From: Subject: Motivators and Barriers To Use Of Combination Therapies In Patients With HIV Disease Date: Thu, 13 Jul 2006 15:51:24 -0400 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0000_01C6A694.3195A860" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.2869 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C6A694.3195A860 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.caps.ucsf.edu/publications/drugmonograph.html Motivators and Barriers To Use Of Combination = Therapies In Patients With HIV Disease

Motivators and Barriers To Use Of Combination Therapies In Patients = With HIV=20 Disease

Ruthann Richter

Maureen Michaels
President, Michaels Opinion = Research=20

Bruce Carlson
Research Associate, Michaels = Opinion=20 Research

Thomas=20 J. Coates PhD
AIDS Research Institute and Center = for AIDS=20 Prevention Studies UCSF=20

CAPS Monograph Series,
occasional paper #5,
January 1998

Center for AIDS Prevention Studies, University of California San=20 Francisco

Table of Contents

I. Introduction=20

II. Study=20 Design

III. Key=20 Findings

A. Motivators=20 to Initiate Therapy

B. Barriers=20 to Initiation of Therapy

C. Other=20 Factors That Influence Decision-Making

D. Issues=20 and Concerns of Women

IV. Study=20 Implications

I. Introduction

The = successful=20 two-drug combination therapy in 1994 and protease inhibitors in 1995 set = the=20 stage for a new era in treatment of HIV disease, creating a burst of = optimism=20 over the prospect that HIV might be a controllable disease. Initial = studies of=20 protease containing triple-drug regimens suggested that these = combinations=20 could, in some cases, slow clinical progression of the disease and = prolong the=20 lives of patients. 1,=20 2 In = anecdotal=20 reports, physicians and patients described a kind of "Lazarus" effect in = which=20 previously disabled individuals found themselves regaining lost = functions,=20 returning to work and planning their futures, instead of preparing for=20 death.

There are still many unknowns about these multi-drug = regimens,=20 including their durability of effect and how many individuals for whom = they will=20 be effective.3,=20 4 Nonetheless, the drugs have proven quite effective in = clinical=20 trials and are helping many people stay alive longer and experience = better=20 quality of life while they are alive.

We thought it important to=20 understand better why people do and do not take advantage of these = therapeutic=20 advances. Developing the medications may be only half of the battle; the = other=20 half involves making sure that HIV infected individuals have access to = the drugs=20 and that they make thoughtful decisions about whether or not to take = them. If=20 some of the barriers to taking the drugs can be addressed, they should.=20

We conducted in-depth qualitative interviews with 114 = individuals in the=20 HIV community--75 HIV infected men and women, 18 hotline operators and=20 supervisors, 11 case managers, and 10 physicians and nurse = practitioners.=20

We found that individuals are motivated to begin = antiretroviral=20 therapy if:

People were deterred from taking advantage = of=20 antiretroviral therapy if:

Based on these findings, we recommend the=20 following:

II. Study Design

In the = current=20 study, our goal was to identify those factors that have both deterred = patients=20 from initiating therapy or motivated them to opt for the new treatment = regimen.=20 We conducted in-depth interviews, either on the telephone or in person, = during=20 October, November and December 1997 with 114 individuals in the HIV = community.=20 These included 75 HIV-positive men and women, 18 hotline operators and=20 supervisors, 11 case managers and 10 physicians and nurse practitioners. = The=20 one-on-one interviews ranged from 30 minutes to more than an = hour.

The=20 patients were recruited through posters and flyers circulated in = treatment=20 centers, clinics, needle exchange programs and support groups and = through=20 referrals from physicians, clinics and case managers. Patients were = recruited=20 from a dozen cities and represent diverse ethnic and racial groups, = including=20 African-American, Asian, Native American, Hispanic and white. Sixty-four = percent=20 of the patients were male and 36 percent female. Thirty-nine percent of = patients=20 identified themselves as heterosexual, 49 percent as gay, 9 percent as = bisexual=20 and 3 percent as lesbian. More than half of the patients, or 53 percent, = had=20 never taken protease inhibitors or combination drug therapy to treat = HIV.=20 Thirty-eight percent were taking combination drug therapy at the time of = the=20 study. Nine percent had initiated combination drug therapy but had = stopped the=20 treatment.

The case managers who participated in the study were = drawn=20 from public and private sector AIDS service organizations in seven = cities. Most=20 indicated that the majority of their clients are HIV-positive. Virtually = all of=20 the case managers interviewed said their HIV-positive clients generally = come=20 from low-income households. Although all the case managers have women = clients,=20 the majority of their clients are men, both gay and heterosexual. Their = clients=20 come from a broad range of racial and ethnic backgrounds. Seven of the = 10 case=20 managers interviewed said most of their HIV-positive clients already had = developed symptoms of AIDS or had been diagnosed with full-blown=20 disease.

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

The = AIDS=20 hotline supervisors and operators represent a cross-section of major = regional=20 hotlines operated by public sector agencies and AIDS service = organizations in=20 eight cities. All of the hotline personnel participated in one of a = series of=20 four 90-minute roundtable discussions via telephone conference = call.

The=20 hotline operators said their role is to respond to inquiries about = sexually=20 transmitted diseases, primarily HIV, and to help HIV-positive = individuals link=20 up with organizations in the community that can address their specific = needs.=20 The hotline supervisors said there has been a notable decrease in the = number of=20 calls from gay men in the community and an increase in calls from = heterosexual=20 men and women. Although hotline staff do not ask a caller's race or = ethnicity,=20 those hotline personnel interviewed said they believe they are receiving = an=20 increased number of calls from people of color. Many of those who call = the=20 hotlines do not have private insurance, according to those interviewed. = Many=20 hotline personnel said they receive a significant number of calls from = people in=20 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=20 option. A large majority of these patients said they were open to the=20 possibility of combination therapy, most often indicating that they = would be=20 motivated to start the treatment if:

Patients already on combination therapy cited = these same=20 factors as an influence in their decision to begin the treatment. In = addition,=20 some of the patients on therapy said they had started treatment=20 because:

Among those patients not on combination = therapy, the vast=20 majority indicated that they were deterred from the treatment primarily = because=20 of:

In addition, a significant number of patients = not on the=20 treatment said they were reluctant to initiate therapy because = of:

The responses from patients were relatively = consistent=20 with reports from physicians and nurse practitioners, who said concern = about=20 side-effects and drug effectiveness, as well as the complexity of the = regimen,=20 were the key factors that deterred patients from initiating therapy. = Physicians=20 and nurse practitioners also said they believed patients shied away from = the=20 treatment because of a fear of drug resistance and a positive view of = their=20 health status.

Seven out of ten of those patients not on = combination=20 therapy said they had not been diagnosed with AIDS and had not had an=20 HIV-related disease. Half of those individuals interviewed who were not = on=20 therapy have been HIV-positive for more than five years, although about = one in=20 10 learned they were positive within the last year. More than = three-quarters=20 indicated they might opt for combination therapy at some point in the=20 future.

Two-thirds of the patients who were not taking = combination=20 therapy said the decision not to begin treatment has not been difficult = for=20 them. Those who have struggled with their decisions said they had = received=20 conflicting information about the therapy or were subject to pressure, = both pro=20 and con, from family members and peers.

More than four in 10 of = the=20 patients not on therapy said they believe it is difficult to take these = drugs,=20 and another one in five perceive that it is "somewhat" difficult. In = fact,=20 two-thirds of those interviewed said they know of someone who has = stopped taking=20 combination therapy. Even so, more than one in five said they do not = believe=20 that combination drug therapy would be difficult to take, once they made = the=20 decision to start. While the vast majority of those interviewed said = they do not=20 have lifestyle factors which would prevent them from undertaking = treatment, one=20 in five believe that it would be difficult for them because of their = eating=20 habits, school or work environments or "busy" = lives.


