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.

31 January 2012

PrEP's role in relationships

via Aidsmap, by Roger Pebody

Seeking to understand why adherence to pre-exposure prophylaxis (PrEP) was extremely high in a study of serodiscordant couples, qualitative researchers have found that trial participants saw PrEP as a way they could preserve their relationship despite the pressures created by the knowledge of different HIV status and the risk of infection.

In an article published online ahead of print last week in the Journal of Acquired Immunity Deficiency Syndromes, Norma Ware and colleagues also report that the support of study staff and of HIV-positive partners was crucial in supporting adherence.

Pre-exposure prophylaxis is a novel HIV-prevention strategy in which HIV-negative people take antiretroviral drugs before possible exposure to HIV, to lower the risk of infection.

Several studies suggest that PrEP is biologically efficacious. However, a major challenge for the real-world effectiveness of PrEP is that it relies on people who are not ill taking medication on a daily basis. Adherence has turned out to be less than perfect in some of the studies: for example, in the iPrEx trial of men who have sex with men, only around half actually took the drugs as prescribed.

However, adherence was significantly better in the Partners PrEP study, which recruited HIV-negative people who were in a stable heterosexual relationship with an HIV-positive person (i.e. they were in a ‘serodiscordant’ relationship), in Kenya or Uganda. Based on pill counts at the prescribing clinic, 97% of prescribed doses were taken. Based on unannounced pill counts at home, 99% of doses were taken. As a result, PrEP was more effective in this population.

In order to better understand why and how these near-perfect levels of adherence were achieved, Norma Ware and colleagues conducted in-depth interviews with 60 of the Partners PrEP trial participants in rural Uganda. Most interviews (45) were conducted with HIV-negative people taking PrEP, while 15 were with their HIV-positive partners. Just over half the participants were men, their average age was 35 and most had been study participants for over a year.

These were long-term relationships, with an average duration of just under ten years. Four out of five couples had children together. However, in most couples the HIV-positive partner was only diagnosed with HIV a few months before the PrEP study began.

Discovery that one partner was HIV-positive while the other was not created a crisis for most couples. HIV-negative partners felt hurt, angry and betrayed by the evidence of infidelity that infection represented to them, and threatened by the prospect of their partner’s imminent illness and premature death. Infected partners, for their part, feared “dying alone.”

Tensions developed, sometimes escalating into violence. Some relationships came close to fracturing under the strain.

Read the rest.


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

30 January 2012

Misconceptions surrounding HIV problematic in India

via The Times of India

Twenty-five years after the first case of HIV/AIDS was reported in the country, experts say the main target in the fight against the disease is misconceptions. After releasing the 13th Behaviour Surveillance Survey Round XIII for 2011, experts in the field said that awareness among the public had gone up but awareness without misconception was low.

Many believe that healthy-looking people have a good immune system and may not test positive for HIV/AIDS. Doctors have been trying to tell people that antiretroviral drugs - the medicines of choice for HIV/AIDS - will only keep the viral load low, but many assume they are safe after taking them. "We require schemes to target misconceptions. Only awareness without misconceptions will strengthen the fight against HIV," said AIDS Prevention And Control (APAC) project director Dr Bimal Charles.
Dr Charles said that in the surveys, people had said cleaning the vagina with vinegar or having sex with monkeys would keep out the infection.

The annual survey report, by APAC project along with Tamil Nadu State AIDS Control Society (TANSACS) and USAID, has been prepared since 1996. The survey is conducted among high-risk groups like female sex workers, gays and injecting drug users and bridge population groups such as truckers and migrant workers.

With a sample size of 5,000, the field work was done in November and December 2011 across 15 towns in Tamil Nadu. The results showed a significant improvement in the behaviour among targeted groups where NGOs were working.

Read the rest.


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

27 January 2012

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.]

25 January 2012

Open Letter to FDA Urging Immediate Review of PrEP

via AIDS Foundation of Chicago

This is an open letter to the Food and Drug Administration, urging the priority review of the drug Truvada for use in PrEP (pre-exposure prophylaxis). The AIDS Foundation of Chicago and 25 other organizations signed this letter to counter the AIDS Healthcare Foundation's protest of the FDA regarding this review. To read the PDF of the letter, with footnotes, click here.

Dear Commissioner Hamburg:

We write as a coalition of 25 leading HIV/AIDS and health organizations to request that FDA grant priority review of a supplemental New Drug Application1 (sNDA) for the approval of emtricitabine/tenofovir disoproxil fumarate (Truvada®) fixed dose combination for preexposure prophylaxis (PrEP) to reduce the risk of HIV infection among adults as part of a comprehensive prevention package including risk reduction counseling and condoms. The rigorous priority review process applicable to efficacy supplements is the best means to promote public health by recognizing the potential of PrEP to offer a major advance in HIV prevention and deserving this priority “where no adequate alternate therapy exists or as a significant improvement compared to marketed products … including nondrug products or therapies.”

Our organizations understand that granting priority review is not tantamount to a final approval. Nevertheless, we are hopeful that the full dossier of data on emtricitabine/tenofovir disoproxil fumarate fixed dose combination of PrEP from multiple clinical trials in different populations
can lead to a responsible regulatory and marketing plan that allows safe use in the populations that may benefit from this innovative development.

The need for significantly improved safe and effective HIV prevention tools is clear. Despite many years of efforts to reduce HIV incidence using available counseling methods, some 50,000 new infections occur annually. Disparities persist so that incidence continues to concentrate among African Americans and Latinos, men who have sex with men (including transgender individuals), and the poor. These grim and stubborn facts led to the creation of the White House directed National HIV/AIDS Strategy for the United States (NHAS), which lists enhanced prevention efforts as a primary objective.3 If emtricitabine/tenofovir disoproxil fumarate for
PrEP satisfies FDA approval criteria, health programs and individuals will have improved choices to address a domestic priority and save lives.

