Providing a range of prevention options: In conversation with Linda-Gail Bekker

Original content from our Mapping Pathways blog team

We need options. Not everyone in the world is a good pill taker. Like so many things in life, we may realise that people need different prevention options since they have different personalities.

In the final part of this five-part series, Linda-Gail Bekker of the Desmond Tutu HIV Centre, a Mapping Pathways partner organisation, speaks about the importance of adherence, both in clinical trials and the real world, and the challenges and issues facing adolescents. Read parts one, two, three and four

MP: You have mentioned adolescents as a particular vulnerable group in South Africa. In an interview conducted earlier this year, your colleague, Dr. Melissa Wallace, also talked about adolescents as an especially at-risk group. What are some factors that make them so vulnerable?

LGB: One particular reason why adolescents are highly at risk for HIV is because many are at the stage of their lives where they may be experimenting with their sexuality. They may also find themselves in relationships where negotiating condoms may be incredibly difficult.

This maybe the case with younger women whose relationships can be with older men and young MSM outing themselves for the first time and who may then choose to go out with older men.  In that situation, being able to use a PrEP tablet discreetly and under their own control could be a life-saving step.

So putting prevention into the hands of the vulnerable becomes a very important tool. But we can only do this if we are sure it’s safe in this population, which requires carefully run clinical research in order to adequately test the product in the relevant populations.

This requires resources and investment from sponsors and funding agencies even though this is often regarded as “high risk investment”. In that regard, I’m delighted that we’ll be starting an MP3 project (methods of prevention) based on a grant awarded to us by the National Institutes of Health (NIH) to look at PrEP and other biomedical prevention modalities in adolescents between 14-17 years old.

MP: Adherence is an issue that has come up quite a bit this year, from M2012 to AIDS 2012. How much are people talking about adherence and about taking lessons learned from trials into the real world?

LGB: Adherence is the Achilles heel of the HIV prevention and treatment worlds. This is where biology meets behavior. We know that the pill is efficacious – Partners PrEP showed that beautifully. In fact, every single one of the clinical trials has shown that once adherence increases there is a direct correlation with efficacy in the results. Starting with the 39% in the CAPRISA study leading on to 44% in the iPrEx study and going on to an astounding 75% in the Partners PrEP study – each one had an increased overall adherence rate and with this an increase in point efficacy, so the correlation appears to be a real phenomenon.

In addition, the sub-studies done in every trial showed that high adherers within a study had a better efficacy compared to the lower adherers. So we can quite confidently say there is a robust relationship between adherence and efficacy.

So how do we get people to adhere? Motivations play a great role. Partners PrEP which enrolled discordant couples had a great in-built motivation that one was protecting a loved one by taking the pill, which may be the reason we saw particularly high adherence for that population.

I think we also need to understand that not everybody in this world is a good pill-taker. There will be those who just cannot bring themselves to swallow pills on a daily basis. So PrEP may not be a very good idea for them. In that situation, maybe a rectal microbicide or a microbicide that’s part of a lubricant may work very well for that individual.

We need options. If we get to that stage in the future where other prevention technologies are available, like getting a shot in the arm that lasts three months, then we need that option on the table too. Like so many things in life, we may realise that people need different prevention options since they have different personalities.

MP: What are some of your final thoughts on what needs to happen to stem the HIV epidemic?

LGB: We need to have conversations on several different levels: ethical, scientific, public health, politics and priorities. Different countries and communities will be at different places. Some of the hard questions are : Who pays? How will we implement this prevention strategy? Is this strategy for the generalised epidemic or is it only for selected key populations? Who are the key populations? What are the social factors that make them vulnerable? Is this ethical? Does it make sound public health sense? What wont be afforded if we go this route? Who will benefit if we do?

Those are all very hard questions but they deserve to be asked and certainly require ongoing dialogue. This brings us back to the Mapping Pathway- we have been contributing to the dialogue through this project. We also need to do the modeling exercises and implement some feasibility type projects and then continue to raise more questions., It’s a wonderful thing that we are at a point where we can actually have these conversations. They are not hypothetical questions anymore. It is urgent to have these discussions in such a way that the next steps become clear and infections can be averted before too much more time is lost.

Linda-Gail Bekker is deputy director of the Desmond Tutu HIV Centre at the Institute of Infectious Disease and Molecular Medicine, University of Cape Town. She also serves as the chief operating officer of the Desmond Tutu HIV Foundation, a Mapping Pathways partner organisation. 

Stay tuned for the Mapping Pathways monograph, coming in early 2013

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

via AllAfrica.com, interview with Dr. Sengeziwe Sibeko

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

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

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

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

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

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

So what did you do next?

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

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

Read the rest.


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

Keep up the fight for microbicides

via AllAfrica.com, by Julie Frederikse

Africans tracking the worldwide HIV epidemic have not found much to celebrate since Aids began ravaging the continent 30 years ago, but researchers are optimistic that they are learning as much from their failures as their successes.

