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[hnn-ch] HealthNet News Community Health #33, 8/Nov/04

==============================================================
No. 33 HEALTHNET NEWS COMMUNITY HEALTH 8/Nov/04
Antiretroviral Drugs: Barriers to Use
==============================================================
COMMENTARY, Managing Editor

WHY DO AIDS PATIENTS DECLINE TREATMENT?
1. Safe and effective introduction of antiretroviral (ARV)
drugs for HIV/AIDS
2. South Africans shun a remedy for AIDS
3. An investigation of why eligible patients do not receive HAART
4. Effects of depressive symptoms and mental health quality of
life on use of highly active antiretroviral therapy among
HIV-seropositive women

IS ‘PERFECT’ ADHERENCE TO ARV TREATMENT POSSIBLE?
5. Barriers to antiretroviral adherence for patients living with
HIV infection and AIDS in Botswana
6. Highly active antiretroviral therapy adherence: The patient's
point of view

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
EDITORS: Jill Durocher Leela McCullough, Ed.D
Managing Editor SATELLIFE
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
HNN-CHAT: A discussion forum for the HealthNet News Community
Talk to 1,600 of your colleagues in resource poor settings
Discuss this issue of HealthNet News by sending a message
to your colleagues at hnn-chat@healthnet.org.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Dear HealthNet News Community,

Until recently, social and cultural barriers to utilizing AIDS
treatment have been overshadowed by economic and political
deterrents, related to cost and availability of antiretroviral
(ARV) drugs. Now that these drugs are more widely available,
healthcare providers and community workers are faced with the
challenge of understanding how AIDS patients’ knowledge, attitudes
and beliefs affect their decision to take ARV drugs and adhere to
complex treatment regimens. A deeper understanding of the stigma,
fear, and uncertainty experienced by AIDS patients is fundamental.

This issue of Community Health highlights the various barriers to
the successful introduction of ARV treatment into a community.
Whether one cites lack of trust in his/her healthcare provider or
fear of side effects, the common solution to overcoming these
impediments is increased public awareness and support of ARV
treatment. A supportive environment can help to ‘dispel
misconceptions about AIDS treatment’ and to provide comprehensive
care to those persons following a strict treatment regimen. The
uncertainty and fear associated with AIDS treatment can only begin
to be alleviated through the active participation of all
stakeholders--healthcare providers, community workers, family
members, and people living with HIV—-in the care and treatment
of AIDS patients.

Jill Durocher
SATELLIFE
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

1. Safe and effective introduction of antiretroviral (ARV) drugs
for HIV/AIDS

CO: © Family Health International
SO: http://www.FHI.org/en/HIVAIDS/pub/fact/introarv.htm

The introduction of antiretroviral drugs as part of HIV clinical
care has made AIDS more of a manageable chronic illness with
restored economic productivity and social functioning. But these
effects have been seen only in settings where resources were
available to make the drugs affordable and there are health
service capacities to optimize their sustained, safe and effective
use. There are multiple requirements for such an effect that can
be grouped into three areas: (1)the drugs, (2)the client, and (3)
the health system. Persons living with HIV/AIDS (PLHA) play a
crucial role in the design and implementation of antiretroviral
(ARV) drug introduction into HIV/AIDS prevention and care
programs.

ANTIRETROVIRAL DRUGS
A dramatic reduction in viral load (the level of virus in the
blood) with resulting arrest in immune damage is achieved by
combining at least three drugs from the various classes of
antiretroviral drugs into a "cocktail." This three-drug cocktail
is called "Highly Active Antiretroviral Therapy" (HAART). Each
class of anti-HIV drugs attacks the virus at a different stage of
replication while is it growing in the human host lymphocyte
cell. The common classes of drugs currently on the market are the
nucleoside reverse transcriptase inhibiters such as zidovudine
(AZT), lamivudine (3TC), abacavir; the non-nucleoside reverse
transcriptase inhibitors such as nevirapine and efavirenz; and
the protease inhibitors such as indinavir, ritonavir and
lopinavir. Drug-related issues that influence their use include
the following,