The PrEP sNDA for Truvada® meets criteria set out in FDA’s Manual of Policies and Procedures for priority review. As organizations committed to ending the AIDS epidemic, we appreciate how the history of FDA’s regulatory tools for fast track approval or for accelerated and priority review introduced the current suite of HIV therapeutic drugs to treat active infection. In the present case, there is a clear unmet need for new effective methods for preventing HIV infection, a need that is as urgent today as was the need for HIV therapeutics over the past two and more decades.

HIV advocacy organizations made it possible to launch such regulatory procedures for the benefit of all patient disease groups when those tools were not yet available. We are not aware of any legitimate reason to thwart the faster introduction of medicines FDA determines to be safe and effective to stop HIV, nor should anyone turn back the pages of history and act against the interests of patients to do so now. Unfortunately, recent actions by the AIDS Healthcare Foundation regarding PrEP would introduce unwarranted roadblocks in the FDA process of making responsible decisions about potentially useful medicines and public health. Those actions also foster misunderstandings of the careful balancing of risk and benefits that informs a mature marketing permission based on all available data. Those actions would also set an unhelpful precedent as PrEP research evolves in the future and the FDA is asked to review nontenofovir- based regimens (e.g. maraviroc), microbicide gels, and intermittent PrEP. We urge that FDA continue its public health promotion goals now in the service of the critical need to prevent, as well as treat, HIV and grant this priority review.

We would be happy to discuss the priority review process as applied to HIV prevention further at your convenience. Mitchell Warren, Executive Director of AVAC, acts as the contact person for the organizations signing this letter (tel: 1-212-796-6423 or email: Mitchell@avac.org).

Sincerely,
AIDS Foundation of Chicago
AIDS Legal Referral Panel
AIDS Resource Center Ohio
AIDS Research Consortium of Atlanta
AIDS United
amfAR, The Foundation for AIDS Research
Asian & Pacific Islander Wellness Center
AVAC: Global Advocacy for HIV Prevention
Black AIDS Institute
Caracole, Inc.
Chicago Black Gay Men’s Caucus
Fenway Health
HIV Prevention Justice Alliance
International Rectal Microbicide Advocates
Justice Resource Institute
LA Gay and Lesbian Center
Multicultural AIDS Coalition
National Alliance of State and Territorial
AIDS Directors
National Black Gay Men's Advocacy
Coalition
National Latino AIDS Action Network
National Minority AIDS Council
Ohio AIDS Coalition
Project Inform
San Francisco AIDS Foundation
SisterLove, Inc.
Ursuline Sisters of Youngstown HIV/AIDS Ministry
Us Helping Us

Read the PDF version of the article (with footnotes) here.


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

Concerns around Gilead's Truvada used as prevention

via Financial Times, by Christine Livoti

Gilead Sciences’ (NASDAQ: GILD) once-daily Truvada pill has seen only tepid interest for adoption in the HIV prevention setting, despite treatment guidelines by the Centers for Disease Control (CDC), experts told Biopharm Insight. This is largely related to issues around feasibility, cost and historical evidence for other prevention strategies, which may not be remedied even with the FDA label Gilead is seeking, infectious disease experts said.

Last December, the company announced a supplemental NDA (sNDA) regulatory application for its currently marketed HIV drug Truvada, a potential therapy to reduce the risk of acquiring HIV, commonly described as pre-exposure prophylaxis (PrEP). Truvada has been approved since 2004 for use in combination with other antiretroviral drugs to treat HIV infection.
Truvada has not been approved yet as a preventative therapy in HIV.

Results from the Phase III iPrEx study reported in the New England Journal Of Medicine in December 2010 showed prophylactic effect from Truvada given orally among men who have sex with men (MSM). In January 2011, the CDC issued interim guidance on the use of PrEP in this population.
While HIV therapy is much more manageable than previously, with fewer pills and side-effects, experts in recent years have begun to initiate therapy in earlier stages of the viral infection, and most recently in uninfected individuals to prevent infection. While multiple PrEP studies have reported encouraging data, multiple hurdles to adoption still remain.

Slow uptake thus far

This news service reported in December 2010 that uptake of Truvada as an HIV prophylaxis therapy would likely be slow, as non-HIV specialists would largely be responsible for prescriptions. Infectious disease specialists reported few, if any, prescriptions in this indication, when interviewed by this news service.

The University of North Carolina division of infectious disease has not been prescribing PrEP, said Dr Christopher Hurt, clinical assistant professor. He added there has been some talk in the medical community that primary care providers and potentially ob-gyns would be responsible for PrEP prescription, similar to how they are responsible for oral contraceptives.

He noted in some urban areas, particularly San Francisco, Boston, New York and Washington, DC, with stronger healthcare settings for MSM, have probably been prescribing PrEP more frequently as they regularly see those individuals at risk of HIV infection. He noted his clinic had some discussion about offering PrEP to partners of current patients, but no decision was finalized. Those partners need to be in care somewhere, where potential side effects can be monitored, he added.

Read the rest.


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

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.]

24 January 2012

Attitudes and acceptance of PrEP among key populations

via PLoS ONE, by Andreas B. Eisingerich, Ana Wheelock, Gabriela B. Gomez, Geoffrey P. Garnett, Mark R. Dybul, Peter K. Piot

Background

The use of antiviral medications by HIV negative people to prevent acquisition of HIV or pre-exposure prophylaxis (PrEP) has shown promising results in recent trials. To understand the potential impact of PrEP for HIV prevention, in addition to efficacy data, we need to understand both the acceptability of PrEP among members of potential user groups and the factors likely to determine uptake.

