fellows). That meant that for the first time - I remember this so clearly - I was removed from the everyday numbing situation that I had been in back in South Africa.

So it was only when the National Institutes of Health (NIH) in Washington DC brought all the global health experts together, and their presentations showed me that this is how Asia is doing with the HIV and Aids situation, this is how the United States is doing, and this is you in sub-Saharan Africa - I almost collapsed! I never realised that this is the situation in the region where I'm from. It made me decide that I'm going to go home and be part of the solution.

So what did you do next?

I thought, we can't be waiting for women to come to the clinic, to be sick and to die - there's got to be a way to prevent women getting HIV in the first place. I wanted to do something major, and I saw that it must be through the public health route. So I went into Caprisa and met Dr. Quarraisha Abdool Karim. The time that I joined coincided with a conference on the potential of microbicides to fight HIV. So I thought, wow, I'm in the right place, this could save women's lives. I became the overall gynecologist of the study, so I like to think of it as my baby.

When I joined the field there hadn't been any success stories with microbicides. There were lots of negative trials and the field was almost dying. I remember talking to Dr. Henry Gabelnick (head of Caprisa's research partner, the U.S. reproductive health group, CONRAD) who is the greatest proponent of microbicides, and I told him, if you give up on this concept you give up on women. Because I see this as a woman-empowering strategy. It gives women the opportunity to be in control when they can't negotiate other safe sex practices.

Read the rest.


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

South Africa's Health Services: An Interview with CAPRISA's Dr. Quarraisha Abdool Karim

via AllAfrica.com, interview with Dr.Quarraisha Abdool Karim

Dr. Quarraisha Abdool Karim is an infectious diseases epidemiologist and associate scientific director of the Centre for the Aids Programme of Research in South Africa (Caprisa). AllAfrica's Julie Frederikse spoke to the 51-year-old and asked her about the challenges facing her team as they search for effective ways to prevent HIV and other sexually transmitted infections.

We appreciate that there are many challenges. To simply walk in and say, doctors and nurses, you must now provide this or that - it won't work. We are aware that services are very strained in the public health sector. Morale is low, staff feel overwhelmed, and nurses often don't get sufficient support in the implementation of policy decisions.

So we have been working with the family planning nurses, using a Quality Improvement Strategy model that's been used extensively to improve the quality of health care delivery and access to important health interventions. It's similar to Paolo Freire's work in education, in that we aim to work with health care staff using empowering and enabling approaches.

How would you assess the government's sexual and reproductive health services in South Africa?

This country has one of most enviable lists of contraceptive methods available at no cost, yet the main method used is Depo Provera (which a recent study has shown to double the risk of transmission of HIV to women). There are IUDs and implants, which may be much better, safer options. So why are they not being promoted? Even with the injectables, there is NET-EN (norethisterone enanthate), which has a lower dose of progesterone and has a favourable safety profile for use by young people.

The point is that we have as policy on our essential drug list an extensive group of fertility control methods, so why is this not translated into access at point of delivery? The answer relates to the fact that the normal interaction time between a health professional and a client is very short, sometimes as short as 30 to 40 seconds. This doesn't leave time to consider other contraceptive options. We know you can't change people overnight, especially when their prescribing patterns are limited to just giving an injection, and perhaps asking a question like, 'do you know your HIV status?' But we know that we've got to change health care provision - to include HIV testing, screening for STIs and cervical cancer, just to mention a few. It's got to be part of a comprehensive model for prevention and treatment - but the challenges are in how to integrate this in over-stretched clinics.

Read the rest.


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

In Conversation with Kate Morrow: Of Microbicides, Sensations, and Adherence (Part 1)

Original content from the Mapping Pathways blog team

Kathleen (Kate) Morrow is a staff psychologist at the Miriam Hospital and an associate professor (research) of Psychiatry and Human Behavior at the Alpert Medical School of Brown University. She is driving two innovative microbicide projects – Project LINK and Project MIST. Kate is also a member of the IRMA Steering Committee.



MP: What got you started down the path of HIV prevention?

KM: From a personal perspective, I spent much of the ’80s losing people to the epidemic – that was a very powerful experience in my life. Then, after I trained to become a clinical psychologist, I worked as a clinician in an outpatient substance abuse clinic and many of my patients were infected with HIV. At that point, I was a Masters level clinician. When I went back for my doctorate, I decided to study HIV prevention – and it’s been my work ever since.