* All ARVs are still costly, even with recent dramatic price
reductions, when compared to STD or TB drugs, for example.
* Side effects of the drugs are common and need to be clinically
monitored. Side effects may lead to stopping or changing the
drug, or changing life style to reduce alcohol intake in case of
liver toxicity.
* HIV can easily become resistant to ARVs, hence the need to
combine different classes of ARVs to treat patients.
* Most of the ARVs interact with other drugs commonly used in the
treatment of opportunistic diseases such as tuberculosis and
fungal infections. This requires adjusting the dosage of the
drugs or the discontinuing ARVs while taking other medication.
* Most of the ARVs currently available have strict medication
schedules or storage requirements although medical advances are
developing new drugs and drug combinations to make them easier
to take with fewer side effects. The protease inhibitors, for
example, require a very strict time regimen to be effective
(e.g., indinavir every eight hours on an empty stomach). Some
require refrigeration (e.g., ritonavir, lopinavir). Others need
precautions to avoid severe side effects (indinavir, for
example, requires at least 1 liters of water a day to avoid
kidney stones; efavirenz can cause insomnia with chaotic dreams,
requiring it to be taken only at night). Pregnant women should
not use efavirenz.
* ARV must be taken lifelong if AIDS is to be a manageable chronic
illness. It requires a lifelong relationship between client and
the health team.

THE CLIENT ON ARV
Adherence (also called compliance or concurrence) to the complex
and lifelong ARV medication is the key to sustained effectiveness
and less of a chance that HIV will become resistant to ARVs. In
general, regimens without protease inhibitors are easier to take.
Other regimens require taking medication once or twice a day, and
do not require strict timing, an empty stomach or large fluid
intake. The following are issues from the client's perspective
that should be considered and incorporated in planning,

* Starting ARVs is committing to lifelong medication and entails
enduring the almost universal initial period of unpleasant side
effects. It also requires identifying financial resources
necessary for regular medical visits, costs of laboratory tests
and treatment costs. The self-discipline and financial burden
associated with ARV should be discussed at the start of
treatment.
* Continuous drug information or even drug counseling by the care
provider and pharmacist is essential to improved adherence.
* Emotional support for clients on ARV remains a cornerstone of
care.
* Issues of when, how and to whom to disclose need to be carefully
planned.
* Treatment failure is common and when there are no alternatives to
the initial ARV regimen, there must be support to ensure
continuation of care and referral to palliation and home care.
* ARV may create false hope of safety among users and result in
increased high risk behavior. Although it is biologically
plausible that effective use of ARV would reduce viral loads in
vaginal fluids and semen–and as a result reduce sexual
transmission–no studies have demonstrated this at the
population level. Services have to ensure ongoing counseling
about the need to continue protective action and information on
the effects of ARV for clients and their sexual partners.
* Information and education for communities and society on the
realities of ARV use should also be in place. ARVs are neither a
cure nor a preventive tool per se. The media will have a key role
to play in educating the public. PLHA play an effective role in
community education.

THE HEALTH SYSTEMS
To optimize the benefits of ARV for greatly reduced morbidity,
mortality and improved quality of life, the following need to be
addressed simultaneously,