Methods and Findings

Surveys of willingness to use PrEP products were conducted with 1,790 members of potential user groups (FSWs, MSM, IDUs, SDCs and young women) in seven countries: Peru, Ukraine, India, Kenya, Botswana, Uganda and South Africa. Analyses of variance were used to assess levels of acceptance across different user groups and countries. Conjoint analysis was used to examine the attitudes and preferences towards hypothetical and known attributes of PrEP programs and medications. Overall, members of potential user groups were willing to consider taking PrEP (61% reported that they would definitely use PrEP). Current results demonstrate that key user groups in different countries perceived PrEP as giving them new possibilities in their lives and would consider using it as soon as it becomes available. These results were maintained when subjects were reminded of potential side effects, the need to combine condom use with PrEP, and for regular HIV testing. Across populations, route of administration was considered the most important attribute of the presented alternatives.

Conclusions

Despite multiple conceivable barriers, there was a general willingness to adopt PrEP in key populations, which suggests that if efficacious and affordable, it could be a useful tool in HIV prevention. There would be a willingness to experience inconvenience and expense at the levels included in the survey. The results suggest that delivery in a long lasting injection would be a good target in drug development.

Read the full study here.


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

23 January 2012

Separating the Smoke from the Fire: Lubricant Use and HIV


Original content from the Mapping Pathways blog team

The January 2012 issue of Sexually Transmitted Diseases – Journal of the American Transmitted Diseases Association has published data from a rectal health and behavior study whose findings “suggest some lubricant products may increase vulnerability to STIs”. The study concludes that “because of wide use of lubricants and their potential as carrier vehicles for microbicides, further research is essential to clarify if lubricant use poses a public health risk”. The paper has fueled a tremendous amount of discussion in HIV treatment and prevention communities around the world because such a link would have massive repercussions. Perhaps the title of the article also helped spark the dialogue: “The Slippery Slope: Lubricant Use and Rectal Sexually Transmitted Infections: A Newly Identified Risk”.

The questions are popping up quickly. What does this mean? Do we begin to alter strategies? Do we wait for conclusive proof? How will the layperson interpret this? Use lubricants or not? Which ones? Water-based? Silicone? Oil-based? Healthcare and advocacy professionals are wondering whether this will impact the messages they communicate to people. One discussion forum grappling with these issues is the membership listserv run by IRMA (International Rectal Microbicide Advocates). The listserv has been the site of a lively conversation among individuals from various countries. And this discussion has been ongoing for a few years. IRMA has a Lube Safety Working Group, and has some great resources on this issue via their blog.

“We need to be clear – there are only associations between lube use for anal intercourse and STDs. There is no proof that lube use causes increased risk. We simply don’t know that. Because we don't know, IRMA has long been advocating for a lube safety research agenda to fill in our gaps in the science and the evidence base,” says Jim Pickett, Director of Prevention Advocacy and Gay Men’s Health at the AIDS Foundation of Chicago, chair of IRMA, and a member of the Mapping Pathways team.

“Our key messages still hold true. 1) More research is urgently needed to explore if there is a link between lube use and acquiring HIV and/or rectal STIs. 2) It is unclear whether any particular type or brand of lube might increase, decrease, or have no effect on acquiring HIV and/or rectal STIs. 3) Using male or female condoms is still considered the best way to prevent acquiring HIV and STIs during anal intercourse. In addition, the use of condom-compatible lubes has been associated with a decreased risk of condoms breaking or slipping. 4) It is not possible at this time to recommend for or against using lubes if having anal intercourse without condoms. Lube use on its own is not a proven method of HIV or STI prevention,” explains Jim.

Read on for an interesting debate on various aspects of the study, prevention options, risk reduction, and risk elimination.

George Victor,  a Project Coordinator and health educator who works with men who have sex with men (MSM) and other minority groups, describes the strategy his team is following: “For now, the data we have indicates that unprotected anal sex carries the highest risk of HIV infection, that latex condoms should always be used correctly with water-based lubrication, and that the rectum has a higher concentration of CD4 cells and a larger surface area than the vagina – which means higher opportunities for infection. Therefore, correct and consistent use of condoms and water-based lubricants, together with quarterly HIV testing and STI screening and treatment is the best bet we have today.”

Paul Whannel, a communications coordinator with the AIDS Project of Central Iowa, made an interesting point saying, “I question why there’s not a third option: If an MSM is unwilling to use barriers, use silicone lube – it’s at least potentially safer than water-based... A growing segment of MSM will simply ‘check out’ if you're only willing to talk barrier use. Shouldn’t we be talking risk reduction with those guys?”

“Don't forget that many of us gals will simply ‘check out’ as well!” adds Carrie E. Foote, PhD, an Associate Professor of Sociology at Indiana University-Purdue University who has been living with HIV for over 20 years. “I suspect most women and their male partners (especially those who exclusively have sex with women) rarely get any messages at all about anal intercourse. It was nice to see that half the participants in the study were women.”

“Paul, I hear what you are saying and agree with you in principle. I think that for prevention purposes, however, the most effective mechanical methods of prevention would involve some sort of barrier,” responds George. “Having said that, I agree that choice is important. We don’t say to guys that they MUST use a condom and water-based lube. We have a discussion, conduct risk reduction and assessment, and find solutions that are locally available and practical. Our role is to provide information, support, and very importantly options.”

“As rectal microbicide advocates, our whole reason for being is to help serve those for whom condoms don't work (for whatever reason). We are interested in the research and development of safe, effective, acceptable and accessible rectal microbicides for those very people,” points out Jim. “However, I think it gets tricky when we get to making a recommendation regarding lube use as harm reduction (any kind) in the absence of data.”

“What does risk reduction mean anyway?” asks Aditya Bondyopadhyay, an HIV advocate working in India. “Is it not a fact that the only sure method of avoiding risk of infection is to consistently and correctly use a condom in every instance of penetrative anal sex? I feel the emphasis should stay here. Other ways can and should be in addition to this, not stand-alone.”

