Mapping Pathways is a multi-national project to develop and nurture a research-driven, community-led global understanding of the emerging evidence base around the adoption of antiretroviral-based prevention strategies to end the HIV/AIDS epidemic. The evidence base is more than results from clinical trials - it must include stakeholder and community perspectives as well.

Showing posts with label HPTN 052. Show all posts
Showing posts with label HPTN 052. Show all posts

31 May 2012

Developing multiple prevention strategies, Part II—In conversation with U.S.-Based Jessica Terlikowski

Original content from the Mapping Pathways blog team

“We need to ensure access to all forms of prevention and treatment is readily and easily available for anyone who needs it, so people can reduce their risk, get the prevention and care they need, reduce onward transmission and lead healthy lives.”


Jessica Terlikowski is director of regional organizing at AIDS United based in Washington, D.C. and was most recently a policy manager at the AIDS Foundation of Chicago. Both organizations are Mapping Pathways partners. Jessica is co-founder of the Chicago Female Condom Campaign, and coordinates the National Female Condom Coalition. She was recently honored by the AIDS Legal Council of Chicago  as “Advocate of the year” for outstanding work in making a difference in the lives of people with HIV and AIDS. 

 In part 1 of her interview, Jessica discussed the importance of scaling up interventions we know that work while moving forward with new strategies like PrEP. In part II of the interview, she discusses some of the challenges that have to be overcome in the HIV prevention landscape.

MP: In our previous conversation, you mentioned a lack of political will to invest in resources? Could you elaborate on that?

JT: In the United States, there are a number of state and federal lawmakers who are proposing deep cuts to health care, prevention, and other public assistance programs in the name of “fiscal responsibility.” They claim that by reducing the government’s spending on such programs, we can begin to turn the U.S. economy around. However, such cuts would be devastating to those of us who already struggle financially and have limited to no access to healthcare – the majority of people with HIV. Additionally, decimating health and social safety net programs results in higher future costs which simple doesn’t make good economic sense.

Federal funding for syringe-exchange programs has recently been banned once more, just two years after our Congress lifted a 21-year ban. These programs provide sterile syringes, male and female condoms, HIV and hepatitis counseling and testing, vaccinations, and many other lifesaving services to injection-drug users and their partners.  Syringe exchange is one of the most successful and cost-effective interventions we have. 

We’re in a situation now where we are getting conflicting messages from our leaders. On the one hand, we have Secretary of State Hillary Clinton saying, “we can have an AIDS-free generation “, while at the same time Congress is making decisions that undercut efforts to actually get us to that point.

MP: Why is the work that Mapping Pathways is doing important right now?

JT: Our work especially matters because we have a number of tools now and coming down the pike to stem the HIV epidemic. We have several strategies at our disposal including PrEP and TLC+. While the stakeholder interviews and community input sessions are hugely beneficial to us, they also inform, educate and create a discussion among the stakeholders and the communities they belong to.

Many people’s knowledge of ARV-based prevention strategies is limited. They also have a lot of questions and concerns. . We are creating a space for people to learn and to discuss each of the options and how they relate to each other. Mapping Pathways participants then communicate and discuss the broader issues with their own communities. This is something that we are working on now—the dissemination of the community and expert perspectives we collected in the first year of the project.

Mapping Pathways is also important here in the U.S. because HIV continues to be a big problem here that especially impacts people who are already marginalized: people with low incomes, gay men, transgender women and women of color, people who use drugs. These are communities whose needs must be prioritized if we are to reduce the number of new HIV infections.

Mapping Pathways is all about having conversations about ARV-based prevention strategies. We need to make sure that these strategies are not going to be reserved just for people who already have access to healthcare.  We need to ensure access to all forms of prevention and treatment is readily and easily available for anyone who needs it, so people can reduce their risk, get the prevention and care they need, reduce onward transmission and lead healthy lives.

MP: Is this possible in the U.S. context right now?

JT: It is, but it won’t happen overnight. AIDS is a social justice issue and not just a public health issue. We have to talk about many other issues when we talk about HIV, like sex, drugs, and poverty, which are not things many people feel comfortable talking about. Our job as advocates is to raise these issues with decision makers and educate and organize our communities to build the necessary political will.
  
MP: What is the most satisfying part of your job?

JT: I think the most satisfying part of my job is working with others who share a common passion and drive on these issues. We are all deeply committed to working with our communities to increase political will for greater investment in and attention on HIV prevention, treatment, and care issues.