* Training health teams (doctor, nurse, counselor, pharmacist,
laboratory staff) in both the public and private sectors, with
regular updates on treatment and care options.
* Reorganizing services to integrate HIV care in outpatient
departments and at health centers to allow for space, privacy
and time and linkages with TB-DOTS and STI programs.
* Strengthening rapid registration of new drugs and drug
procurement and management systems to ensure continuous
availability of the drugs and avoidance of pilferage and
misuse.
* Expanding and integrating quality VCT into health systems as
an entry point to prevention and care.
* Strengthening and upgrading laboratory facilities. Although
viral load measurements may not be essential for safe and
effective use, CD4 counts or cheaper alternatives are needed to
help providers and clients decide together when to start and
when to switch or stop treatment.
* There needs to be laboratory monitoring for potential side
effects.
* Communicating to the public at large on the benefits and risks
of ARV treatment.
* Strengthening and scaling up comprehensive care programs
(management of opportunisitic infections, preventive therapies,
TB-DOTS, home care, palliative care, social support) to
accommodate ARV use and continue to care for a majority of
patients not on ARV.
* Strengthening prevention programs to link closely with care and
ARV treatment programs and reinforce the need for prevention as
a primary goal within and beyond the health sector.

In summary, the good news is that ARVs are becoming a welcome
addition to greatly improve the quality of life of many more
PLHAs. All efforts need to be made to ensure that patients can
adhere and health systems can accommodate these new interventions.

+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

2. South Africans shun a remedy for AIDS

SO: CDC HIV/STD/TB Prevention News Update 10/22/04
http://www.cdcnpin.org/scripts/News/

(Washington Post 10.21.04, Craig Timberg)
After struggling to make antiretroviral drugs (ARVs) available in
the developing world, medical authorities have discovered many
people in the advanced stages of AIDS are reluctant to take them.
Such reluctance constitutes an unexpected barrier in countries
like South Africa, where 600 people die of AIDS each day,
according to analysts, and about 5 million have HIV.

Fear of the drugs’ side effects, widespread skepticism of Western
medicine, the reluctance of public figures to say positive things
about ARVs, and reverence for traditional healers lead many
patients to shun the drugs. Many activists blame the situation on
President Thabo Mbeki and his health minister, Manto Tshabalala
Msimang, who, instead of pushing ARVs, have repeatedly emphasized
good nutrition and clean water as keys to treating HIV/AIDS.

“A very big part of the problem is the government is still in
denial,” said Zachie Achmat, head of South Africa’s Treatment
Action Campaign.

“Mbeki scared a lot of patients,” said Francois Venter, a doctor
who treats people with AIDS with free ARVs at Johannesburg
General Hospital. He estimated that one of three patients who
need ARVs refuse them. “They are just terrified of the side
effects,” he explained.

Anglo American, a mining conglomerate, offers free ARVs to all
140,000 of it is employees. Brian A. Brink, a physician
overseeing the program, said 34,000 employees have HIV and at
least 8,500 are at a point in their illness when they should be
taking ARVs. But only about 2,050 have taken advantage of the
program, leaving 75 percent not having sought out the easily
accessible ARVs. Brink attributes the gap to a combination of the
stigma of HIV/AIDS, uncertainty about the ARVs’ effectiveness,
and fear of side effects.

--------------------------------------------------------------

3. An investigation of why eligible patients do not receive HAART

AU: Maisels L, Steinberg J, Tobias C.
SO: AIDS Patient Care and STDS 2001 Apr; 15(4): 185-91.
http://www.liebertpub.com/

ABSTRACT
Treatment with highly active antiretroviral therapy (HAART)
decreases morbidity and mortality for persons with human
immunodeficiency virus/acquired immunodeficiency syndrome
(HIV/AIDS) and reduces costs of care. Yet many patients for whom
HAART is indicated do not receive it. This study investigated the
reasons why certain patients of a community health center with
HIV/AIDS did not receive HAART between 1997 and 1998. Medical
record reviews were performed to determine which patients for whom
HAART was indicated (according to United States Public Health
Service guidelines) were not prescribed HAART. Chart reviews and
patient interviews were conducted to determine why they did not
receive HAART. Of the 88 patients eligible for HAART, 60 (69%)
had it prescribed in 1997-1998. Of the remaining 28 patients, 3
did not receive HAART because their provider never discussed it
with them. For 6 patients (21%), the provider discussed HAART but
did not recommend it; 16 patients (57%) declined HAART although
their provider recommended it, and 3 (11%) accepted their
provider's recommendation but never started HAART. Patients' most
common reasons for refusing HAART were not being ready for strict
adherence to a complex regimen (7/16) and fear of side effects
(6/16). Other reasons included active drug use, religious
beliefs, homelessness, confidentiality concerns, depression, and
feeling well without HAART. Providers did not recommend HAART
because of active drug use (4/6), lack of engagement with care
(2/6) as well as homelessness, depression, and the perception that
the patient was doing well without HAART. Providers should be
trained to offer all patients the opportunity to develop a plan to
address barriers to adherence and the support needed to implement
it. Resources should also target the treatment of substance abuse
and mental illness to improve the usage of HAART.