“The only really ‘sure method of avoiding risk of infection’ is abstinence from anal and oral intercourse – which could be classified as risk elimination,” says Mark Hubbard from Tennessee in the US. “That’s pretty useless for most of the adults we’re trying to reach; everything else, including the consistent use of condoms, is ‘risk reduction.’ The effectiveness of all risk reduction methods varies and is dependent on the user. ALL of these methods (including abstinence and condom use) have advantages and disadvantages that are very real, and vary from person to person.”

Doreen Hardy highlighted the need for a different type of data: “We need better behavioral data – exactly how are people having anal sex? There are so many variables to consider beyond latex and lubes – the degree of sphincter relaxation before penetration, sexual position, concomitant drug use, frequency, etc. Behavioral data could trump the lubricant data. It is such a difficult subject for sexuality educators because it is hard to build rationale with so little evidence. The default educator has become porn and frankly they do a terrible job. Their objective is to edit for arousal value (usually by eroticizing power) not educational value so a lot of people think furtive, hard, and fast anal sex is the norm. Now that it has become a common part of the sexual repertoire of Americans, I think people are willing to talk about it without having it be shrouded in homophobia.  Maybe someone can start with focus groups and move on to larger quantitative studies.”

“One striking thing is that this was mainly a study of people in committed relationships (56% of sex reported was with main partners) and not of casual sex. Casual/one-off sex only featured in less than 5% of encounters or 12% if you add in ‘acquaintances’. Most of the rest (83%) is between main or regular partners or ‘friends’. This makes the ‘the only thing we can say is to use condoms every time’ line even more incomplete as a response: We have to say it, but most research finds that condom use in long-term relationships, even serodiscordant ones, is an exception not a rule,” says a journalist specializing in HIV. “There are way too many uncertainties and confounders in this study to make any pronouncement on its basis … they didn't get into what people might be doing sexually that led them to choose one lube over another, or to use lube at all. I agree with Jim; we cannot make any recommendations about what lube to use on the basis of this study.”

A doctor summed up the overall mood perfectly at the end, “I'm thankful that a lot of the folks on this list are advocating for, conducting, and funding some of the very research we need to be able to answer the questions. I am awaiting the next wave of research with anticipation.”


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

Discordancy in sexual partnerships in Sub-Saharan Africa

via Sexually Transmitted Infections, by Hiam Chemaitelly, Ide Cremin, Jim Shelton, Timothy B Hallett, Laith J Abu-Raddad

Objective

To describe patterns of HIV infection among stable sexual partnerships across sub-Saharan Africa (SSA).

Methods

The authors defined measures of HIV discordancy and conducted a comprehensive quantitative assessment of discordancy among stable partnerships in 20 countries in SSA through an analysis of the Demographic and Health Survey data.

Results

HIV prevalence explained at least 50% of the variation in HIV discordancy, with two distinct patterns of discordancy emerging based on HIV prevalence being roughly smaller or larger than 10%. In low-prevalence countries, approximately 75% of partnerships affected by HIV are discordant, while only about half of these are discordant in high-prevalence countries. Out of each 10 HIV infected persons, two to five are engaged in discordant partnerships in low-prevalence countries compared with one to three in high-prevalence countries. Among every 100 partnerships in the population, one to nine are affected by HIV and zero to six are discordant in low-prevalence countries compared with 16–45 and 9–17, respectively, in high-prevalence countries. Finally, zero to four of every 100 sexually active adults are engaged in a discordant partnership in low-prevalence countries compared with six to eight in high-prevalence countries.

Conclusions

In high-prevalence countries, a large fraction of stable partnerships were affected by HIV and half were discordant, whereas in low-prevalence countries, fewer stable partnerships were affected by HIV but a higher proportion of them were discordant. The findings provide a global view of HIV infection among stable partnerships in SSA but imply complex considerations for rolling out prevention interventions targeting discordant partnerships.


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

20 January 2012

Efficacy of Behavioral Interventions to Increase Condom Use and Reduce Sexually Transmitted Infections

via Medscape, by Scott-Sheldon, Lori A. J. PhD; Huedo-Medina, Tania B. PhD; Warren, Michelle R. BA; Johnson, Blair T. PhD; Carey, Michael P. PhD

Objective

In the absence of an effective HIV vaccine, safer sexual practices are necessary to avert new infections. Therefore, we examined the efficacy of behavioral interventions to increase condom use and reduce sexually transmitted infections (STIs), including HIV.

Design

Studies that examined a behavioral intervention focusing on reducing sexual risk, used a randomized controlled trial or a quasi-experimental design with a comparison condition, and provided needed information to calculate effect sizes for condom use and any type of STI, including HIV.

Methods

Studies were retrieved from electronic databases (eg, PubMed, PsycINFO) and reference sections of relevant papers. Forty-two studies with 67 separate interventions (N = 40,665; M age = 26 years; 68% women; 59% Black) were included. Independent raters coded participant characteristics, design and methodological features, and intervention content. Weighted mean effect sizes, using both fixed-effects and random-effects models, were calculated. Potential moderators of intervention efficacy were assessed.

Results

Compared with controls, intervention participants increased their condom use [d+ = 0.17, 95% confidence interval (CI) = 0.04, 0.29; k = 67], had fewer incident STIs (d+ = 0.16, 95% CI = 0.04, 0.29; k = 62), including HIV (d+ = 0.46, 95% CI = 0.13, 0.79; k = 13). Sample (eg, ethnicity) and intervention features (eg, skills training) moderated the efficacy of the intervention.
 Conclusions: Behavioral interventions reduce sexual risk behavior and avert STIs and HIV. Translation and widespread dissemination of effective behavioral interventions are needed.*

Read more here.


