#bearsrepeating: New media at Vancouver focuses on familiar, essential concerns

The AVAC Twitter feed has been alight over the last several days as the team tries to capture, in 140 characters, some of the key findings and messages coming out of IAS 2015. A quick search of #IAS2015 shows the range of topics covered over days of concurrent sessions running morning to night. A lot has been covered but if one were to—albeit unscientifically—distill key take-homes based on retweets, favorited tweets and Twitter’s “top tweets” some perhaps unusual suspects rise to the top.

AVAC’s second-most-popular tweet of the week wasn’t on the exciting data from START, the final results of HPTN 052 or the announcement that a young woman remains “in remission” after 11 years. In fact, it was a tweet on the qualitative data presented from the ADAPT study. It noted a simple finding on a complex issue: the need for interventions to reduce HIV-related stigma to help ensure PrEP success.

Looking beyond the AVAC Twitterverse, among the top tweets when searching the #IAS2015 hashtag is one from UN Women linking out to data on barriers some women still face when trying to initiate and stay on treatment (and AVAC covered in an earlier IAS blog post).

Both of these “findings” could easily be filed under “non-shock of the week,” to borrow a phrase from the indomitable activist and writer Kenyon Farrow—but what is shocking in fact is that the statements still need to be made. (Looking for reasons why—consider elsewhere in social media, AIDS activists on Facebook fulminating about an all-male panel on HIV testing and the 90-90-90 goals, in a thread that included the suggestion: if you’re a man invited to be on an all male panel—decline.”)

The reason these tweets garner attention is because there’s a lot of talk, perhaps even lip service, and far too little action when it comes to reducing stigma, truly engaging people who are living with or at risk of HIV or violence or discrimination in programs that will meaningfully change their lives. It’s not that biomedical solutions can be set aside but they can’t work without action on these other fronts. #oldnews #bearsrepeating.

Fortunately, AIDS remains a place for activists who don’t give up—even if it means re-stating what ought to be operating principles. One source, at this meeting, is the Canadian Declaration by Persons Living with HIV, outlines how the goals of the Vancouver Consensus “will only be achieved through a comprehensive, community-driven, global response that respects the human rights of people living with HIV and communities affected by HIV”.

For more fresh ways to restate this imperative, check out Wednesday’s plenary presentation by Michel Kazatchkine (UN Special Envoy for HIV/AIDS in Eastern Europe and Central Asia), who reminded the audience of the harm of stigmatization and social marginalization experienced by some vulnerable populations in Russia, Eastern Europe and Central Asia—and the detrimental effect on access to services and health. Policies that criminalize—whether by official or unofficial policy—and drive people underground and away from care.

High-altitude PrEP: The birds-eye view of discussions and data in Vancouver

It speaks volumes about the, well, volumes of PrEP data emerging from the International AIDS Society meeting in Vancouver that we can’t even try to summarize all the findings here in P-Values. Excellent round-ups can be found on the NAM website and you can access some of the PrEP sessions online. In this post, we offer up a birds-eye view of what is known and what is anticipated in the coming weeks and months.

Guidelines are … coming!

On July 17, the Friday before the conference opened, UNAIDS released two new documents: a “Q and A” document on oral PrEP, and WHO/UNAIDS released a background paper, developed jointly with AVAC, titled “Oral Pre-exposure Prophylaxis: Putting a new choice in context”.

What context, you ask? Well, there’s the rub… at least for now. In the cover note from UNAIDS and in the actual text of the latter document, reference is made to a forthcoming recommendation from WHO on PrEP. This guidance is, “likely to be significantly broader than previously and creates real opportunities for moving forward with implementing PrEP as part of comprehensive HIV programmes.”

Exactly what the recommendation will be, and when in 2015 it will be released, remains to be seen (although at the meeting, WHO leadership has alluded to an expedited process—mentioning a September release in one public session). But the “PrEP in context” document spells out the scope: PrEP works for men and women when it’s taken correctly. It’s an important option for people at risk of HIV. It’s safe, needed and should be introduced in close collaboration with civil society and communities in need and at risk. In the absence of the actual recommendation, there may be little action—but this preview could and should catalyze action to be ready for when the recommendation comes as well as for action that can happen in the meantime.

The picture is getting clearer

Guidelines don’t turn into programs over night. And it’s important to anticipate the questions—many already being asked—that will only become more urgent when there is an official recommendation on PrEP. The conference provided some concrete info to consider and feedback to various partners on how PrEP is working in the real(-ish) world of open-label access and demonstration projects. Here are some key takeaways from sessions that can be found by the abstract numbers here:

PrEP is a needed, additional option. An unofficial (aka from a seat in the session) analysis of the baseline characteristics gay men and other men who have sex with men who participated in PrEP studies shows that the vast majority reported condomless anal sex at the time of trial enrollment. Some of these trials had prior condomless sex as an entry criteria, and self-reporting of sex acts can be unreliable. But with these caveats, it’s still useful to note where PrEP trial participants were, in terms of ability to negotiate condom use with every sex act, when they began research.

