Motivators and Barriers To Use Of Combination Therapies In Patients With HIV
Disease

Ruthann Richter

Maureen Michaels
President, Michaels Opinion Research

Bruce Carlson
Research Associate, Michaels Opinion
Research

Thomas
J. Coates PhD
AIDS Research Institute and Center for AIDS
Prevention Studies UCSF

CAPS Monograph Series,
occasional paper #5,
January 1998

Center for AIDS Prevention Studies, University of California San
Francisco

Table of Contents

I. Introduction

II. Study
Design

III. Key
Findings

A. Motivators
to Initiate Therapy

B. Barriers
to Initiation of Therapy

C. Other
Factors That Influence Decision-Making

D. Issues
and Concerns of Women

IV. Study
Implications

I. Introduction

The successful
two-drug combination therapy in 1994 and protease inhibitors in 1995 set the
stage for a new era in treatment of HIV disease, creating a burst of optimism
over the prospect that HIV might be a controllable disease. Initial studies of
protease containing triple-drug regimens suggested that these combinations
could, in some cases, slow clinical progression of the disease and prolong the
lives of patients. 1,
2 In anecdotal
reports, physicians and patients described a kind of "Lazarus" effect in which
previously disabled individuals found themselves regaining lost functions,
returning to work and planning their futures, instead of preparing for
death.

There are still many unknowns about these multi-drug regimens,
including their durability of effect and how many individuals for whom they will
be effective.3,
4 Nonetheless, the drugs have proven quite effective in clinical
trials and are helping many people stay alive longer and experience better
quality of life while they are alive.

We thought it important to
understand better why people do and do not take advantage of these therapeutic
advances. Developing the medications may be only half of the battle; the other
half involves making sure that HIV infected individuals have access to the drugs
and that they make thoughtful decisions about whether or not to take them. If
some of the barriers to taking the drugs can be addressed, they should.

We conducted in-depth qualitative interviews with 114 individuals in the
HIV community--75 HIV infected men and women, 18 hotline operators and
supervisors, 11 case managers, and 10 physicians and nurse practitioners.

We found that individuals are motivated to begin antiretroviral
therapy if:

they experienced a decline in their health
status;

they saw or heard about improvements in other
patients;

they obtained better research information about the
drugs;

they came to believe that the therapy would prolong
their lives;

their physicians had recommended it; and/or

they learned how to cope with the treatment regimens
and drug side effects.

People were deterred from taking advantage of
antiretroviral therapy if:

they had concerns about the short- and long-term side
effects of the drugs;

their health was good;

they had concerns about the effectiveness of the
drugs;

they were concerned that the treatment regimens were
too demanding;

they felt that they could manage the disease without
drugs;

they were concerned about developing drug resistant
virus;

they rely on holistic or alternative approaches to
managing their disease; and

their medical provider had not recommended that they
begin treatment.

Based on these findings, we recommend the
following:

Clinicians need multiple forums in which they can
share information with other clinicians and discuss possible approaches to
treatment.

Clinicians and patients need time to discuss whether
or not to start antiretrovirals.

The information needs of people extend beyond how the
drugs work to how to cope with the drug regimens and their side
effects.

Other resources used by patients to gain information
must be as accurate, comprehensive, and as current as possible.

Women need special services to assist them in deciding
about antiretroviral therapy.

Spanish speaking patients are not being well-served by
the public health system and need more

Spanish-speaking clinicians and interpreters in order
to benefit from antiretroviral therapy.

Patients and clinicians need access to the best
information possible on alternative and holistic remedies to treat HIV.

Pharmaceutical companies are encouraged to continue
drug development so that antiretrovirals can become even more effective and
easier to take with fewer side effects.

II. Study Design

In the current
study, our goal was to identify those factors that have both deterred patients
from initiating therapy or motivated them to opt for the new treatment regimen.
We conducted in-depth interviews, either on the telephone or in person, during
October, November and December 1997 with 114 individuals in the HIV community.
These included 75 HIV-positive men and women, 18 hotline operators and
supervisors, 11 case managers and 10 physicians and nurse practitioners. The
one-on-one interviews ranged from 30 minutes to more than an hour.

The
patients were recruited through posters and flyers circulated in treatment
centers, clinics, needle exchange programs and support groups and through
referrals from physicians, clinics and case managers. Patients were recruited
from a dozen cities and represent diverse ethnic and racial groups, including
African-American, Asian, Native American, Hispanic and white. Sixty-four percent
of the patients were male and 36 percent female. Thirty-nine percent of patients
identified themselves as heterosexual, 49 percent as gay, 9 percent as bisexual
and 3 percent as lesbian. More than half of the patients, or 53 percent, had
never taken protease inhibitors or combination drug therapy to treat HIV.
Thirty-eight percent were taking combination drug therapy at the time of the
study. Nine percent had initiated combination drug therapy but had stopped the
treatment.

The case managers who participated in the study were drawn
from public and private sector AIDS service organizations in seven cities. Most
indicated that the majority of their clients are HIV-positive. Virtually all of
the case managers interviewed said their HIV-positive clients generally come
from low-income households. Although all the case managers have women clients,
the majority of their clients are men, both gay and heterosexual. Their clients
come from a broad range of racial and ethnic backgrounds. Seven of the 10 case
managers interviewed said most of their HIV-positive clients already had
developed symptoms of AIDS or had been diagnosed with full-blown
disease.

The physicians in the study were recruited in seven cities
through contacts with AIDS service organizations. All treat a significant number
of HIV-positive patients, who account for 30 to 100 percent of their caseload.
The majority of physicians interviewed described their HIV-positive patients as
gay, white men ranging in age from the early 20s to late 40s. Only 10 to 20
percent of their patients are African-American or Hispanic. Between 10 and 75
percent of their patients had developed symptomatic disease.

The AIDS
hotline supervisors and operators represent a cross-section of major regional
hotlines operated by public sector agencies and AIDS service organizations in
eight cities. All of the hotline personnel participated in one of a series of
four 90-minute roundtable discussions via telephone conference call.

The
hotline operators said their role is to respond to inquiries about sexually
transmitted diseases, primarily HIV, and to help HIV-positive individuals link
up with organizations in the community that can address their specific needs.
The hotline supervisors said there has been a notable decrease in the number of
calls from gay men in the community and an increase in calls from heterosexual
men and women. Although hotline staff do not ask a caller's race or ethnicity,
those hotline personnel interviewed said they believe they are receiving an
increased number of calls from people of color. Many of those who call the
hotlines do not have private insurance, according to those interviewed. Many
hotline personnel said they receive a significant number of calls from people in
rural, or non-metropolitan areas, who do not have access to AIDS service
organizations.

III. Key Findings

All of the patients interviewed who were not on
combination therapy said they were aware of the availability of this treatment
option. A large majority of these patients said they were open to the
possibility of combination therapy, most often indicating that they would be
motivated to start the treatment if:

they experienced a decline in their health
status;

they saw or heard about improvements in other
patients;

they obtained better research information about the
drugs; and/or

they came to believe that the therapy would prolong
their lives.

Patients already on combination therapy cited these same
factors as an influence in their decision to begin the treatment. In addition,
some of the patients on therapy said they had started treatment
because:

their physicians had recommended it; and/or

they learned more about the possibility of adjusting
the treatment regimen, if necessary.

Among those patients not on combination therapy, the vast
majority indicated that they were deterred from the treatment primarily because
of:

concern about possible short- and long-term
side-effects;

the positive state of their health; and

concern or skepticism about the effectiveness of the
drugs.

