The NAM treatment survey

When would you start HIV treatment? What are your biggest worries about it? If you’re on it, how has it affected you? These were some of the questions NAM asked in a recent online survey. Gus Cairns analyses the results – and the participants’ illuminating comments.

When would you start HIV treatment? What are your biggest worries about it? If you’re on it, how has it affected you? These were some of the questions NAM asked in a recent online survey. Gus Cairns

analyses the results – and the participants’ illuminating comments.

It all started earlier this year when I was asked by Professor Ian Weller of University College Hospital in London if I’d speak at the biennial Glasgow Congress on Drug Therapy in HIV Infection, which he chairs. The subject was “When to Start Therapy: the Patient’s Viewpoint”.

I was honoured, but daunted, because I had no idea what most patients thought about when to start taking treatment. I know what I’d thought: I started AZT in 1989, with very mixed feelings, and subsequently stopped HIV treatment altogether for four years. No enthusiast me. That was in another era, when it really was possible to doubt if the drugs were any better than the disease. When combination therapy finally came along, my ten T-cells and I clutched at it like a drowning man. I had no idea, though, what a newly-diagnosed patient in the era of ‘manageable’ HIV thought about antiretroviral drugs.

In addition, international guidelines changed last year. Given the results of the large SMART study and others, which indicated that there was a benefit to starting treatment earlier, the three most influential sets of treatment guidelines (the US, UK and European ones) now recommend that treatment is started at a CD4 count of 350, rather than 200. Had this important change filtered through to the patients, and did they go along with it? I’d no idea.

There have of course been studies of patient opinion on treatment before, mainly focusing on what drives good and poor adherence. One US study from 2003¹ found that adherence was a dynamic phenomenon that changed over time with patients’ changing beliefs, attitudes, emotions, and daily and larger life events. It also found that intentional non-adherence was often driven by side-effects. In 2007, Rob Horne of Brighton and Sussex University Hospitals found very similar results,² adherence to HIV therapy was driven by a constantly-shifting trade-off in patients’ minds between the experience and fear of side-effects (like my AZT-caused anaemia) and the perceived necessity for the medicine (like my ten T-cells). But these were relatively small studies conducted before the guidelines changed and concentrated solely on adherence. I felt I needed more to go on.   

So working with Keith Alcorn, NAM’s Senior Editor, and the team at NAM, we devised a comprehensive online survey and put it on aidsmap, NAM’s website. We made it quite detailed, and in order to extend it to as many of aidsmap’s international readers as possible, translated it into Spanish, French and Portuguese. It went online on 12 September 2008.

As I write, the survey is still online but is due to be finished before this edition of HTU goes to print. The results published here represent data collected up to 10 December 2008, but because we had a large response early in the survey, results are unlikely to change significantly.

It is important to remember that people responding to internet surveys like this are a self-selected sample. They were, presumably, people who had access to a computer, people who were interested enough in HIV to visit aidsmap and respond to the survey, and people who understood the questions. This means they can’t be taken to be representative of the entire HIV-positive population, even those on treatment. However we believe that the answers to some of the questions, such as those about people’s concerns about treatment and their experience of side-effects at least indicate which issues are likely to predominate in the HIV-positive population as a whole.

The survey structure

A total of 2194 people with HIV have answered the survey to date. The majority, about 69%, answered the English survey, but there were respectable returns to the Spanish (16%) and French (13%) surveys. There wasn’t much usage of the Portuguese survey, with only 36 respondents.

The survey was divided into four sections. Its initial aim was a fairly narrow one: to find out whether patients were aware of the new guidelines recommending starting HIV treatment at a CD4 count of 350 and whether this had made a difference to their own decisions on when to start. For this reason, although we didn’t want to exclude anyone, we initially asked people if they lived in a selection of developed countries (North America, Europe, Japan and Australasia) that appeared on a drop-down list.