MP: And how did microbicides come into the picture?

KM: In the course of my post-doctoral fellowship I was introduced to microbicides by my mentor, Ken Mayer. Like many people, I didn’t even know what a microbicide was at that point! He asked me to pursue the notion of acceptability and how these new products would fare in that regard. I became very interested in how that was going to work, and it just…suited me as far as what I wanted my career to be about. It was about so many things close to my heart – giving people (especially women) the power and control to prevent HIV, something that didn’t interfere with their lives… My work primarily focused on women to begin with. Ultimately, I’ve gotten involved in the broader reality of what microbicides will be (I hope!), including vaginal and rectal microbicides for both men and women.

In my work with acceptability, a big issue for me was that we were conceptually equating acceptability and adherence. It’s like we were saying if they adhere to it, it must be acceptable and if it’s acceptable they’ll adhere to it. In my mind, that’s not a given. I mean, I would love to believe that if it’s acceptable, everyone will use it – but I don’t think that’s necessarily true given the relational and contextual issues that surround microbicide use.

MP: What is Project LINK all about?

KM: Project LINK began in 2006. It is funded primarily by a grant from the National Institutes of Health, and was also supported by CONRAD. It is part of the NIH’s Microbicide Innovation Program.It is focused on the female user experience. The main idea is to try to understand how the formulation of a microbicide – the properties and characteristics of the gel itself – relates to the experiences the users have. The study involves approximately 350 women. The data collection is now complete, and we hope to have the results in the coming months.

We’ve been running into a lot of adherence issues across microbicides trials since the very beginning. LINK is trying to understand what the user experience is given the kind of formulations that they’re using and the properties of those formulations. Each product has its own constituents, its ingredients, and the way they interact with each other and with other external factors. If we can link these formulation characteristics to a woman’s experience, then maybe we can fix or enhance that experience and make it something that women can at least tolerate – if not enjoy.

MP: Could you explain with an example?

KM: Take, for example, leakage. Leakage is something that we always deal with when it comes to vaginal gels. Some gels leak while others are good at not leaking out. If leakage is a bad experience for women then we can alter the “recipe” of the formulation, so to speak, to minimize that leakage or to make it happen at a different, more preferable point in time. The idea is to figure out what women can feel and experience at a very sensory level, in their vaginas, and pinpoint which sensation is being driven by which of the gel’s properties or performance characteristics.

MP: What stage is Project LINK at currently? And what’s the end goal?

KM: We’ve developed a set of scales to show the range of different sensations and experiences reported by women when they use the products. Basically, these scales allow women to rate products given specific statements. We then tested four novel gels using these scales. The idea was to capture a range of women’s experiences from a relatively low-viscosity gel to a high-viscosity gel, along with other varying parameters (yield stress, dilutions properties, etc.). When the women had evaluated all four gels, at the end of their final visit in the study, they provided data on which formulation they would prefer. Their experiences impacted the product they chose – different women chose different experiences.

Now, we’re analyzing the data to understand the correspondence (hence, Project LINK) between the sensations and the properties of the gels. Once we’ve done that, we can try and make the microbicides feel better to the user – and make them work better, too. Obviously, the formulation is primarily about delivery and efficacy – to get the active ingredient where it needs to go, do what it needs to do, and stay there for as long as it needs to. That’s key. But if we can figure out how to make the best formulation for drug delivery and make it one that women can at least tolerate, if not like, then we have a better shot at effectiveness overall. If it feels good, women will use it.

Actually, there are two ways of looking at microbicide gels. First, you could think of it as a product with a neutral impact on the sexual experience – some people enjoy sex the way it is and don’t want it altered by a product. This would also be useful for women who need the microbicide to be covert. Second, you can develop a product that actually enhances sexual pleasure. Hopefully, if people like it, that would increase the likelihood of their using it. And if it’s efficacious to begin with, then that means we’re reducing the possibility for HIV infection.

Watch this space for Part 2 of this interview, where Kate talks about the broadening scope of her research in Project MIST, behavioral science, what inspires her, and the hardest part about her job.