In addition, a significant number of patients not on the
treatment said they were reluctant to initiate therapy because of:

the demands of the treatment regimen;

a feeling that the drugs are "too
experimental;"

a concern about taking medications in general;

a feeling that they could manage the disease without
drug therapy;

a fear of drug resistance;

a reliance on holistic or alternative treatment
approaches; and

the lack of a recommendation from a medical provider
that they begin treatment.

The responses from patients were relatively consistent
with reports from physicians and nurse practitioners, who said concern about
side-effects and drug effectiveness, as well as the complexity of the regimen,
were the key factors that deterred patients from initiating therapy. Physicians
and nurse practitioners also said they believed patients shied away from the
treatment because of a fear of drug resistance and a positive view of their
health status.

Seven out of ten of those patients not on combination
therapy said they had not been diagnosed with AIDS and had not had an
HIV-related disease. Half of those individuals interviewed who were not on
therapy have been HIV-positive for more than five years, although about one in
10 learned they were positive within the last year. More than three-quarters
indicated they might opt for combination therapy at some point in the
future.

Two-thirds of the patients who were not taking combination
therapy said the decision not to begin treatment has not been difficult for
them. Those who have struggled with their decisions said they had received
conflicting information about the therapy or were subject to pressure, both pro
and con, from family members and peers.

More than four in 10 of the
patients not on therapy said they believe it is difficult to take these drugs,
and another one in five perceive that it is "somewhat" difficult. In fact,
two-thirds of those interviewed said they know of someone who has stopped taking
combination therapy. Even so, more than one in five said they do not believe
that combination drug therapy would be difficult to take, once they made the
decision to start. While the vast majority of those interviewed said they do not
have lifestyle factors which would prevent them from undertaking treatment, one
in five believe that it would be difficult for them because of their eating
habits, school or work environments or "busy" lives.

A. Motivators to Initiate Therapy

Patients were most likely to be motivated to begin therapy
when they began to see their health deteriorate, based on changes in T-cell
counts and viral load, hospitalization or the emergence of an opportunistic
infection. Seeing or hearing word of improvements in other patients and getting
access to better information about the drugs also served as strong motivating
factors. Some patients also indicated that they began drug treatment because
they believed it would prolong their lives. Others said a positive
recommendation from their physician was key to starting therapy. Factors
mentioned less often by patients included information about possible changes in
the drug regimen and resolution of payment issues.

Nearly all of the
patients currently on combination therapy said they planned to continue taking
the drugs, although some qualified this by saying, "if it continues to work," or
"until something better comes along." Patients were motivated to continue on
therapy by improvement in their health indicators, such as increased or
stabilized T-cell counts, decreases in viral load, weight gain or a general
sense of improved health.

"I'll take them as long as I have to. They make me feel like I'm not
sick," said a heterosexual Hispanic female from New
York.

Six in ten of the men and women on combination therapy said the treatment
had not been difficult for them, while three in 10 said it has been difficult. A
few said taking combination therapy had been only "somewhat" difficult. More
than two-thirds of patients reported experiencing some side-effects from the
drugs. The group was divided between those who said the regimen schedule was
difficult to maintain and those who did not find the regimen
difficult.

"I'm still alive. I wouldn't be here today if it weren't for all the
drugs," said a heterosexual white female from Miami.

"It's better to
take them than not," said another patient, a gay African-American female from
New York. "God knows where I would be without them."

Health indicators, including disease
progression, changes in T-cell counts and viral load
Seven in 10
patients who were not on therapy indicated that they are open to the possibility
of treatment "when the time is right." For most of these patients, that time
will come when their health begins to deteriorate, as indicated by declining
T-cell counts or increases in viral loads (sometimes qualified as "consistent"
or "significant" changes in their numbers), the onset of an opportunistic
infection or hospitalization.

Disease progression was also frequently
mentioned as a reason for starting therapy for those patients interviewed who
already had begun the treatment regimen. Eight in 10 said they opted for therapy
when there were clear indications of a deterioration in their health. Nine in 10
physicians also cited disease progression as a key factor in a patient's
decision to start therapy, and about two-thirds of case managers said this was a
strong motivator.

"I wanted to go herbal, Chinese herbs, but my system was breaking down,"
said a gay African-American woman from New York who is on combination therapy.
"I was getting worse, I got PCP, and they told me I wasn't going to get
better."

"I was in the hospital. I was
willing to try anything at that point. Maybe I was a guinea pig, but I was
willing to take anything. Friends said it was a miracle drug," reported a
heterosexual African-American woman from Miami."

Seeing improvements in others

Seeing or hearing about improvements in others also has a
strong influence on patients' thinking about combination therapy. Almost half of
those interviewed who were not on therapy said they felt encouraged to start
treatment based on what they had heard about or witnessed in others about the
positive effects of the drugs in HIV-positive individuals. Similarly, for those
patients already on therapy, half said hearing reports of improvements in others
had encouraged them to obtain treatment.

"When I first heard about the therapy, I thought, `Thank God!' I knew
that it would work for me and saw that it was working for my friends already,"
said a gay African-American man from San Francisco who is now on combination
therapy.

"The new drugs have made a difference in people, physical
things," said one gay, African-American man from Washington, D.C. who is not
on the therapy. "I have seen the Lazarus syndrome, people getting up out of
their death beds. The most dramatic changes are among those who were the
sickest. The effect takes a matter of weeks. There are fewer deaths. It gives
hope.

"

Patients reported that news media, support groups,
HIV-positive peers and personal experience all served as sources of information
about the value of the drugs.

"I heard about the cocktail on the news," said a heterosexual
African-American man from Washington, D.C. "It's working. You hear it on TV
and see some people, like Magic Johnson."

Case managers cited positive reports about the drugs as the number one
motivator for patients. About eight of 10 physicians and nurse practitioners
also noted that patients were influenced to start therapy based on improvements
they saw, or heard about, in others. Hotline personnel reported that some
patients were motivated to start combination therapy when they heard that the
treatment had brought the virus down to undetectable levels in some HIV-positive
individuals.

The availability of better research
information
More than half of those patients not on combination therapy
said they would start treatment sooner if there were better research information
about the effectiveness of the drugs beyond five years, the long-term
side-effects and the length of time required on therapy. One third said they
would be motivated to begin combination therapy if they knew they would not
experience any short- and long-term side-effects. These patients also said they
wanted more evidence that these drugs constitute a "cure" for HIV.

"I'm hoping for the best about combination therapy, but without any
long-term data on the results, I'm not certain," said one gay white man from
San Francisco who is currently not on treatment. "But overall, I'm hopeful
since fewer people are passing away."

The responses from physicians, nurse practitioners and case managers
suggested they feel a strong need for more scientific evidence on the value of
the drugs. Most notably, seven out of 10 physicians and nurse practitioners said
they believed patients would be motivated to take combination therapy if there
were more or better research information on its effectiveness. More than half
the case managers said they believed their clients would be influenced to start
therapy if more research information were available.

"The doctor wants me to start taking the drugs, and she gave me some
books to read," reported a heterosexual African-American man from Washington,
D.C. "She wants me to think about what drugs I want to take and think about
commitment. But the things I have to read don't say how long the side-effects
will last. Or what happens if you miss timing the drugs? Or what else can you
take? Aspirins? Or when do you know if it works? Or how long before you know
when to switch (to another combination)?"

A belief that the therapy prolongs
life
Almost half of those patients taking
combination therapy, particularly those who have developed AIDS or had
opportunistic infections, said they decided to go on treatment because they
hoped it would prolong their lives. A few noted that they believed combination
therapy was their last hope and they felt they had "nothing to lose" by trying
it.

"At first, I thought, `Now I have to take pills for the rest of my
life.' But I hope this will prolong my life enough for them to find a cure,"
said a heterosexual African-American man from New York who is currently on
therapy.