Sub-Saharan Africa still carries the biggest burden of HIV worldwide, and while there has been a significant improvement in access to antiretroviral treatment in recent years, scientists searching for a gel or vaccine that can prevent HIV infection ride a rollercoaster of hope and disappointment.

Take the case of a husband and wife team from the University of KwaZulu-Natal in South Africa. Professors Salim Karim and Quarraisha Abdool Karim head up a research unit that has been at the forefront of clinical trials to find a safe and effective microbicide to protect women from HIV.

In July 2010, delegates at the last World Aids conference gave the couple a standing ovation when they announced the results of one of the most promising studies on HIV prevention to date. Their team at the Centre for the Aids Program of Research in South Africa (Caprisa), showed that a vaginal gel called tenofovir was able to reduce sexual transmission of the virus by 39 percent overall and 54 percent in women who used it consistently.

But the euphoria over this breakthrough has dissolved into disappointment, with the unexpected finding of a wider sub-Saharan African study that the microbicidal gel, when prescribed daily, does not prevent HIV infections. This has led to the suspension of tenofovir in the Vaginal and Oral Interventions to Control the Epidemic (Voice) trial.

Tenofovir is an antiretroviral drug that is taken successfully by many people living with Aids to suppress the virus. The hope had been that tenofovir could also be used to prevent HIV infection. Women are twice as likely as their male partners to acquire HIV during sex and account for 60 percent of adult HIV infections in sub-Saharan Africa. An effective microbicide would give women the option of applying the vaginal gel themselves before sex, without necessarily informing their partners.

Read the rest.


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

Current State of Microbicide Research

via Cold Spring Harbor Perspectives in Medicine, by Robin J. Shattock and Zeda Rosenberg

Microbicides represent a potential intervention strategy for preventing HIV transmission. Vaginal microbicides would meet the need for a discreet method that women could use to protect themselves against HIV. Although early-generation microbicides failed to demonstrate efficacy, newer candidates are based on more potent antiretroviral (ARV) products. Positive data from the CAPRISA 004 trial of tenofovir gel support use in women and represent a turning point for the field. This article reviews current progress in development of ARV-based microbicides. We discuss the consensus on selection criteria, the potential for drug resistance, rationale for drug combinations, and the use of pharmacokinetic (PK)/pharmacodynamic (PD) assessment in product development. The urgent need for continued progress in development of formulations for sustained delivery is emphasized. Finally, as the boundaries between different prevention technologies become increasingly blurred, consideration is given to the potential synergy of diverse approaches across the prevention landscape.

An effective microbicide may be one of the best ways to address a central gap in current HIV prevention strategies: lack of a discreet method that women can use to protect themselves from infection. Recently, the World Health Organization reported that AIDS is the leading cause of death among women of reproductive age globally, and particularly in sub-Saharan Africa (World Health Organization 2009). Methods available to prevent HIV include condoms, male circumcision, and behavioral interventions, but data indicate that they are insufficient to protect women. Among women in sub-Saharan Africa, one of the highest-risk factors for acquiring HIV is being in a stable long-term relationship where condom use is low (Shattock and Solomon 2004).

Condoms are impractical for women who want to conceive children or who cannot persuade their partners to use them. Next to an effective vaccine, microbicides (topical preexposure prophylaxis [PrEP]) and oral PrEP have the greatest potential to provide women with protection they can control. Both could be configured to protect men and women from transmission of HIV during unprotected anal intercourse.
Microbicides are topical PrEP products, such as gels, capsules, tablets, films, and intravaginal rings (IVR). They are designed to be applied either around the time of coitus, used on a daily basis (gels and films), or to deliver product over a prolonged period

Read the Rest.


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

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

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

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

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

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

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

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

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

Read the rest.


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

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.]

A Defining Moment in HIV Control

via The Lancet, by Salim S Abdool Karim, Quarraisha Abdool Karim

A defining moment in the global AIDS response has been reached. The discourse is no longer about HIV prevention or HIV treatment; it is now about HIV control through the implementation of antiretrovirals as key components of combination interventions. Barely a year ago, visions of HIV control would have been considered far-fetched. The impetus for this change in mindset, which has been building since the XVIII International AIDS Conference in Vienna last year, emanates from the compelling evidence that antiretroviral drugs prevent HIV infection in the general heterosexual population, which is released this week and presented at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Rome by the Partners PrEP1 and Botswana TDF22 trials.