Read the first part of Jessica’s interview here, and learn more about the Mapping Pathways learnings from the U.S. here



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22 May 2012

Developing multiple HIV prevention strategies - In conversation with U.S.-based Jessica Terlikowski

Original content from the Mapping Pathways blog team

“We must build the political will for investment in each these HIV- prevention strategies”

Jessica Terlikowski is director of regional organizing at AIDS United based in Washington, D.C. and was most recently a policy manager at the AIDS Foundation of Chicago. Both organizations are Mapping Pathways partners. Jessica is co-founder of the Chicago Female Condom Campaign, and coordinates the National Female Condom Coalition. She was recently honored by the AIDS Legal Council of Chicago  as “Advocate of the year” for outstanding work in making a difference in the lives of people with HIV and AIDS. 

 MP: How did you get involved in the field of HIV prevention?

JT: I got involved in the field of HIV prevention through my commitment to women’s reproductive health and rights, which is where I got my professional start. I have been a staunch reproductive rights advocate ever since I can remember.  When I moved to Chicago, there was a position available at the AIDS Foundation of Chicago and microbicide education and advocacy education was a part of the job.  I didn’t have an in-depth knowledge of the field at the time and was eager to learn.  

 MP: Is there a prevention strategy that you are especially passionate about?

JT: I think the key is to have as many prevention strategies available as possible. I am, however, extremely passionate about female condoms as they are an important tool for any receptive partner—woman or man—to reduce their risk of HIV and other STDs. They are particularly important for women though as female condoms are the only HIV and STI prevention options that also prevents unintended pregnancies. The global South has recognized the value of this tool for quite some time and the U.S. is starting to get there now too. We are seeing more and more community based organizations, clinics and health departments prioritize female condoms as a result of increased advocacy from a handful of us. The U.S. female condom movement is growing and building momentum.

What I am really concerned about is making sure that people are aware of what prevention strategies exist, so they know what is out there and can access what they need when they need it. We owe it to the communities to push for both existing tools like male and female condoms, sterile syringes, PEP, as well as emerging biomedical tools like microbicides and PrEP.

MP: What Mapping Pathways activities have you and AIDS United engaged in recently?

JT: We adapted the analyses from stakeholder interviews and online survey the Mapping Pathways team conducted in 2011 and created a PowerPoint slide deck which provides  a strong overview of the Mapping Pathways methodology, definitions of ARV-based prevention terms and an overview of ARV-based prevention strategies (read more about the presentation here). We conducted community input sessions with stakeholders at the CDC’s National HIV Prevention Conference and with a number of stakeholders at and AIDS United convening of southern grantees.  

A key finding  was that when we talked about ARV-based prevention strategies, people’s minds would go straight to PrEP instead of thinking of the full portfolio of ARV-based prevention strategies—TLC+, vaginal and rectal microbicides, and PEP. We also learned that there is a real need for developing a common vocabulary around these options to ensure we are all talking about the same thing. At times stakeholders would interpret use the term “treatment as prevention” to refer to PrEP when it is actually referring to TLC+.

A major theme arising from the stakeholder interviews, the survey outcomes as well the community input sessions was that though people are excited about the possibilities of ARV-based prevention strategies as a whole, they are also concerned about how the vast majority of the people who need these options could pay for them.

MP: What are some of the issues, financial and otherwise, that keep coming up in the field of HIV prevention?

JT: I think one of the biggest issues that keep coming up is that of resource allocation. Many are asking where the HIV field can and should invest its resources in order to have the most impact. Since HPTN052, some say that we should pull resources from traditional prevention programs to invest in TLC+ and suggest that people don’t use condoms anyway. Others say that due to resource limitations, it simply isn’t feasible to get everyone who is HIV-positive on treatment.

The reality is that there is no magic bullet that is going to turn the tide on the epidemic in the U.S. or around the world.  We need as many options available as possible and we need to scale up the interventions that we know to work, including increasing availability to sterile syringes and male and female condoms, while also continuing to invest in research for emerging options ensuring that HIV-positive people who need treatment can access it. We can’t afford to play either/or here. Instead, we must build the political will for investment in each these strategies.

Check back next week for part II of the interview in which Jessica discusses ways we can make HIV prevention and treatment a reality for the people who need it most.



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

19 April 2012

The Effectiveness of ARV's Used for HIV Prevention

via AIDSmeds, by Tim Horn

While studies exploring the effectiveness of antiretroviral (ARV) therapy for HIV prevention purposes have generally yielded encouraging results, a group of researchers at the University of North Carolina at Chapel Hill suggest that the way forward is not entirely clear and that additional research is needed, particularly in understanding the combined benefits of biomedical and behavioral interventions in specific at-risk communities.  