Almost half of the physicians, nurse practitioners and
case managers said their patients had been motivated to start therapy because of
a belief that it would prolong their lives. On the other hand, only one quarter
of patients who were not on the regimen said they believed it might help them
live longer.

"The drugs do give people hope that something can be done to prolong
life," said a bisexual Hispanic woman from Los Angeles who has yet to take the
drugs.

Perceptions about effective treatments for
HIV
Nearly all patients currently on therapy, regardless of sex,
sexual orientation, race or ethnicity, said they believe combination drug
therapy, "taking your meds" or using a mix of drug therapy and holistic
treatments are the most effective methods to treat HIV. At the same time, about
half of those on combination therapy also said that lifestyle or attitude were
effective ways to treat HIV. These included changes in diet, exercise and a
positive attitude toward the disease. Fewer than one in 10 of those currently on
combination therapy cited alternative or holistic approaches as effective
treatments for HIV.

An understanding that the regimen can be changed,
if necessary
About a third of those currently on combination therapy said
they were more inclined to start treatment when they learned more about the
ability to try different combinations if the first set of drugs did not work for
them. Others on therapy said they became more motivated to begin therapy when
they learned that the drug regimen could be altered to fit their lifestyles or
were told that the side-effects would not necessarily be permanent.

"There are so many combinations that you'll always be able to switch if
you can't take the side-effects," said one gay African-American man from
Washington, D.C. who is on combination therapy.

Only about one in ten patients not on therapy said the ability to
manipulate the regimen would motivate their decision-making, although nearly
half cite the regimen as a barrier to their initiating therapy. About one in
five case managers said they believed patients were more apt to start therapy if
they knew the regimen were somewhat flexible and could be made to fit more
easily into people's lives.

Physician recommendation
More than
half of patients on therapy said they were prompted to start treatment on the
basis of their physicians' recommendation. However, fewer than two in 10
patients not on the treatment said they would begin combination therapy if their
doctors told them they needed to.

"I was willing to try anything. I trusted my doctor and I saw other
people at my doctor's office who said, `You'll like that,'" reported one gay
African-American man from Chicago who is taking combination
therapy.

More than a third of the case managers and about one in four physicians
and nurse practitioners said they believed that patients trusted their
caregivers to the extent that a positive physician recommendation would prompt
them to start therapy.

Psychological well-being
Though not
cited by patients themselves, physicians, nurse practitioners and case managers
said a patient's psychological well-being often played a role in his or her
willingness to start drug therapy. Nearly half of the physicians and nurse
practitioners and a majority of the case managers interviewed cited the
patient's outlook as a factor in the initiation of therapy. Case managers noted
that both extreme positive and negative outlooks could prompt a patient to opt
for therapy. For example, some patients who are very positive and optimistic may
choose to start therapy because they are confident that the drugs will help
them. On the other hand, patients who are depressed or pessimistic about their
health, usually because of disease progression, may start drug therapy because
they believe it offers them a last chance for prolonging their
lives.

B. Barriers to Initiation of Therapy

Patients interviewed who were not on combination therapy
were most likely to cite concern about side-effects as a barrier to treatment.
Patients also frequently mentioned their positive health status, as well as a
concern about the effectiveness of the drugs, as factors that had deterred them
from starting treatment. Other factors that often deterred them from treatment
were concerns about the demands of the treatment regimen, misgivings about drugs
in general or a feeling among patients that they could manage the disease
without the drugs. In addition, some patients said they believed the drugs were
"too experimental" or indicated that they were afraid of developing a resistance
to the current, or future, therapies. Finally, some patients said they relied on
holistic or alternative approaches to treat their HIV or were waiting for better
treatments to come along. In many instances, patients said their doctors had
recommended treatment, though some said their physicians had advised them not to
begin treatment yet. The cost of treatment and concerns about loss of privacy
were only rarely mentioned by patients as barriers to initiation of
therapy.

Concern about short- and long-term
side-effects
Concern about side-effects was the most frequently mentioned
barrier to initiating combination therapy among HIV-positive patients who had
never taken medications to treat HIV. Eight in 10 of these patients cited
concerns about side-effects as a deterrent to therapy, particularly given the
absence of symptoms and other positive health indicators.

Frequently,
these patients used the word "toxic" in describing drugs for treating HIV,
citing this as a reason for not taking the drugs. As many as one in four of
these patients also said they won't begin combination therapy yet because they
believe the long-term side-effects are unknown and they fear the drugs will make
them feel worse or cause damage to their organs, particularly the kidneys or
liver. While there was a generalized concern about side-effects among many of
these patients, a few said they did not want to experience any side-effects at
all or were uncertain about whether the side-effects might diminish or disappear
over time.

"I don't have a good opinion of the meds because of what they are doing
to those around me," said a gay, African-American man from Los Angeles who is
not on the therapy. "I see my friends getting sick due to the side-effects and
that makes me not want to take them. I have seen my friends die while taking
the drugs. I feel the drugs will kill me before the virus will. They are all
very toxic and worse for the body than the virus."

"The drugs
are `working' in some people because they are very sick and have made
compromises with the side-effects. It depends on the individual," said a gay
Hispanic woman from Miami.

Those patients interviewed who are currently taking combination therapy
also reported that the potential side-effects, fear about toxicities, their
inability to tolerate these effects and uncertainty over whether the medications
would work for them were the primary obstacles to initiating therapy.

The
patients' responses were consistent with reports from physicians and nurse
practitioners, case managers and hotline supervisors and operators. Physicians
identified side-effects as one of the chief concerns of patients in weighing
therapy, along with concerns about the long-term effectiveness of the drugs and
the complexity of the regimen. In fact, nine out of 10 physicians said they
describe the negative side-effects of combination therapy to patients,
particularly gastrointestinal effects such as diarrhea and nausea. Some also
inform patients that if they start therapy, they may experience neuropathy, a
lack of energy, rashes or kidney problems. Two-thirds of case managers
interviewed also said they discussed the possible side-effects with their
clients, with specific references to nausea, diarrhea, rashes, possible kidney
problems, lack of energy or loss of appetite.

Hotline operators also
reported that callers had strong negative perceptions of side-effects. Callers
told them they had heard that certain drugs were intolerable and would affect
their ability to work at their jobs. These callers were afraid side-effects from
the drugs would diminish the quality of their lives and restrict their mobility.
Callers who were already on therapy often inquired about specific side-effects
they were experiencing, such as loss of sensation in the hands or feet, diarrhea
and nausea, weight gain and "crix belly," the hotline workers reported. As one
patient put it, "Introduce a `foreign' medication into the body and it also
kills some good cells."

Health indicators, including T-cell counts and
viral load
Among patients not taking combination therapy, more than six
in 10 of those interviewed said the positive state of their health was a pivotal
factor in not electing therapy. In fact, more than eight in 10 said they were
optimistic about the state of their health. These patients said that they "feel
healthy," "don't feel sick," or "have had not any opportunistic
infections."

"I'm keeping my options open for when I really need treatment, when the
physical symptoms would be more real to me," said one heterosexual white woman
from Miami. "If I had my first opportunistic infection, maybe I would have a
different outlook."

"The way I feel at present, I wouldn't take these
drugs, but the door is not closed on the subject," said another patient, a gay
white man from San Francisco. "I hope other options are available in the
future. I would have to be at a point where I must start (drug therapy)
because my health is at a point where no other options are available. I
consider therapies the last option."

Patients indicated that they
rely heavily on their T-cell counts as one measure of their health. Nearly
four in 10 of the HIV-positive individuals interviewed specifically said they
had not started combination therapy because their T-cell counts are too high
or have been relatively stable for a long period of time. Occasionally, these
individuals indicated that their doctors are in agreement that combination
therapy was not necessary yet.