If they didn’t live in one of these countries, they were not excluded from the survey, but answered a separate section of it. This didn’t ask for demographic information such as gender, age and ethnicity, but it did ask if people were on treatment, what their concerns and doubts were about it, and what side-effects they had experienced. The people answering this section were also asked about three additional concerns, which we felt were more relevant to respondents in resource-limited settings; whether they were worried about accessing drugs, maintaining a regular supply, and whether cost was a factor for them.

We also asked all respondents if they knew about the new guideline recommendation on when to start HIV treatment and if they were aware of the importance of adherence.

For respondents in the named developed countries, we asked if they were drug naïve (had never been on treatment), were on treatment currently, or had started treatment but subsequently stopped. We also asked for demographic information.

They were then guided to three different sections which asked the same questions about their concerns before starting therapy – in other words, what their concerns were now if they were considering starting or restarting HIV treatment, and what their concerns had been if they were already on it. People who had never taken treatment were asked at what CD4 count they would start. People already on treatment were also asked about when they started, at what CD4 count, what their concerns were now they were taking it and also about side-effects.

In retrospect, it would probably have been better to ask the same questions of all respondents. We got a higher than expected response from people in resource-limited countries, and some felt a sense of injustice at being excluded from certain questions.

“The survey was targeting only some continents. Africa, Uganda in particular, was not mentioned. In Uganda HIV therapy is started only when CD4 is 200. Can the next survey also cover Uganda?” asked one. Another commented: “This survey only seems to be interested in the countries on the list.”

Others pointed out that in parts of the world which are seen as resource-rich, drug access and cost could be an issue too. A US respondent said: “In the USA, HIV robs many of living a life. I was a well paid professional but now if I were to work I would lose my social security disability and Medicare. The USA is so quick to help the rest of the world while many HIV-positive US citizens lie on sidewalks.”

Country of residence and treatment status

Of the 2194 people with HIV who responded to the survey, not surprisingly, the best-represented country was the UK, but it was by no means a majority: just over a third of respondents (36%) said they were living in the UK.

Another quarter came from Spain, the USA and France, 17% from other developed countries, while just under a quarter (22%) came from resource-limited countries. A higher proportion of people who answered the Spanish (32%) and, especially, the French (46%) surveys came from resource-limited countries. People responding to the Spanish survey were no less likely to be on treatment, but the proportion of people in the French survey on treatment was lower. This may reflect differences in treatment availability between Latin America and Francophone Africa.

In the developed countries, over three-quarters of respondents (77%) were on treatment, while 17 % had yet to start. One of the striking results from the survey was the tiny number of respondents who were on treatment breaks – just 29 people, or 1% of the total. It is unclear whether this reflects a very small proportion of people taking ‘drug holidays’ or if it is because people who have stopped treatment are less likely to read and correspond about HIV – probably a bit of both.

In the resource-limited countries, just under half of the respondents (49%) were on treatment and 39% were not (12% didn’t answer).

Demographics and CD4 counts

Our respondents were in the majority quite new to treatment. Half of them had started treatment since 2004; a third since 2006; and one in six in 2008. One respondent said he was filling out the survey on the day he was diagnosed.

As mentioned above, we only asked for demographic information about the people who responded from the developed world. This provided a picture of a middle-aged and predominantly white gay male population. The average age of respondents was 35-40, and 88% described themselves as white. Only 10% of respondents to the English survey were women, but that proportion rose to nearly a quarter in the other three surveys. Similarly, only 15% of the English survey respondents said they were heterosexual but that rose to 32% in the French survey and 45% in the Spanish. These figures might have been different if we’d included respondents from resource-limited countries in this section.

The answers to our questions about CD4 counts provided the strongest evidence that this was a treatment-aware and well-informed group of people. One surprising result was that only 11% of respondents to the English survey said they had a CD4 count under 300, and even fewer in the other three languages.

The majority also answered ‘yes’ to the question “Did you know that the recommended time to start treatment in Europe and North America is when your CD4 count is around 350 cells/mm³?” – although this may have been prompted by the way the question was asked. Eighty-five per cent answered ‘yes’ to this overall and 70% of respondents in resource-limited countries answered ‘yes’.