One concern some have raised is that PrEP is going to cause people to abandon condoms, and these data are a reminder that suggest that PrEP needs to be there for is going to be sought out by people who are already not able to use condoms all the time. The information shared by these participants bears out the argument that PrEP is an additional, needed option.

PrEP is feasible—with support. Data from the US PrEP demonstration (Demo) project in San Francisco presented by Albert Liu (San Francisco Department of Public Health) show that those gay men and other MSM at highest risk based on reported behaviors were able to adhere to PrEP regimens sufficiently well to achieve protective levels. Adherence happens in an environment—family, community, country—and the parameters of this environment need to be taken into account as PrEP rolls out. Sybil Hosek (Stroger Hospital of Cook County and ATN) also called for “more in-depth understanding of the historical, societal, behavioral, and attitudinal barriers to PrEP access and adherence among those most impacted in the US—young black MSM.” Dr. Liu also noted that participants in the Demo Project received a financial incentive (USD$25 per study visit). Retention was good in this trial, but the role of incentives need to be interrogated—see our blog here for more on this issue.

People can figure out whether they need PrEP. Beatriz Grinsztejn (Fundação Oswaldo Cruz (Fiocruz)) reported on a Brazilian demonstration project that is the first in a middle-income country in a trial-naïve population (i.e., not post-trial access.) Among gay men and other men who have sex with men, and transgender women offered PrEP, roughly half opted to use the strategy. Uptake was higher among those who self-referred (as opposed to learning about PrEP during an HIV testing visit). These data reinforce that people in some contexts can recognize risk and be interested in PrEP. Is 50 percent uptake success—e.g., people are assessing what will work for them? Or will patterns of uptake change over time? That’s exactly the kind of question that further investigation as PrEP rolls out.

PrEP works in women and men AND women and men are not the same. As we discussed in a blog on Tuesday, there have been various statements at the conference that PrEP doesn’t work as well in women. These need to be tempered and nuanced. No prevention strategy works all the time for every individual and sometimes this is related to biology, other times to culture, context and society. A poster presentation on barriers and facilitators to PrEP use from the ADAPT open-label study of PrEP in young women in South Africa, provides a fascinating, multi-faceted look at how many parameters affected participants’ choices. These sorts of investigations are crucial to introducing PrEP in ways that do work for both men and women. On the biological plausibility front, data reported from the Botswana TDF2 open-label extension trial in men and women found high levels of protection in both sexes—though the numbers were small. As Gus Cairns explains in a terrific post on PrEP for vaginal versus rectal exposure, there are areas for further investigation and a need for careful messaging. But when PrEP is taken by women in many settings, these women are protected. Let’s remember, and act, on that.

Living Below Detection: Another case of HIV remission

Jessica Handibode is an AVAC staff member.

Whenever I see or deliver a presentation about the state of HIV cure research one of the most interesting topics is how the field is defining what it means to be cured of HIV infection. Many researchers and community groups have pushed for the term “remission” to be used since there are no scientifically proven tests to determine whether an individual’s HIV will return. Recent cases of HIV “cures”—as they were reported in the media—like the two men from Boston and the Mississippi Child, have all ended in viral rebound. This further strengthens the case for the use of the term remission.

At the IAS 2015 conference on Monday, Dr. Asier Sáez-Cirión, of the Pasteur Institute in Paris, the same researcher working with the VISCONTI Cohort, introduced the world to an eighteen-year-old HIV-positive female living without treatment for over 11 years. This young woman offers a proof-of-concept for long-term control of HIV without treatment and pushes how the field might define remission of HIV.

What are the facts?
This young woman was born to a woman living with HIV who did not have viral control. Shortly after birth, the young woman was put on antiretroviral therapy and confirmed to be HIV-positive four weeks later. The mother reports that her daughter had challenges taking medication consistently during the first seven years of her life and that she stopped ART altogether twice.

During both treatment interruptions she experienced viral rebounds 75,190 copies/mL of blood & 97,000 copies/ mL of blood respectively. After both viral rebounds, she started treatment again and achieved virologic suppression. When the girl was about six years old, she stopped treatment and doctors’ visits. In research parlance, she was “lost to follow-up”. When the young woman returned to care a year later, she had an undetectable viral load. Since then, this young woman, who is now 18 years old, has remained undetectable without treatment except for two viral blips. Viral blips, or viremia, are periods where the number of viral copies rises above the limit of detection (40 viral copies/mL of blood). The first viral blip occurred at 11 years (509 copies/mL of blood) and the second at 14 years (48 copies/mL of blood). However she hasn’t been cured. In lab tests, HIV can be isolated and grown from cells from her blood.