--------------------------------------------------------------

4. Effects of depressive symptoms and mental health quality of
life on use of highly active antiretroviral therapy among
HIV-seropositive women

AU: Cook JA, Cohen MH, Burke J, Grey D, Anastos K, Kirstein L,
et al.
SO: J Acquir Immune Defic Syndr. 2002 Aug 1;30(4):401-9.
http://www.jaids.org/

ABSTRACT
This study examines the effects of depressive symptoms and mental
health quality of life on utilization of highly active
antiretroviral therapy (HAART) among HIV-seropositive women. Data
were collected biannually from 1996 through 1998 in a prospective
cohort study. Women reported use of antiretroviral therapy, health
and mental health status, demographics, and social and behavioral
factors; CD4 count and viral load also were assessed. Random
effects regression models estimated the longitudinal effects of
depressive symptoms and mental health quality of life on the
probability of HAART utilization, controlling for clinical
indicators (CD4 count, viral load, symptom presence), demographics
(race, age, education), behavioral factors (drug/alcohol use,
clinical trials participation), service features (insurance
status, mental health service utilization), and study site. High
levels of depressive symptoms and poor mental health quality of
life were found, and they significantly reduced the probability of
HAART utilization. Receiving mental health services significantly
increased the probability of utilizing HAART. HIV-seropositive
women characterized as being in poor mental health were less
likely to use HAART, whereas those receiving treatment of mental
health difficulties were more likely to use HAART. These findings
suggest that efforts to enhance women's access to psychological
treatment may increase their use of the latest HIV therapies.

+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
What are your thoughts or questions on this issue?
Send a message to your colleagues at hnn-chat@healthnet.org
+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

5. Barriers to antiretroviral adherence for patients living with
HIV infection and AIDS in Botswana

AU: Weiser S, Wolfe W, Bangsberg D, Thior I, Gilbert P, Makhema J,
et al.
SO: J Acquir Immune Defic Syndr. 2003 Nov 1; 34(3): 281-8.
http://www.jaids.org/

ABSTRACT
BACKGROUND: Botswana has the highest rate of HIV infection in the
world, estimated at 36% among the population aged 15-49 years. To
improve antiretroviral (ARV) treatment delivery, we conducted a
cross-sectional study of the social, cultural, and structural
determinants of treatment adherence. METHODS: We used both
qualitative and quantitative research methodologies, including
questionnaires and interviews with patients receiving ARV
treatment and their health care providers to elicit principal
barriers to adherence. Patient report and provider estimate of
adherence (>/=95% doses) were the primary outcomes. RESULTS: One
hundred nine patients and 60 health care providers were
interviewed between January and July 2000; 54% of patients were
adherent by self-report, while 56% were adherent by provider
assessment. Observed agreement between patients and providers
was 68%. Principal barriers to adherence included financial
constraints (44%), stigma (15%), travel/migration (10%), and side
effects (9%). On the basis of logistic regression, if cost were
removed as a barrier, adherence is predicted to increase from
54% to 74%. CONCLUSIONS: ARV adherence rates in this study were
comparable with those seen in developed countries. As elsewhere,
health care providers in Botswana were often unable to identify
which patients adhere to their ARV regimens. The cost of ARV
therapy was the most significant barrier to adherence.