Drug-naïve patients in developed countries were asked when they would start treatment. Nearly half (47%) said “When my clinic advises” but the other half had a target: 37% said they’d want to start as soon as or even sooner than the guidelines suggest, at a CD4 count of 350 or above.  Only 15% said they’d start at 300 or lower and only 4% would wait till their CD4 count reached the previous guideline level of 200 – so the new guidelines seem to have been taken on board, for aidsmap readers at least.

In contrast, when the people on treatment in developed countries were asked what their CD4 count was when they had started, less than a quarter (24%) had started at a CD4 count over 350 and 42% at a count under 200. In addition, around one-sixth had started treatment in the pre-HAART days – before 1997. Taken together, these data suggest that, broadly speaking, people were starting treatment in line with the guidelines that applied at the time they were judged to be ready to start.

Concerns about therapy

Probably the most detailed and interesting quantitative data from the survey came from the series of questions we asked people about their concerns before starting therapy, and what concerns they had now they were on it. We asked everyone if they had concerns about the following subjects before starting therapy, whether they were already taking it or not:

• Side-effects

• Effectiveness of the therapy against HIV

• Impact of taking therapy on stigma and confidentiality

• Issues of lifestyle and practicality

• Interactions with other drugs

• Whether they were worried about not being able to adhere to therapy

• Combining HIV therapy with complementary/traditional therapies

…and, as we said above, we also asked respondents in resource-limited countries if they were worried about access to therapy, maintaining a regular supply, and cost.

One message came through loud and clear from these questions. By some way, the most significant worry people had before starting treatment was the fear of side-effects.  Nearly four out of five people (78%) had ‘major’ or ‘important’ concerns about possible drug side-effects before starting treatment. The only other categories where more than half of respondents reported concerns were the effectiveness of the drugs (54%) and lifestyle and practicality (53%), although stigma and confidentiality concerns were important for a lot of people too.

Were those on treatment less likely to have been worried about these issues before starting than people who hadn’t yet started? No: the proportion that worried about the different topics was more or less identical regardless of treatment status. This consistency suggests people were giving honest answers about their concerns and not dramatising or underplaying the issues affecting them.

There were important differences between respondents in resource-limited countries and developed-world respondents here. While everyone was worried about side-effects to the same degree, people in the resource-limited countries tended to worry about nearly everything else more too. In particular they were disproportionately concerned about drug interactions, stigma and confidentiality, adherence, and combining drugs with traditional medicine in comparison with their counterparts in the developed world. In the resource-limited countries, people who were drug naïve were more likely to cite worries than people on treatment. These differences may reflect a lack of information on treatment, as well as the very different circumstances.

These concerns abated to some extent when people started treatment, only to be replaced by others. Once people had started therapy, the proportion for whom most of the above topics were a ‘major concern’ was approximately halved. However it was replaced by a different concern; not worrying about immediate side-effects, but worrying about what side-effects might come along in the future. Fully 60% of respondents taking treatment said they worried about the potential long-term effects of drugs (patients in resource-limited countries also had significant concerns about continued regular drug supply (51%) and cost (32%).

Side-effects

What about those side-effects? Are they common and, if so, do they have a significant effect on health and quality of life? We asked all the respondents who were on treatment about a specific list of side-effects that covered most of the ones seen in patients. These were:

• Nausea/diarrhoea

• Psychological side-effects such as dizziness, bad sleep, bad dreams

• Fatigue and anaemia

• Skin rashes, dry skin, hair loss etc

• Sexual dysfunction

• Fat loss/gain/body shape change

• Symptoms suggestive of neuropathy such as numbness, tingling and pain

• Liver problems

• Kidney problems

• Bone problems such as osteoporosis and fractures

We then asked them to say if these side-effects:

• Were transient and short term

• Affected quality of life for more than three months

• Had a serious long-term effect on quality of life.