A. Motivators to Initiate = Therapy

Patients were most likely to be motivated to = begin therapy=20 when they began to see their health deteriorate, based on changes in = T-cell=20 counts and viral load, hospitalization or the emergence of an = opportunistic=20 infection. Seeing or hearing word of improvements in other patients and = getting=20 access to better information about the drugs also served as strong = motivating=20 factors. Some patients also indicated that they began drug treatment = because=20 they believed it would prolong their lives. Others said a positive=20 recommendation from their physician was key to starting therapy. Factors = mentioned less often by patients included information about possible = changes in=20 the drug regimen and resolution of payment issues.

Nearly all of = the=20 patients currently on combination therapy said they planned to continue = taking=20 the drugs, although some qualified this by saying, "if it continues to = work," or=20 "until something better comes along." Patients were motivated to = continue on=20 therapy by improvement in their health indicators, such as increased or=20 stabilized T-cell counts, decreases in viral load, weight gain or a = general=20 sense of improved health.

"I'll take them as long as I have to. They make me feel like I'm = not=20 sick," said a heterosexual Hispanic female from New=20 York.


Six in ten of the men and women on combination therapy said the = treatment=20 had not been difficult for them, while three in 10 said it has been = difficult. A=20 few said taking combination therapy had been only "somewhat" difficult. = More=20 than two-thirds of patients reported experiencing some side-effects from = the=20 drugs. The group was divided between those who said the regimen schedule = was=20 difficult to maintain and those who did not find the regimen=20 difficult.

"I'm still alive. I wouldn't be here today if it weren't for all = the=20 drugs," said a heterosexual white female from Miami.

"It's = better to=20 take them than not," said another patient, a gay African-American = female from=20 New York. "God knows where I would be without = them."


Health indicators, including = disease=20 progression, changes in T-cell counts and viral load
Seven = in 10=20 patients who were not on therapy indicated that they are open to the = possibility=20 of treatment "when the time is right." For most of these patients, that = time=20 will come when their health begins to deteriorate, as indicated by = declining=20 T-cell counts or increases in viral loads (sometimes qualified as = "consistent"=20 or "significant" changes in their numbers), the onset of an = opportunistic=20 infection or hospitalization.

Disease progression was also = frequently=20 mentioned as a reason for starting therapy for those patients = interviewed who=20 already had begun the treatment regimen. Eight in 10 said they opted for = therapy=20 when there were clear indications of a deterioration in their health. = Nine in 10=20 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=20 strong motivator.

"I wanted to go herbal, Chinese herbs, but my system was = breaking down,"=20 said a gay African-American woman from New York who is on combination = therapy.=20 "I was getting worse, I got PCP, and they told me I wasn't going to = get=20 better."

"I was in the hospital. I = was=20 willing to try anything at that point. Maybe I was a guinea pig, but I = was=20 willing to take anything. Friends said it was a miracle drug," = reported a=20 heterosexual African-American woman from = Miami."


Seeing improvements in = others

Seeing or hearing about improvements in others = also has a=20 strong influence on patients' thinking about combination therapy. Almost = half of=20 those interviewed who were not on therapy said they felt encouraged to = start=20 treatment based on what they had heard about or witnessed in others = about the=20 positive effects of the drugs in HIV-positive individuals. Similarly, = for those=20 patients already on therapy, half said hearing reports of improvements = in others=20 had encouraged them to obtain treatment.

"When I first heard about the therapy, I thought, `Thank God!' I = knew=20 that it would work for me and saw that it was working for my friends = already,"=20 said a gay African-American man from San Francisco who is now on = combination=20 therapy.

"The new drugs have made a difference in people, = physical=20 things," said one gay, African-American man from Washington, D.C. who = is not=20 on the therapy. "I have seen the Lazarus syndrome, people getting up = out of=20 their death beds. The most dramatic changes are among those who were = the=20 sickest. The effect takes a matter of weeks. There are fewer deaths. = It gives=20 hope.

"

Patients reported that news media, support groups,=20 HIV-positive peers and personal experience all served as sources of = information=20 about the value of the drugs.

"I heard about the cocktail on the news," said a heterosexual=20 African-American man from Washington, D.C. "It's working. You hear it = on TV=20 and see some people, like Magic Johnson."


Case managers cited positive reports about the drugs as the = number one=20 motivator for patients. About eight of 10 physicians and nurse = practitioners=20 also noted that patients were influenced to start therapy based on = improvements=20 they saw, or heard about, in others. Hotline personnel reported that = some=20 patients were motivated to start combination therapy when they heard = that the=20 treatment had brought the virus down to undetectable levels in some = HIV-positive=20 individuals.

The availability of better research=20 information
More than half of those patients not on combination = therapy=20 said they would start treatment sooner if there were better research = information=20 about the effectiveness of the drugs beyond five years, the long-term=20 side-effects and the length of time required on therapy. One third said = they=20 would be motivated to begin combination therapy if they knew they would = not=20 experience any short- and long-term side-effects. These patients also = said they=20 wanted more evidence that these drugs constitute a "cure" for = HIV.

"I'm hoping for the best about combination therapy, but without = any=20 long-term data on the results, I'm not certain," said one gay white = man from=20 San Francisco who is currently not on treatment. "But overall, I'm = hopeful=20 since fewer people are passing away."


The responses from physicians, nurse practitioners and case = managers=20 suggested they feel a strong need for more scientific evidence on the = value of=20 the drugs. Most notably, seven out of 10 physicians and nurse = practitioners said=20 they believed patients would be motivated to take combination therapy if = there=20 were more or better research information on its effectiveness. More than = half=20 the case managers said they believed their clients would be influenced = to start=20 therapy if more research information were available.

"The doctor wants me to start taking the drugs, and she gave me = some=20 books to read," reported a heterosexual African-American man from = Washington,=20 D.C. "She wants me to think about what drugs I want to take and think = about=20 commitment. But the things I have to read don't say how long the = side-effects=20 will last. Or what happens if you miss timing the drugs? Or what else = can you=20 take? Aspirins? Or when do you know if it works? Or how long before = you know=20 when to switch (to another combination)?"



A belief that the therapy = prolongs=20 life
Almost half of those patients = taking=20 combination therapy, particularly those who have developed AIDS or had=20 opportunistic infections, said they decided to go on treatment because = they=20 hoped it would prolong their lives. A few noted that they believed = combination=20 therapy was their last hope and they felt they had "nothing to lose" by = trying=20 it.

"At first, I thought, `Now I have to take pills for the rest of = my=20 life.' But I hope this will prolong my life enough for them to find a = cure,"=20 said a heterosexual African-American man from New York who is = currently on=20 therapy.

Almost half of the physicians, nurse = practitioners and=20 case managers said their patients had been motivated to start therapy = because of=20 a belief that it would prolong their lives. On the other hand, only one = quarter=20 of patients who were not on the regimen said they believed it might help = them=20 live longer.

"The drugs do give people hope that something can be done to = prolong=20 life," said a bisexual Hispanic woman from Los Angeles who has yet to = take the=20 drugs.


Perceptions about effective = treatments for=20 HIV
Nearly all patients currently on therapy, regardless = of sex,=20 sexual orientation, race or ethnicity, said they believe combination = drug=20 therapy, "taking your meds" or using a mix of drug therapy and holistic=20 treatments are the most effective methods to treat HIV. At the same = time, about=20 half of those on combination therapy also said that lifestyle or = attitude were=20 effective ways to treat HIV. These included changes in diet, exercise = and a=20 positive attitude toward the disease. Fewer than one in 10 of those = currently on=20 combination therapy cited alternative or holistic approaches as = effective=20 treatments for HIV.