"My viral load is declining and my T-cells are high and have been for 10
years," reported a gay white man from Seattle. "My doctor says there is no
need for the drugs yet. We'll continue to monitor my numbers. I see that as
the best idea, too."

Although patients are more apt to rely on T-cell counts
as an indicator of health, a third of those not on combination therapy said they
also have considered their viral loads, which are low or stable, to be a factor
as well. Still, one in five patients questioned the relevance or accuracy of
viral load numbers. A few individuals noted that their viral loads fluctuated
widely over a short period of time, and in the case of one individual, over a
period of a few hours. In a small number of cases, patients not on combination
therapy discounted the value of T-cell counts or viral loads altogether,
questioning the validity of these measurements.

"T-cell and viral load counts don't impact my decisions about drugs. Too
many people become obsessed with numbers. I have had tests done within hours
of each other that don't agree by a lot. Low T-cells don't mean you're dying,"
said a heterosexual white woman from Miami.

Nearly all physicians and nurse practitioners and case
managers indicated that they do not try to "persuade" clients to start therapy.
The decision to start therapy lies with the patients and is very much related to
disease progression. While most doctors and nurse practitioners interviewed said
patients struggle with the decision to start therapy, they said most of their
patients opt for the treatment when confronted with signs of disease
progression, such as changes in T-cell counts or viral loads or the onset of
opportunistic infections. Half of the physicians and nurse practitioners
interviewed said the patients' positive perceptions of their current health were
a barrier to treatment.

"My test results show I'm in relatively good health. I haven't taken
them so far and am doing well, so why start now? I feel that I can deal with
it without the medications. I'm concerned that I will react negatively to the
therapies," said a gay Asian man from Seattle.

Uncertainty and/or skepticism about the
effectiveness of therapy
Among those HIV-positive patients
interviewed who were not on combination therapy, seven in 10 cited doubts about
the effectiveness of the drugs as a reason for not starting therapy. About six
in 10 of these patients said they believe the drugs work for most people while
three in 10 said that, in their experience, the drugs work for some but not for
others. At the same time, however, nearly three-quarters of these patients said
they are skeptical about the effectiveness of the combination therapy,
questioning whether the drugs would work for them or whether they would continue
to work over the long-term. More than one in four in 10 said they expect the
drugs would not work for them at some point in the future.

"At first they thought the drugs could eradicate the virus, but now we
know it won't," said a bisexual white woman from Seattle who is not on
combination therapy. "They help only 50 percent, and there are
side-effects."

"As with any medication, it will work for some and not
for others," said a heterosexual Hispanic woman from New York. "It's very
individual."

Among those patients who were uncertain about how effective combination
therapy would be for them personally, a few said they believe "people are dying
on medications" and indicated that they know of people for whom the therapy did
not work. A few also said that they believed the "first combination always
fails." One individual specifically referred to news reports about an
"increasing failure rate." Gay men were somewhat more likely than others to say
they are skeptical about the long-term effectiveness of the therapy.

"People are still dying from AIDS while they are taking these
medications," said a gay, African-American man from Los Angeles. "The rate of
mortality has slowed down, but the drugs are not necessarily saving lives. It
makes me stay where I'm at in not taking meds."

"There is a lot of fear
about the medications because of the uncertainty. For a while people are doing
well, then they start to fail in the long run," said a gay white man from San
Francisco is not on therapy.

Among patients who were taking combination therapy, one in six said they
had doubts about whether the medications would prove to be effective for them.
This concern had been an obstacle to initiating therapy, these patients said.

Patient beliefs about whether the therapy would be effective for them
may reflect in part the reservations of their caregivers. Nine out of 10
physicians and nurse practitioners who were interviewed said they personally
were concerned about how well combination therapies work, the long-term efficacy
of the drugs and the clinical impact of the drugs on new therapies that might be
developed in the future. More than six in 10 of the case managers interviewed
expressed similar concerns.

Hotline personnel said they receive calls
from a significant number of people who believe protease inhibitors are a cure
for HIV and that the drugs work for everyone. To counter this belief, both
hotline operators and case managers say they emphasize with patients that
individuals respond differently to the drugs. For instance, one hotline operator
said he informs patients that "35 percent of people (with HIV) can't even take
(the drugs), or if they do, they lose efficacy."

The demands of the
treatment regimen
More than half of those patients not taking combination
therapy said they were concerned about the impact of the treatment regimen on
their lives. These patients indicated that they believed the regimen would force
them to alter their schedules or lifestyles. For instance, they noted that they
would have to modify their eating habits and adhere to a schedule of set times.
Patients often made mention of the fact that there were "too many pills" to
take. A few even remarked on the "size of the pills." About one in 10 of these
patients said they had not started combination therapy because they know they
cannot or will not adhere or are not ready to "commit" to the
regimen.

"It's the side-effects, the neuropathy," said a gay white man from
Seattle. "And the inconvenience, the pills all at different times of the day
or night, take with food, without food, keep it refrigerated. I could do it,
but I'd rather not until I have to."

Among those patients who were already on therapy, half also indicated
that concern about having to adhere to a treatment regimen had been a barrier to
treatment. Caregivers also give heavy weight to a patient's ability to adhere to
the treatment in deciding whether to recommend the therapy. Eight out of 10
physicians and nurse practitioners said a patient's ability to comply with the
regimen is a significant factor in their decision on whether to prescribe
combination therapy. Some physicians say mental health disorders, substance
abuse problems and addictions are strongly considered when prescribing
combination therapy, as these problems could impact a patient's ability to
comply with treatment.

Seven out of 10 physicians said they describe the
regimen to patients as a drawback to combination therapy. Case managers also
were likely to describe the regimen as a negative aspect of combination therapy,
including the many pills that need to be taken and the need to follow a
complicated schedule. Three in 10 case managers said they told clients that a
drawback to combination therapy is the need to "commit" to the regimen or that
patients "can't stop taking the drugs" once they begin.

Hotline personnel
also frequently used the word "commitment" to describe the decision to start
therapy. They reported that some HIV-positive patients did not want to begin a
combination therapy drug program because they don't believe they can maintain
the regimen and are afraid that it cannot be stopped.

"Once you start, you will always have to take the pills," said a
heterosexual African-American woman from Miami. "They will make me feel sick.
I see what they do to some people and this scares me. I hope that if I ever
have to take them, they will make me feel better, not worse. I want to live,
so if I have to take them, I will."

General attitudes toward
medications
Nearly half of those who are not
on combination therapy are influenced in their decisions by attitudes they hold
about medications in general, according to reports from patients and case
managers. Most frequently, patients said they don't want to take medications
that they will need for the rest of their lives. A few individuals also believed
that drugs are most beneficial to the sickest patients. One former substance
abuser expressed a fear that combination therapy drugs would become addictive. A
few patients are convinced that when drugs work, it is because of a belief they
will work.

"If the drugs are `working' for some people, I think it is because of
their mind, body and soul. People believe it is working and that positive
attitude is part of why the load goes down, T-cells go up and they feel
better. But I wouldn't burst the bubble of people using them. Their belief is
part of why it works," said a heterosexual white woman from
Miami.

More than a third of patients already on combination therapy said their
attitudes about medications in general had stood in the way of treatment.
Similarly, roughly a third of physicians and nurse practitioners said patients'
misgivings about drugs in general had been a barrier to initiation of
therapy.