“Recent research developments in [pre-exposure prophylaxis, or PrEP] and [treatment of people living with HIV to curtail HIV transmission] provide a unique opportunity to highlight areas of advancement that have galvanized changes in HIV treatment and prevention, and to highlight topic areas that remain undecided and controversial,” write Myron Cohen, MD, and his colleagues in an editorial published ahead of print by the journal AIDS.

The paper reviews much of the scientific research that has contributed to our current understanding of ARV treatment as prevention, including pharmacologic and observational studies, ecological evaluations and various modeling and empirical data. And despite the completion of several sound clinical trials—also summarized by Cohen and his colleagues and reviewed here—gaps in knowledge remain.

The Limits of HPTN 052

Building on the results of cohort and mathematical modeling studies, the HIV Prevention Trials Network began a randomized clinical trial, called study 052 (HPTN 052), to confirm a prevention effect from ARV therapy. While the study is ongoing, its Data Safety and Monitoring Board recommended nearly a year ago that the interim results be made publicly available.

As previously reviewed by AIDSmeds, the trial demonstrated a 96 percent reduction in HIV transmission among monogomous heterosexual HIV-serodiscordant couples in which the HIV-positive partner was started on ARV therapy, compared with couples in which the positive partner had not started HIV treatment.

Read the rest.


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

25 January 2012

Implications for social services in the time of PrEP and other new prevention technologies

via New America Media, by Zalined Mohammed

“The pendulum swing towards earlier treatment could come at the expense of other services,” said Lin. “Prevention efforts through education have been reduced and support to CBOs is significantly down. Many organizations have had to merge or close down.”

Major medical breakthroughs over the past year in the treatment of HIV/AIDS are setting off some surprising alarm bells.

While praised for their life-saving potential, they are causing a change in the dynamics of HIV/AIDS care – a shift that may squeeze out social services needed to support patients while they’re in treatment.
The focus in treatment is shifting increasingly towards HIV/AIDS medications and preventative strategies, such as Pre-Exposure Prophylaxis (PrEP) and HPTN 052.

At a recent forum in Oakland, attendees questioned how the new HIV medicines would directly affect their lives.

“It’s exciting, but will it help save lives in our communities?” asked Deborah Royal, a nurse practitioner at East Bay AIDS Center.

Providers and patients agree that advances in medication and a focus on prevention are positive steps towards treating the disease and slowing disease transmission, but also emphasize the importance of what they call “psychosocial” factors in determining whether a person starts and stays in treatment.

“The easy part is prescribing the medication, but how is the patient going to get the medications paid for?” asked Dr. Royce Lin, an HIV specialist who serves on the board of the Asian and Pacific Islander Wellness Center (APIWC). He noted, “if someone is monolingual, if someone is undocumented they may never even make it in the first place.”

Dr. Monica Gandhi, an HIV and primary care provider at Ward 86, one of the oldest and largest HIV/AIDS clinics in the country, pointed to several barriers that commonly prevent female patients from adhering to treatment protocols. “Gender based violence, poverty, social instability around taking care of children and not having social supports themselves prevent women from staying in treatment.”

Read the rest.


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

30 December 2011

Mapping Pathways 2011: The year in voices

Original content from the Mapping Pathways blog team

“We are on the verge of a significant breakthrough in the AIDS response. The vision of a world with zero new HIV infections, zero discrimination, and zero AIDS-related deaths has captured the imagination of diverse partners, stakeholders and people living with and affected by HIV. New HIV infections continue to fall and more people than ever are starting treatment. With research giving us solid evidence that antiretroviral therapy can prevent new HIV infections, it is encouraging that 6.6 million people are now receiving treatment in low- and middle-income countries: nearly half those eligible.” - Michel Sidibe, UNAIDS Executive Director, World AIDS Day report


Earlier this month, WHO and UNAIDS released a World AIDS Day report providing a snapshot of goals and progress made in 2011 toward HIV/AIDS prevention. We thought we’d provide a snapshot of the Mapping Pathways project as well – but through the voices of some of the most memorable and inspiring people we spoke with this year.

APRIL:
“It’s been like Christmas every day since July at the International AIDS Conference in Vienna when the CAPRISA study results came out… We’ve gotten over this first hurdle; we’ve proven that we can create new ways to prevent HIV through the use of ARVs taken orally or applied topically but now we have to figure out how to get that pill, or gel, or whatever into the right hands in the right place at the right time. We’re grappling with all the problems that come with success.” - Jim Pickett: ‘Success! Now what?’
   