There were interesting differences between the absolute proportion of side-effects and the severity of them. A large proportion of people had experienced side effects, with 80-90% saying they had had nausea or diarrhoea and nearly as many saying they had suffered from psychological effects, fatigue or anaemia, and skin problems. These proportions may sound very high but are not that surprising given that we were asking if people had ever experienced them, even if only once or a long time ago. What was perhaps more worrying was that people in the resource-limited countries said they had experienced more fat redistribution and kidney, liver and bone problems, which may indicate the effect of suboptimal drug regimens such as ones based on d4T.

However, frequency of side-effects is not the same as severity. When asked about the side-effects that had produced the most serious, long-term effects on their quality of life, patients everywhere came out with one predominant answer – lipodystrophy. This was by some way the side-effect most likely to have a severe effect on quality of life, especially in patients from resource-limited countries. In the developed world, patients also reported psychological problems, fatigue and sexual dysfunction – problems that patients from resource-limited countries might also experience but possibly be more stoical about. The more serious side-effects indicative of organ toxicity were in general transient – maybe because people switched therapy if they happened – and less likely to be prolonged and problematic. (Note the chart below has one-third the scale of the previous one: no side-effect was experienced as serious and long term by more than 28 per cent of patients.)

Other comments and themes

We also asked people if they had any other comments at the end of the survey, and a quarter of respondents to the English survey (382 people) took the opportunity to comment. These comments provided such a wealth of information that it almost needs another article to do them justice. Again, people used the space for many reasons: to give us a brief life story; to sound off about doctors and the medical profession, or to praise them; to tell us what a good or bad time they’d had with side-effects; and to criticise or praise the survey itself.

Going through the comments, however, a number of specific themes emerged.

1.    Long term survivors. As mentioned above, only one in six respondents started therapy before 1997. However, we didn’t ask specifically about date of diagnosis and it’s possible other respondents had soldiered on without therapy from the early 1990s.  A number mentioned being diagnosed in the 1980s; one was now 82 years old. Several mentioned the issue I cited in my own case, being put off from taking therapy because of the side-effects of the old regimes: One said: “When I first became sick AZT was the only drug. That coloured my decision to wait for other treatment.”

Others just felt the survey was not designed with them in mind:

“I started therapy in 1993 and many of the questions don’t apply to me, as you did what the doctors told you and hoped to stay alive”

“I had to answer ‘no access to treatment’ when you asked why I didn’t start because I was diagnosed in 1986. There are some of us still around you know!”

2. Doctor and patient. Many cited a specific consultant or healthcare worker who had helped them, and were full of praise: “I have a great working relationship with my doctor and his team. I’m in two clinical trials, the doctors talk to each other and I feel very well informed,” said one. Another found nurses rather than doctors to be more helpful: “The nursing staff have been much more helpful and informative than the doctor. I do not understand what the doctor has said so ask the nurse after seeing the doctor.”

A number of patients, however, mentioned that the way the NHS worked made it difficult to maintain relationships with valued healthcare workers:

“I had an excellent consultant who knew everything about me but she was in a temporary post and everyone in the clinic was shocked when she was not employed permanently. This made me lose confidence in my clinic”

“My infectious diseases doctor only wants to concentrate on HIV. I have high lipids, blood pressure, depression, unexplained back pain and he expects my GP to monitor them. Too many doctors, too many co-pays, too many things to track” (US patient)

3. Side-effects. As mentioned above, this was already a major concern, and a number of patients wanted to expand on this theme further:

“I am a nurse and expected to be able to handle a lot of my side effects but it scared me when the drugs made me feel out of control. No health professional said it would be that bad.”