A feeling that the drugs are too "experimental"
Nearly
half of those not on combination therapy said they have reservations about what
they perceive to the experimental nature of the drugs used to treat HIV, most
often citing a lack of research data or saying that the drugs are "not
well-researched." People also said they believed the drugs "haven't been around
long enough," were approved by the FDA too quickly or have been given to the HIV
community too early. Generally, those who identify themselves as heterosexual,
especially those of Hispanic background, are much more likely than gay men to
view combination therapy as "too experimental." A few people specifically stated
that they "don't want to be guinea pigs" or don't want to take "experimental
drugs."

"There is so little known about the drugs and what the long-term effects
will be regarding one's health, drug resistance, side-effects," said one
heterosexual Hispanic woman from Seattle. "After AZT's fiasco, I won't be a
guinea pig."

"(When drug therapy was recommended), I thought, `I'm
going to be a guinea pig.' There's not enough information and a lot of bad
press on AZT. The drugs are toxic. I don't want to be experimented on," said
one heterosexual African-American woman from Miami.

"So little is known
about the drugs," commented another patient, a gay white man from San
Francisco. "It's all experimental, and they are testing on people as they go
along."

Four in 10 physicians said perceptions among patients that the drugs are
still experimental had been an obstacle to treatment. However, less than one in
five of the case managers cited this as a barrier. The "experimental" nature of
the drugs was only mentioned by one in 10 of patients already on combination
therapy.

The ability to manage the disease without medication and
beliefs about HIV
Eight in 10 patients not on combination therapy said
they believed changes in lifestyle or attitude were the most effective form of
treatment for HIV. A good diet was cited by more than half of these patients as
the most effective way to treat the disease. Also named as effective treatments
were good rest, exercise, a "positive lifestyle," spiritual growth, a positive
attitude, reduced stress, vitamins, control over one's life and reduced
consumption of alcohol and recreational drugs.

Four in 10 of those not on
combination therapy hold beliefs about HIV and their abilities to manage the
disease that impact their decision to start therapy. Some patients said they
believe drugs may not be necessary to treat HIV, with some patients believing
that drugs are only needed five to 10 years after infection. Fully one quarter
of those interviewed also expressed the view that HIV drugs may cause more
damage to their bodies than the virus itself, and one individual said she
believes HIV may not be the only cause of AIDS. There are also some patients who
express a positive conviction that HIV is "not a death sentence" or "won't be
the cause of my death," a belief that minimizes their perceived need for
medication.

"I have a strong distrust about the disease and the medications
themselves, as well as those entities pushing these costly and toxic drugs on
HIV-positive people," said one bisexual, African-American man from Washington,
D.C.

"Being HIV-positive doesn't prey on my mind. If you take care of
yourself, you can live a long life. It's like having diabetes. You have to
change your way of living," said a gay white man from New
York.

Fear of resistance and concern about drug
failure
About four in 10 of the individuals
not on combination therapy said they feared they would become resistant to the
drugs, which would no longer work for them. One in five expressed a concern that
once they start combination therapy, they would not be able to stop because they
would be subject to resistance. A few patients also said they believe that
resistance always occurs with combination therapy drugs or that they would be
worse off if they stopped taking the drugs because the disease would progress
more rapidly.

Among those not on combination therapy, slightly more than
half said they were concerned the drugs would fail at some point in the future.
A quarter of these patients said they don't know whether the drugs might fail,
often commenting that it "depends on the individual." Notably, gay white men are
far more likely to indicate a concern about future drug failure. The majority of
Hispanic patients interviewed said they don't know whether the drugs might
fail.

About three in 10 patients who were on combination therapy said
they hesitated about starting the drugs because of concerns about building a
resistance to the current therapies, as well as future treatments that might be
developed. While the majority of these patients said they were not concerned
that the drugs might fail, the gay white men among them were concerned, with
more than half expressing this fear.

"I waited three years due to a lack of need, but concern about
resistance also came into play," said a gay white man from San Francisco who
is now on therapy. "It's better to take as few drugs as possible for as long
as possible to avoid resistance and leave my options
open."

Almost two-thirds of physicians and nurse practitioners also said they
believed fear of resistance played a role in patients' reluctance to initiate
therapy. However, fewer than one in 10 case managers cited fear of resistance as
an obstacle to treatment, although one in four managers said they do tell
clients that taking a combination drug therapy could affect their ability to
take antiretroviral drugs in the future.

Use of alternative or
holistic remedies
Four in ten patients not on therapy said they believe
holistic or alternative approaches are the most effective ways to treat HIV.
Acupuncture and herbal remedies were among the most frequently mentioned
approaches to therapy among those patients not on treatment. Other alternative
or holistic treatments believed to be effective are creative visualization,
meditation, homeopathy, massage, biofeedback, acidophilus, blue-green algae,
flower essences and marijuana. A few of these patients attributed increases in
T-cells or viral load reductions to these alternative approaches.

"I want to control what happens in my body," said a gay Hispanic woman
from Miami. "Acupuncture, Chinese herbs and biofeedback is working for me. My
viral load is undetectable and my T-cells are 800."

Most patients not taking combination therapy said they
would not object to the treatment "when it becomes necessary." Still, only one
third said that some form of drug treatment, including combination drug therapy,
is one of the most effective methods of treating HIV. Others said effective
treatment of HIV includes using medications "as needed" or using a mix of drug
therapy and holistic treatments. Only a few said they believed in exclusive use
of holistic or alternative remedies and would reject drug therapies out of
hand.

"It gets to be tricky. If effective is defined as reducing (viral) load
and feeling better, then protease inhibitors are effective," said a gay,
African-American man from Washington, D.C. who is not on combination therapy.
"But drugs are only short-term remedies. A holistic approach, the mental,
physical and spiritual, is the most effective in the long
run."

Among those patients currently taking the drugs, fewer
than one in 10 said use of holistic or alternative remedies had been a factor in
their decision to start therapy. About a third of physicians, and roughly one in
five case managers, also said they believed patients' reliance on alternative or
holistic remedies was an obstacle to treatment with combination
therapy.

"The alternative medicine craze is hurting people and exploiting
people's hopes," said one physician from Dallas. "I'm troubled by things I'm
hearing from some patients that the AIDS virus doesn't exist or that the
medicines are a hoax. Patients hear that information coming from certain
groups in the San Francisco Bay Area, and it carries a particular air of
credibility because of where it's coming from."

Recommendation of medical
providers
A significant number of patients not
on combination therapy, or about three-quarters, reported that their doctors had
recommended that they begin treatment. On the other hand, one in four said their
doctors had not recommended that they initiate therapy yet. Two out of 10 of
these patients specifically said they have been influenced in their decisions
not to start combination therapy as a result of interactions with their
caregivers.

Often these patients say their doctors have withheld a
recommendation to start therapy based on the patients' T-cell counts. Some
patients also said they believe their doctors have not yet recommended therapy
because the physicians had an optimistic view of the patients'
health.

More than four in 10 of these patients said that when therapy was
recommended, their initial reaction was that it would not be a good move; one in
four said they had questions and reservations about the therapy. One in five
patients said when they first heard about combination therapy, they thought it
would be a "good thing," but half of them added, "not yet."

A desire
to wait for better treatments
About one in five of those not on
combination therapy indicated that they are "waiting for the future" in the hope
that better treatments will be developed. Some said they believe that the next
generation of drugs will be more effective and easier to take, and others said
they are "leaving their options open" for the future. About one in 10 patients
not on therapy also said they are trying to remain free of drugs for the time
when they will really need them.

"I want to do what it takes to stay healthy," said a gay white man from
San Diego. "The advances have been great, and I feel that they will develop
better drugs in the future. I've heard there are other drugs that are better,
and I want those. I'll wait until better drugs come on the
market."