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

HPV vaccine may be beneficial to young women with HIV

via AIDSmeds

Young women living with HIV may benefit from vaccinations that protect against cervical cancer, according to a new study showing that many HIV-positive women averaging 21 years of age are negative for the human papillomavirus (HPV) types typically associated with tumors, according to a new analysis. These encouraging findings were presented at the 2nd International Workshop on HIV and Women, held January 9 and 10 in Bethesda, Maryland, and were reported by the National AIDS Treatment Activist Project (NATAP).

Two HPV vaccines are approved for use in the United States: Gardasil and Cervarix. The U.S. Centers for Disease Control and Prevention (CDC) recommends them for all 11- and 12-year-old girls and all females between 13 and 26 years of age who have not been vaccinated or completed the three-injection series. The vaccines help protect against four HPV genotypes, two of which—types 16 and 18—are major causes of cervical cancer.

The effectiveness of HPV vaccination in women living with HIV isn’t known, with some experts suggesting that efficacy will be lower, on the assumption that many young women infected with HIV have also been infected with HPV genotypes 16 and/or 18. A clinical trial, conducted by the Adolescent Medicine Trials Network for HIV/AIDS Interventions, is being conducted to answer these questions.

Early results from the study, presented by Jessica Kahn, MD, of the University of Cincinnati and her colleagues, help answer one of these questions. According to her team’s results, most of 99 women enrolled to receive HPV vaccination were negative for high-risk HPV types.

Read the rest.


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

Ribbons Without Rights Don't Save Lives

via The Huffington Post, by Serra Sippel

Last month, the President's Emergency Plan for AIDS Relief (PEPFAR), in partnership with George W. Bush Institute, Susan G. Komen for the Cure, and UNAIDS, launched the global "Pink Ribbon Red Ribbon" campaign, an initiative that integrates cervical and breast cancer education, screening, and treatment with HIV services. It's a move that has the potential to reduce the number of cancer deaths among women living with HIV and improve their overall health. Given that women living with HIV are at an increased risk of developing cervical cancer, it makes sense. It's a logical and critical part of what PEPFAR is calling care and support services.

What doesn't make sense is that planning a family and preventing further HIV transmission is not part of what PEPFAR is calling care and support. HIV was responsible for 60,000 maternal deaths in 2008, and pregnancy alone could put women at higher risk of transmitting and acquiring HIV. Integrating and linking voluntary family planning, HIV, and cervical cancer prevention saves lives, improves access to quality care and promotes human rights. Including family planning in Pink Ribbon Red Ribbon would help women manage childbearing and protect themselves and their partners from infection or re-infection (think female condoms) and should be automatic.

UNAIDS has stated as much. "We must take AIDS out of isolation and provide young girls with opportunities to negotiate their sexual relationships and receive sexuality education so that they can protect themselves from infection," said UNAIDS Executive Director Michel Sidibé at this year's Commission on the Status of Women. "If we don't do this, our vision of zero new infections will remain a dream."

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

From Tuskegee to Transparency: An Evolution in the Ethics and Accountability of Clinical Trials Involving Human Subjects

via RH Reality Check, by Anna Forbes and Kate Ryan

People who participate in clinical trials take the enormous step of volunteering to test a product that may be useful and, sometimes, life-saving if it turns out to be effective. They play an irreplaceable role in research to prevent, treat, and sometimes cure illness – as well as to find other ways to improve people’s health and lives.

Trial participants make a profoundly personal contribution and accept potential medical, social, and personal risks on behalf of others. An ethical trial is one that eliminates or minimizes participants’ risks as much as possible, invests in making sure that participants understand clearly what they are volunteering for, and protects their rights at every step.

For example, without clinical trials, we would not have seen recent advances in antiretroviral drugs to treat HIV, long-acting contraceptive choices that allow women greater control over their use, or microbicides that may be able to protect women from HIV.

The United States government has rules to protect people who participate in federally-funded biomedical and behavioral research. The rules vary depending on which agency is supporting the research, but they all share a starting point known as the Common Rule, a set of regulations for all federally-funded research involving human participants, whether it is conducted inside or outside the U.S.

But those rules have not always been in place, and there are some shameful chapters in the history of medical research supported by the United States that include violations of the most basic standards of ethical behavior.  This history has left some people deeply suspicious of clinical trials and the motives of those who conduct them. Many explain their suspicion with one word: “Tuskegee.”