MAY:
“There is a threat – still distant but definitely visible – that we will lose this astonishing success through complacency… We can make AIDS rare – and eliminate it entirely from rich countries – using technologies that we already have. The question is whether we have the will to do it.”  - Mark Chataway: Using antiretrovirals to prevent new infections

“There’s still so much we don’t know, and these are open questions rather than being settled questions… 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.”  - Julie Davids: FEM-PrEP closure update – What does ‘futility’ mean exactly?

“I think whenever the field starts to go on emotion, we get into trouble… Human behavior keeps messing up the plot.”  - Dr. Linda-Gail Bekker: Of Mice, men, and microbicide trials   

JUNE:
 “I put the word MSM on the board, and do you know what one woman participant said? She said, ‘By MSM do you mean men who have sex with men? Yes, they must die; and if not, they must be killed!’ I was so taken aback. I thought, ‘Oh my God, this is where the advocacy has to start from.’” - Brian Kanyemba: A snapshot of advocacy in Africa

“The level of efficacy seen in the HPTN052 study is stunning, and is extremely important on several fronts. First, in terms of the potential of this strategy to reduce transmission, it is clearly an effective option… Of course, there are some issues associated with this strategy as well.”  - Dr. Joe Romano: Thoughts on the microbicide pipeline and the recent HPTN 052 results

“I believe that it is a political, economic and human tragedy that the first time our country has had a national HIV/AIDS strategy is exactly at the same time that we’re being told there are no resources to put it fully into place... We are, in significant ways, being restrained from putting our best minds and hearts at the forefront of this effort. When we get to the end of the day, there are good ideas, and then there are good ideas that are fully funded.”  - Julie Davids: The economic effect of HIV/AIDS in the US

JULY:
“Sex sells. People in the commercial world use sex to sell things like cars, toothpaste, pens…almost anything! Why not use sex to sell safer sex?”  - Anne Philpott: How sexy sex can help prevent HIV transmission

“Working with vulnerable populations like transgender individuals and men who have sex with men (MSM) was really an eye opener. These are people who often have nothing to their name (often not even a roof over their head), are disowned by society and their families and are completely discriminated and stigmatized against. Yet a number of them were keen to help spread awareness about HIV/AIDS, prevention options and vaccines so that others may benefit from the information and not get infected with HIV. This degree of humanity is truly remarkable.”  - Dr. Sonali Kochhar: PrEP in India

AUGUST:
“My sense is that many people are still very uncomfortable and not quite able to figure out why we’re talking about PrEP in the Indian context. Many senior people in the field feel the focus needs to be on TLC+.”  - Anjali Gopalan: Notes from India – concerns and challenges around PrEP

“The matchmaking started because people living with HIV don’t disclose their status to their parents. In India, when the boy is 30 or the girl is 24-25, the parents want them to get married. They start looking for partners and the person who is infected is unable to talk freely to them and say, ‘Look, I have HIV and I can’t get married.’ That’s when they come to me and ask, ‘My parents are planning to get me married to an HIV-negative person – now what do I do?’ So we say okay, we’ll look for someone for you."  - Dr. Suniti Solomon: A modern-day HIV love story

“Clearly if people abstained from sex, or had sex with partners they knew to be uninfected, or used condoms 100% of the time, we wouldn’t have the HIV epidemic. But obviously, spreading billboards all over the world has not cut it.” - Dr. Linda-Gail Bekker: Safe-sex education – too little, too much?

“Placebo controlled trials are essential for the evaluation of the safety and efficacy of new products.  The placebo control group in a clinical trial provides the means of establishing any specific safety issues with a product, as well as the effectiveness of the product at preventing HIV transmission… Once a microbicide product has been adequately shown to prevent HIV transmission, it will no longer be possible to run placebo controlled trials, and the “window” will be closed."  - Dr. Joe Romano: What happens when the ‘placebo window’ closes?

SEPTEMBER:
“It boggles me that I still have to make the case for understanding the relational and contextual nature of HIV transmission and the need to recognize that people and technologies are interactive and interdependent."  - Judith Auerbach: Addressing social drivers of HIV/AIDS

“Even among groups of experts, I have noticed people getting confused – misapplying data, conclusions, or assumptions...”  -  Lori Heise: Tricky Terminology in HIV Prevention – Microbicides and Oral PrEP

“Giving gay men more information about their health only empowers them to make informed decisions. The fear that gay men will take PrEP, forego condoms and become out of control disease spreaders, harkens to the days when men feared women would become crazed nymphomaniacs thanks to the new birth control pill.” -Alex Garner: Open letter Urges that PrEP debate should be based on ‘facts not misinformation’

OCTOBER:
“Firstly, we need to work out whether this result is true or not. But even if it is true, it’s quite possible that we need to balance the benefits of avoiding an unwanted pregnancy against the small increased risk of acquiring HIV infection.”  - Dr. Tim Farley: Hormonal contraceptives and HIV – the grey area