About a third of physicians and nurse practitioners said they believe
that patients have not opted for combination drug therapy because they are
waiting for improved treatments that might become available. Hotline personnel
also said they believe there is a group of people who are waiting for drugs that
are more easily tolerated, have fewer long-term side-effects and are cheaper or
less complicated to take. These patients tend to view themselves as healthy
enough to wait for better options.

Cost issues
Patients not on
combination therapy rarely cited cost as a barrier to treatment. In fact, only
one patient from a state where ADAP has reportedly been closed to patients
indicated that she wanted to start combination therapy but was unable to find a
program that would pay for it.

"I've found the combination I want, but ADAP won't pay," said one
heterosexual African-American woman from Miami. "I just heard about the
pharmaceutical companies' compassionate use program, so I'll ask my doctor to
write to them when he gets back from vacation."

Two others who were interviewed said that if they decided to start, they
did not know who would pay or were concerned that they earned too much to
qualify for assistance but not enough to afford the drugs. Nine out of ten
patients not on therapy said they knew where to obtain the drugs if, and when,
they made the decision to start therapy.

"Medicaid and Medicare are for the poor, but not for the "average Joe"
like myself," said one patient, a bisexual African-American man from
Washington, D.C. "I don't make enough to pay for them, but I make too much to
quality for government assistance."

While two in 10 patients on therapy said coverage for cost of the drugs
was a factor in deciding to start therapy, they were expressing concern that
they might get cut off from programs once they had begun therapy.

While
patients reported relatively little concern about issues of cost, their
caregivers frequently perceived the cost of treatment to be an obstacle. Nearly
half of the case managers and more than two-thirds of physicians and nurse
practitioners cited cost as a barrier to initiation of therapy.

Hotline
operators and supervisors also reported frequently receiving questions about
cost of treatment and payment mechanisms. They reported that callers were
unaware of programs for which they might qualify and said some patients believed
they did not qualify for a drug assistance program because they earned too much,
were too poor or were undocumented. Hotline operators also said they spoke to
people who had drug prescriptions in hand but had not had them filled because
they had changed jobs and were waiting for their insurance plans to
activate.

Privacy considerations
Concerns about privacy were
mentioned by one in 10 patients who were not on combination therapy as a factor
influencing their decisions not to initiate therapy. These patients worried that
their HIV status would be revealed or that they would have to answer questions
from family, co-workers and others if they began taking medications.

"Three times a day to take pills is a hassle. To follow the regimen
isn't easy to do publicly. People look at you if you take pills in public,"
said a heterosexual African-American man from Miami.

"My 9-year-old son
would see me taking all these medications, and I'm not ready yet to tell him
I'm sick," said a heterosexual Hispanic woman from New
York.

Privacy issues were rarely mentioned as a barrier to therapy by
physicians and nurse practitioners or case managers. However, hotline personnel
reported that callers were often reluctant to initiate drug therapy because they
were afraid to file a claim with a private insurance company. These callers were
concerned that employers would learn of their condition once they started
ordering drugs. They feared discrimination, loss of their jobs, loss of benefits
or inability to receive new benefits. The hotline personnel also reported
concern among some heterosexual and bisexual men that their families would learn
their HIV status and reject them based on the assumption that "only gay men get
HIV."

C. Other Factors That Influence
Decision-making

It is clear from the study that patients are
hungry for information about new drugs and must make decisions about treatment
in the face of sometimes conflicting reports about drug effectiveness,
side-effects and other aspects of treatment. Some rely on their caregivers for
guidance, while others are distrustful of the medical profession and look for
direction from other sources, such as members of a support group or publications
geared to HIV-positive individuals. Ultimately, however, it is the patient who
decides whether, and when, to start treatment.

"It's hard to know what is reliable and unreliable," said one bisexual
African-American man from New York. "We (HIV-positive people) share
information because the doctors don't tell us the same things. You use your
own judgment."

"My doctor and I have looked at a few options, but
since I don't have an interest (in drug therapy), we don't spend a lot of time
on it. He sees it as being my decision," said another patient, a gay white man
from Seattle.

The role of caregivers, case managers and
others
Most of the patients who are on combination therapy said it
was their physicians who first suggested this form of treatment. In one of the
strongest differences noted between men and women, men were twice as likely as
women to be influenced by information received from their physicians in deciding
on treatment. Overall, the men interviewed said the most reliable information
about treatment came from their doctors, followed by peers who are HIV-positive.
The study also found that men were more likely than women to rely on an extended
HIV information and resource network, including pharmacists, Internet sites and
publications from groups such as Project Inform, Positively Aware, Poz, Beta
News and the federal Centers for Disease Control and Prevention.

Most of
the men and women on therapy said their doctors usually spend enough time during
office visits in discussing their condition. Yet several patients noted that
they were not satisfied with the time they spent with their physicians and
actively sought out other physicians who were more attentive. In the case of one
woman, an African-American patient who is on public assistance, the decision to
initiate therapy was directly related to finding a physician at a public health
facility "who spent time with me, getting to know me, rather than seeing
different doctors every time I went and who spent five minutes asking the same
questions as the last doctor and two minutes about me."

Among those
patients not on combination therapy, eight in 10 said their health care
providers spent enough time with them and answered their questions. Those men
and women who said they believed their doctors were "too busy" or "didn't spend
enough time with them" were frequently patients at public health clinics. A few
patients also said they actively sought out doctors who they felt met their
needs, most often looking for those physicians who were specialists in HIV
treatment.

"At the clinic in the hospital, there was always a different (doctor),"
said one heterosexual African-American man from Washington, D.C. "They never
asked about my HIV and it was on my records. They only treated me for what I
was there for. I asked to be referred to a specialist because I wanted to know
more."

"I'm not unhappy with the doctor but with the rushed
environment," said a heterosexual, African-American woman from Miami. "But I'm
pretty dogmatic. I insist on answers, and I write down my
questions."

About four in 10 of those not currently on therapy said their doctors
described the benefits of treatment as decreased viral load and increased T-cell
counts. Less frequently, patients said they had been told by their doctors that
combination drug therapy would make them "feel better," help them live longer,
have a positive effect on their emotional well-being, combat the virus, rebuild
their immune systems or result in fewer opportunistic infections.

Nearly
three in 10 patients not on therapy said their doctors had not told them
anything specific about the benefits of combination drug therapy. Among these
patients, however, a majority indicated that they and their doctors had agreed
that combination drug therapy was not yet necessary. A few said they had told
their physicians they were opposed to drug therapy and would not discuss it with
them.

While half of those on therapy said they had no trouble
understanding the "jargon" or information they received about HIV and drug
treatments, four in 10 indicated that they don't always understand what the
doctors are saying to them or what they are reading. Often, however, patients
said they ask for clarification in "laymen's language" when they don't
understand what physicians tell them. A number of patients commented that they
had become confused with the variety of acronyms and different names for
drugs.

Among those patients who are taking combination therapy, six in 10
said their doctors described the benefits as decreased viral load and increased
T-cell counts. About a third said their doctors told them that combination
therapy would help them live longer or make them "feel better." The majority of
patients on therapy, or six in 10, said they had no trouble understanding the
"jargon" they encounter in visits with their doctors or in information received
from other sources. Those patients on therapy are somewhat less likely than
those not on therapy to indicate that they don't always understand the
information they are being given. Nevertheless, three in 10 said they don't
always understand the information and while many ask for clarification, a few
said they simply "trust their doctors."

Physicians said they believed
they played the most influential role in patients' decisions to initiate
combination drug therapies. Only one physician interviewed said that case
managers had an influence on patients' decisions, whereas case managers were far
more likely to view themselves as being involved in patient decision-making.
Physicians also indicated that nurse practitioners, patients' partners and
spouses, as well as friends and HIV-positive peers, had a strong influence in
patients' decisions to start therapy. Physicians indicated that while they might
recommend treatment, they did not pressure patients and ultimately left the
decision to them.

