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

598 Abstracts 32381-32384

12th World AIDS Conference

HAART (combination treatment with two or more antiretroviral agents, including
one protease inhibitor) among patients in a clinic (C) versus clinical trials (T)
setting.
Methods: Patients had been on stable HAART for at least one month. On the
study day pts were interviewed and had a pill count check (ahderence indicators)
and plasma HIV-1-RNA (vRNA) assayed by Roche Amplicor method (LOD = 400
copies/ml). Demographics, CD4 cell counts (cells/ugL) and vRNA at baseline
(at or prior to initiation of HAART) were identified by chart review. Antiretroviral
response was good if vRNA on study day was undetectable or > logs below
baseline, intermediate if 0.5 < vRNA < 2 logs and poor if <0.5 logs below
baseline. Adherent pts were defined by self report as missing doses less than
2x/week, and by pill count if they were >80%.
Results: 56 C and 28 T pts were treated for a mean of seven months (range
one to 71 mos). By self report 80% of C versus 89% of T pts were adherent (p =
ns). By pill count 73% of C versus 95% of T pts were adherent (p < 0.05). Mean
baseline vRNA was 160165 C versus 181888 T (p = ns) and mean baseline CD4
count was 182 C versus 320 T (p < 0.01). Study day mean vRNA was 62336
C versus 33033 T (p = ns) whereas CD4 count was 280 and 486 respectively
(p < 0.01). Mean decrease in vRNA during HAART was 114371 in C versus
134562 in T (p = ns) and mean increase in CD4 was 89 versus 107 respectively
(p = ns). However, when vRNA responses were defined as above, 78% of T pts
showed good response versus 39% of C pts (p < 0.05). In univariate analysis
employment and private insurance correlated with good antiretroviral responses
while in multivariate analysis only private insurance was identified.
Conclusion: A "snapshot" assessment of pts receiving out-patient HAART
demonstrates an advantage, with respect to good virologic responses and adherence measures (pill count), in the clinical trials versus clinic setting. An understanding of the factors contributing to these differences might lead to improved
outcomes.
32381 The Midwest AIDS Training and Education Partners
(MATEP) adherence initiative: Rationale and goals
Bonnie Lubin1, N. Linsk2, R. Sherer3, B. Schechtman2. 1Hektoen Institute 627,
South Wood Street, Chicago, Illinois, 60612; 2Midwest AIDS Training &
Education Center, Chicago, IL; 3Cook County HIV Primary Care Center,
Chicago, IL, USA
Issue: Highly active anti-retroviral therapy (HAART) requires highly motivated
patients able to adhere to complex medication schedules, in spite of adverse drug
effects and drug interactions. Clinicians and consumers alike are ill equipped to
deal with extraordinarily high demands for adherence to HAART.
Project: In order to develop consensus on the education, training and medical,
behavioral, social and familial support needs of people living with HIV and of
HIV clinicians, and to explore adherence lessons from other disciplines, MATEP
convened ~100 HIV clinicians, persons with, advocates, behavioral practitioners, researchers, pharmaceutical industry and media representatives as well as
policy makers in a twelve month inter-active initiative including two face to face
meetings (11/97-Washington & 1/98 Chicago) and work in the interim via four
working groups: Personal Support for Adherence; Systems Responses to Adherence; Tools for Assessment and Practice; and Technology Transfer from other
Disciplines. The Initiative is producing a variety of outcome products (e.g. video
and audio tapes for mass distribution) and sponsoring two large conferences.
Results: There was consensus among the participants on the need to develop patient-specific methodologies to assess, support and maintain adherence
to HAART in a variety of care settings. Priority was placed on: 1) targeted,
patient education materials addressing readiness to adhere based on current
best practices and systematic transfer of information from behavioral and clinical
research knowledge bases; 2) clinician training and assessment tools including
adherence curricula for health workers of all disciplines with emphasis on multipronged initiatives and multi-modal learning models; 3) acquiring knowledge from
other disciplines and disease states; and 4) system-wide measures to address
adherence training for policy makers, legislators, and payors.
Lessons Learned: The entire spectrum of the HIV community is willing to attack the problem of assessing, developing and supporting adherence to HAART.
The transfer of information to the field needs to be based on complex and evolving
knowledge. Research into the clinician/patient interaction and on the behavioral
variables affecting adherence needs to continue. We also need to develop multipronged methodologies to get research results, curriculum and products into the
field quickly in response to changes in therapy.
32382 Towards a new approach for the assessment of
adherence to therapy
Victoria Gordillo1, R. Fernandez2, B. Ramiro2, A. Hoyos3. 1 Universidad
Complutense de Madrid Espaholeto 9, 10B 28010 Madrid; 2Ngo Cauces,
Psychologist Madrid, Spain; 3Ngo Cauces, Psychologist Bogota, Colombia
Background: Key for the success of HAART are the ability and willingness of
HIV-positive individuals to adhere to complex antiretroviral regimens. This con
cept involves not only clinical/pharmacological aspects but also psychological
and relational ones; moreover, it implies a reappraisal of the role of dialogue
and interaction between patients and clinicians. Consequently, developing new
strategies and indicators could be helpful.
Objective of the Study: To find a new method to assess adherence given that
the tablet counting through pharmacy records makes possible that patients lie
according to diverse motives.