--------------------------------------------------------------

6. Highly active antiretroviral therapy adherence: the
patient's point of view

AU: Guarinieri, Mauro
SO: J Acquir Immune Defic Syndr 15 Dec 2002, 31(3): S167-69.
http://www.jaids.org/

“However brilliant the achievement of the modern medical machine,
the complicated social world of individual lives always lurks
outside the clinic door. Adherence to medications brings these
two worlds into conflict.”(1)

There is widespread acknowledgment that successful treatment with
highly active antiretroviral therapy (HAART) requires the patient
to maintain consistent adherence to the prescribed regimen on a
long-term basis. Adherent patients have been shown to have reduced
viral loads and increased CD4 counts, live longer, and have better
quality-adjusted survival (2). The consequences of nonadherence
are also obvious: poorer adherence leads to incomplete viral
suppression and allows disease to progress.

Initial clinical trials of HAART demonstrated that 80% to 90% of
patients receiving protease inhibitor therapy could achieve viral
loads <400 copies/mL.(3) However, in current real-world clinical
practice, less than half of patients achieve this goal. The new
and unique challenges associated with combination therapies for
HIV and AIDS require that healthcare providers address the issues
created by adherence to complex regimens through multifactorial
interventions tailored to patients' needs.

With the astonishing advances in HIV therapeutics during the past
two decades, one would think that studies on the nature of
nonadherence and the effectiveness of strategies to help patients
overcome it would also have proliferated. On the contrary, despite
mountains of research showing that not getting adherence right
leads to early treatment failure, largely limited to “adherence is
bad” studies using a variety of high- and low-tech methods to
demonstrate what we already knew, the literature and the know-how
concerning interventions to improve adherence still is
surprisingly weak. This sorry state may reflect how confusing
adherence is for HIV professionals and how difficult it is to make
adherence part of a real “agreement reached after negotiation
between a patient and healthcare professional that respects the
beliefs and wishes of the patient in determining whether, when
and how medicines are to be taken”.(4) Improving this situation
will require a commitment from purchasers and providers to
generate new research.

The main question is how to balance HAART, drug toxicity, quality
of life, lifestyle, daily routine, social conditions, health
beliefs, and adherence. How much is quality of life diminished
because of antiviral-caused cardiovascular diseases, neurologic
diseases, nephritic disease, hepatic diseases, metabolic
disorders, body shape changes, pancreatic diseases, sexual
dysfunction, and assorted gastrointestinal complications?
Regardless of viral suppression and CD4 count, all of these
problems hinder good adherence to treatment.

Although it may seem to be a no-brainer, the main finding on
adherence reported at recent conferences is that HIV support
services need to be linked with a patient's regular medical care.
We are not simply talking about a doctor in a white coat offering
a smile and a pat on the back. What quite a few studies have shown
is that direct intervention is key: a mix of adherence advice,
one-on-one counseling, and group support organized by trained
professionals and geared toward a patient's specific needs.
Direct intervention, researchers have found, seems to work for
everyone. Whether patients are happy or depressed; have low
self-esteem or huge egos; are white, black, or Latino; young or
old; addicted to drugs, alcohol, or nothing at all—everyone can
benefit from having a healthcare provider who does more than
measure CD4+ count and dispense medication. The ways in which
this direct intervention can be carried out are many and varied.