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

18 January 2012

AFC's "Inside Story" fills the void in HIV/AIDS news coverage

via AIDS Foundation of Chicago, by Gregory Trotter

Inside StoryPeople seeking news and stories about HIV/AIDS have a new place to turn.

The AIDS Foundation of Chicago (AFC) is proud to announce its new blog, Inside Story.  Be it a breakdown of complicated legislative issues, an explanation of medical breakthroughs or rendering of powerful stories of people living with HIV in Chicago — Inside Story provides a new outlet to help fill the void in mainstream daily news coverage.

“Given the political and fiscal challenges we face in the HIV/AIDS sector, it’s more important than ever that we tell our stories,” said David Ernesto Munar, president/CEO of the AIDS Foundation of Chicago. “Inside Story will help us do just that.”

“The people affected by HIV are not just statistics and dollar amounts. Their stories are diverse, joyful and heartrending,” Munar said. “We have a responsibility to tell those stories.”

Inside Story will first and foremost tell the stories of the people who comprise the AFC family: employees and board members, community partners, and the thousands of people served by the vast network of HIV medical and support services, case management and housing assistance in Chicago.
These stories will strive to break down stigma while shedding light on underreported topics in Chicago.

Take for example, the story of Will Wilson, an HIV-positive man and longtime HIV advocate, who suddenly found himself struggling to meet the new filing requirements of the Illinois AIDS Drug Assistance Program.

“It’s like looking through a plate glass window and knowing you can’t reach what’s on the other side,” said Wilson, on nearly being bumped from ADAP. “It’s just really, really, really scary.”

But Inside Story will also provide perspective on national and international issues, such as the recent reinstatement of the ban on federal funding for syringe exchanges or the emergence of pre-exposure prophylaxis (PrEP) as a useful tool for HIV prevention.

AFC staff writer Gregory Trotter provides most of the content for Inside Story.

Trotter received his M.S.J. from Northwestern University’s Medill School of Journalism in 2008. Prior to coming to AFC, he worked as a newspaper reporter in Missouri and New Hampshire, winning awards for business and features reporting. His stories have appeared in the Washington Post, USA Today, Dallas Morning News, and on Politifact, among other news outlets throughout the country.

You can subscribe to Inside Story’s RSS feed to get the latest blog posts. Please spread the word: Inside Story will take you inside the stories of the people committed to stopping the epidemic in Chicago and beyond.

Read Inside Story here.


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

The year ahead: Q&A with Jim Pickett

Original content from the Mapping Pathways team

MP: In terms of studies and projects, what are you most looking forward to this year?

JP:
It’s going to be an eventful year in the HIV prevention world – I’m excited, energized, and daunted, all at the same time! I’m looking forward to just following the science and seeing where that takes us. For instance, rectal microbicide trials are taking an international leap and moving up into phase 2, which is HUGE.

The other big aspect we all need to focus on this year is getting into the implementation particulars around PrEP. There is a PrEP implementation project starting in the US – about 500 gay men split between San Francisco and Miami who will be given PrEP. This is an actual implementation project, NOT a research study, and we hope to learn a great deal from it. There are critical questions around delivering the intervention: How do you get the pill to people? How do you help make sure they’re adherent? How do you keep them in the loop for ongoing testing, so you know soon if they seroconvert? We don’t know the answers because we’ve never done it! It will be very interesting and informative to see how that plays out…what comes up, what works, what’s a problem, and what needs to be changed.

There are also studies (some are happening and some are scheduled to begin in 2012) looking at different ways of dosing PrEP. Right now, we have proof that PrEP used every day works. But what about intermittent dosing – a few times a week or just around the time of sex? What about those strategies? We won’t have hard data in this year but we’ll start learning more. If we can, in fact, do intermittent dosing, or dosing just around the time of sex, that could be great – it would reduce costs, and importantly, make it easier for people to adhere. We may also find out that intermittent dosing, or dosing around the time of sex, doesn’t work. Whatever we find out will be critical to assess as we move forward with PrEP as an HIV prevention strategy.

MP: What are your thoughts on the upcoming US presidential election?

JP: I’m daunted by the 2012 American elections. Whatever happens will be critical for the entire world in terms of how we move forward with the provision of services, science, and research. American elections are always important for everybody, with far-reaching implications – and this time, the stakes are really high. It’s a critical year. But I guess you could say that about every election. When wouldn’t we say it’s critical?

MP: What about the global political landscape?

JP: If you look at politics globally, with economic crises rolling across much of the world, how governments support this work or not will be really important. We don’t want to lose ground. UNAIDS put out a report in November – an annual global snapshot – that shows that 50% of people who need treatment are now on treatment. That’s a big jump up, a good number. We’re going in the right direction and we’ve been able to achieve that even in tough times. But you’re only as good as you are today and we don’t want to lose that ground – we want to move to a place where everyone who needs treatment has it, not just half. Half is better than where we were, but we need to move forward.

We all need to keep a close eye on global politics and how that affects priorities in terms of both provision of treatment for people with HIV and ongoing work in prevention. We can’t treat ourselves out of this. We have to have a solid mix of prevention and treatment and care. Our approach needs to be holistic; if we start throwing things to the side and looking at one or two “magical” solutions, we’re going to be in trouble. When you have new things, there’s a desire to say that the old things don’t work, let’s just look at the new things and throw everything else out. Also, in times of economic scarcity, there is a tendency to pare down. We have to be smarter, use our money more strategically. Does everything work equally well? No. Can we get rid of some things? Probably, yes. But that requires a lot of thought and analysis, and every decision needs to be localized.

I think that’s what this year is going to be characterized around...how we start to make sense – and use – of all this science we’re amassing. We’re getting more and more into the rubber-hits-the-road phase.

MP: In terms of conferences in 2012, what are the highlights for you?