An understanding that the regimen can be = changed,=20 if necessary
About a third of those currently on combination = therapy said=20 they were more inclined to start treatment when they learned more about = the=20 ability to try different combinations if the first set of drugs did not = work for=20 them. Others on therapy said they became more motivated to begin therapy = when=20 they learned that the drug regimen could be altered to fit their = lifestyles or=20 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=20 you can't take the side-effects," said one gay African-American man = from=20 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=20 half cite the regimen as a barrier to their initiating therapy. About = one in=20 five case managers said they believed patients were more apt to start = therapy if=20 they knew the regimen were somewhat flexible and could be made to fit = more=20 easily into people's lives.

Physician = recommendation
More than=20 half of patients on therapy said they were prompted to start treatment = on the=20 basis of their physicians' recommendation. However, fewer than two in 10 = patients not on the treatment said they would begin combination therapy = if their=20 doctors told them they needed to.

"I was willing to try anything. I trusted my doctor and I saw = other=20 people at my doctor's office who said, `You'll like that,'" reported = one gay=20 African-American man from Chicago who is taking combination=20 therapy.


More than a third of the case managers and about one in four = physicians=20 and nurse practitioners said they believed that patients trusted their=20 caregivers to the extent that a positive physician recommendation would = prompt=20 them to start therapy.

Psychological well-being
Though = not=20 cited by patients themselves, physicians, nurse practitioners and case = managers=20 said a patient's psychological well-being often played a role in his or = her=20 willingness to start drug therapy. Nearly half of the physicians and = nurse=20 practitioners and a majority of the case managers interviewed cited the=20 patient's outlook as a factor in the initiation of therapy. Case = managers noted=20 that both extreme positive and negative outlooks could prompt a patient = to opt=20 for therapy. For example, some patients who are very positive and = optimistic may=20 choose to start therapy because they are confident that the drugs will = help=20 them. On the other hand, patients who are depressed or pessimistic about = their=20 health, usually because of disease progression, may start drug therapy = because=20 they believe it offers them a last chance for prolonging their=20 lives.


B. Barriers to Initiation of = Therapy

Patients interviewed who were not on combination = therapy=20 were most likely to cite concern about side-effects as a barrier to = treatment.=20 Patients also frequently mentioned their positive health status, as well = as a=20 concern about the effectiveness of the drugs, as factors that had = deterred them=20 from starting treatment. Other factors that often deterred them from = treatment=20 were concerns about the demands of the treatment regimen, misgivings = about drugs=20 in general or a feeling among patients that they could manage the = disease=20 without the drugs. In addition, some patients said they believed the = drugs were=20 "too experimental" or indicated that they were afraid of developing a = resistance=20 to the current, or future, therapies. Finally, some patients said they = relied on=20 holistic or alternative approaches to treat their HIV or were waiting = for better=20 treatments to come along. In many instances, patients said their doctors = had=20 recommended treatment, though some said their physicians had advised = them not to=20 begin treatment yet. The cost of treatment and concerns about loss of = privacy=20 were only rarely mentioned by patients as barriers to initiation of=20 therapy.

Concern about short- and long-term=20 side-effects
Concern about side-effects was the most frequently = mentioned=20 barrier to initiating combination therapy among HIV-positive patients = who had=20 never taken medications to treat HIV. Eight in 10 of these patients = cited=20 concerns about side-effects as a deterrent to therapy, particularly = given the=20 absence of symptoms and other positive health = indicators.

Frequently,=20 these patients used the word "toxic" in describing drugs for treating = HIV,=20 citing this as a reason for not taking the drugs. As many as one in four = of=20 these patients also said they won't begin combination therapy yet = because they=20 believe the long-term side-effects are unknown and they fear the drugs = will make=20 them feel worse or cause damage to their organs, particularly the = kidneys or=20 liver. While there was a generalized concern about side-effects among = many of=20 these patients, a few said they did not want to experience any = side-effects at=20 all or were uncertain about whether the side-effects might diminish or = disappear=20 over time.

"I don't have a good opinion of the meds because of what they = are doing=20 to those around me," said a gay, African-American man from Los Angeles = who is=20 not on the therapy. "I see my friends getting sick due to the = side-effects and=20 that makes me not want to take them. I have seen my friends die while = taking=20 the drugs. I feel the drugs will kill me before the virus will. They = are all=20 very toxic and worse for the body than the virus."

"The = drugs=20 are `working' in some people because they are very sick and have made=20 compromises with the side-effects. It depends on the individual," said = a gay=20 Hispanic woman from Miami.


Those patients interviewed who are currently taking combination = therapy=20 also reported that the potential side-effects, fear about toxicities, = their=20 inability to tolerate these effects and uncertainty over whether the = medications=20 would work for them were the primary obstacles to initiating = therapy.

The=20 patients' responses were consistent with reports from physicians and = nurse=20 practitioners, case managers and hotline supervisors and operators. = Physicians=20 identified side-effects as one of the chief concerns of patients in = weighing=20 therapy, along with concerns about the long-term effectiveness of the = drugs and=20 the complexity of the regimen. In fact, nine out of 10 physicians said = they=20 describe the negative side-effects of combination therapy to patients,=20 particularly gastrointestinal effects such as diarrhea and nausea. Some = also=20 inform patients that if they start therapy, they may experience = neuropathy, a=20 lack of energy, rashes or kidney problems. Two-thirds of case managers=20 interviewed also said they discussed the possible side-effects with = their=20 clients, with specific references to nausea, diarrhea, rashes, possible = kidney=20 problems, lack of energy or loss of appetite.

Hotline operators = also=20 reported that callers had strong negative perceptions of side-effects. = Callers=20 told them they had heard that certain drugs were intolerable and would = affect=20 their ability to work at their jobs. These callers were afraid = side-effects from=20 the drugs would diminish the quality of their lives and restrict their = mobility.=20 Callers who were already on therapy often inquired about specific = side-effects=20 they were experiencing, such as loss of sensation in the hands or feet, = diarrhea=20 and nausea, weight gain and "crix belly," the hotline workers reported. = As one=20 patient put it, "Introduce a `foreign' medication into the body and it = also=20 kills some good cells."

Health indicators, including T-cell = counts and=20 viral load
Among patients not taking combination therapy, more = than six=20 in 10 of those interviewed said the positive state of their health was a = pivotal=20 factor in not electing therapy. In fact, more than eight in 10 said they = were=20 optimistic about the state of their health. These patients said that = they "feel=20 healthy," "don't feel sick," or "have had not any opportunistic=20 infections."

"I'm keeping my options open for when I really need treatment, = when the=20 physical symptoms would be more real to me," said one heterosexual = white woman=20 from Miami. "If I had my first opportunistic infection, maybe I would = have a=20 different outlook."

"The way I feel at present, I wouldn't take = these=20 drugs, but the door is not closed on the subject," said another = patient, a gay=20 white man from San Francisco. "I hope other options are available in = the=20 future. I would have to be at a point where I must start (drug = therapy)=20 because my health is at a point where no other options are available. = I=20 consider therapies the last option."

Patients indicated = that they=20 rely heavily on their T-cell counts as one measure of their health. = Nearly=20 four in 10 of the HIV-positive individuals interviewed specifically = said they=20 had not started combination therapy because their T-cell counts are = too high=20 or have been relatively stable for a long period of time. = Occasionally, these=20 individuals indicated that their doctors are in agreement that = combination=20 therapy was not necessary yet.

"My viral load is declining and my T-cells are high and have = been for 10=20 years," reported a gay white man from Seattle. "My doctor says there = is no=20 need for the drugs yet. We'll continue to monitor my numbers. I see = that as=20 the best idea, too."

Although patients are more apt to rely on = T-cell counts=20 as an indicator of health, a third of those not on combination therapy = said they=20 also have considered their viral loads, which are low or stable, to be a = factor=20 as well. Still, one in five patients questioned the relevance or = accuracy of=20 viral load numbers. A few individuals noted that their viral loads = fluctuated=20 widely over a short period of time, and in the case of one individual, = over a=20 period of a few hours. In a small number of cases, patients not on = combination=20 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=20 many people become obsessed with numbers. I have had tests done within = hours=20 of each other that don't agree by a lot. Low T-cells don't mean you're = dying,"=20 said a heterosexual white woman from = Miami.