“Despite the success of HAART the stigma of LD [lipodystrophy] has a devastating effect. Appearance and its psychology could be better handled in the overall literature”

“I am very scared of the side-effects especially this body-changing lipoatrophy” (recent starter)

4. Disclosure, stigma and isolation. Stigma was specifically mentioned by a few people, and they had mixed feelings about whether taking treatment might make this worse rather than better. “Taking meds feels like a rubber stamp on my diagnosis; once I say I am taking ARVs[antiretrovirals] then I have disclosed my status,” said one. But another said, “With the drugs, people cannot see a difference between me and the general population. It lessens stigma and encourages people to get tested.” A number mentioned they were living in extremely isolated conditions. Two, for instance, were in rural towns in Spain and one in a small town in northern Iceland. Others bemoaned the lack of HIV-specific social groups. For others, the isolation was self-imposed: “I think there are long term issues of trust that have never gone away. I am extremely secretive of my diagnosis.”

5. Access and cost. As we mentioned above, respondents mentioned struggling to secure medications, not only in the countries we would identify as being resource-limited, but also in some ‘rich’ countries:

“I wish the WHO could make it a law that people must be started at 350. I’m still not on treatment here in Africa having been diagnosed with HIV and TB for 13 years and seeking ARVs for ten.”

“I recently lost my job and my Atripla co-payment [the amount a health insurance company asks a patient to contribute to prescription charges] is over $300 a month. I am worried sick about this” (US patient).

6. Mental health. People wanted specifically to mention that emotions also swayed treatment decisions. “You did not list depression as a reason for not staying on meds,” said one. Another said: “One thing you didn’t mention that could delay treatment was fear. I waited almost 5 years to tell anyone or seek treatment: I had zero T-cells.”

Another talked starkly about not knowing if they wanted to live at all: “No question allowed for the patient’s decision-making to be influenced by a lack of desire to live a longer life as HIV positive. This was my own reason for initially refusing treatment.” Another had triumphed over grief, however: “Taking meds is my way of saying I want to live and not give up, even though my partner of 25 years has passed away.”

Conclusions

As we said, a number of studies have already found out what contributes to willingness to take treatment and to good adherence. In the main, their conclusions were of the “you don’t say!” variety; having negative views of therapy makes you reluctant to take it; believing it will work makes you keen.³

This survey adds or reinforces several points:

• It is important to assess depression, social isolation and health beliefs BEFORE people start taking HIV drugs.

• Most patients these days are happy to start taking therapy sooner.

• The fear of side-effects still extremely important, especially lipodystrophy, as is previous experience of them.

• The simplest things help most with adherence: alarms, pill boxes, once-a-day regimes.

• A partnership with a trusted healthcare provider (of various types) is as important as ever.

Many thanks to Keith Alcorn and the team at NAM for devising and putting up the survey and for Prof. Ian Weller for prompting it in the first place. A webcast of a presentation about the NAM survey can be viewed at www.hiv9.com/webcasts/MDI/index.htm - look for the “Hot Topics and Late Breakers 2” section in the congress presentations.

What happens to the survey information?

The initial results of the survey were presented at the Ninth International Congress on Drug Therapy in HIV Infection, held in Glasgow in November 2008. The information gathered from the survey formed part of a well-received presentation on ‘When to Start Therapy?: the Patient’s Viewpoint’.

The Congress is an important event on the HIV calendar and brought together 3000 delegates, including HIV doctors, nurses and pharmacists from 80 different countries. It aims to provide an opportunity for those attending to learn and share good practice in the drug treatment of HIV.

Discussions after the presentations showed that audience members had recognised key themes. These included the importance of a patient feeling ready to start taking treatment, whether CD4 counts criteria for starting therapy would become less crucial over time, and the fear of side-effects as a major disincentive for taking therapy.

Here at NAM, feedback from people living with HIV is essential in informing our work, and the survey results will be considered carefully as we develop and shape our future projects, including our new patient information booklet on side-effects, which will be published in the next few weeks.

As HIV Treatment Update has a broad audience both among people living with HIV and health professionals working in the HIV sector in the UK, and is distributed free through HIV clinics, we hope that the thoughts and feelings of the people who completed the survey will reach an audience who can learn from and act on them.

There may be further opportunities to use the results of the survey in the coming months and we would like to take this opportunity to thank everyone who took the time to complete it.