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

Contraceptive injections and HIV transmission risk - what happens now?

via aidsmap, by Roger Pebody

With new data suggesting that injectable contraceptives may double the risk both of acquiring and passing on HIV, how will this affect women’s contraceptive choices? What are the implications for family planning policy in countries with a high burden of HIV?

Panellists on a teleconference on the topic, organised by AVAC last week, agreed that the data do not yet provide definitive answers and that healthcare providers need to avoid frightening women away from contraceptive methods they know and trust.

Experts are mindful that the HIV-related risks need to be balanced with contraception’s benefits for maternal and child health. Family planning helps to prevent unintended pregnancies and the number of unsafely performed abortions, thereby reducing maternal deaths, disabilities and infertility. It can prevent high-risk pregnancies among adolescents, older women, women in poor health and women who have had many births or births spaced too closely together. Because it helps women to space births, child mortality rates are lower; mothers have more time to breastfeed, improving infant health; and women have more time to recover physically and nutritionally between births.

Moreover, preventing unwanted pregnancies in women with HIV is also one component of strategies to reduce mother-to-child HIV transmission.

At the International AIDS Society’s conference in Rome in July, Dr Renee Heffron of the University of Washington presented results from an analysis of data from the Partners in Prevention cohort in seven African countries. The results, reported on Aidsmap at the time, showed that HIV-negative women who were in a relationship with an HIV-positive man had twice the risk of acquiring HIV if they used hormonal contraception. Furthermore, HIV-positive women had twice the risk of transmitting HIV to their male partners if they used hormonal contraception.

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

Epidemiological impact of tenofovir gel on the HIV epidemic in South Africa

via pubmed.gov, by Williams BG, Abdool Karim SS, Karim QA, Gouws E.

Background

Tenofovir gel, an antiretroviral-based vaginal microbicide, reduced HIV acquisition by 39% in women in a recent randomized controlled clinical trial in South Africa.

Methods

To inform policy, we used a dynamical model of HIV transmission, calibrated to the epidemic in South Africa, to determine the population-level impact of this microbicide on HIV incidence, prevalence, and deaths and to evaluate its cost-effectiveness.

Results

If women use tenofovir gel in 80% or more of sexual encounters (high coverage), it could avert 2.33 (0.12 to 4.63) million new infections and save 1.30 (0.07 to 2.42) million lives and if used in 25% of sexual encounters (low coverage), it could avert 0.50 (0.04 to 0.77) million new infections and save 0.29 (0.02 to 0.44) million deaths, over the next 20 years. At US $0.50 per application, the cost per infection averted at low coverage is US $2392 (US $562 to US $4222) and the cost per disability-adjusted life year saved is US $104 (US $27 to US $181); at high coverage the costs are about 30% less.

Conclusions

Over 20 years, the use of tenofovir gel in South Africa could avert up to 2 million new infections and 1 million AIDS deaths. Even with low rates of gel use, it is highly cost-effective and compares favorably with other control methods. This female-controlled prevention method could have a significant impact on the epidemic of HIV in South Africa. Programs should aim to achieve gel use in more than 25% of sexual encounters to significantly alter the course of the epidemic.

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

Research Linking Contraceptives to HIV Raises Policy Questions

via PBS Newshour, by Talea Miller

A study showing injected hormonal birth control could make women more vulnerable to HIV is raising big questions about medical guidance in regions with high HIV rates.

Research conducted by the University of Washington in seven African countries found use of injected hormonal contraceptives doubled women's risk of contracting HIV and the chances of passing HIV to a partner.

Policymakers are moving cautiously in response to the findings, which were first released this summer at an HIV conference and published again this week by the Lancet. The World Health Organization has scheduled a January 2012 review of the research, but for now the organization and the U.S. Agency for International Development are making no new contraceptive recommendations and the two groups have emphasized the study's limitations.

In a statement released in August when the study first surfaced, USAID noted flaws in the study's design and called for a randomized, controlled version to flesh out the results. The agency also noted that while a few previous studies show a connection between hormonal contraception and HIV transmission, the majority of previous research found no association.

"USAID does not believe that a change in contraceptive policy or programming is appropriate or necessary at this time," the statement said, and a USAID spokesperson said Tuesday that finding still stands.
The WHO also took issue with the study's reliance on data based off observations in a written response to the Lancet publication.

Read the rest.