Nearly all physicians and nurse practitioners = and case=20 managers indicated that they do not try to "persuade" clients to start = therapy.=20 The decision to start therapy lies with the patients and is very much = related to=20 disease progression. While most doctors and nurse practitioners = interviewed said=20 patients struggle with the decision to start therapy, they said most of = their=20 patients opt for the treatment when confronted with signs of disease=20 progression, such as changes in T-cell counts or viral loads or the = onset of=20 opportunistic infections. Half of the physicians and nurse practitioners = interviewed said the patients' positive perceptions of their current = health were=20 a barrier to treatment.

"My test results show I'm in relatively good health. I haven't = taken=20 them so far and am doing well, so why start now? I feel that I can = deal with=20 it without the medications. I'm concerned that I will react negatively = to the=20 therapies," said a gay Asian man from = Seattle.


Uncertainty and/or skepticism = about the=20 effectiveness of therapy
Among those HIV-positive patients = interviewed who were not on combination therapy, seven in 10 cited = doubts about=20 the effectiveness of the drugs as a reason for not starting therapy. = About six=20 in 10 of these patients said they believe the drugs work for most people = while=20 three in 10 said that, in their experience, the drugs work for some but = not for=20 others. At the same time, however, nearly three-quarters of these = patients said=20 they are skeptical about the effectiveness of the combination therapy,=20 questioning whether the drugs would work for them or whether they would = continue=20 to work over the long-term. More than one in four in 10 said they expect = the=20 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=20 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=20 side-effects."

"As with any medication, it will work for some = and not=20 for others," said a heterosexual Hispanic woman from New York. "It's = very=20 individual."


Among those patients who were uncertain about how effective = combination=20 therapy would be for them personally, a few said they believe "people = are dying=20 on medications" and indicated that they know of people for whom the = therapy did=20 not work. A few also said that they believed the "first combination = always=20 fails." One individual specifically referred to news reports about an=20 "increasing failure rate." Gay men were somewhat more likely than others = to say=20 they are skeptical about the long-term effectiveness of the = therapy.

"People are still dying from AIDS while they are taking these=20 medications," said a gay, African-American man from Los Angeles. "The = rate of=20 mortality has slowed down, but the drugs are not necessarily saving = lives. It=20 makes me stay where I'm at in not taking meds."

"There is a lot = of fear=20 about the medications because of the uncertainty. For a while people = are doing=20 well, then they start to fail in the long run," said a gay white man = from San=20 Francisco is not on therapy.


Among patients who were taking combination therapy, one in six = said they=20 had doubts about whether the medications would prove to be effective for = them.=20 This concern had been an obstacle to initiating therapy, these patients = said.=20

Patient beliefs about whether the therapy would be effective for = them=20 may reflect in part the reservations of their caregivers. Nine out of 10 = physicians and nurse practitioners who were interviewed said they = personally=20 were concerned about how well combination therapies work, the long-term = efficacy=20 of the drugs and the clinical impact of the drugs on new therapies that = might be=20 developed in the future. More than six in 10 of the case managers = interviewed=20 expressed similar concerns.

Hotline personnel said they receive = calls=20 from a significant number of people who believe protease inhibitors are = a cure=20 for HIV and that the drugs work for everyone. To counter this belief, = both=20 hotline operators and case managers say they emphasize with patients = that=20 individuals respond differently to the drugs. For instance, one hotline = operator=20 said he informs patients that "35 percent of people (with HIV) can't = even take=20 (the drugs), or if they do, they lose efficacy."

The demands = of the=20 treatment regimen
More than half of those patients not taking = combination=20 therapy said they were concerned about the impact of the treatment = regimen on=20 their lives. These patients indicated that they believed the regimen = would force=20 them to alter their schedules or lifestyles. For instance, they noted = that they=20 would have to modify their eating habits and adhere to a schedule of set = times.=20 Patients often made mention of the fact that there were "too many pills" = to=20 take. A few even remarked on the "size of the pills." About one in 10 of = these=20 patients said they had not started combination therapy because they know = they=20 cannot or will not adhere or are not ready to "commit" to the=20 regimen.

"It's the side-effects, the neuropathy," said a gay white man = from=20 Seattle. "And the inconvenience, the pills all at different times of = the day=20 or night, take with food, without food, keep it refrigerated. I could = do it,=20 but I'd rather not until I have to."


Among those patients who were already on therapy, half also = indicated=20 that concern about having to adhere to a treatment regimen had been a = barrier to=20 treatment. Caregivers also give heavy weight to a patient's ability to = adhere to=20 the treatment in deciding whether to recommend the therapy. Eight out of = 10=20 physicians and nurse practitioners said a patient's ability to comply = with the=20 regimen is a significant factor in their decision on whether to = prescribe=20 combination therapy. Some physicians say mental health disorders, = substance=20 abuse problems and addictions are strongly considered when prescribing=20 combination therapy, as these problems could impact a patient's ability = to=20 comply with treatment.

Seven out of 10 physicians said they = describe the=20 regimen to patients as a drawback to combination therapy. Case managers = also=20 were likely to describe the regimen as a negative aspect of combination = therapy,=20 including the many pills that need to be taken and the need to follow a=20 complicated schedule. Three in 10 case managers said they told clients = that a=20 drawback to combination therapy is the need to "commit" to the regimen = or that=20 patients "can't stop taking the drugs" once they begin.

Hotline = personnel=20 also frequently used the word "commitment" to describe the decision to = start=20 therapy. They reported that some HIV-positive patients did not want to = begin a=20 combination therapy drug program because they don't believe they can = maintain=20 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.=20 I see what they do to some people and this scares me. I hope that if I = ever=20 have to take them, they will make me feel better, not worse. I want to = live,=20 so if I have to take them, I will."


General attitudes toward=20 medications
Nearly half of those who = are not=20 on combination therapy are influenced in their decisions by attitudes = they hold=20 about medications in general, according to reports from patients and = case=20 managers. Most frequently, patients said they don't want to take = medications=20 that they will need for the rest of their lives. A few individuals also = believed=20 that drugs are most beneficial to the sickest patients. One former = substance=20 abuser expressed a fear that combination therapy drugs would become = addictive. A=20 few patients are convinced that when drugs work, it is because of a = belief they=20 will work.

"If the drugs are `working' for some people, I think it is = because of=20 their mind, body and soul. People believe it is working and that = positive=20 attitude is part of why the load goes down, T-cells go up and they = feel=20 better. But I wouldn't burst the bubble of people using them. Their = belief is=20 part of why it works," said a heterosexual white woman from=20 Miami.


More than a third of patients already on combination therapy said = their=20 attitudes about medications in general had stood in the way of = treatment.=20 Similarly, roughly a third of physicians and nurse practitioners said = patients'=20 misgivings about drugs in general had been a barrier to initiation of=20 therapy.

A feeling that the drugs are too = "experimental"
Nearly=20 half of those not on combination therapy said they have reservations = about what=20 they perceive to the experimental nature of the drugs used to treat HIV, = most=20 often citing a lack of research data or saying that the drugs are "not=20 well-researched." People also said they believed the drugs "haven't been = around=20 long enough," were approved by the FDA too quickly or have been given to = the HIV=20 community too early. Generally, those who identify themselves as = heterosexual,=20 especially those of Hispanic background, are much more likely than gay = men to=20 view combination therapy as "too experimental." A few people = specifically stated=20 that they "don't want to be guinea pigs" or don't want to take = "experimental=20 drugs."