"I don't believe in persuading patients (to go on combination therapy),"
said one physician from Dallas. "I give them information to read, news
articles, AIDS-care pamphlets. If you pressure them, it won't work. It's up to
them to decide and usually they will come around."

"The decision (to
begin combination therapy) lies primarily with the patient," said another
physician from Seattle. "But I have dissuaded some patients from starting if
it isn't their decision, but that of some other
influence."

When discussing the benefits of combination therapy with their patients,
physicians most frequently said they emphasize the treatment will:

reduce the chances for opportunistic
infections;

decrease viral load counts;

strengthen or protect the immune system;

increase patients' energy levels;

increase T-cell counts;

help patients feel better emotionally;

help patients live longer;

help patients stay healthy;

help patients gain weight; and

prevent hospitalization.

In discussing drawbacks of combination therapy,
physicians most often mention:

the side-effects;

the demands of the regimen;

the cost of medication;

drug toxicities; and

a lack of long-term knowledge about drug
effectiveness.

Physicians were apt to believe that their HIV-positive
patients had a relatively good understanding of the meaning of their T-cell
counts and viral loads; the differences between monotherapy and combination
therapies; the general purposes and effects of protease inhibitors; and the
importance of strict compliance with drug regimens. On the other hand,
physicians said they believed patients had a relatively poor understanding of
the general purpose of nucleoside analogs; their personal level of tolerance for
various antiretroviral drugs; and the relevance of p24 antigens.

Case
managers generally agreed with physicians on those areas in which patients had a
good or poor understanding. The one difference was that case managers were more
apt to believe that patients had a poor understanding of the general purpose and
effects of protease inhibitors.

Case managers indicated that doctors, in
addition to the patients themselves, play the most important role in the
decision to initiate drug therapy. Case managers also believe they have some
influence on the decision and that clients' friends who are HIV-positive have a
role in decision-making. Only one of the case managers interviewed said that he
did not discuss the benefits or drawbacks of combination therapy with his
clients, deferring instead to their physicians. Virtually all case managers said
they provide their clients with printed information about combination therapy
that is prepared by pharmaceutical companies and AIDS service
organizations.

"Clients are looking for accurate, updated, consistent,
statistical information on new and improved drugs. It gives them more to grasp
onto, a more positive outlook. It encourages them because it means they
understand what the positive effects will be and the proper time to go on the
drugs," said one case manager from New York.

When discussing HIV
treatments with clients who have not started drug therapy, case managers said
they describe a variety of benefits but most frequently report telling clients
that combination therapy may:

decrease viral load and increase T-cell counts;

result in increased energy levels;

protect the immune system;

help clients live longer;

help clients stay healthy; and

not necessarily cause side-effects.

When discussing drawbacks of combination therapy with
patients, case managers are most likely to emphasize:

side-effects;

the regimen

the need to commit to therapy once it is begun;

the possibility of drug resistance; and

the cost of medication.

One case manager in Miami said that the "the more
educated (clients are) about combination drug therapies, the more power they
have to choose what is best for them."

"I give both sides of the coin (about combination therapy), and it's the
client's choice," said another case manager from New York. "They take a little
bit from everybody and then make up their own minds. I don't know what will
happen in the future, and I couldn't live with myself if there were bad
effects (from the drugs)."

Another case manager expressed similar misgivings about offering a
recommendation to clients to initiate therapy.

"I tend to direct my clients to their doctors for their medical
questions," said the case manager from San Francisco. "I feel that I should
play as neutral a role as possible. If we had more effective treatments, I
would feel more comfortable encouraging them to start."

Hotline personnel were sharply critical of the care being provided to
HIV-positive individuals by physicians and other caregivers. Often, they say, it
becomes their job to "debrief" patients after a visit with physicians because
physicians fail to give patients the information they need. The hotline
personnel said they believed patients were not given adequate explanations of
the meaning of laboratory tests and that few doctors spent enough time telling
patients what to anticipate with combination therapy, including possible
side-effects. Many times they reported receiving calls from patients seeking to
confirm a doctor's recommendation to start therapy. In fact, hotline supervisors
said that some doctors give out hotline numbers to patients to get explanations
about drug therapies or answer patient questions.

According to
supervisors, patients are "nervous and feel pressured to get on the treatments."
Hotline supervisors generally agreed that doctors do not appreciate the enormity
of the decision for patients in initiating therapy. They said some doctors
discouraged patients from starting the treatment by failing to explain how a
triple combination drug regimen could fit the lifestyle or schedule of a
patient. As a result, supervisors and operators say, some patients don't believe
the regimen will work for them and neglect to fill their
prescriptions.

Overall, there are strong perceptions among hotline
personnel that some HIV-positive people are not receiving adequate medical care
because:

Many HIV-positive individuals are receiving treatment
from their general practitioners who do not have expertise in treating HIV.
One operator who has been working on an AIDS hotline for more than a decade
said that even HIV experts have made it clear that general practitioners and
family practice physicians should not prescribe protease inhibitors because
the protocol is too complex.

Patients who only speak Spanish are frequently being
treated by physicians who do not speak the language. Because Hispanics have a
cultural tendency to implicitly trust physicians, these patients do not
question what information they can glean from their physicians.

The public health system is not equipped to deal with
the ongoing needs of HIV-positive individuals and is not adequately serving
some patients, particularly African-American and Latino patients. Hotline
personnel also said they sensed a strong distrust of public health workers
among African-American patients. They said patients often were intimidated by
the system and were discouraged from receiving care by long waits for a brief
visit with a physician, sometimes as little as two minutes. One operator said
that there is a sense that doctors at public health clinics put restrictions
on who can receive combination therapy. The hotline workers said they strongly
believed that once patients entered the system, they were likely to be
prescribed medications.

Hotline staff said they emphasize to callers the need for
the patient and the doctor "to have open lines of communication," "to understand
each other" and for patients to feel secure enough to talk about everything.
Operators and supervisors said they frequently counseled callers to find a new
doctor to treat their HIV if this atmosphere of positive communication did not
exist or if they felt other important health issues were at
stake.

Information sources
Although doctors are most often
cited as reliable sources of information about HIV therapy by those patients who
are not on treatment, they are named as reliable sources by less than half of
these patients. Those not on combination therapy cited other HIV-positive
individuals as reliable sources of information nearly as often as they mention
doctors. While a substantial majority of African-Americans do view doctors as
reliable information sources, gay men were more likely to point to other
HIV-positive individuals as reliable information sources.

"The doctors at my HMO don't know as much about HIV as I do, so I often
don't feel a need to talk with them," said a bisexual Hispanic woman from Los
Angeles.

One in five patients not on therapy said they consider support groups as
a credible source of information about HIV and treatments. Other frequently
mentioned sources of reliable information on HIV therapy include publications
such as Beta, Poz and Positively Aware; HIV seminars, fairs and workshops; and
medical journals and reports on treatment studies.

Among those patients
not on combination therapy, most notably among the gay men interviewed, the
mainstream media is most often cited as an unreliable source of information
about HIV therapies.

"There is hype in the media (about the benefits of combination therapy),
which only explains one side to the issue. They are giving a skewed side to
the drug issue," said one heterosexual African-American female patient from
Seattle.

Although drug companies are named as unreliable sources of information as
frequently as the mainstream media, both are mentioned by fewer than one in five
of those patients interviewed. Other sources considered unreliable by patients
not on therapy include other HIV-positive people, doctors, the general public,
herbal remedy companies, Project Inform, nurse practitioners and the FDA. One in
ten patients not on therapy said they could not think of any unreliable sources,
perceiving all information as useful, and one in ten said they did not know who
to trust.

