Bridging the Gap: Conference Record [Abstract book, International Conference on AIDS (12th: 1998: Geneva, Switzerland)]

81 8 Abstracts 42224-42228

12th World AIDS Conference

Lessons learned: Informed community imput should be an integral part of
HIV clinical research to ensure that basic ethical research principles are put into
practice. Community should be involved in the planning, design, protocol review,
data safety and monitoring, and evaluation to safeguard their interests and those
of clinical trial participants.
S42224 Models of practice for ethical review of HIV clinical trials
Donald Seaton. Canadian HIV Trials Network 3132 Maple street, Vancouver, BC,
V6J 4X3, Canada
Issue: Adapting models of practice to an HIV specific ethical review board.
Project: The Canadian HIV Clinical Trials Network has a National Ethical Review Committee (NERC) to provide ethical approval for physicians who wish to
participate in HIV clinical trials, but who lack an Institutional Review Board (IRB).
After six years of operation, NERC is developing and adapting standardized models in three areas: forms of consent, policy on recurring ethical issues, and terms
of reference. These models are drawn from NERC's experience, a draft Canadian
"Code of Ethical Conduct for Research Involving Humans", and consultation and
cooperation with HIV community activists from across Canada who were working
on model forms of consent.
Results: Models of practice have given a preliminary indication of faster and
more consistent approvals of clinical trials as well as increased awareness among
trial sponsors of ethical issues relating to HIV clinical trials. Adaptations specific to
NERC's HIV mandate have been clearly identified, and assist NERC in insisting
upon ethical standards derived from our HIV clinical trials experience, which
might not be flagged by a standard IRB. These adaptations continue to evolve
as the therapeutic agents under investigation and the populations affected by the
epidemic in Canada change.
Lessons Learned: Models of practice benefit both clinical trial investigators
and the IRB, but must be modified to reflect ethical concerns specific to HIV.
42225 1Discussion of the process and activities associated with
the development of HIV special needs plans in New York
State
Hope Plavin, H. Cruz, I.S. Feldman, E.J. Anderson, J.P. Delorenzo,
J.A. Whitaker, D.J. Jemiolo. AIDS Institute NYS Department of Health, ESP
Corning Tower Room 478, NY, USA
Purpose: To present and discuss the policy making administrative and research
activities undertaken by the State of New York in developing and implementing
"HIV Special Needs Plans", Medicaid managed care plans specifically targeted
to the care and treatment of persons with HIV infection.
Methodology: The State of New York has been in the process of developing
HIV Special Needs Plans over the past four years. Activities associated with the
development of these targeted managed care plans include: receipt of a research
grant from the federal government, a Special Project Of National Significance
grant; conduct of quality of care and life survey research; conduct of quantitative
research to ascertain Medicaid cost and utilization trends for persons with HIV
infection in New York State; award of HIV Special Needs Plan planning grants to
a variety of consumer and provider groups to solicit input and recommendations
regarding the development of these plans; and convening of an advisory group
comprised of HIV care providers and consumers, health plan representatives and
consumer groups who together have provided the state with input and guidance
in the development of these plans.
Results: The State of New York is now poised to issue a formal procurement that will result in the qualification and certification of entities known as
HIV Special Needs Plans. The legal framework for these plans is found in a
federal waiver (Section 1115 of the Social Security Act) granted the State by the
Federal Government. This waiver allows implementation of a general Medicaid
managed care program under which most Medicaid recipients residing in New
York State would be enrolled in managed care programs. Included within this
waiver is authorization to develop and implement Special Needs Plans for two
distinct populations, those individuals who are HIV positive and those individuals
with serious mental illness. In addition to this, legislation was enacted in New York
State in 1996 that authorizes the creation of these plans and describes specific
fiscal and programmatic requirements of these entities (Special Needs Plans).
Lessons Learned: The development of HIV Special Needs Plans in New
York State has evolved over a period of years and has included significant developmental work. The information presented will provide all attendees fiscal,
administrative, organizational and programmatic requirements agreed upon for
SNP Certification.
S42226 Ensuring equitable access to protease inhibitors
Scout1, J.B. Bradford2, T.J. Eller2, T.W. Jones3, B.C. Smith3. 1Basile Ryan, Inc.
7928 Carrleigh Pkwy.; 2Survey, Evaluation & Research Lab, Richmond, VA;
3Philadelphia EMA HIV Commission, Philadelphia, PA, USA