"There is so little known about the drugs and what the long-term = effects=20 will be regarding one's health, drug resistance, side-effects," said = one=20 heterosexual Hispanic woman from Seattle. "After AZT's fiasco, I won't = be a=20 guinea pig."

"(When drug therapy was recommended), I thought, = `I'm=20 going to be a guinea pig.' There's not enough information and a lot of = bad=20 press on AZT. The drugs are toxic. I don't want to be experimented = on," said=20 one heterosexual African-American woman from Miami.

"So little = is known=20 about the drugs," commented another patient, a gay white man from San=20 Francisco. "It's all experimental, and they are testing on people as = they go=20 along."


Four in 10 physicians said perceptions among patients that the = drugs are=20 still experimental had been an obstacle to treatment. However, less than = one in=20 five of the case managers cited this as a barrier. The "experimental" = nature of=20 the drugs was only mentioned by one in 10 of patients already on = combination=20 therapy.

The ability to manage the disease without medication = and=20 beliefs about HIV
Eight in 10 patients not on combination therapy = said=20 they believed changes in lifestyle or attitude were the most effective = form of=20 treatment for HIV. A good diet was cited by more than half of these = patients as=20 the most effective way to treat the disease. Also named as effective = treatments=20 were good rest, exercise, a "positive lifestyle," spiritual growth, a = positive=20 attitude, reduced stress, vitamins, control over one's life and reduced=20 consumption of alcohol and recreational drugs.

Four in 10 of = those not on=20 combination therapy hold beliefs about HIV and their abilities to manage = the=20 disease that impact their decision to start therapy. Some patients said = they=20 believe drugs may not be necessary to treat HIV, with some patients = believing=20 that drugs are only needed five to 10 years after infection. Fully one = quarter=20 of those interviewed also expressed the view that HIV drugs may cause = more=20 damage to their bodies than the virus itself, and one individual said = she=20 believes HIV may not be the only cause of AIDS. There are also some = patients who=20 express a positive conviction that HIV is "not a death sentence" or = "won't be=20 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=20 themselves, as well as those entities pushing these costly and toxic = drugs on=20 HIV-positive people," said one bisexual, African-American man from = Washington,=20 D.C.

"Being HIV-positive doesn't prey on my mind. If you take = care of=20 yourself, you can live a long life. It's like having diabetes. You = have to=20 change your way of living," said a gay white man from New=20 York.

Fear of resistance and concern about drug=20 failure
About four in 10 of the = individuals=20 not on combination therapy said they feared they would become resistant = to the=20 drugs, which would no longer work for them. One in five expressed a = concern that=20 once they start combination therapy, they would not be able to stop = because they=20 would be subject to resistance. A few patients also said they believe = that=20 resistance always occurs with combination therapy drugs or that they = would be=20 worse off if they stopped taking the drugs because the disease would = progress=20 more rapidly.

Among those not on combination therapy, slightly = more than=20 half said they were concerned the drugs would fail at some point in the = future.=20 A quarter of these patients said they don't know whether the drugs might = fail,=20 often commenting that it "depends on the individual." Notably, gay white = men are=20 far more likely to indicate a concern about future drug failure. The = majority of=20 Hispanic patients interviewed said they don't know whether the drugs = might=20 fail.

About three in 10 patients who were on combination therapy = said=20 they hesitated about starting the drugs because of concerns about = building a=20 resistance to the current therapies, as well as future treatments that = might be=20 developed. While the majority of these patients said they were not = concerned=20 that the drugs might fail, the gay white men among them were concerned, = with=20 more than half expressing this fear.

"I waited three years due to a lack of need, but concern about=20 resistance also came into play," said a gay white man from San = Francisco who=20 is now on therapy. "It's better to take as few drugs as possible for = as long=20 as possible to avoid resistance and leave my options=20 open."


Almost two-thirds of physicians and nurse practitioners also said = they=20 believed fear of resistance played a role in patients' reluctance to = initiate=20 therapy. However, fewer than one in 10 case managers cited fear of = resistance as=20 an obstacle to treatment, although one in four managers said they do = tell=20 clients that taking a combination drug therapy could affect their = ability to=20 take antiretroviral drugs in the future.

Use of alternative or = holistic remedies
Four in ten patients not on therapy said they = believe=20 holistic or alternative approaches are the most effective ways to treat = HIV.=20 Acupuncture and herbal remedies were among the most frequently mentioned = approaches to therapy among those patients not on treatment. Other = alternative=20 or holistic treatments believed to be effective are creative = visualization,=20 meditation, homeopathy, massage, biofeedback, acidophilus, blue-green = algae,=20 flower essences and marijuana. A few of these patients attributed = increases in=20 T-cells or viral load reductions to these alternative = approaches.

"I want to control what happens in my body," said a gay Hispanic = woman=20 from Miami. "Acupuncture, Chinese herbs and biofeedback is working for = me. My=20 viral load is undetectable and my T-cells are = 800."

Most patients not taking combination therapy = said they=20 would not object to the treatment "when it becomes necessary." Still, = only one=20 third said that some form of drug treatment, including combination drug = therapy,=20 is one of the most effective methods of treating HIV. Others said = effective=20 treatment of HIV includes using medications "as needed" or using a mix = of drug=20 therapy and holistic treatments. Only a few said they believed in = exclusive use=20 of holistic or alternative remedies and would reject drug therapies out = of=20 hand.

"It gets to be tricky. If effective is defined as reducing = (viral) load=20 and feeling better, then protease inhibitors are effective," said a = gay,=20 African-American man from Washington, D.C. who is not on combination = therapy.=20 "But drugs are only short-term remedies. A holistic approach, the = mental,=20 physical and spiritual, is the most effective in the long=20 run."

Among those patients currently taking the = drugs, fewer=20 than one in 10 said use of holistic or alternative remedies had been a = factor in=20 their decision to start therapy. About a third of physicians, and = roughly one in=20 five case managers, also said they believed patients' reliance on = alternative or=20 holistic remedies was an obstacle to treatment with combination=20 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=20 hearing from some patients that the AIDS virus doesn't exist or that = the=20 medicines are a hoax. Patients hear that information coming from = certain=20 groups in the San Francisco Bay Area, and it carries a particular air = of=20 credibility because of where it's coming = from."


Recommendation of medical=20 providers
A significant number of = patients not=20 on combination therapy, or about three-quarters, reported that their = doctors had=20 recommended that they begin treatment. On the other hand, one in four = said their=20 doctors had not recommended that they initiate therapy yet. Two out of = 10 of=20 these patients specifically said they have been influenced in their = decisions=20 not to start combination therapy as a result of interactions with their=20 caregivers.

Often these patients say their doctors have withheld = a=20 recommendation to start therapy based on the patients' T-cell counts. = Some=20 patients also said they believe their doctors have not yet recommended = therapy=20 because the physicians had an optimistic view of the patients'=20 health.

More than four in 10 of these patients said that when = therapy was=20 recommended, their initial reaction was that it would not be a good = move; one in=20 four said they had questions and reservations about the therapy. One in = five=20 patients said when they first heard about combination therapy, they = thought it=20 would be a "good thing," but half of them added, "not yet."

A = desire=20 to wait for better treatments
About one in five of those not on=20 combination therapy indicated that they are "waiting for the future" in = the hope=20 that better treatments will be developed. Some said they believe that = the next=20 generation of drugs will be more effective and easier to take, and = others said=20 they are "leaving their options open" for the future. About one in 10 = patients=20 not on therapy also said they are trying to remain free of drugs for the = time=20 when they will really need them.

"I want to do what it takes to stay healthy," said a gay white = man from=20 San Diego. "The advances have been great, and I feel that they will = develop=20 better drugs in the future. I've heard there are other drugs that are = better,=20 and I want those. I'll wait until better drugs come on the=20 market."