Perhaps most common is a variation on the system set up by The New
York State AIDS Institute, which funds so-called “adherence
services” that provide support and education at the same site
where patients get their regular HIV medical care. Researchers
found that this step alone made people more than twice as likely
to adhere perfectly to their regimens.(5) Other creative and
successful ideas for improving adherence abound. A group of
researchers from Harlem Hospital and Columbia University organized
an 8-week “participatory theater” program that featured skits,
presentations, talk sessions, and support groups.(6) HIV-positive
people who enrolled in the program discussed their obstacles to
adherence and, in the process, established closer bonds with other
attendees. The result of the program was the creation of a new
community support system that kept those involved happier and thus
more likely to adhere to their medications. The Harlem
participatory theater program highlights what many studies found
to be the most important factor in encouraging adherence: directly
addressing problems that are unique to specific groups of people.
Women, some studies have found, are more likely than men to have
lower adherence due to depression or anxiety.(7) Other
researchers have found that drug and alcohol use can have a major
negative impact on adherence (8) and requires its own brand of
intervention targeting users' specific issues. The same goes for
being a child (9), a prisoner (10), having a mental disorder, and
being single.

Quality adherence to antiretroviral therapy is an ongoing process
in which the patient needs to be directly involved. It is not
something a person naturally possesses or lacks. Mastering the
skills involved in adopting complex treatment regimens is a
learning process. Interventions to increase adherence must
address cultural differences within race, gender, sexual
orientation, and religion. They must be tailored to meet
culturally relevant barriers, including differences in language.
Efforts must continue that help patients complete treatment,
paying close attention to sociocultural circumstances and the
psychologic and economic factors that may impede adherence.

Physicians should not automatically assume a future of poor
adherence by their patients based on demographic and behavioral
characteristics. These assumptions, on the part of the clinician,
could stigmatize patients or sabotage the patient-doctor
relationship, thereby introducing an additional impediment to
adherence. An emphasis on language that stresses the inability of
the patient to adhere to the devised medication regimen should be
dropped and replaced with language that stresses the role of the
patient in devising and implementing an individualized treatment
plan. Such language should be as elementary as possible without
reference to medical jargon.

The bottom line is that for most HIV-positive people, missing
medications is not only a matter of dreading side effects,
loathing the idea of taking so many pills, or simply forgetting.
There are complicated factors at work for almost every patient,
which require a lot more attention than most people are willing to
acknowledge. Study after study has shown that special intervention
programs located in the same place where people get their HIV care
is a major step. The hope is that, ultimately, people will be able
to simultaneously receive help for not only the physical effects
of their HIV infection but also for the equally devastating
emotional effects.

References are available upon request at info@healthnet.org.

+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
NOTICE TO READERS:

Material in Community Health is covered by copyright. SATELLIFE
gratefully acknowledges the generous permissions granted by the
following copyright holders: Massachusetts Medical Society, The
American Academy of Pediatrics, American College of Physicians,
The American College of Surgeons, American Public Health Assoc,
Baywood Publishing Co, Blackwell Publishers, British Medical
Journal Publishing Group, Elsevier Science, Ethiopian Public
Health Assoc, François-Xavier Bagnoud Center for Health and Human
Rights, International Union Against TB and Lung Disease, Kenya
Medical Assoc House, Kluwer Academic Publishers, Makerere
University, Medical Assoc of South Africa, Medical Assoc of
Tanzania, Oxford University Press, The Royal Society of Medicine
Press Limited, University of Chicago Press, the Women’s Health
and Action Resource Centre and authors of the articles delivered
herein.

COPYRIGHT
Community Health is an electronic newsletter published monthly by
SATELLIFE and distributed via e-mail to health professionals in
developing countries. It contains current health information from
medical publishers who have granted permission for use within the
developing world only. Unauthorized reproduction, distribution,
or sale of Community Health is not permitted. Community Health
may not be posted on any World Wide Web or FTP site, or used for
commercial purposes.

If your colleagues or affiliated institutions have e-mail access
and would like to receive Community Health, please have them
contact: info@usa.healthnet.org
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
SATELLIFE has obtained information in Community Health from sources
believed to be reliable. However, because of the possibility of
human or mechanical error by our sources, SATELLIFE does not
guarantee the accuracy, adequacy, or completeness of any
information and is not responsible for any errors or omissions or
for the results obtained from the use of such information.

END

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