What does this all mean?
Well, first it means that this young woman can control her virus without treatment, but her virus has not been eradicated. Since researchers can stimulate her cells to start producing virus in the lab, it is possible that she could experience another rebound. This is also supported by the two viral blips she experienced at 11 and 14 years old. In spite of this, she is capable of long-term virologic control—without ART.

Is she in remission or is she just controlling her virus?
She’s doing both! Long term post-treatment control has become a new area of discussion as cases like the VISCONTI cohort and this young woman are introduced to the field. The VISCONTI cohort, a group of French post-treatment controllers, were all treated early (within the first six months of infection) and were on suppressive treatment for a median time of three years before stopping treatment. The individuals in this cohort have been able to maintain control at very low or undetectable levels for about nine years off treatment. Post-treatment controllers differ from rare natural controllers known as “elite controllers” and “long-term non-progressors”. Both elite controllers and long-term non-progressors have protective immune responses that allow these individuals to control HIV without treatment. These individuals also have greater immune and inflammatory responses than HIV-positive individuals on ART. Remission, like cure, is a term with a specific emotional resonance. It is often thought about as the period of time where the disease is absent but could return. Both terms are fairly commonly used in the cancer field where, for instance, you are considered “in remission” for a certain number of years before you are “cancer-free”.

But there are so few cases of either remission or cure in HIV that it is very difficult to say when and how they should be used—or how to define them. With an individual like this young woman, it’s not possible to predict—because there are no comparators for her experience—when, if ever, she might have a rebound of HIV. She has been undetectable longer than the Berlin Patient has been cured, yet the presence of virus in her body means that she doesn’t meet the criteria for being cured. With so much uncertain science, the language sometimes fails us. But regardless of whether you describe this young woman as being in remission or a post-treatment controller, her experience pushes the science of HIV cure research forward and offers new hope for the future.

Science, Solutions and Questions at Vancouver IAS Conference

“Science has delivered solutions. The question is: When will we put it into practice?”

So says the last line of the Vancouver Consensus Statement, a stirring call for expanding access to antiretrovirals for treatment and prevention as part of a comprehensive response to AIDS. AVAC signed the statement, released at the start of this year’s conference of the International AIDS Society. So did virtually every notable scientist and physician in the field. And we firmly believe in the contents of the statement.

Over Sunday and Monday pre-conference satellite sessions and in the official program, we heard a lot of science. On Monday, there were presentations of data from HPTN 052 and START—two complementary trials of ART in people living with HIV. There were also data from the ADAPT and IPERGAY PrEP trials and a press conference looking ahead to news from later this week.

For all of this, the Vancouver Consensus Statement is the backdrop—as is the news, released by UNAIDS just prior to the launch of the conference, that the global total of people initiated on ART has exceeded 15 million, and that incidence has begun to drop in some places.

Overall, it is a very good time to be on the side of scientific solutions to the HIV pandemic. And that’s where AVAC stands. But listening closely at the conference and in recent months, we’d offer this additional formulation of the consensus statement’s closing line: “Science has delivered the questions. The solution is: Not shying away from the answers.”

One of the primary solutions that science has delivered is the use of antiretroviral therapy for people living with HIV, both for their own health and to reduce the risk of onward transmission. In a special presentation on Monday (The Strategic Timing of Anti-Retroviral Treatment (START) Study: Results and Their Implications (Monday 20 July, 11:00-12:30), Jens Lundgren (University of Copenhagen) presented data from the START trial, which showed significant benefits for people living with HIV who started ART regardless of CD4 cell count, versus those who started treatment as indicated by the guidelines where they lived. As described in May, when data from the study were first reported, immediate initiation more than halved the risk of serious adverse events, serious non-AIDS events, or deaths.

This is the first major meeting since the START data started making waves (between START and PrEP, this may be the most pun-able conference to date), reaffirming global campaigns to expand ART coverage and to make ART the cornerstone of efforts to end AIDS.

If START has a twin, it is HPTN 052, which also saw data presented on Monday. Mike Cohen (UNC and HIV Prevention Trials Network) delivered the complete findings from HPTN 052, which first reported interim results in 2011 (View slides and abstract via the Conference Programme, session MOAC01: TasP: Just Do It. Monday 20 July, 11:00–12:30)

In that preliminary report, immediate initiation of ART (in this trial, at CD4 cell counts above 350) dramatically reduced the chances that an individual would pass HIV to his or her primary partner.