About a third of physicians and nurse practitioners said they = believe=20 that patients have not opted for combination drug therapy because they = are=20 waiting for improved treatments that might become available. Hotline = personnel=20 also said they believe there is a group of people who are waiting for = drugs that=20 are more easily tolerated, have fewer long-term side-effects and are = cheaper or=20 less complicated to take. These patients tend to view themselves as = healthy=20 enough to wait for better options.

Cost issues
Patients = not on=20 combination therapy rarely cited cost as a barrier to treatment. In = fact, only=20 one patient from a state where ADAP has reportedly been closed to = patients=20 indicated that she wanted to start combination therapy but was unable to = find a=20 program that would pay for it.

"I've found the combination I want, but ADAP won't pay," said = one=20 heterosexual African-American woman from Miami. "I just heard about = the=20 pharmaceutical companies' compassionate use program, so I'll ask my = doctor to=20 write to them when he gets back from = vacation."


Two others who were interviewed said that if they decided to = start, they=20 did not know who would pay or were concerned that they earned too much = to=20 qualify for assistance but not enough to afford the drugs. Nine out of = ten=20 patients not on therapy said they knew where to obtain the drugs if, and = when,=20 they made the decision to start therapy.

"Medicaid and Medicare are for the poor, but not for the = "average Joe"=20 like myself," said one patient, a bisexual African-American man from=20 Washington, D.C. "I don't make enough to pay for them, but I make too = much to=20 quality for government assistance."


While two in 10 patients on therapy said coverage for cost of the = drugs=20 was a factor in deciding to start therapy, they were expressing concern = that=20 they might get cut off from programs once they had begun = therapy.

While=20 patients reported relatively little concern about issues of cost, their=20 caregivers frequently perceived the cost of treatment to be an obstacle. = Nearly=20 half of the case managers and more than two-thirds of physicians and = nurse=20 practitioners cited cost as a barrier to initiation of = therapy.

Hotline=20 operators and supervisors also reported frequently receiving questions = about=20 cost of treatment and payment mechanisms. They reported that callers = were=20 unaware of programs for which they might qualify and said some patients = believed=20 they did not qualify for a drug assistance program because they earned = too much,=20 were too poor or were undocumented. Hotline operators also said they = spoke to=20 people who had drug prescriptions in hand but had not had them filled = because=20 they had changed jobs and were waiting for their insurance plans to=20 activate.

Privacy considerations
Concerns about privacy = were=20 mentioned by one in 10 patients who were not on combination therapy as a = factor=20 influencing their decisions not to initiate therapy. These patients = worried that=20 their HIV status would be revealed or that they would have to answer = questions=20 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=20 isn't easy to do publicly. People look at you if you take pills in = public,"=20 said a heterosexual African-American man from Miami.

"My = 9-year-old son=20 would see me taking all these medications, and I'm not ready yet to = tell him=20 I'm sick," said a heterosexual Hispanic woman from New=20 York.


Privacy issues were rarely mentioned as a barrier to therapy by=20 physicians and nurse practitioners or case managers. However, hotline = personnel=20 reported that callers were often reluctant to initiate drug therapy = because they=20 were afraid to file a claim with a private insurance company. These = callers were=20 concerned that employers would learn of their condition once they = started=20 ordering drugs. They feared discrimination, loss of their jobs, loss of = benefits=20 or inability to receive new benefits. The hotline personnel also = reported=20 concern among some heterosexual and bisexual men that their families = would learn=20 their HIV status and reject them based on the assumption that "only gay = men get=20 HIV."


C. Other Factors That Influence=20 Decision-making

It is clear from the study that = patients are=20 hungry for information about new drugs and must make decisions about = treatment=20 in the face of sometimes conflicting reports about drug effectiveness,=20 side-effects and other aspects of treatment. Some rely on their = caregivers for=20 guidance, while others are distrustful of the medical profession and = look for=20 direction from other sources, such as members of a support group or = publications=20 geared to HIV-positive individuals. Ultimately, however, it is the = patient who=20 decides whether, and when, to start treatment.

"It's hard to know what is reliable and unreliable," said one = bisexual=20 African-American man from New York. "We (HIV-positive people) share=20 information because the doctors don't tell us the same things. You use = your=20 own judgment."

"My doctor and I have looked at a few options, = but=20 since I don't have an interest (in drug therapy), we don't spend a lot = of time=20 on it. He sees it as being my decision," said another patient, a gay = white man=20 from Seattle.


The role of caregivers, case = managers and=20 others
Most of the patients who are on combination therapy = said it=20 was their physicians who first suggested this form of treatment. In one = of the=20 strongest differences noted between men and women, men were twice as = likely as=20 women to be influenced by information received from their physicians in = deciding=20 on treatment. Overall, the men interviewed said the most reliable = information=20 about treatment came from their doctors, followed by peers who are = HIV-positive.=20 The study also found that men were more likely than women to rely on an = extended=20 HIV information and resource network, including pharmacists, Internet = sites and=20 publications from groups such as Project Inform, Positively Aware, Poz, = Beta=20 News and the federal Centers for Disease Control and = Prevention.

Most of=20 the men and women on therapy said their doctors usually spend enough = time during=20 office visits in discussing their condition. Yet several patients noted = that=20 they were not satisfied with the time they spent with their physicians = and=20 actively sought out other physicians who were more attentive. In the = case of one=20 woman, an African-American patient who is on public assistance, the = decision to=20 initiate therapy was directly related to finding a physician at a public = health=20 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=20 questions as the last doctor and two minutes about me."

Among = those=20 patients not on combination therapy, eight in 10 said their health care=20 providers spent enough time with them and answered their questions. = Those men=20 and women who said they believed their doctors were "too busy" or = "didn't spend=20 enough time with them" were frequently patients at public health = clinics. A few=20 patients also said they actively sought out doctors who they felt met = their=20 needs, most often looking for those physicians who were specialists in = HIV=20 treatment.

"At the clinic in the hospital, there was always a different = (doctor),"=20 said one heterosexual African-American man from Washington, D.C. "They = never=20 asked about my HIV and it was on my records. They only treated me for = what I=20 was there for. I asked to be referred to a specialist because I wanted = to know=20 more."

"I'm not unhappy with the doctor but with the rushed=20 environment," said a heterosexual, African-American woman from Miami. = "But I'm=20 pretty dogmatic. I insist on answers, and I write down my=20 questions."


About four in 10 of those not currently on therapy said their = doctors=20 described the benefits of treatment as decreased viral load and = increased T-cell=20 counts. Less frequently, patients said they had been told by their = doctors that=20 combination drug therapy would make them "feel better," help them live = longer,=20 have a positive effect on their emotional well-being, combat the virus, = rebuild=20 their immune systems or result in fewer opportunistic = infections.

Nearly=20 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=20 patients, however, a majority indicated that they and their doctors had = agreed=20 that combination drug therapy was not yet necessary. A few said they had = told=20 their physicians they were opposed to drug therapy and would not discuss = it with=20 them.

While half of those on therapy said they had no trouble=20 understanding the "jargon" or information they received about HIV and = drug=20 treatments, four in 10 indicated that they don't always understand what = the=20 doctors are saying to them or what they are reading. Often, however, = patients=20 said they ask for clarification in "laymen's language" when they don't=20 understand what physicians tell them. A number of patients commented = that they=20 had become confused with the variety of acronyms and different names for = drugs.

Among those patients who are taking combination therapy, = six in 10=20 said their doctors described the benefits as decreased viral load and = increased=20 T-cell counts. About a third said their doctors told them that = combination=20 therapy would help them live longer or make them "feel better." The = majority of=20 patients on therapy, or six in 10, said they had no trouble = understanding the=20 "jargon" they encounter in visits with their doctors or in information = received=20 from other sources. Those patients on therapy are somewhat less likely = than=20 those not on therapy to indicate that they don't always understand the=20 information they are being given. Nevertheless, three in 10 said they = don't=20 always understand the information and while many ask for clarification, = a few=20 said they simply "trust their doctors."