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

An integrated structural intervention to reduce vulnerability to HIV and sexually transmitted infections among female sex workers in Karnataka state, south India

via BMC Public Health, by Vandana Gurnani, Tara S Beattie, Parinita Bhattacharjee , Cfar Team, H L Mohan , Srinath Maddur, Reynold Washington, Shajy Isac, B M Ramesh, Stephen Moses and James F Blanchard

Abstract

Background:

Structural factors are known to affect individual risk and vulnerability to HIV. In the context of an HIV prevention programme for over 60,000 female sex workers (FSWs) in south India, we developed structural interventions involving policy makers, secondary stakeholders (police, government officials, lawyers, media) and primary stakeholders (FSWs themselves). The purpose of the interventions was to address context-specific factors (social inequity, violence and harassment, and stigma and discrimination) contributing to HIV vulnerability. We advocated with government authorities for HIV/AIDS as an economic, social and developmental issue, and solicited political leadership to embed HIV/AIDS issues throughout governmental programmes. We mobilised FSWs and appraised them of their legal rights, and worked with FSWs and people with HIV/AIDS to implement sensitization and awareness training for more than 175 government officials, 13,500 police and 950 journalists.

Methods:

Standardised, routine programme monitoring indicators on service provision, service uptake, and community activities were collected monthly from 18 districts in Karnataka between 2007 and 2009. Daily tracking of news articles concerning HIV/AIDS and FSWs was undertaken manually in selected districts between 2005 and 2008.

Results:

The HIV prevention programme is now operating at scale, with over 60,000 FSWs regularly contacted by peer educators, and over 17,000 FSWs accessing project services for sexually transmitted infections monthly. FSW membership in community-based organisations has increased from 8,000 to 37,000, and over 46,000 FSWs have now been referred for government-sponsored social entitlements. FSWs were supported to redress >90% of the 4,600 reported incidents of violence and harassment reported between 2007-2009, and monitoring of news stories has shown a 50% increase in the number of positive media reports on HIV/AIDS and FSWs.

Conclusions:

Stigma, discrimination, violence, harassment and social equity issues are critical concerns of FSWs. This report demonstrates that it is possible to address these broader structural factors as part of large-scale HIV prevention programming. Although assessing the impact of the various components of a structural intervention on reducing HIV vulnerability is difficult, addressing the broader structural factors contributing to FSW vulnerability is critical to enable these vulnerable women to become sufficiently empowered to adopt the safer sexual behaviours which are required to respond effectively to the HIV epidemic.


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

MTN Statement on Decision to Discontinue Use of Oral Tenofovir Tablets in VOICE, a Major HIV Prevention Study in Women

via Microbicide Trials Network

VOICE, an HIV prevention trial evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women – daily use of one of two different ARV tablets or of a vaginal gel – will be dropping one of the oral tablets from the study. The decision to discontinue use of tenofovir tablets in VOICE comes after a routine review of study data concluded that the trial will not be able to demonstrate that tenofovir tablets are effective in preventing HIV in the women enrolled in the trial. VOICE will continue to test the safety and effectiveness of the other oral tablet, Truvada®, a combination of tenofovir and emtricitabine, and of the vaginal gel formulation of tenofovir.

Importantly, the review, which was conducted by the National Institute of Allergy and Infectious Diseases (NIAID)’s independent Prevention Trials Data and Safety Monitoring Board (DSMB), identified no safety concerns with any of the products being studied in VOICE.

VOICE – Vaginal and Oral Interventions to Control the Epidemic – involves 5,029 women at 15 trial sites in Uganda, South Africa and Zimbabwe. The trial is being conducted by the Microbicide Trials Network (MTN), an HIV/AIDS clinical trials network funded by the National Institute for Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver Institute for Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health.

The study was designed with five study groups: tenofovir gel, an inactive placebo gel, oral tenofovir, oral Truvada and an inactive placebo tablet. The women in each group (about 1,000) are asked to take their assigned study product daily. VOICE is the only trial evaluating the daily use of an ARV tablet – an approach called oral pre-exposure prophylaxis, or PrEP – and a vaginal gel in the same study. This design is important for determining how each product works compared to its control (placebo gel or placebo tablet) and which approach women prefer.