In general, hotline personnel said patients appear to rely on a
variety of different sources for information and referral. Those organizations
repeatedly cited as credible sources were Project Inform, Beta News, Poz and Bay
Windows.

As for information provided by pharmaceutical companies, hotline
staff said they believe it needs to be considered with "caution." Yet hotline
staff said pharmaceutical ads, particularly those appearing at bus stops,
shelters, on radio and TV and in magazines are a credible information source on
drug therapies. One operator also noted that a company-sponsored "food fair" in
South Florida had been an effective way to bring people together to learn about
protease inhibitors.

Most hotline supervisors said their organizations
develop their own materials for in-house use and to send to callers. Some
operators and supervisors said patients remained confused by the multiple
general and brand drug names and had a hard time remembering which drugs they
were taking or which drugs had been recommended to them. The hotline personnel
said those materials that worked best were simple fact sheets on viral loads and
protease inhibitors in general.

D. Issues and Concerns of Women

HIV-positive women generally express concern about the
lack of information on the effects of combination therapy in women. More than
one-third of women interviewed said they believe there is a lack of research
about HIV drug therapies involving women and indicated that this research gap
had contributed to their decision not to initiate treatment. Women are also
somewhat more apt than men to express concern about long-term side-effects of
the medications, particularly citing apprehension, or the lack of research,
about the drugs and child-bearing.

"I heard about protease inhibitors very early, but there's no research
on women's issues," said a gay Hispanic woman from Miami.

"There is
confusion about my viral load. It's been fluctuating. The question is, should
I go on therapy or not? I chose not to due to the lack of information on how
women react to the medications. I would rather take alternative, natural
methods," said a heterosexual white woman from Vancouver,
Washington.

While men tend to rely on specialized print publications for information
about HIV treatment, women were less likely to look to the print media for
information. Rather, women said face-to-face communications with doctors,
support group members and other HIV-positive individuals, were their most
reliable sources of information. Importantly, women identify support groups as
reliable sources of information as often as they mentioned their doctors but
note that finding support groups for women is difficult. Women also were twice
as likely as men to say they began combination therapy because they trusted the
information provided by their physicians.

Women also reported getting
different information from physicians than men. Fewer than two in 10 of those
women not on therapy said their doctors described a decrease a viral load as one
of the benefits of combination therapy. By contrast, two-thirds of gay men not
on therapy said their doctors described this as a benefit of treatment. Women
not on therapy most often said their doctors told them the benefits of therapy
would be an increase in T cells and a sense of "feeling better."

Some
hotline operators reported receiving more calls from women than from men,
sometimes from partners or spouses of HIV-positive men. These operators agreed
that while there was a lot of material generally available on the pros and cons
of protease inhibitors, there was little research information available on
combination therapies as they relate to women. Hotline personnel did say that
they believed women were better at researching and getting answers about HIV
treatment, often sought emotional support "more honestly" and sooner than men
did, but had fewer support groups to rely upon than men.

IV. Study Implications

HIV-positive
individuals face an enormously complex set of issues in deciding whether to
elect, or reject, combination therapy. The study suggests that patients are
taking a thoughtful approach to the issue, relying on advice from their
physicians, the experience of other HIV-positive individuals and a variety of
other information sources in making what is an important personal choice.
Because of the nature of HIV disease, which may progress over a period of many
years, patients have the benefit of time in making this choice. In the process,
it is critical that they have access to expert clinicians and other reliable
resources in the HIV community to help them make an informed
decision.

Clinicians need a forum in which they can share information
with other clinicians and discuss possible approaches to treatment. Many of the
physicians and patients interviewed are approaching antiretroviral therapy with
caution. Some clinicians and patients are concerned that the experience with new
drugs is so limited that their effects are not known. All HIV clinicians and
patients need access to expert clinicians so that they can make maximally
informed decisions. Increasing the ways that clinicians can share their
experiences in using antiretroviral medications can only help them and others
use them in a more informed way. Telephone hot- and warm-lines, telephone
conference calls, and conferences are needed to insure that clinicians have
access to and are giving the best advice to their patients.

Clinicians
and patients need time to discuss whether or not to start antiretrovirals. Many
clinicians and patients reported that they did not have time to engage in
complete discussions about the medications and how to use them. Given the
importance of their use, strategies need to be devised to insure that patients
with HIV have sufficient access to information to get their questions answered
and concerns addressed.

The information needs of people extend beyond how
the drugs work to how to cope with the drug regimens and their side effects.
Individuals have a lot of information on how the drugs work to reduce the impact
of HIV infection. Individuals have many concerns about the regimens and side
effects and whether or not they will be able to manage taking the drugs and
dealing with those side effects. Clinicians and hotline operators need to share
clinical experiences in this arena, and patients need good information about how
others have coped with these demanding regimens.

Other resources used by
patients to gain information must be as accurate, comprehensive, and current as
possible. Hotline operators need to have access to continuing education so that
they can provide callers with the best information available on the drugs.
Regional hotlines, which are now operated independently, also should develop
outlets for sharing information and consider developing cooperative working
relationships. In addition, groups that maintain HIV web sites also have a
responsibility to keep their sites well-maintained and current, indicating when
an entry was most recently updated.

Women need special services to assist
them in deciding about antiretroviral therapy. Women were often reluctant to
initiate combination therapy because they believed there was too little research
on the impact of the drugs on women and childbearing. Clearly, there is a need
for more scientific research in this arena. The study also suggests that women
rely heavily on face-to-face communications to obtain information about
combination therapy, yet they found it difficult to locate support groups. This
is a gap that needs to be addressed in the HIV community. In addition, women are
not finding a voice in existing publications about HIV and could benefit from a
newsletter devoted strictly to women's issues and the impact of antiretroviral
therapy on women. The study also suggests that Spanish-speaking patients are not
being well-served, particularly by the public health system. These patients
could benefit from policies aimed at increasing the availability of
Spanish-speaking clinicians and interpreters in the HIV
community.

Patients and clinicians need access to the best information
possible on alternative and holistic remedies to treat HIV. The medical
community could benefit from more scientific research on the impact of these
remedies on HIV-positive patients. Clinicians also should be aware of these
approaches and the existing medical literature on them and be respectful of
these alternatives.

Pharmaceuticals need to be encouraged to continue
drug development so that antiretrovirals can become even more effective and
easier to take with fewer side effects.

Notes

1. Cameron B, Heath-Chiozzi M, Kravcik S, et al. Prolongation of
life and prevention of AIDS in advanced HIV immunodeficiency with ritonavir. In:
Program and abstracts of the Third Conference on Retroviruses and Opportunistic
Infections; January 28 February 1, 1996; Washington, DC. Abstract LB6a

2.
Lalezari J, Haubrich R, Burger HU, et al. Improved survival and decreased
progression of HIV in patients treated with saquinavir (Invirase, SQV) plus
HIVID (zalcitabine, ddC). In: Program and abstracts of the XI International
Conference on AIDS; July 7-12, 1996; Vancouver, British Columbia. Abstract
LB.B.6033.

3.
Deeks, S. et al. Incidence and Predictors of Virologic Failure of Indinavir
(IDV) and/or Ritonavir (RTV) in an Urban Health Clinic. Presented at the 37th
meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy,
September 29, 1997.

4. Carpenter, Charles C.J., et al. Antiretroviral
therapy for HIV Infection in 1997, Updated Recommendations of the International
AIDS Society-USA Panel, Consensus Statement, Journal of the American Medical
Association, June 25, 1997, Vol. 277, No. 24.

This research monograph was funded by a grant from
Glaxo-Wellcome.

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