Physicians said they = believed=20 they played the most influential role in patients' decisions to initiate = combination drug therapies. Only one physician interviewed said that = case=20 managers had an influence on patients' decisions, whereas case managers = were far=20 more likely to view themselves as being involved in patient = decision-making.=20 Physicians also indicated that nurse practitioners, patients' partners = and=20 spouses, as well as friends and HIV-positive peers, had a strong = influence in=20 patients' decisions to start therapy. Physicians indicated that while = they might=20 recommend treatment, they did not pressure patients and ultimately left = the=20 decision to them.

"I don't believe in persuading patients (to go on combination = therapy),"=20 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=20 them to decide and usually they will come around."

"The = decision (to=20 begin combination therapy) lies primarily with the patient," said = another=20 physician from Seattle. "But I have dissuaded some patients from = starting if=20 it isn't their decision, but that of some other=20 influence."


When discussing the benefits of combination therapy with their = patients,=20 physicians most frequently said they emphasize the treatment will:

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

Physicians were apt to believe that their = HIV-positive=20 patients had a relatively good understanding of the meaning of their = T-cell=20 counts and viral loads; the differences between monotherapy and = combination=20 therapies; the general purposes and effects of protease inhibitors; and = the=20 importance of strict compliance with drug regimens. On the other hand,=20 physicians said they believed patients had a relatively poor = understanding of=20 the general purpose of nucleoside analogs; their personal level of = tolerance for=20 various antiretroviral drugs; and the relevance of p24 = antigens.

Case=20 managers generally agreed with physicians on those areas in which = patients had a=20 good or poor understanding. The one difference was that case managers = were more=20 apt to believe that patients had a poor understanding of the general = purpose and=20 effects of protease inhibitors.

Case managers indicated that = doctors, in=20 addition to the patients themselves, play the most important role in the = decision to initiate drug therapy. Case managers also believe they have = some=20 influence on the decision and that clients' friends who are HIV-positive = have a=20 role in decision-making. Only one of the case managers interviewed said = that he=20 did not discuss the benefits or drawbacks of combination therapy with = his=20 clients, deferring instead to their physicians. Virtually all case = managers said=20 they provide their clients with printed information about combination = therapy=20 that is prepared by pharmaceutical companies and AIDS service=20 organizations.

"Clients are looking for accurate, updated, = consistent,=20 statistical information on new and improved drugs. It gives them more to = grasp=20 onto, a more positive outlook. It encourages them because it means they=20 understand what the positive effects will be and the proper time to go = on the=20 drugs," said one case manager from New York.

When discussing HIV=20 treatments with clients who have not started drug therapy, case managers = said=20 they describe a variety of benefits but most frequently report telling = clients=20 that combination therapy may:

When discussing drawbacks of combination = therapy with=20 patients, case managers are most likely to emphasize:

One case manager in Miami said that the "the = more=20 educated (clients are) about combination drug therapies, the more power = they=20 have to choose what is best for them."

"I give both sides of the coin (about combination therapy), and = it's the=20 client's choice," said another case manager from New York. "They take = a little=20 bit from everybody and then make up their own minds. I don't know what = will=20 happen in the future, and I couldn't live with myself if there were = bad=20 effects (from the drugs)."


Another case manager expressed similar misgivings about offering = a=20 recommendation to clients to initiate therapy.

"I tend to direct my clients to their doctors for their medical=20 questions," said the case manager from San Francisco. "I feel that I = should=20 play as neutral a role as possible. If we had more effective = treatments, I=20 would feel more comfortable encouraging them to = start."


Hotline personnel were sharply critical of the care being = provided to=20 HIV-positive individuals by physicians and other caregivers. Often, they = say, it=20 becomes their job to "debrief" patients after a visit with physicians = because=20 physicians fail to give patients the information they need. The hotline=20 personnel said they believed patients were not given adequate = explanations of=20 the meaning of laboratory tests and that few doctors spent enough time = telling=20 patients what to anticipate with combination therapy, including possible = side-effects. Many times they reported receiving calls from patients = seeking to=20 confirm a doctor's recommendation to start therapy. In fact, hotline = supervisors=20 said that some doctors give out hotline numbers to patients to get = explanations=20 about drug therapies or answer patient questions.

According to=20 supervisors, patients are "nervous and feel pressured to get on the = treatments."=20 Hotline supervisors generally agreed that doctors do not appreciate the = enormity=20 of the decision for patients in initiating therapy. They said some = doctors=20 discouraged patients from starting the treatment by failing to explain = how a=20 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=20 the regimen will work for them and neglect to fill their=20 prescriptions.

Overall, there are strong perceptions among = hotline=20 personnel that some HIV-positive people are not receiving adequate = medical care=20 because:

Hotline staff said they emphasize to callers = the need for=20 the patient and the doctor "to have open lines of communication," "to = understand=20 each other" and for patients to feel secure enough to talk about = everything.=20 Operators and supervisors said they frequently counseled callers to find = a new=20 doctor to treat their HIV if this atmosphere of positive communication = did not=20 exist or if they felt other important health issues were at=20 stake.

Information sources
Although doctors are most = often=20 cited as reliable sources of information about HIV therapy by those = patients who=20 are not on treatment, they are named as reliable sources by less than = half of=20 these patients. Those not on combination therapy cited other = HIV-positive=20 individuals as reliable sources of information nearly as often as they = mention=20 doctors. While a substantial majority of African-Americans do view = doctors as=20 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=20 don't feel a need to talk with them," said a bisexual Hispanic woman = from Los=20 Angeles.


One in five patients not on therapy said they consider support = groups as=20 a credible source of information about HIV and treatments. Other = frequently=20 mentioned sources of reliable information on HIV therapy include = publications=20 such as Beta, Poz and Positively Aware; HIV seminars, fairs and = workshops; and=20 medical journals and reports on treatment studies.

Among those = patients=20 not on combination therapy, most notably among the gay men interviewed, = the=20 mainstream media is most often cited as an unreliable source of = information=20 about HIV therapies.

"There is hype in the media (about the benefits of combination = therapy),=20 which only explains one side to the issue. They are giving a skewed = side to=20 the drug issue," said one heterosexual African-American female patient = from=20 Seattle.


Although drug companies are named as unreliable sources of = information as=20 frequently as the mainstream media, both are mentioned by fewer than one = in five=20 of those patients interviewed. Other sources considered unreliable by = patients=20 not on therapy include other HIV-positive people, doctors, the general = public,=20 herbal remedy companies, Project Inform, nurse practitioners and the = FDA. One in=20 ten patients not on therapy said they could not think of any unreliable = sources,=20 perceiving all information as useful, and one in ten said they did not = know who=20 to trust.

In general, hotline personnel said patients appear to = rely on a=20 variety of different sources for information and referral. Those = organizations=20 repeatedly cited as credible sources were Project Inform, Beta News, Poz = and Bay=20 Windows.

As for information provided by pharmaceutical companies, = hotline=20 staff said they believe it needs to be considered with "caution." Yet = hotline=20 staff said pharmaceutical ads, particularly those appearing at bus = stops,=20 shelters, on radio and TV and in magazines are a credible information = source on=20 drug therapies. One operator also noted that a company-sponsored "food = fair" in=20 South Florida had been an effective way to bring people together to = learn about=20 protease inhibitors.

Most hotline supervisors said their = organizations=20 develop their own materials for in-house use and to send to callers. = Some=20 operators and supervisors said patients remained confused by the = multiple=20 general and brand drug names and had a hard time remembering which drugs = they=20 were taking or which drugs had been recommended to them. The hotline = personnel=20 said those materials that worked best were simple fact sheets on viral = loads and=20 protease inhibitors in general.