On September 16, 2011, the NIAID Prevention Trials DSMB reviewed VOICE study data for the period between Sept. 9, 2009, when the study began, and July 1, 2011. Based on this interim review, the DSMB determined that it was not possible to show whether oral tenofovir tablets were any better than a placebo for preventing HIV in the women assigned to that study group. The DSMB therefore recommended that the women randomized to the oral tenofovir tablet group discontinue their use of the study product. This recommendation does not apply to the women in the groups using either the tenofovir gel or oral Truvada tablets, or the corresponding placebos; the DSMB recommended that these four study groups continue in VOICE.

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

CAPRISA Team Acknowledged for Outstanding Achievement in Global Health

Via EurekaAlert.

[June 20, 2011] the CAPRISA 004 study leadership team [was] awarded the inaugural Drug Information Association (DIA) President's Award for Outstanding Achievement in World Health. The award recognizes the team's significant contribution to the field of HIV prevention and is being presented during the opening plenary of the annual DIA conference. The CAPRISA 004 study demonstrated the effectiveness of tenofovir 1% gel in reducing the risk of HIV and herpes infection in women.

"The CAPRISA 004 trial provides new hope for women who bear the brunt of the HIV epidemic in Africa. When implemented, it could have a profound impact on the course of this epidemic," said Study Co-principal Investigator Dr. Salim S. Abdool Karim, Director of CAPRISA and Pro Vice-Chancellor (Research) of the University of KwaZulu-Natal, South Africa. "This breakthrough would not have been possible without the close collaboration between the three South African and the three U.S. partners who led this study; I am proud and honored to receive this award on behalf of this remarkable team."

The Center for the AIDS Program of Research in South Africa (CAPRISA) of the University of KwaZulu-Natal and Columbia University spearheaded the trial in partnership with FHI and CONRAD, with the support of USAID, and the South African government through the Technology Innovation Agency (TIA). Gilead Sciences donated the active ingredient for the manufacture of the gel.

"We are pleased that the DIA has recognized the CAPRISA team's outstanding achievement and significant contribution to the fields of microbicide research and HIV prevention," said Howard Jaffe, M.D., President and Chairman of the Board of the Gilead Foundation. "Gilead congratulates the principal investigators, study staff and partners, and commends the courageous women who participated in this historic trial."

The CAPRISA 004 study of tenofovir gel involved 889 women at two sites in KwaZulu-Natal, South Africa. Women in the study were advised to use the gel up to 12 hours before sex and again soon after having sex, for a maximum of two doses within 24 hours. Women using the gel with the active ingredient had an average of 39% fewer HIV infections and 51% fewer genital herpes infections compared to women who used a placebo gel. These results provided the first evidence that an antiretroviral drug can reduce the risk of HIV in women.

"USAID made the right decision in supporting the CAPRISA 004 trial. We were thrilled to collaborate with the South African government in funding the study and we continue to work closely with a wide range of partners in planning for all of the aspects of implementation as we await the results of confirmatory trials," said Dr. Jeff Spieler, Senior Technical Advisor in Science and Technology in Population and Reproductive Health (PRH) at USAID.

Read the rest here.

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

95,000 Adolescents Living With HIV in India: UN Report

Via DNA India.

India, where 95,000 adolescents are living with HIV, has been listed along with the sub-Saharan countries having the highest number of youngsters infected by the deadly virus, according to a UN report.

In the age group of 10-19 years, India with 46,000 infected girls and 49,000 boys, has been ranked tenth in the list of countries most affected with HIV in 2009, the report 'Opportunity in Crisis: Preventing HIV from early adolescence to young adulthood' said.

Read the rest here.

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

FEM-PrEP CLOSURE UPDATE: What does “futility” mean exactly?

It’s only been a few months into 2011, and last year’s trend of headline-making PrEP-related news continues. Last month, the FEM-PrEP trial was halted due to futility. This means that it was determined the study could not answer the question of whether daily Truvada worked, or not, in terms of preventing HIV among the trial population. Click here for the Mapping Pathways post on the trial closure.

Data collection for a final endpoint analyses report has begun. According to sources from Family Health International (FHI), primary endpoint data gathering will continue till around August 2011, and a final analysis of the primary endpoint and some secondary analyses can be expected to be completed by the end of this year. See more about the objectives and endpoints for these analyses here.