“It’s really critical we know what research is and is not being done, what evidence does and does not exist, so that we have a solid understanding of the implications of these technologies in various social, economic, cultural, and political contexts that exist in different countries. It’s only then that we can begin to think about investing in them and the best ways to implement them."  - Molly Morgan Jones: Mapping Pathways so far – the ‘literature review’

NOVEMBER:
“If you’re talking about early treatment, you’ll have one person saying, ‘This is a quantum leap from where we are now, and it’s operationally impossible.’ And then you’ll have another person saying, ‘Well, if you have cancer, the doctor doesn’t wait till you’re half dead to give you the treatment, and so we should have been doing this years ago.’ And both are very valid points; it’s just how do you get those two people, who are equally important in making this happen, make it happen?” - Daniella Mark: It’s a question of ‘how’ in South Africa Part 1 & Part 2

DECEMBER:
“PrEP … is hard as hell to figure out. Hard as hell. But that’s what we have to do – we have to be right there, at the hardest place possible, trying to get the answers.” - Jim Pickett: Triumphs and Trials in 2011


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

21 December 2011

Pause and Rewind with Jim Pickett: Triumphs and Trials in 2011


Original content from the Mapping Pathways blog team

“PrEP … is hard as hell to figure out. Hard as hell. But that’s what we have to do – we have to be right there, at the hardest place possible, trying to get the answers.”

MP: Was 2011 a significant year with regard to new HIV prevention methods?

JP: Definitely. I think it’s been a really dynamic year. The discussion around ARV-based prevention has been heated, it’s been passionate, and it’s been very broad. The field as a whole has received so much attention this year because of all the studies that were reported, beginning in 2010. The lively discussion has put the research and advocacy that’s been ongoing for years on so many people’s radar for the first time.

MP: What were some of the biggest highlights in the prevention landscape this past year?

JP: In terms of the actual science that was reported out this year, a couple of studies were really important. The HPTN 052 trial proved beyond a shadow of a doubt that providing treatment to people can be very effective as a means of prevention as well as for treating the individual with HIV. It was something we all pretty much knew but we didn’t have a randomized controlled trial to prove it. Now we have one – and that’s really powerful.

There have also been significant results on the use of pre-exposure prophylaxis (PrEP) in heterosexual individuals. The Partners PrEP study and the TDF2 Botswana study have brought further proof that oral prevention – taking a pill every day – can work to prevent HIV, and can work quite well.

On the other side, we’ve had some confounding results as well. The FEM-PrEP trial closure, due to the fact it was unable to prove the effectiveness of Truvada in preventing HIV infection among HIV-negative women, has left us scratching our heads. The VOICE trial, which is investigating both microbicides and PrEP, had to close the tenofovir gel and pill arms due to futility – they weren’t going to be able to show these interventions work to prevent HIV.

We’ve come up against ‘futility’, and now there’s a huge question mark. We don’t yet know what is going on: Was it something biological? Was it because adherence was poor? Why did these products work in other trials? While there have been very encouraging results about PrEP, the jury is still out – for instance, is this a good intervention for heterosexuals, especially women? Both PrEP trials that have shown futility have been for women. These critical questions need to be addressed.

MP: What has the debate around PrEP been like? What are people saying?

JP: Like I mentioned, the debate around ARVs as prevention has been very dynamic. Wherever you are on the analysis of these new strategies, whether you are critical of these or really excited about them, much of the discussion has been fruitful and invigorating.

What has upset me, though, is that some people (whether they’re researchers, advocates, public health workers, or policymakers) have been drawing lines and pitting interventions against one other. For instance, PrEP, ARVs for HIV-negative people to prevent HIV acquisition, is being pitted against treatment, ARVs for HIV-positive people. There’s been a lot of discussion on who “deserves” the drugs and who doesn’t – I don’t think that’s helpful in any way. We should all be working to get ARVs to those who need them – HIV-positive people, of course, and also HIV-negative individuals who need them, can use them, and would find them very beneficial. It’s about ARV access writ large.

MP: Why do you think this has happened?

JP: This is what happens in times of scarcity and economic trauma. People say, “We can’t possibly do everything, so we should do only this and not that.” It’s not surprising, but it’s still disheartening. We need to think broadly, globally and not dismiss new interventions because they’re challenging or bring up lots of questions. PrEP does bring a ton of issues: It’s brand new, it’s just out of the box, we’ve never done this before, and it’s hard as hell to figure out. Hard as hell. But that’s what we have to do – we have to be right there, at the hardest place possible, trying to get the answers. That’s where we should be spending our energy.