D. Issues and Concerns of = Women

HIV-positive women generally express concern = about the=20 lack of information on the effects of combination therapy in women. More = than=20 one-third of women interviewed said they believe there is a lack of = research=20 about HIV drug therapies involving women and indicated that this = research gap=20 had contributed to their decision not to initiate treatment. Women are = also=20 somewhat more apt than men to express concern about long-term = side-effects of=20 the medications, particularly citing apprehension, or the lack of = research,=20 about the drugs and child-bearing.

"I heard about protease inhibitors very early, but there's no = research=20 on women's issues," said a gay Hispanic woman from = Miami.

"There is=20 confusion about my viral load. It's been fluctuating. The question is, = should=20 I go on therapy or not? I chose not to due to the lack of information = on how=20 women react to the medications. I would rather take alternative, = natural=20 methods," said a heterosexual white woman from Vancouver,=20 Washington.


While men tend to rely on specialized print publications for = information=20 about HIV treatment, women were less likely to look to the print media = for=20 information. Rather, women said face-to-face communications with = doctors,=20 support group members and other HIV-positive individuals, were their = most=20 reliable sources of information. Importantly, women identify support = groups as=20 reliable sources of information as often as they mentioned their doctors = but=20 note that finding support groups for women is difficult. Women also were = twice=20 as likely as men to say they began combination therapy because they = trusted the=20 information provided by their physicians.

Women also reported = getting=20 different information from physicians than men. Fewer than two in 10 of = those=20 women not on therapy said their doctors described a decrease a viral = load as one=20 of the benefits of combination therapy. By contrast, two-thirds of gay = men not=20 on therapy said their doctors described this as a benefit of treatment. = Women=20 not on therapy most often said their doctors told them the benefits of = therapy=20 would be an increase in T cells and a sense of "feeling = better."

Some=20 hotline operators reported receiving more calls from women than from = men,=20 sometimes from partners or spouses of HIV-positive men. These operators = agreed=20 that while there was a lot of material generally available on the pros = and cons=20 of protease inhibitors, there was little research information available = on=20 combination therapies as they relate to women. Hotline personnel did say = that=20 they believed women were better at researching and getting answers about = HIV=20 treatment, often sought emotional support "more honestly" and sooner = than men=20 did, but had fewer support groups to rely upon than men.


IV. Study = Implications

HIV-positive=20 individuals face an enormously complex set of issues in deciding whether = to=20 elect, or reject, combination therapy. The study suggests that patients = are=20 taking a thoughtful approach to the issue, relying on advice from their=20 physicians, the experience of other HIV-positive individuals and a = variety of=20 other information sources in making what is an important personal = choice.=20 Because of the nature of HIV disease, which may progress over a period = of many=20 years, patients have the benefit of time in making this choice. In the = process,=20 it is critical that they have access to expert clinicians and other = reliable=20 resources in the HIV community to help them make an informed=20 decision.

Clinicians need a forum in which they can share = information=20 with other clinicians and discuss possible approaches to treatment. Many = of the=20 physicians and patients interviewed are approaching antiretroviral = therapy with=20 caution. Some clinicians and patients are concerned that the experience = with new=20 drugs is so limited that their effects are not known. All HIV clinicians = and=20 patients need access to expert clinicians so that they can make = maximally=20 informed decisions. Increasing the ways that clinicians can share their=20 experiences in using antiretroviral medications can only help them and = others=20 use them in a more informed way. Telephone hot- and warm-lines, = telephone=20 conference calls, and conferences are needed to insure that clinicians = have=20 access to and are giving the best advice to their = patients.

Clinicians=20 and patients need time to discuss whether or not to start = antiretrovirals. Many=20 clinicians and patients reported that they did not have time to engage = in=20 complete discussions about the medications and how to use them. Given = the=20 importance of their use, strategies need to be devised to insure that = patients=20 with HIV have sufficient access to information to get their questions = answered=20 and concerns addressed.

The information needs of people extend = beyond how=20 the drugs work to how to cope with the drug regimens and their side = effects.=20 Individuals have a lot of information on how the drugs work to reduce = the impact=20 of HIV infection. Individuals have many concerns about the regimens and = side=20 effects and whether or not they will be able to manage taking the drugs = and=20 dealing with those side effects. Clinicians and hotline operators need = to share=20 clinical experiences in this arena, and patients need good information = about how=20 others have coped with these demanding regimens.

Other resources = used by=20 patients to gain information must be as accurate, comprehensive, and = current as=20 possible. Hotline operators need to have access to continuing education = so that=20 they can provide callers with the best information available on the = drugs.=20 Regional hotlines, which are now operated independently, also should = develop=20 outlets for sharing information and consider developing cooperative = working=20 relationships. In addition, groups that maintain HIV web sites also have = a=20 responsibility to keep their sites well-maintained and current, = indicating when=20 an entry was most recently updated.

Women need special services = to assist=20 them in deciding about antiretroviral therapy. Women were often = reluctant to=20 initiate combination therapy because they believed there was too little = research=20 on the impact of the drugs on women and childbearing. Clearly, there is = a need=20 for more scientific research in this arena. The study also suggests that = women=20 rely heavily on face-to-face communications to obtain information about=20 combination therapy, yet they found it difficult to locate support = groups. This=20 is a gap that needs to be addressed in the HIV community. In addition, = women are=20 not finding a voice in existing publications about HIV and could benefit = from a=20 newsletter devoted strictly to women's issues and the impact of = antiretroviral=20 therapy on women. The study also suggests that Spanish-speaking patients = are not=20 being well-served, particularly by the public health system. These = patients=20 could benefit from policies aimed at increasing the availability of=20 Spanish-speaking clinicians and interpreters in the HIV=20 community.

Patients and clinicians need access to the best = information=20 possible on alternative and holistic remedies to treat HIV. The medical=20 community could benefit from more scientific research on the impact of = these=20 remedies on HIV-positive patients. Clinicians also should be aware of = these=20 approaches and the existing medical literature on them and be respectful = of=20 these alternatives.

Pharmaceuticals need to be encouraged to = continue=20 drug development so that antiretrovirals can become even more effective = and=20 easier to take with fewer side = effects.



Notes

1. Cameron B, Heath-Chiozzi M, Kravcik S, et al. = Prolongation of=20 life and prevention of AIDS in advanced HIV immunodeficiency with = ritonavir. In:=20 Program and abstracts of the Third Conference on Retroviruses and = Opportunistic=20 Infections; January 28 February 1, 1996; Washington, DC. Abstract = LB6a

2.=20 Lalezari J, Haubrich R, Burger HU, et al. Improved survival and = decreased=20 progression of HIV in patients treated with saquinavir (Invirase, SQV) = plus=20 HIVID (zalcitabine, ddC). In: Program and abstracts of the XI = International=20 Conference on AIDS; July 7-12, 1996; Vancouver, British Columbia. = Abstract=20 LB.B.6033.

3.=20 Deeks, S. et al. Incidence and Predictors of Virologic Failure of = Indinavir=20 (IDV) and/or Ritonavir (RTV) in an Urban Health Clinic. Presented at the = 37th=20 meeting of the Interscience Conference on Antimicrobial Agents and = Chemotherapy,=20 September 29, 1997.

4. Carpenter, Charles C.J., et al. = Antiretroviral=20 therapy for HIV Infection in 1997, Updated Recommendations of the = International=20 AIDS Society-USA Panel, Consensus Statement, Journal of the American = Medical=20 Association, June 25, 1997, Vol. 277, No. 24.=20

This research monograph was funded by a grant from=20 Glaxo-Wellcome.

Ordering Information:

To request a free, single copy of a CAPS Monograph,
please call=20 415/597-4662 or write to=20

CAPS Monograph, Center for AIDS Prevention Studies,
74 New = Montgomery=20 Street, Suite 600
San Francisco, CA 94105

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