Meanwhile, as we await this report, many interesting conversations have been taking place about possible causes for the trial’s closure and what this might mean for the big picture on PrEP. How will this affect other similar trials, such as the VOICE trial, which is underway? What about future biomedical trials? What caused FEM-PrEP to be unable to answer the central question of the trial and be deemed “futile”⎯was it biological gender differences in drug activity and route of exposure, socio-cultural factors or simply flaws in the study design? How big a factor was adherence, and what lessons can we learn for future trials to create better ways of monitoring and encouraging adherence?

“There’s still so much we don’t know, and these are open questions rather than being settled questions,” remarked Julie Davids, Director of National Advocacy and Mobilization and lead coordinator of the HIV Prevention Justice Alliance from the AIDS Foundation of Chicago, a Mapping Pathways partner organisation. Davids, who observed that a “healthy conversation” was now happening among advocates, people living with HIV, researchers and others, also commented on the idea of “futility”: “‘Futility’ in common usage sounds really bad; outside the trial context, it means ‘hopeless.’ But in fact, in the trial context, ‘futility’ is not a definitive answer. It simply means that we don’t yet know and this way we’re proceeding is not going to answer the question⎯we can’t prove that the intervention worked, and we can’t prove that the intervention didn’t work … There are still things to be learned.”

John S. James from AIDS Treatment News looked at the trial’s closure from a behavioral point of view, discussing the need for science to take socio-cultural factors into account: “The iPrEx trial worked much better at the U.S. sites (Boston and San Francisco) than at other sites, where participants would often have strong reason to give their medication to someone who was sick due to HIV, and not tell the researchers. All of the FEM-PrEP sites were in Africa, where access to life-saving HIV treatment is much worse than in Boston or San Francisco. Unlike iPrEx, FEM-PrEP had no U.S., European, or other sites where no one would need to divert the pills to save the life of a family member or friend.”

Read on for a lively discussion on the how’s, why’s and what-if’s of FEM-PrEP

Read more »

Discontinuation of the FEM-PrEP Trial - a quick round-up

This week saw a major development in the HIV prevention field: the Independent Data Monitoring Committee (IDMC) for the FEM-PrEP trial  concluded that it would be unlikely to prove the effectiveness of Truvada in preventing HIV infection among the study population, i.e., HIV-negative women who are at risk of infection through sexual transmission. As a result, Family Health Iinternational (FHI) – which is implementing the trial with research centers in Africa – has decided to discontinue the study.

Get the details as well as FHI’s perspective on the FHI website.

The CAPRISA group thanked FHI for carrying out the study and providing extremely significant interim results, and the iPrEx team stated that they look forward to working with the FEM-PrEP team to understand the results better. NIAID (National Institute of Allergy and Infectious Diseases) released a statement expressing disappointment at the halt of the trial, emphasizing the need for continuing research, and confirming that it will continue with the VOICE (Vaginal and Oral Interventions to Control the Epidemic) study while informing all current  VOICE participants about the FEM-PrEP results as early as possible.

The Microbicide Trials Network, the group conducting the VOICE study, issued a statement saying, "While it is disappointing that FEM-PrEP will not be able to provide information about Truvada for preventing HIV in women, the decision to stop the study should have no immediate impact on the VOICE study. VOICE is an ongoing trial involving women in Uganda, South Africa and Zimbabwe testing Truvada as well as the ARV tablet tenofovir and a vaginal microbicide containing tenofovir in gel form. VOICE will help determine which approach – daily use of the gel or tablet – is safe, effective and preferred by women for preventing HIV."

In The Wall Street Journal, Mark Schoofs outlined various possible explanations for the disappointing results, including potential adherence issues, as well as the physiological differences between men and women (essentially, these differences could mean a pill like Truvada may work better at preventing HIV infection among gay men or women with rectal exposure to HIV, than heterosexual women exposed vaginally.)  The New York Times deemed the termination of the trial “an unexpected setback” while the Washington Post discussed preliminary data.

South Africa’s Mail & Guardian presented the views of Dr. Khatija Ahmed of the Setshaba Research Centre in Pretoria. Dr. Ahmed led the research at one of the FEM-PrEP trial sites, and she points out that the halt of the trial “shows that you can't extrapolate that what happens in one population group will give you the same results in another population group.” She also stresses the need for ongoing research into HIV prevention options, given the high prevalence of HIV in sub-Saharan Africa.


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