In the data Cohen presented here, the initial finding holds true. Over the course of the trial, there were eight “linked” transmission events (where the virus acquired matched that of the partner enrolled in the study) in couples where the HIV-positive partner had initiatied ART. Where transmission did occur, it usually happened in the context of incomplete virologic suppression—either a person had started ART too recently to be completely suppressed or because of adherence challenges.

The bottom line: virologic suppression makes HIV transmission between individuals where one person is living with HIV and the other is not highly unlikely. The treatment that has a prevention benefit is also good for the individual—so on every count, the science appears to have provided the solution.

And yet. The real world is a decidedly unscientific place.

In HPTN 052, there were 26 unlinked transmission events, where a person with a known HIV-positive partner acquired HIV from outside the primary partnership followed in the study. So having one partner who is virologically suppressed isn’t protective for an HIV-negative person who, for a variety of reasons, may have other partners and/or other sources of risk, such as injection drug use.

This reality is one of the many places where science and social, cultural and personal realities demand multiple solutions. The number of unlinked cases of HIV is a reminder that people exist in complex realities, with multiple partners and various behaviors.

Another powerful reminder of this context came at a pre-conference satellite on the global status of women’s access to ART. That session presented preliminary findings from an ongoing investigation commissioned by UN Women and carried out in collaboration with the ATHENA Network, Salamander Trust and AVAC. Combining a participatory methodology in which women living with HIV defined, delivered and assessed questions about health care experiences and an in-depth literature review, the work to date shows that women are being reached by ART but that the rights-based framework that allows them to remain on ART after initiation is, in many instances, lacking.

What to do with these data?

One answer does lies in science. Earlier this year, at the Conference on Retroviruses and Opportunistic Infections, the investigators of the Partners Demonstration Project presented the results of their combination PrEP and treatment study in which the HIV-negative member of a serodiscordant couples was offered PrEP as a “bridge to ART” for the person living with HIV. Right now, the data say that PrEP reduces risk of HIV acquisition regardless of who your partner is or how many partners you have (for more on PrEP, see below). And it turned out that, over the course of the study, very few new cases of HIV occurred. For 48 percent of the time, couples were using PrEP alone. PrEP and ART overlapped during 27% of the time, ART was used alone 16% of the time, and neither was used 9% of the time.

WHO did not formally publish their new ARV guidelines at this meeting. However, Gottfried Hirnschall, who directs WHO’s HIV department, did say that additional formal guidance on both PrEP and ART would be released by the end of the year. It is even possible that “rapid advice” could be available sooner—perhaps even in a matter of weeks. Hirnschall anticipated that these new ARV guidelines would recommend the offer of treatment for all adults and adolescents regardless of CD4 count as well as PrEP being offered as an additional prevention choice for people at substantial risk of HIV infection.

As Ambassador Debbi Birx, head of the US PEPFAR program stated in her Monday morning plenary, “Don’t wait for the paper” from WHO or other agencies. “Act on the science and evidence now.”

Acting on science is, as Ambassador Birx and other speakers have noted, just part of the solution. Success depends on non-scientific solutions that are, in some cases, getting lip-service but struggling for real traction today. Women in the global survey described above consistently reported the benefit of peer-delivered treatment literacy, non-stigmatizing sexual and reproductive health care, and rights-based care for all women, including those who aren’t pregnant when they enter the health system.

The science, if we really listen, says something slightly different. It says that ART for people living with HIV and PrEP for people who are at risk, and peer-delivered treatment literacy, and rights-based health care environments for women, men, young people and all key populations can begin to end the epidemic—if and only if other strategies are scaled up at the same time.

PrEP Talk: Promising, Perplexing
Monday was also a big day for PrEP data (slides can be downloaded from the session MOAC03 from the online conference programme), with data from the ADAPT trial that evaluated various dosing strategies, including once-daily, fixed intermittent dosing and event-driven dosing. The study enrolled South African women and gay men and transwomen in Thailand and the US. Overall, people were able to take PrEP, reported principal investigator Bob Grant. Individuals who were counseled to take the drug on a daily basis had a higher coverage of sex acts than those who were advised to use a non-daily strategy. For this group, the missed dose was usually post-sex—a finding that echoes reports from women who participated in the FACTS 001 trial of 1% tenofovir gel, which also tested a coitally-related dosing schedule. In both ADAPT and FACTS 001 cases, the dose after sex proved difficult—participants weren’t at home and/or weren’t in the emotional or physical space where they felt they could swallow a pill or insert a gel.

The good news from ADAPT is that PrEP continues to be feasible and acceptable in a variety of settings and demographics—bolstering the call for this strategy to be rolled out as an additional prevention option for all individuals at high risk.