When the female condom was first introduced, it wasn’t given the attention and support it needed and a lot of people dismissed it. I think that really hobbled its potential for a long time. I don’t want to see PrEP in the same place – being disparaged before we’ve had a chance to explore and fully understand its potential.

MP: How can the Mapping Pathways project help in this context?

JP: The Mapping Pathways project will be offering a synthesis of literature, real-world experience, and key stakeholder opinions from vastly different perspectives and regions of the world. This is going to be extremely helpful because we know that just having great science isn’t going to get any of these interventions rolling. This project is helping create and disseminate information that countries, regions, states, and cities can use to make informed decisions about how they engage with these new prevention technologies – or not. I think the key word here is “informed”. What we’re all hoping is that these decisions are made based on a combination of science, feasibility, and acceptability in each region.

The fact that we’re going to be able to play a role in that process is very exciting. Wearing my Mapping Pathways hat, I’m really proud of the work we’ve done this year. The first wave of data collection is done – we’re now analyzing our literature review, our survey results and stakeholder interviews, and results from our ExpertLens process. I’m very excited about the data and analysis that we’ve been able to pull together as a multinational team. And now we get to start sharing these great insights with the world!

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.


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

21 October 2011

How Would a PrEP Rollout Impact the HIV Epidemic?

via AIDS: Official Journal of the International AIDS Society, by El-Sadr, Wafaa M.; Coburn, Brian J.; Blower, Sally M.

Background

The HPTN 052 study demonstrated a 96% reduction in HIV transmission in discordant couples using antiretroviral therapy (ART).

Objective

To predict the epidemic impact of treating HIV discordant couples to prevent transmission.

Design

Mathematical modeling to predict incidence reduction and the number of infections prevented.
Methods

Demographic and epidemiological data from Ghana, Lesotho, Malawi and Rwanda were used to parameterize the model. ART was assumed to be 96% effective in preventing transmission.

Results

Our results show there would be a fairly large reduction in incidence and a substantial number of infections prevented in Malawi. However, in Ghana a large number of infections would be prevented, but only a small reduction in incidence. Notably, the predicted number of infections prevented would be similar (and low) in Lesotho and Rwanda, but incidence reduction would be substantially greater in Lesotho than Rwanda. The higher the proportion of the population in stable partnerships (whether concordant or discordant), the greater the effect of a discordant couples intervention on HIV epidemics.

Conclusions

The effectiveness of a discordant couples intervention in reducing incidence will vary among countries due to differences in HIV prevalence and the percentage of couples that are discordant (i.e., degree of discordancy). The number of infections prevented within a country, as a result of an intervention, will depend upon a complex interaction among three factors: population size, HIV prevalence and degree of discordancy. Our model provides a quantitative framework for identifying countries most likely to benefit from treating discordant couples to prevent transmission.


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

13 September 2011

The Latest Treatment Action Campaign (TAC) Briefing - Antiretrovirals and Prevention


Exciting new evidence has demonstrated the potential of antiretroviral medicines (ARVs) to prevent HIV from being sexually transmitted. This TAC briefing explains the evidence and then discusses policy implications. 

 

Our recommendations

  1. The WHO must release its guidelines on serodiscordant couples.
  2. People living with HIV should be offered highly active antiretroviral treatment (ART) when their CD4 counts fall below 350 cell/mm3, or if they have an AIDS illness or TB.
  3. HIV-positive people in serodiscordant couples should be offered ART irrespective of their CD4 count.
  4. For serodiscordant couples trying to conceive, both partners should be offered ARVs until conception is confirmed, after which the HIV-positive partner should continue on ART.
  5. Pre-exposure prophylaxis (PrEP) should be made available to sex workers.
  6. In other cases, pre-exposure prophylaxis should be made available to HIV-negative people who request it or who will --in the opinion of their nurse or doctor-- likely benefit from it.
  7. The rollout of ARVs for prevention must not divert funding away from treatment programmes. Achieving universal access for people with HIV must remain the priority for governments, policy makers and funders.
  8. Effective prevention interventions such as voluntary medical male circumcision and ensuring availability of male and female condoms continue to be critically important.

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

12 September 2011

Rwanda Plans to Treat HIV Discordant Couples with ART

via Plus News

HIV-positive Rwandans in discordant relationships will start taking antiretroviral treatment (ART) as soon as they test positive as part of a plan to boost national HIV prevention and treatment efforts.