The Partners PrEP trial,1 involving 4758 HIV discordant couples from Kenya and Uganda, found that daily oral tenofovir disoproxil fumarate (TDF) and TDF-emtricitabine reduced HIV transmission by 62% and 73%, respectively. The Bostwana TDF2 trial,2 in 1200 heterosexual men and women from the general population, found that daily oral TDF-emtricitabine reduced HIV transmission by 63%. These findings follow close on the heels of the CAPRISA 004 trial3 of tenofovir gel, the iPrEX trial4 of oral TDF-emtricitabine in men who have sex with men, and the HPTN 052 trial5 of early antiretroviral treatment as HIV prevention. Importantly, these new findings fill a critical gap in HIV prevention with a readily available antiretroviral approach to prevent heterosexual transmission in both men and women (figure). Women benefit from a new prevention option under their control, which is particularly important for those not assured of their partner's fidelity or willingness to use a condom. The hope these studies add to HIV prevention is further bolstered by the recent step taken by the pharmaceutical company Gilead Sciences Inc to lodge TDF and emtricitabine with the UNITAID patent pool,12 thus enabling lower cost versions of the drugs to be manufactured and thereby facilitating wider access in poor countries.

 There is now no doubt that antiretroviral drugs prevent HIV infection. However, important scientific questions remain. Does the inclusion of emtricitabine in pre-exposure prophylaxis (PrEP) formulations provide sufficient additional benefit to warrant the additional costs and side-effects? Are levels of effectiveness and safety similar for daily use and use-with-sex of PrEP? Do the safety, effectiveness, cost, and acceptability profiles of oral and topical PrEP merit implementation of both formulations? Does PrEP lead to masking of HIV acquisition that is then revealed once PrEP is withdrawn? Can the new results be generalised to the type of hyper-endemic settings (HIV incidence more than 5% per annum) where the FEMPrEP trial13 was done? Since inadequate drug levels may not have been responsible for the lack of effectiveness observed in the FEMPrEP study,14 the search for an explanation for this intriguing and contrary result needs to be pursued with vigour.

There are also many practical questions about implementation: how to increase uptake of HIV testing;15 how often to monitor HIV status in people on PrEP; how to achieve high coverage in those at highest risk; how to maintain high levels of adherence; how to reduce the risk of migration away from condoms (behavioural disinhibition); and how to monitor the risk of drug resistance. While attempts are being made to obtain data to address these questions and to generate data to guide effective implementation, the development of normative guidance by WHO/UNAIDS and submissions for regulatory approvals of TDF and TDF-emtricitabine as PrEP for HIV infection are key next steps.

As antiretroviral drugs take a key role in the global effort to control the HIV epidemic, there is much to be learned from the contraceptive field where multiple technologies, approaches, formulations, and dosing options were developed to enable and maximise user choice and increase levels of uptake, coverage, and adherence and thereby improve the public health impact.

Beyond the questions of implementation, the future scientific challenge looming large for PrEP is finding a drug or class of drugs with a resistance profile that does not interfere with existing first-line and second-line AIDS treatment. Treatment of HIV-positive people for HIV prevention and PrEP and microbicides for HIV-negative people are two sides of the same coin, and cannot be viewed in isolation from each other. Although research on treatment for prevention, PrEP, and microbicides has mostly occurred in separate silos, their findings converge into a single focus in HIV prevention and necessitate guidance on how to use all three strategies synergistically for maximum benefit depending on the nature of the HIV epidemic. There is no magic bullet for the HIV epidemic. Treatment for prevention will be dependent on the extent to which couples establish their HIV status, whether the HIV-positive partner in a discordant couple adheres to therapy, and whether the HIV-negative partner maintains fidelity within the partnership. PrEP will be dependent on the extent to which people seek to establish and regularly monitor their HIV status and those on PrEP adhere to their regimen and clinical monitoring. Hyper-endemic communities, such as those in South Africa where HIV prevalence in the community is high, may require both interventions jointly and synergistically: treatment of people infected with HIV to reduce risk of transmission within the discordant couple, and PrEP to reduce the HIV-negative partner's risk of HIV acquisition from outside partners.

Therein lie the three most complex policy, implementation, fiscal, and ethical challenges generated by these new findings. First, how to scale up HIV testing, a key prerequisite in settings with stigma and discrimination. Second, how to extend antiretrovirals for both treatment and prevention when many of Africa's health systems are already struggling to cope with patients with AIDS and are not able to initiate antiretroviral therapy in everyone who currently needs it for their survival. Third, in the context of limited resources how best to ration and prioritise the limited available implementation capacity.

In this defining moment in the response to HIV, a global commitment to increased financial resources for implementation, health systems strengthening, and greater implementation efficiency is imperative. Anything less will crush the hope and promise that antiretroviral drugs can change the course of the HIV epidemic.
We were the co-Principal Investigators of the CAPRISA 004 trial of tenofovir gel. QAK is co-Principal Investigator of the HIV Prevention Trials Network, which is undertaking HPTN 052 trial of treatment for prevention. SSAK is an executive committee member of the Microbicide Trials Network, which is undertaking VOICE trial of oral and topical PrEP.


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