JP: The 2012 International Microbicides Conference will take place in Sydney in April. And the granddaddy of all conferences, the International AIDS Conference, is being held in Washington, DC in July. It’s the first time it’s been in the US for a couple of decades because we had a ban on people with HIV traveling here, which precluded us from being able to host that conference. The ban was recently lifted by the Obama administration. This conference is going to be a big deal. It’ll put the spotlight on DC, in terms of DC’s support for HIV/AIDS both domestically and internationally. It’ll also be another great opportunity for Mapping Pathways to disseminate information and we’re hoping we’ll be able to utilize that huge stage – the biggest AIDS stage there is.

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.]

17 January 2012

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.]

16 January 2012

Viral load's effect on ARV therapy

via aidsmap, by Michael Carter

Suppressing viral load to below 50 copies/ml may not be enough to ensure the long-term success of antiretroviral therapy, according to a UK study published in the March edition of Clinical Infectious Diseases.

Using ultra-sensitive viral load assays, investigators at the Royal Free Hospital, London, found that patients with a viral load between 40-49 copies/ml were significantly more likely to experience a rebound in viral load above 50 copies/ml and 400 copies/ml when compared to individuals with viral load between 39 and 3 to 10 copies/ml and patients with a truly undetectable viral load.

The investigators recommend “treatment efficacy should be reviewed” for patients whose viral load is above the very lowest levels.

However, the authors of an editorial accompanying the study are less convinced about the significance of its findings.

The goal of modern HIV therapy is a viral load below 50 copies/ml. Studies have shown that a sustained increase above this level is associated with the virological failure of therapy and the emergence of drug-resistant strains of HIV.

Assays capable of accurately measuring viral load to 40 copies/ml have been developed. In approximately two-thirds of cases, the assays can also detect viral load to a threshold of 10 copies/ml.
Viral load at an ultra-low level – between 3 to 10 copies/ml – is often labelled “residual viraemia” and cannot be eradicated with treatment intensification.

Read the rest.


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

14 January 2012

Microbicides 2012 Registration is Open!

ASHM Australasian HIV/AIDS Conference 2011"To share in the latest developments in HIV prevention through microbicides and other technologies, this is the conference to attend. The conference is the key event in the microbicides world, where cutting edge research will be presented by world experts, and you will have a chance to interact with people involved at every level of microbicides development "-Professor John Kaldor, The Kirby Institute and Conference co-Chair

Come to Sydney in April for the 2012 International Microbicides Conference - 'From Discovery to Delivery', with state of the art plenary lectures on microbicides and other aspects of HIV prevention research, cross-disciplinary symposia, oral abstracts, and poster sessions.

M2012 will be a global forum for the presentation and discussion of the latest information on microbicides and oral pre-exposure prophylaxis for HIV prevention and their interface with other prevention strategies. There will be a strong emphasis on the role of community in both research and implementation of scientific findings. The conference is interdisciplinary, and will include basic science, pharmacokinetics, formulation and delivery, clinical research, public health, prevention science, and social and behavioural research.

Why Should You Come?

1. LEARN... From experts from around the world who will speak on key issues in HIV prevention technologies.
2. NETWORK... with a cross-disciplinary group of researchers, community representatives and policy makers, to support you in applying new approaches and perspectives in your work.
3. PARTICIPATE... in sessions that will range from state of the art lectures, to debates on hot topics in microbicides development.

Learn more here!


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

13 January 2012

Migrant population bears highest burden of HIV in India

via The Times of India, by Kounteya Sinha

Migration is fuelling India's HIV epidemic. National AIDS Control Organisation's latest figures show that besides high risk populations like sex workers, the highest burden of HIV is among migrants - 3.6%, which is 10 times the HIV prevalence among the general population.

With migration rates increasing, the prevalence will only get worse. According to the 2001 census, 30.1% of the population was considered to have migrated (314 million) - a considerable increase from 27.4% in 1991. NACO has, therefore, identified 108 railway stations - which are both source and destination of migrants travelling in search of work. These are now the focus of the country's anti-HIV fight.

Red Ribbon Express (RRE), which chugs out of Delhi on Thursday, will stop at most of these 108 identified stations to test migrants for HIV besides carrying out counselling and spreading anti-HIV messages. During it's year-long journey, RRE will traverse through 23 states, cover 30,000 km and stop at 162 stations.

Speaking to TOI, a NACO official said, "Migrants are one of the major focus areas this time with the RRE. Last year, RRE stopped at 152 stations and reached out to 8 million people directly. This time, around 30-40 stops will be to mainly address migrants."

NACO has identified 122 districts with high out-migration across 11 states which are on priority for starting up community level interventions. Another 75 important transit locations have been identified across these 122 districts from where these migrants usually board long distance trains/buses to reach their destinations.

Studies on the relationship between migration and HIV conducted by NACO in three popular migration corridors - Ganjam-Surat, Darbhanga-Delhi and Azamgarh-Mumbai - threw up shocking findings. It showed that two to four times more number of informal workers had non-regular partners or visited sex workers with only 25% using condoms. Around 5% male migrants and 13% female migrants reported sexually transmitted infections, nearly double the national average.

Read the rest.


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

12 January 2012

First Phase III European PrEP trial for gay men launched by ANRS!

via iPrEx News
ipergay
The ANRS (French National Agency for Research on AIDS and Viral Hepatitis) is about to launch in Europe the first pre-HIV exposure prevention trial in men who have sex with men.

This phase III trial—ANRS IPERGAY—will start at the end of January 2012, in Paris (Hôpital Saint-Louis, Professor Jean-Michel Molina and Hôpital Tenon, Professor Gilles Pialoux) and Lyon (Hôpital de la Croix-Rousse, Dr Laurent Cotte), and later in Montreal in Quebec (CHUM Hôpital Hôtel Dieu, Dr Cécile Tremblay). The trial will include 300 volunteers in the pilot phase and ultimately 1900 in total.