Of concern and for careful tracking by advocates, is messages coming from the podium that PrEP may not work as well for women as it does for men whose primary risk is via anal sex. It is clear that women need to take daily oral PrEP for longer periods of time before they have protective levels in their vaginal tissue. It is also clear that adhering to a daily oral regimen may be difficult for some women, just as it is for some men. But what’s happened over the past few days with casual references from NIAID Director Tony Fauci and other leading scientists is a sowing of confusion that appears to contradict the US FDA recommendation and data from the Partners PrEP and TDF2 trials that found comparable protection for men and women.

Sometimes science raises questions, and we’re all for these questions coming to light. But it’s essential that the language be clear and that the way to certainty be mapped out. Right now, the discussion feels more risky than scientific—at a time when science is supposed to reign.

VMMC at IAS 2015: Cause for celebration and concern

Advocates tracking the pace and coverage of voluntary medical male circumcision have a new, concise resource in the form of a two-page “progress brief” from the World Health Organization. The document was launched in time for the International AIDS Society’s meeting in Vancouver and reports a “remarkable expansion to nearly 9.1 million voluntary medical male circumcisions (VMMC) performed for HIV prevention through 2014 in priority countries of East and Southern Africa.” Even more remarkable: among the 9.1 million, more than 3 million were performed in 2014 alone.

The report also states that, “Sufficient resources to reach at least 80% VMMC coverage must be available for this one-time, long-term efficacious intervention for both individual and public health HIV prevention, while preparing for VMMC sustainability within broader prevention programming.” As AVAC has covered in recent months, funding for VMMC has dropped at the precise moment that these gains in numbers and coverage are being made (for background, see our VMMC section in AVAC Report 2014/15: Prevention on the Line and this year’s Resource Tracking Report, HIV Prevention Research & Development Funding Trends, 2000–2014).

The bold consensus statement released at the Vancouver meeting by the International AIDS Society and signed by many leaders in the field calls for expanded access to ART for treatment and prevention. Unfortunately, the statement does not mention VMMC as a critical strategy for sustained funding and ambitious targets–an omission also found in the Declaration from the 2012 World AIDS Conference.

In the three years between these meetings, tremendous progress—captured in the new brief—has been made. But to sustain this momentum, VMMC needs to be specifically identified as central to bringing epidemic levels of new infections to an end. Rhetoric, funding and programming all need to follow, or else the progress brief in one or two year’s time may be far less encouraging than it is today.

 

AVAC’s HIV Testing Blog Series #1: Can HIV Self-Testing Help Slow the Epidemic?

On July 17th, the World Health Organization Released new consolidated guidelines on HIV testing services that bring together new and existing recommendations on the intervention that WHO calls “the gateway to prevention services and life-saving treatment and care.” HIV testing is also the first “90” in the UNAIDS Fast Track targets that seek to have 90 percent of people living with HIV tested, 90 percent of those individuals tested on ART, and 90 percent of those on ART virologically suppressed by 2020. Given that WHO estimates just 51 percent of people living with HIV know their status, there’s much work to be done on the testing front. The new consolidated guidance provides recommendations for lay provider testing (e.g., not by a medical professional) and advises countries on how best to target.

AVAC will be delving into various aspects of the advocacy, policy and implementation landscape around testing in P-Values posts in the coming months. In this blog, by veteran HIV journalist Mark Mascolini, we take a look at self-testing—an intervention that doesn’t yet have full WHO guidance, but is on the horizon.

How would you rate a personal diagnostic system that’s accurate, easy-to-use, private, and completely confidential? Five stars, perhaps, until you learn that it costs more than many who need it most say they can pay, misses all diagnoses in a key disease period, and may inspire false—and risky—confidence. That quick take on the pros and cons of HIV self-testing distills a slowly swelling data cache, a World Health Organization (WHO) Technical Update, and two well-reasoned analyses of new technologies that could change the way many high-risk people learn they carry HIV and may even limit HIV transmissions. But research has yet to nail down whether the clear benefits of self-testing outweigh potential drawbacks. In its new guidelines on HIV testing services WHO says that there “promising evidence” for the acceptability of self-testing and recommends implementation through country demonstration projects and pilot programmes, but stops short of a general recommendation. For this, WHO says it will wait for data from several trials whose results are expected in 2015/2016.

In the meantime, though, there’s a wealth of information for advocates and activists to consider.

Possible pluses and minuses of HIV self-testing

Pluses

Minuses

Privacy

Cannot detect early infection

Anonymity

Requires self-motivation for follow-up

Ease of use

Misunderstanding of procedure, interpretation

Accuracy

Mental distress over positive result

Testing option for high-risk people

Cost impact on access

Mutual testing of sex partners

Partner coercion

Easier repeat testing, for example, for PrEP

Condom-free sex after negative result

Wider HIV testing lowers late-diagnosis rate

Missed opportunity for STI screening

Where does testing fit in to “ending AIDS??