"There is evidence that antiretroviral treatment, once started early for eligible HIV-positive patients, alleviates their suffering and reduces the devastating impact of the pandemic," Anita Asiimwe, head of the Institute of HIV/AIDS Disease Prevention and Control, told IRIN/PlusNews. "Antiretroviral therapy has the potential both to reduce mortality and morbidity rates among HIV-infected people, and to improve their quality of life."

In May 2011, a landmark study - HPTN 052 - showed major reductions in HIV transmission among discordant couples due to early treatment. The authors of the nine-country study concluded that earlier initiation of HIV treatment led to a 96 percent reduction in HIV transmission to the uninfected partner.

According to the government, an estimated 7.1 percent of cohabiting couples seeking voluntary counselling and testing services in the capital, Kigali, are HIV discordant. Infections within stable relationships have been identified as one of the main sources of new cases in Rwanda.

Read the rest.

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

19 August 2011

From iPrEx to TDF2: A Quick Look at the Prevention Journey this Past Year


Starting in July 2010, encouraging results from a number of HIV prevention studies have revolutionized the HIV prevention landscape over this past year – from using oral PrEP and microbicides among HIV-negative people to reduce the risk of infection, to providing early antiretroviral treatment to people with HIV to reduce the risk of transmitting the infection to their uninfected partners.

Here is a quick look at six of the most significant trials: CAPRISA 004, iPrEx, FEM-PrEP, HPTN 052, Partners, and TDF2 that, together, are radically changing the way we look at prevention.

July 2010: CAPRISA 004 – a microbicide study
Background: Conducted by the Centre for the AIDS Programme of Research in South Africa (CAPRISA), Family Health International (FHI), and CONRAD. Funded by the United States Agency for International Development (USAID) and Technology Innovation Agency (TIA).
Who: 889 sexually active women.
Where: South Africa.
What: 1% tenofovir vaginal gel, applied within 12 hours before and after sexual intercourse.
Key results: The microbicide provided 39% protection from HIV acquisition. In women who used the gel more than 80% of the time, there was 54% efficacy. The gel also halved the women’s risk of acquiring HSV-2, the virus that causes genital herpes and also increases the risk of contracting HIV.

To know more about this study, click here and here.

November 2010: iPrEx – a large-scale, Phase III PrEP study
Background:Funded by the U.S. National Institutes of Health (NIH) through a grant to the J. David Gladstone Institutes, a non-profit independent research organization affiliated with the University of California at San Francisco (UCSF). Additional funding provided by the Bill & Melinda Gates Foundation.
Who: 2,499 men who have sex with men and transgender women who have sex with men.
Where: Peru, Ecuador, South Africa, Brazil, Thailand and the US.
What: Once-daily does of Truvada (oral FTC-TDF – emtricitabine and tenofovirdisoproxilfumarate), as well as monthly HIV testing and risk-reduction counseling.
Key results: PrEP provided 42-44% protection from HIV acquisition. The protective effect was even higher among those with good pill adherence. According to the initial findings, with 50% adherence reported, the efficacy was 50%; with 90% adherence reported, there was 73% efficacy. Updated findings were presented at the International AIDS Society conference in Rome: the drug had 92% efficacious in preventing HIV infection amongst those who had detectable drug levels; overall efficacy was 42%.

To know more about this study, click here and here.

April 2011: FEM-PrEP – a Phase III PrEP study
Background: Implemented by Family Health International (FHI) in partnership with research centers in Africa. Funded by the United States Agency for International Development (USAID), with early funding from the Bill & Melinda Gates Foundation.
Who: 1,951 sexually active women.
Where: Kenya, South Africa, and Tanzania.
What: Once-daily does of Truvada (oral FTC-TDF – emtricitabine and tenofovirdisoproxilfumarate), as well as HIV testing and counseling.
Key results: The interim FEMPrEP study results were inconclusive. As determined by a preliminary data review, the study would not have been able to demonstrate whether or not Truvada was effective in preventing HIV in women in this study. FHI, therefore, decided to close the trial early due to futility.

To know more about this study, click here and here.

May 2011: HPTN 052 – a Phase III antiretroviral study
Background:Conducted by the HIV Prevention Trials Network (HPTN). Funded by the National Institute for Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health (NIH). Additional support provided by the NIAID-funded Adult Clinical Trials Group.
Who: 1,763HIV serodiscordant couples, in which the HIV-infected partner had a CD4+ cell count of 350-550 cells/mm^3.
Where: Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, United States and Zimbabwe.
What: Initiation of early antiretroviral treatment, as well as regular counseling.
Key results:The interim review showed that antiretroviral treatment reduced the risk of HIV transmission from treated partner to uninfected partner by 96%.

To know more about this study, click here and here.