ANRS IPERGAY will involve men who have sex with men and seronegative trans men who have anal sex with men without routine use of condoms, with at least two different sexual partners in the six months prior to trial participation. Participation will last for between 12 (minimum) and 48 (maximum) months.

The trial will compare two groups of participants, one given Truvada®, the other a placebo, taken in both cases during the period of sexual activity, starting before sexual relations and ending afterwards.
All participants, irrespective of group, will be offered various means of prevention: free condoms, regular HIV screening, regular screening for and treatment of sexually transmitted diseases, vaccination against hepatitis A and B. Participants can ask for personalized prevention advice, if they wish.

An important part of the trial will involve a social sciences study of the profiles of participants and analysis of their sexual behavior, in particular regarding condom use, and will determine whether or not they take the medication as intended.

Participants will be invited to the hospital every two months or so for an interview and for clinical examinations, including screening tests.

The ANRS will sponsor and fund the trial, and Gilead will supply the medication.

The HIV community-based association Aides helped draw up the protocol, is a scientific and operations partner in the trial, and is a member of the scientific board. It will coordinate recruitment in the field and provide volunteers with prevention support.

ANRS press contact:Marie-Christine Simon – Tel :  +33 (0) 1 53 94 60 30  marie-christine.simon@anrs.fr


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

11 January 2012

What it really takes to prevent mother-to-child HIV transmission


Background

The World Health Organization (WHO) has called for the “virtual elimination” of pediatric HIV: a mother-to-child HIV transmission (MTCT) risk of less than 5%. We investigated uptake of prevention of MTCT (PMTCT) services, infant feeding recommendations, and specific drug regimens necessary to achieve this goal in Zimbabwe.

Methods and Findings

We used a computer model to simulate a cohort of HIV-infected, pregnant/breastfeeding women (mean age, 24 y; mean CD4, 451/µl; breastfeeding duration, 12 mo). Three PMTCT regimens were evaluated: (1) single-dose nevirapine (sdNVP), (2) WHO 2010 guidelines' “Option A” (zidovudine in pregnancy, infant nevirapine throughout breastfeeding for women without advanced disease, lifelong combination antiretroviral therapy for women with advanced disease), and (3) WHO “Option B” (pregnancy/breastfeeding-limited combination antiretroviral drug regimens without advanced disease; lifelong antiretroviral therapy with advanced disease). We examined four levels of PMTCT uptake (proportion of pregnant women accessing and adhering to PMTCT services): reported rates in 2008 and 2009 (36% and 56%, respectively) and target goals in 2008 and 2009 (80% and 95%, respectively). The primary model outcome was MTCT risk at weaning.

The 2008 sdNVP-based National PMTCT Program led to a projected 12-mo MTCT risk of 20.3%. Improved uptake in 2009 reduced projected risk to 18.0%. If sdNVP were replaced by more effective regimens, with 2009 (56%) uptake, estimated MTCT risk would be 14.4% (Option A) or 13.4% (Option B). Even with 95% uptake of Option A or B, projected transmission risks (6.1%–7.7%) would exceed the WHO goal of less than 5%. Only if the lowest published transmission risks were used for each drug regimen, or breastfeeding duration were shortened, would MTCT risks at 95% uptake fall below 5%.

Conclusions

Implementation of the WHO PMTCT guidelines must be accompanied by efforts to improve access to PMTCT services, retain women in care, and support medication adherence throughout pregnancy and breastfeeding, to approach the “virtual elimination” of pediatric HIV in Zimbabwe.

Read the rest of the study here.


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

09 January 2012

Apparent declining efficacy in randomized trials: examples of the Thai RV144 HIV vaccine and South African CAPRISA 004 microbicide trials

via AIDS, by O’Hagan, Justin J.; Hernán, Miguel A.; Walensky, Rochelle P.; Lipsitch, Marca

Recent HIV prevention trials have given hope that a suite of interventions that effectively reduce individuals’ risk of HIV infection will soon be widely available. In two studies, the RV144 and CAPRISA 004 trials, the relative risk of infection increased toward the null value of one over time. The RV144 and CAPRISA investigators interpreted these trends as evidence that the interventions’ effects declined over the study period and suggested that their respective findings may be explained by waning vaccine efficacy and decreasing adherence. Here, we discuss these trends in the trials’ results and note that, in addition to the possible mechanisms cited by the investigators, their apparent waning efficacy may be explained in part by selection bias due to heterogeneity in infection risk, an explanation that has not been considered previously. This bias arises when study participants vary in their susceptibility to infection, for example, because of differences in immune systems or exposure to infection. This can lead to increasing differences in the composition of the study population in each trial arm over time as those at highest risk become infected, and can occur despite comparability between arms at baseline. This issue is termed ‘frailty’ in statistics and demography, in which a large body of literature addresses the matter. We also discuss several methods that can improve understanding of the effects of infectious disease interventions and risk factors by assessing the impact of frailty on results.

Variation in frailty among study participants likely creates trends in the incidence of infection over the course of a study. To understand this phenomenon, consider a theoretical placebo-controlled randomized trial, in which the risk of infection varies among participants. The highest risk individuals in such a trial are expected to become infected earlier, leaving a pool of lower risk individuals at later time points. If the intervention being tested is effective, the decline in the incidence of infection over time will be larger in the placebo arm because these individuals experience no direct protection from the intervention, and so those at high-risk will be quickly depleted, thereby lowering the infection rate over follow-up. However, high-risk individuals in the active arm may remain uninfected due to the protection conferred by the intervention, so the active arm's infection rate will be less affected. Consequently, the time-specific rate ratio for treatment vs. placebo will increase over time from a value of less than one initially to a value that may exceed one later. This phenomenon has also been termed ‘survivor bias’, ‘survivor cohort effect’, ‘crossing of hazards’ and ‘depletion of susceptibles’, and is observed in both chronic and infectious disease research.