Testing is the cornerstone of the UNAIDS launched the 90-90-90 initiative, which aims to ensure that 90 percent of everyone living with HIV know their HIV status by 2020, and that 90 percent of those individuals are on ART and 90 percent of individuals on ART are virologically suppressed.

Just achieving the first 90—the testing goal—is a major undertaking. UNAIDS estimates that that 54 percent of people living with HIV across the globe don’t know they’re infected, To reach that goal, many countries are launching plans to massively expand HIV testing—and the draft versions of PEPFAR country operation plans that circulated earlier in 2015 bore this out with funding and detailed national planning. Much of this expansion is focused on linking people who test positive to ART; there is far less discussion of how testing could be used as an entry point for additional prevention services, including PrEP, for people who are HIV negative. But for PrEP-watchers, this is a key concern. Leveraging testing expansion as an entry point for effective prevention could revolutionize HIV prevention; in addition,  safe and effective PrEP use requires HIV testing on a regular basis to ensure that the mono- or dual-therapy is not being used by someone who has acquired HIV.

Is self-testing a partial solution?
With all of this context, the question remains: How can public health authorities expand HIV testing when many high-risk people avoid it because they fear stigma and discrimination—especially if they test positive? HIV self-testing—usually done at home—could be a big part of the answer because it’s completely private. All HIV self-tests are easy to use, though users must be able to read and understand instructions. Studies of the oral HIV self-test found that more than 80 percent of users understood how to use the kit and interpret the results. Research involving untrained self-testers found low operator error rates ranging from 0.37 to 5.4 percent.

No one doubts the demand for confidential self-testing systems. Two recent systematic reviews of self-test studies in the US, Europe, Asia, and Africa figured that 70 percent of potential users in one analysis and up to 84 percent in another found current HIV self-test kits acceptable, and high proportions thought them easy to use. And it seems clear that home-use kits can reach high-risk people. An FDA modeling study of an oral fluid diagnostic test predicted that 2.8 million people would use the test in 1 year and that it would prevent 4,000 new HIV transmissions. Half of the participants in another analysis said the self-test was their first HIV test. In countries that license HIV self-tests, kits can be bought off the shelves of many pharmacies or purchased online. Vending machines may one day dispense HIV self-tests.

Ready access to these tests, and their confidentiality, could encourage repeat use by high-risk people and facilitate the regular HIV testing necessary for effective PrEP. (UNITAID issued a call for proposals on PrEP that could include an HIV self-test.) A trusted self-test could promote mutual testing by sex partners. One systematic review determined that 80 to 97 percent of test users reported partner testing. Some research suggests rapid self-test kits will enable joint testing by new partners and could alter subsequent sexual behavior. Research confirms the intuitive assumption that wider HIV testing cuts the late-diagnosis rate and thus improves individual HIV care.

Current self-test devices use either a spot of blood from a finger pin-prick or oral fluid swabbed from the mouth. A systematic review found that potential users consistently preferred the oral test over the finger-prick. The oral test may yield an incorrect result a bit more often than the blood tests (see table below), but all tests licensed by regulatory agencies are highly reliable. WHO cautions though, that user errors and local HIV prevalence can affect self-test accuracy. People who want to buy an HIV test online should make sure regulators have licensed the test they seek because unlicensed tests may be less accurate.

Cost and inability to detect HIV in the early months of infection are two prime drawbacks of current HIV self-tests. For example, two licensed tests in the United States cost about US$40 per kit, while a test licensed in the United Kingdom in 2015 costs £30 (USD$46) Most survey respondents in self-test studies said they would not pay more than US$20 for such a test. In many regions, the poorest people are those with the highest HIV burden, so high cost could undercut the HIV-preventing potential of self-testing.

All current self-tests detect HIV antibodies, which take time to develop in a newly infected person. Almost everyone will have detectable antibodies within three months of infection, but before that someone can be HIV-positive and still test negative on an HIV self-test kit or other HIV antibody tests. Health experts fear that a negative self-test in the first weeks of HIV infection—when viral load and the potential for HIV transmission are highest—could lead some people to feel safe having sex without a condom. Because self-tests detect antibodies, they cannot be used in infants, who carry maternal HIV antibodies even if they are HIV-negative themselves.

The newest HIV self-tests give results in 15 to 20 minutes at home. Some health authorities fear that people who test positive at home may be less likely to seek counseling (which self-test makers facilitate) and less likely to enter care than people who test positive in a center where health workers read rapid-test results and counsel people immediately. If people self-test because they fear stigma, the same fear may keep them from seeking counseling or care. People with limited phone or internet access, some worry, would have a harder time seeking counseling and starting care. And if sexually active people can test themselves for HIV at home, they may be less likely to get tested regularly for other sexually transmitted diseases.