July 2011: Partners – a Phase III PrEP study
Background: Funded by the Bill & Melinda Gates Foundation.  The University of Washington International Clinical Research Center is the study sponsor and coordinated the trial in collaboration with investigators at the study sites.
Who: 4,758 heterosexual African HIV serodiscordant couples, that is, in which one partner had HIV and the other did not. 
Where: Kenya and Uganda.
What: Once-daily does of Truvada (oral FTC-TDF – emtricitabine and tenofovirdisoproxilfumarate) or tenofovir (oral TDF), as well as HIV testing and counseling.
Key results: The risk of infection was reduced by 73% in those who received Truvada, and by 62% in those who received tenofovir alone. Adherence was extremely high: more than 97% of doses dispensed were taken, and 95% of participants stayed in the study.

To know more about this study, click here and here.

July 2011: TDF2 – a PrEP study
Background: Conducted by BOTUSA, a partnership between the Botswana Ministry of Health and the US Centers for Disease Control and Prevention.
Who: 1,200 sexually active men and women.
Where: Botswana.
What: Once-daily does of Truvada (oral FTC-TDF – emtricitabine and tenofovirdisoproxilfumarate), as well as HIV testing and counseling.
Key results: In the primary analysis, it was seen that Truvada reduced the risk of infection by 63%. In the secondary analysis, excluding infections that occurred amongst people who had run out of their Truvada pills and had not taken one for at least 30 days, there was 78% efficacy.

To know more about this study, click here and here.

To stay abreast of research into new prevention technologies, check out AVAC and IRMA.


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

02 August 2011

Antiretroviral prevention methods 'not in competition' with each other

Via AIDSMap, by Keith Alcorn.

Antiretroviral prevention methods are not in competition, and policy makers and providers need to start to thinking about how antiretrovirals, pre-exposure prophylaxis and microbicides will be provided as part of a combination prevention package – and who will benefit most from each method, delegates heard at a satellite meeting on the opening day of the Sixth International AIDS Society Conference (IAS 2011) in Rome.

“You don’t want to have the family planning clinic here, the pills clinic here, the injections clinic here, and the microbicides clinic over here,“ said Dr Stephen Becker of the Bill and Melinda Gates Foundation.

Delegates were discussing the rapidly changing landscape of HIV prevention methods that use antiretroviral drugs. One year ago, at the International AIDS Conference in Vienna, the world heard the results of the CAPRISA study, which showed that a microbicide gel containing tenofovir halved the risk of HIV infection in women who used the vaginal gel consistently.

Since then results from four studies have added to the array of prevention methods that exploit antiretroviral drugs to prevent transmission or acquisition of HIV infection:
  • The iPrEx study showed that taking the antiretroviral combination Truvada (tenofovir and emtricitabine (also known as FTC) reduced the risk of HIV infection in men who have sex with men by 44%.
  • The HPTN 052 study showed that early treatment reduced the risk of HIV transmission to an uninfected regular partner by at least 96%.
  • The Partners study showed pre-exposure prophylaxis with Truvada or with tenofovir alone reduced the risk of HIV infection by between 62% and 73%.
  • The TDF2 study showed that  pre-exposure prophylaxis with Truvada reduced the risk of infection by between 62% and 78%.
The first tenofovir-containing microbicide could receive regulatory approval by the end of 2013, subject to positive results from a confirmatory trial now taking place in South Africa. That study is testing exactly the same dosing regimen as that used in the CAPRISA study, the so-called BAT 24 dosing schedule: one dose Before, one After, and no more than Two doses in 24 hours.

A second CAPRISA study (008) is testing the roll-out of tenofovir gel through family planning clinics in KwaZulu-Natal, comparing the monthly testing and follow-up schedule used in the original CAPRISA study with a three-monthly schedule, in order to examine the feasibility and acceptability of providing a microbicide through existing health services that target sexually active women.

Although the South African government has already begun investing in the scale-up of production facilities to manufacture the gel, the extent of demand for the microbicide is still unclear. Studies of women’s’ attitudes towards the microbicide will be needed to gauge demand, but a lot of work will also be needed to develop demand – and to make sure that women understand how they could benefit from using the microbicide.

“We need to reach out to women who don’t perceive themselves to be at risk, and we should be getting communities to rally round to be early adopters of tenofovir gel,” said Samu Dube of the Global Campaign for MIcrobicides.

“We need to get the product to the places where women are: the family planning clinics, the immunisation centres, antenatal clinics. We also need to target the school health system.”

However, work will also be needed to convince the providers of those services that they have a role to play in expanding women’s opportunities to protect themselves from HIV infection.

Read the rest here.

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