Design/Methods: Descriptive and longitudinal study. The sample population
included 500 HIV-infected people ongoing antiretroviral therapy in a reference
centre located in Madrid. The instruments used as independent variables (IV)
were: a questionnaire about health beliefs, motivation, social support and relationship with her/his doctor and two psychological scales (Beck's depression
and Hamilton's anxiety), plus a pharmacological account based on the no. of
pills forgotten monthly for an already known prescribed regimen. The dependent
variables (DV) were the CD4 count and the plasma viral load.
Results: Using statistical tests (Student's t and Mann-Whitney'U) we found
a significant difference between the direct measures (pill account by pharmacy
records) and the indirect measures (questionnaires and scales with open questions). More than 75% of patients lie -conscient or nonconscient- when they were
asked in the pharmacy about their compliance with the medication.
Conclusion: For a better assessment of adherence to HAART regimens, it is
necessary to use not only direct measures (pill counts) but also indirect methods
which allows to detect when and why the patient is not telling the truth (L variable). This information is necessary for identifying which factors can influence
adherence and what methods need to be developed to improve it. If the subject
of measurement is not an additive entity, qualitative research has to be used,
although their results cannot satisfactorily be quantified (Lancet 1996; 347)
32383 Service delivery models for treatment adherence to
combination antiretroviral therapy
Mark Waters, D. Hoos, B.D. Agins, K.S. Savicki, R. Glaros, B.S. Devore,
S.E. Chorost. AIDS Institute, NYS Department of Health, 5 Penn Plaza, New
York, NY, USA
Issue: Poor adherence to antiretroviral therapy (ART) increases the likelihood
of continued viral replication, and the development of viral mutations that can
cause resistance to ART. There have been limited efforts to support collaborative
partnerships between clinicians, supportive service programs, and consumers to
aid in treatment adherence.
Project: The New York State Department of Health, AIDS Institute will support
a demonstration project of 3-6 innovative models of care that support treatment
adherence starting April 1998. These programs will be required to establish a
network of HIV medical and non-medical service providers that will collaborate to
assess individuals for non-adherence and provide a structure that will assist those
individuals adhere to their medication regimen. These provider networks will be
required to reflect the needs of target populations that include individuals who are:
homeless or marginally housed; actively using drugs; diagnosed with psychiatric
illness; socially isolated; and/or distrusting of or disconnected from the health
care system. The provider networks will be required to provide client-centered
treatment adherence interventions that address the rigors of an ART regimen as
well as the cultural and linguistic needs of target populations.
Provider networks will be required to develop systems to communicate within
their network, collect data, and follow individuals as they access different services. They will be required to identify methods to monitor adherence, as well
as othermethods to evaluate program success. These demonstration projects
will also be assessed as to reproducibility of program design for other patient
populations.
The unique aspects of the different program models chosen for funding will be
presented at the poster session.
32384 Patient compliance on combination HIV anti-retroviral
therapies
John Quirk1, J. Wilks2. 1Room 17 Memorial Hospital Shooters Hill London;
2Greenwich Healthcare London, England
Objective: To outline factors which contribute to poor compliance on Anti-retroviral
therapy in patients on two or more Anti-retroviral drugs.
Designs: Structured interviews involving completion of a questionnaire, by a
Specialist Nurse or Psychologist.
Methods: A cohort of seventy [70] patients on two or more Anti retro-viral drugs
were approached and asked to participate in a structured interview. Issues addressed included the quality and quantity of information given to patients starting
combination therapy, side effects and how patients responded to these. Disruption to daily routine and factors that contribute to poor compliance are outlined.
Patients comments and suggestions were sought to improve drug compliance.
Results: Levels of information given to patients varied, however, the majority
felt that not enough information was given at the commencement of combination therapy. Complex drug regimes were viewed as disruptive to normal daily
routine and required major adjustments to lifestyle. Specialist support to patients
experiencing difficulties with adherence to drug regimes is viewed as important in
ensuring effective compliance. Early intervention by Healthcare staff to deal with
the symptoms and side effects of combined drugs may avoid the need to stop drug
therapy. Timely feedback between the patient and prescribing centre can prevent
the breakdown of the therapeutic alliance and enhance patient compliance.
Conclusion: An increased level of information is needed to assist patients

adjusting their lifestyle to complex drug regimes. The likelihood of enhanced compliance can be achieved with the support of Healthcare staff to monitor side effects
and difficulties experienced by patients. The need for simplified drug regimes and
information exchange are among the comments made by patients participating in
this study. Further research in this area is needed to achieve optimum compliance
with complex and potentially disruptive drug regimes.