Another conceivable drawback of self-testing is that partners will coerce their mates into testing themselves and even abuse them if they don’t or if they test positive. Data supporting or disproving these hypotheses remain limited, and WHO reports no accounts of human rights violations or violence associated with self-testing.

Comparing three representative HIV self-tests

 

Home Access HIV-1 Test System

OraQuick In-Home HIV Test

BioSure HIV Self Test

Licensed

1996 in USA

2012 in USA

2015 in UK

Where can I get it?

Online or by phone

Drug stores

Online

How it works

Blood sample from finger-prick sent to lab.

Oral fluid from mouth swab put in testing device.

Blood sample from finger-prick put in testing device.

How long does it take to get results?

Three to seven business days after you mail test sample.*

20 to 40 minutes

15 minutes

What happens next?

If you test positive, the lab runs a second confirming test.

If you test positive, you must go to testing center or medical clinic for a confirming test.

If you test positive, you must go to testing center or medical clinic for a confirming test.

What else does the testing company provide?

If you test positive on a first test and follow-up test, company provides confidential counseling and referral to an HIV provider in your area.

If you test positive on a first test, company provides confidential counseling and referral for a confirming test.

If you test positive, company offers online assistance to find testing center for a confirming test.

How soon after HIV infection will the test show a positive result?

Test detects HIV antibodies, not HIV itself. Antibodies take 3 to 6 months to develop after infection.

Test detects HIV antibodies, not HIV itself. Antibodies take 3 to 6 months to develop after infection.

Test detects HIV antibodies, not HIV itself. Antibodies take 3 to 6 months to develop after infection.

How accurate is the test?

More than 99.9% of people who are HIV positive will get a positive result. More than 99.9% of people who are negative will get a negative result.

About 92% of people who are HIV positive will get a positive result. That means up to 1 in 12 positive people may get a negative result. Up to 99.98% of people who are negative will get a negative result. About 1 in 5000 results will be false-positive.

99.7% of people who are HIV positive will get a positive result, while 99.9% of people who are negative will get a negative result.

What HIV strains can it detect?

HIV-1

HIV-1 and HIV-2

HIV-1 and HIV-2

How much does it cost?

About $40

About $40

About £30

*Or on day sample arrives in lab with more expensive express service.

A WHO Technical Update concludes that “HIV self-testing has the potential to increase access to HIV testing including among people living with HIV without their knowledge, and those who are in need of HIV care, treatment and support.” The WHO document offers a clear summary of policy and regulatory considerations for policy makers and implementers.

UN Women to highlight the unique barriers to treatment faced by women living with HIV/AIDS

At the pivotal International AIDS Society Conference in Vancouver, Canada from 19-22 July, the focus will be on HIV care and treatment as new data highlights the effectiveness of earlier treatment initiation. Commissioned by UN Women, AVAC, ATHENA network and Salamander Trust will present initial findings from a new global review of the status of access to care and antiretroviral therapy (ART) for women living with HIV. Unique in its methodology, the study was designed and governed by women living with HIV and aims to ensure that their voices, and concerns about specific barriers to access, remain front-and-centre in discussions.

A new report released this week by UNAIDS “How AIDS changed everything,” says the Millennium Development Goal of having 15 million people on life-saving HIV treatment by 2015 has been met – with 40 per cent of all people living with HIV accessing antiretroviral therapy in 2014, a 22-fold increase over 2000. Over the same period, the percentage of pregnant women living with HIV with access to ART rose to 73 per cent.

While celebrating these achievements, challenges persist in ensuring access and adherence to antiretroviral therapy for all. More sex-disaggregated data is needed, particularly of women from marginalized populations. In fact, although women’s enrolment in treatment has increased, data shows that women have lower rates of retention in care in the long-term than men. For a range of reasons related to unequal gender norms and inequalities, women living with HIV often face specific barriers in gaining access to treatment or following it through.
In the first phases of the global study, more than 200 women were interviewed one-on-one or through focus group discussions in four countries from different regions. The next phase in the global study will involve further interviews and country-level policy reviews to provide a fuller picture of women’s access in specific contexts. The final report is expected to be out later this year.

Hear what some women living with HIV had to say about the access to barriers they face:

New Report on HIV Prevention R&D Investment Highlights 2014 Global Funding Trends

The recent UN Report on the Millennium Development Goals (MDGs) calls out the 40 percent reduction in new HIV infections since the MDGs were established in 2000 as a singular MDG achievement1. That progress reflects 15 years of HIV research in many forms—from female condoms and voluntary medical male circumcision, to new strategies for preventing vertical transmission to the scale-up of ART. Over the years, this progress has been supported by investments from many government, philanthropic and private sector funders of HIV prevention research.