Read the rest.


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

06 January 2012

Shifting medical male circumcision to non-physician clinicians in Africa possible

via Aidsmap, by Carole Leach-Lemens

With proper training and supervision task shifting of medical male circumcision to non-physician clinicians in Africa can be done safely, according to researchers in South Africa and North America reporting in the advance online edition of AIDS.

This systematic review and analysis of ten studies (from South Africa, Kenya, Comoros, Nigeria, Zambian and Uganda) with information on over 25,000 circumcisions done by trained non-physician clinicians (nurses, midwives, surgical aides and clinical officers) found adverse events were not serious; and the pooled relative risk in two studies separately reporting outcomes for doctors and non-physicians showed comparable rates of adverse events (1.18: 95% CI: 0.78-1.78).

Evidence from randomised trials and observational studies support the protective effect of male circumcision for men getting HIV. Widespread male circumcision in Africa could prevent up to six million new infections and three million deaths in the next twenty years according to mathematical modelling estimates, note the authors.

With its potential as a high impact and cost-effective intervention both UNAIDS and the World Health Organization (WHO) promote voluntary male medical circumcision, with the latter providing guidelines for scaling-up of services in eastern and southern Africa.

In addition to ethical and acceptability challenges a severe shortage of health care workers in high prevalence countries, notably in Eastern and Southern Africa, is one of the major obstacles to effective scale-up.
Task shifting, the planned delegation of tasks from specialists or doctors to non-physician health care professionals, is a proposed strategy supported by WHO to increase scale-up of HIV treatment and prevention services. Randomised trials have provided evidence of the safety and efficacy of task shifting for ART.

To date evidence of the safety of circumcision by non-physician health care workers has been mixed. Reports of high rates of serious complications, note the authors, have confused those circumcisions undertaken by lay people with little or no training, lack of supervision or supportive equipment with circumcisions undertaken as a result of task shifting.

While there have been systematic reviews looking at the frequency of adverse events after circumcision, none have specifically looked at task shifting, note the authors.

The authors undertook a search of online databases and conference websites up to July 2011 reporting the outcomes of task shifting for circumcision in Africa.

Read the rest.


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

05 January 2012

Measuring quality of life concerns for people living with HIV

via Aidsmap, by Michael Carter

Fears about transmitting HIV to others, worries about the future, self-esteem problems, difficulty sleeping and treatment issues are now important quality of life concerns for people living with HIV that are not measured by existing resources, according to a report on a new quality of life measurement tool published in the online edition of the Journal of Acquired Immune Deficiency Syndromes.

The tool – called PROQOL-HIV (Patient Report Outcomes Quality of Life – HIV) - was developed with the participation of 152 HIV-positive patients in nine countries on five continents.

“PROQOL-HIV is a novel multidimensional HIV-specific HRQL [health-related quality of life] instrument that strives to be sensitive to socio-cultural context, disease stage and treatment in the HAART [highly active antiretroviral therapy] era,” write the authors. “Important new HRQL issues were uncovered from the culturally diverse experiences of PLWHA [people living with HIV/AIDS] in previously under-represented populations.”

Effective antiretroviral therapy has transformed the prognosis of many HIV-positive patients. However, people living with HIV still experience considerable changes in their health-related quality of life. Tools to measure such outcomes were developed in the era before potent HIV treatment became available. Moreover, they did not take account of the geographic, ethnic and cultural diversity of the epidemic.

Therefore an international team of investigators set out to develop a new instrument that was sensitive to the impact of HIV therapy, different diseases stages and applicable across settings. It derived from in-depth interviews conducted with patients living with HIV in 2007 and 2008. The patients were recruited in high-, middle- and low-income countries.
The interviews identified eleven broad areas of concern.

Read the rest.


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

04 January 2012

PMTCT Requires Greater Male Participation in Ethiopia

via PlusNews Global

Ethiopia's new plan to eliminate mother-to-child HIV transmission by 2015 cannot be attained unless men are more meaningfully involved in reproductive health, experts say.

"Among the pregnant women who come to our hospital, less than 10 percent of them come with their partners," said Etalem Gebrehiwot, head nurse at the prevention of mother-to-child transmission (PMTCT) wing of Gandhi Memorial Hospital. "Those who find out that they are living with the virus usually face a problem while taking medicines, given that most prefer to take it without the knowledge of their partners."

Studies show that low male partner involvement is one of the challenges to the success of the country's PMTCT programme.

According to experts, men's involvement in PMTCT can have a positive impact on PMTCT by encouraging their partners to visit antenatal clinics and have skilled health workers attend the birth of their children. In a 2010 Kenyan study, male partner involvement in PMTCT reduced the risks of vertical transmission and infant mortality by more than 40 percent compared to no involvement.

"The biggest challenge we are currently facing is to convince mothers to get tested in order to determine that they are eligible for PMTCT services... the major reason for their resistance is lack of consent from their husbands or partners, who are more influential in family matters including this," said Aster Shewa, who supervises Zewditu Hospital antiretroviral service centre in Addis Ababa.

"Besides, after they know their status, most HIV-positive mothers refrain from disclosing it, which usually impacts the way they use PMTCT services and their effectiveness," she added.

Many men do not see the advantages of an HIV test; one father, whose wife gave birth to a daughter in November 2011, told IRIN/PlusNews: "We are married - what is there to test about?"

"At the moment, hospitals with PMTCT services are increasing, and we have to work hard in convincing pregnant women, along with their partners, to use health facilities with the service in order to reach zero new infections," said Aster.

Read the rest.


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