Issue: In US major cities, HIV Planning Councils must establish priorities for the
equitable distribution of Ryan White CARE Act funds, often without sufficient data
upon which to base their decisions.
Project: To develop data for resource allocation, the Philadelphia HIV Commission conducted an extensive in-field survey during spring and summer 1997.
The study was developed with intensive consumer input and implemented in
conjunction with service providers and other organizations involved with the tar
get population (individuals eligible for services funded by the Ryan White Care
Act). 1,069 completed questionnaires were gathered from HIV+ individuals residing within the Philadelphia metropolitan area. Demographic, HIV status, and
transmission characteristics of the sample closely matched those of the CDC
HIV/AIDS case reports data base, with sufficient cases of racial/ethnic minorities
and women to support sub-population analysis. Due to unexpectedly wide variation in the reported use of protease inhibitors, logistic and multinomial regression
analyses were conducted to identify factors influencing access to this key service.
Results: People of color were less likely than Whites to receive protease
inhibitors because: (1) they were more likely to have public insurance or to be
uninsured, and (2) they were less likely to know what viral load means and less
likely to know their viral load and Tcell counts. Because women were less likely
than men to be privately insured, they were also at risk of not receiving needed
therapy.
Lessons Learned: Many individuals with HIV/AIDS can be expected to have
inadequate information about their health status and about therapies for which
they may be eligible, and these individuals are likely to be disproportionately
racial/ethnic minorities, women, and uninsured or inadequately insured. Special educational efforts will be needed to assist these persons to advocate for
themselves, in order to receive life-sustaining medications.
42227 Enabling an informed personal choice about HIV drug
treatments
John Nicholson. 75 Ardwick Green North, Machestre M12, 6FX, England
Issue: Each person with HIV requires individual access to up-to-date information and independent advice and advocacy, when starting new therapies and
considering choices (to maintain or change treatments.)
Project: New medications have improved the quality of life of people with HIV
in North West England; though no-one is completely free of side-effects and some
people do not manage any combinations. A treatment information and advocacy
service has been developed, to challenge unequal access to treatments (varying
by district of residence, class, race, lifestyle and prescribing consultant), and to
give community support to assist compliance. New information technology, such
as the internet, provides vital information on the range of drugs and effects.
As each individual person's medical and social experiences are different, an
individual approach is preferred to large "drop-in" services - an earlier model
giving "peer support" groups. The former "drop-in" building was closed; and an
Information and Resource Centre was formed for the new service, with extended
opening hours, written and computer source material, phone access to specialist
help-lines, individual peer exchange of personal experience and advice, and
advocacy support from staff.
Results: The approach has been validated by usage and outcome. 373 different individual people used the Information Centre and services in its first 3
months. Fewer than 100 had used "drop-ins" at any time in the previous 3 months.
Increased confidence in approaching consultants has been reported. The useful
nature of information gained (and surprise at ease of gaining it) has been described similarly. Appointments with specialist advisers, holding sessions here,
totalled 161, increasing as people become aware of the service.
Lessons Learned: Every person with HIV is different. The traditional "drop-in"
no longer provides support most needed by most individual people with HIV.
Despite understandable objection to change from existing group users, a planned
move towards individualised service is possible to achieve. Developing medicine
and information technology require non-governmental organisations to focus on
enabling access to information for individuals, so that each person with HIV can
make an informed personal choice about treatment options.
414*/42228 Circumstances of diagnosis of HIV infection in
Belo Horizonte, Brazil
Marcelo A. Campos. Rua Goitacazes 52/703 Centro 30190-050 Belo Horizonte,
Brazil
Background: Belo Horizonte has the fourth largest number of AIDS cases in
Brazil. A large number of patients present with AIDS at diagnosis. This study
assesses the circumstances under which testing for HIV is done in order to
produce guidelines for early diagnosis and care.
Methods: From August/97 all patients attended at Eduardo de Menezes Hospital in or out-patient units were invited to answer a standard questionnare about
how they were found to be HIV+. Preliminary analysis of data of 131 patients
were done.
Results: Females were 26.9%. The mean age at diagnosis was 32.4y (range
18-80). Fluent reading was reported by 21.3%; 68% had familial income lower
than US$7200.00/yr. About 61% were admitted with confirmed serology (2 ELISA
and 1 WB). Of these, 8.9% did not know about their disease. The test was
requested by: a reference service (38.9%); a clinician (51.9%); a judge or police
officer, the patient himself or an employer (2.3%). The reason for testing was: a
disease sign or symptom (61.1%); screening of contacts (22.9%); blood banks
(3.1%); STD clinic surveillance (2.3%); compulsory testing in jails, brothels, army

or surgical services (3%); post rape (1.5%). Of those tested due to clinical suspicion, 32.5% did not authorize testing or receive pre-test counselling. Route of
HIV infection was sex for 73.3% (17.6% of these had less than 3 sex partners
within the past two years); unknown for 15.3%. Of these, 25% had past STD history. Clinical stage at diagnosis was AIDS (53.4%), ARC (11.5%) assymptomatic
(33.6%). Homosexual men had a higher chance of been diagnosed before illness
than women who got AIDS from a single partner: OR 2.38 (1.04-5.47). The first