The 11th annual report on the state of HIV prevention research investment, HIV Prevention Research & Development Funding Trends 2000–2014: Investment Priorities To Fund Innovation In An Evolving Global Health and Development Landscape, suggests that this work is still on the agenda for funders, albeit with a small cohort supplying the bulk of the resources.

The new report, released in Vancouver at the IAS 2015 conference, was prepared by the HIV Vaccines & Microbicides Resource Tracking Working Group (RTWG), led by AVAC, in partnership with the International AIDS Vaccine Initiative and UNAIDS. HIV Prevention Research & Development Funding Trends 2000–2014: Investment Priorities To Fund Innovation In An Evolving Global Health and Development Landscape documents that absolute funding levels have been stable over the past few years. This reflects an overall decline in real spending given biomedical research inflation.

In 2014 funders invested a total of US$1.25 billion in research and development (R&D) for HIV prevention—representing a decrease from the 2013 funding level which totaled US$1.26 billion.

In 2014, the US public-sector and the Bill & Melinda Gates Foundation account for 83 percent of all HIV prevention R&D funding and the number of philanthropic funders engaged in HIV prevention research has continued a steadily decline since 2010. Thus, the report points to the need for a broader funding base.

Despite the slight decline in funding, HIV prevention R&D is still delivering important advances. The 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver July 20-22, will showcase results for a range of groundbreaking research that has been supported over the past several years, including the Strategic Timing of Antiretroviral Treatment (START) trial, the HPTN 052 treatment as prevention trial and several groundbreaking oral PrEP trials.

Results from studies of a vaginal ring containing the antiretroviral dapivirine are expected in the next 12 months. Several different HIV vaccine candidates, neutralizing antibodies and long-acting injectable ARVs are currently in trials that could lead to multiple efficacy trials starting over the next two years.

While the report focuses on financial resources, in also highlights the essential role of individual trial participants. In 2014, there were over a million participants in HIV prevention research trials globally. With continued human and financial investment, the 40 percent reduction in new HIV infections attributed to the MDGs is hopefully only the beginning.

For more information on the HIV Vaccines & Microbicides Resource Tracking Working Group, the full report, executive summary, graphics and slides visit www.hivresourcetracking.org.

1 The MDGs consist of eight global goals, with goal six to combat HIV/AIDS, malaria and other diseases. For more information on the MDGs see: www.un.org/millenniumgoals/aids.shtml.

Demands for PrEP, treatment scale-up, targets and more, all in the new issue of Px Wire

The latest issue of Px Wire, AVAC’s quarterly newsletter on HIV prevention research and implementation, is now available.

Click here to download the new issue.

In this issue we look back at the historic International AIDS Conference that took place in Durban, South Africa, in 2000, how far we’ve come in the response today—and how much further we still need to go.

When the AIDS community gathered in July 2000, the world was still four years away from anything resembling global antiretroviral therapy (ART), but through the activism seen at that conference, the agreement that ART was a human right started then and there. There has since been remarkable scale-up and innovation in the use of ARVs as both treatment and prevention.

This issue of Px Wire describes the calls to expand ART access to all who need it, which have been amplified over the two months since the results of the START trial, which found that initiation of ART in people living with HIV significantly reduced serious clinical events and deaths as compared to people who initiated ART based on the guidelines in their countries.

We also document a growing demand for PrEP, including a robust and spontaneous show of support for expanded daily oral PrEP access for all those at risk by participants at the recent South African AIDS Conference, and the need for updated guidance from the WHO and targets from UNAIDS.

In our centerspread, we again look backwards and forward, at the conferences that took place in Vancouver and Durban in 1996 and 2000 and will again this year and the next.

And we look at the increasing role civil society is playing at developing PEPFAR Country Operating Plans (COPs) which guide targets, geography, interventions and budget levels on an annual basis.

VMMC: Can the Momentum and Investment be Sustained?

While there has been considerable momentum in the scale up voluntary medical male circumcision (VMMC) over the last 2 to 3 years, many VMMC programs are currently facing serious financial resource challenges.

Many priority countries are now in a critical place where they are making considerations for transitioning from the “catch up” phase to the sustainability stage in order to maintain the long-term public health gains of VMMC, against the backdrop of declining financial resources.

As part of their ongoing webinar series on VMMC, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) in collaboration with the World Bank Group provided updates on some of these considerations through a webinar titled “Maintaining HIV Prevention Benefits of Male Circumcision by Incorporating VMMC Into Routine Newborn And Adolescent Health Service Delivery”. In this webinar (audio and slides are available at this link), speakers covered several issues including integrating VMMC into existing health systems, human resources needs, long-term client age scenarios, sustainable financing options among other considerations.

These are important conversations to have now, and advocates, implementers, funders and policy makers need to focus on sustained investment in VMMC and particularly close monitoring to keep programs on track.