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

822 Abstracts 42243-42247

12th World AIDS Conference

did caregivers with only a high school education (pre-test 76%; post-test 81%).
Caregivers who were HIV-infected had somewhat lower pre-test scores (74%)
as compared with non-HIV infected caregivers (81%), but both groups showed
improvement in test scores (85 and 83%, respectively).
Conclusions: Use of an HIV educational booklet alone produced modest improvement in caregivers' basic fund of knowledge about HIV. Written educational
materials may be a useful adjunct to an overall HIV educational program.
42243 HIV treatment education and critical thinking in the
internet
Marcelo Marer. 19 Fulton Street, Suite 308B New York-New York, USA
In the last two years, HIV related information has grown exponentially. The number and variety of venues which disseminate that information has also grown,
nonetheless there are few programs that attempt to evaluate the quality, accuracy
and efficacy of the dissemination of much of the HIV-related information available
in the Internet. Body Positive, a ten-year old community-based organization from
New York City, under a 18-month grant from the National Library of Medicine,
has developed a curriculum on the basics of HIV/AIDS information in the Internet
(and how to access it), on the critical evaluation and selection of Web sites
that best suit the client's needs, and on how to apply critical thinking skills in
the development of a Treatment Education Project that incorporates access to
Internet-based information.
Although it is still vital to identify Web sites with solid HIV/AIDS Treatment
information, it has become increasingly difficult to monitor the quality of that
information. It is therefore, paramount to provide the tools for information access
AND evaluation across the board.
131 *42244 An effectiveness trial comparing AZT/ddl to
AZT/ddC in Thailand
Pimjai Satasit, C. Kunanusont, W. Phoolhaburi. AIDS Division Dept. Of CDC
MOPH, Nonthaburi, Thailand
Issue: To compare clinical, laboratory, and public health outcomes of available
double nucleoside therapy among Thai subjects in terms of real effectivenss in a
large scale multicenter study.
Project: An open label randomized comparison of AZT/ddl to AZT/ddC in
service system of 45 hospitals was initiated in March 1997 after 2 investigator
meetings. Anti-retroviral, data collection packages and randomization code were
supplied by quota according to hospital capacity and number of AIDS cases
reported. Data from each visit were collected and analysed for clinical and public
health events. Laboratory analysis was conducted among a subset of data, where
available.
Results: Among 1,095 anti-retroviral naive HIV infected persons with CD4
200-350 cells/mm3 included in March to November 1997, 538 were randomized
for AZT + ddl and 557 for AZT + ddC. Data of 80,372 person-days were collected.
There were 5 deaths (3 vs 2), 1 disease progression (0 vs 1), 7 quit (6 vs 1),
15 loss to follow up (7 vs 8), 31 mild adverse effects (9 vs 22), and 78 regimen
changes (61 vs 17), all not significantly different. CD4 and total lymphcyte counts
were poorly correlated (r = 0.09, p-value 0.037). However, subjects with total
lymphocyte <800/mm3 were about 9 times more likely to have CD4 < 200/mm3
(OR 8.96, 95%CI 3.45, 23.85, p < 0.001)
Lessons Learned: Large scale clinical trial is possible in Thai settings. Effectiveness of AZT/ddl when compared to AZT/ddC is not different on a short term
follow up for clinical and public health outcomes. Total lymphocyte count can
substitute CD4 count in some occasions but results must be carefully interpret.
42245 1Effective methods used to recruit and retain HIV-infected
women in a randomized clinical trial
Michele Gill1 2, L. Brock3, D.M. Israelski4, P. Kim2, K.N. Nevill-Manning2,
D. Spiegel2. 1Dept. of Psychiatry; 2Stanford University Stanford, CA; 3AIDS
Community Research Consortiom, Redwood City CA; 4San Mateo CTY AIDS
Program/Stanford, San Mateo, CA, USA
Issue: Given the need to study and document the medical and psychosocial
problems and issues particular to HIV-infected women, the challenges and obstacles to recruiting HIV-infected women into clinical trials need to be understood
and overcome.
Project: HIV-infected women living in major urban areas were recruited into
a one-year study to examine the effectiveness of group psychotherapy for improving mood and medical treatment adherence, and reducing HIV risk behavior.
Efforts to successfully recruit women centered around establishing and maintaining close collaborations amongst researchers, local health providers, and
community leaders and programs that offered culturally relevant advice and sanctioned the study. Securing the support of key clinical staff who are 'gatekeepers'
to community groups distrustful of research, was crucial to accessing members
of their population, especially the hard to reach. Improving enrollment required

removing obstacles that prevent participation and addressing many of the issues
relevant to women, such as providing assistance with child care and transportation services. To meet the challenge of maintaining participation in a year-long
program, commitment was built through close personal contact with participants
through the intake process and throughout the study, and by mobilizing monetary
incentives for participation and follow-ups.

Results: 38 women were successfully recruited to date, 45% African-American
and 70% low-income. Follow-up rates for the first assessment at 3 months was
86%, and 85% for the second assessment at 6 months.
Lessons Learned: The challenges to recruiting and retaining HIV-infected
women in clinical trials can be overcome by implementing strategies that recognize the special needs of women with HIV and that eliminate the access barriers
to their participation.
|42246 Greater involvement of PLWHIV/AIDS in a research and
care project
Isaac Mabosung Tita-Gwenjeng1, A. Bourgeois2, N.E. Mpoudi3, J.N. Torimiro2,
R. Mimbiang4, M.J. Atangana1, M.D. Kabeyene1. 1 United Brothers and Sisters
(U.B.S.), PO. Box 906, 2Projet Presica, Yaounde; 3 Yaounde Military Hospital,
Yaounde; 4 Yaounde Central Hospital and SWAA, Yaounde, Cameroon
Introduction: Up to December 94, the fight against AIDS was limited to prevention, sensitization and fundamental scientific research. Medical care which was
seperated from research started with the birth of UNIAIDS. Cameroon, Senegal
and Guinea Bissau are carrying out a study on the genetic diversity of HIV in
Collaboration with ORSTOM and IMEA. The Objective of PRESICA (Prevention
of AIDS in Cameroon) which started it's activities in May 1996 in the Yaounde
Military Hospital, is to improve the care given to HIV positive persons whithin the
framework of the Project.
Justification and Objectives: Research on vaccin and therapy is making
little headway because of the diversity of the types and sub-types of HIV. Thus
PRESICA has set out to study the clinical, biological and virological characteristics of HIV in accordance with the different types and sub-types. It also aims to
improve medical and psycho-social care as well as the prevention of the infection
in Cameroon.
Method: The individuals must be HIV positive and more than 15 years old with
a karnousky index of more than 70. Anonimity and Confidentiality are preserved.
For three years, those selected receive free medical consultation. Subjects are
counselled before and after test. Those who test positive are encouraged to notify
their patners. Systematic medical control is done to those who sign the follow-up
booklet every 3 months. The other specific tests are done every 6 months. Drugs
available are freely given to subjects following their needs. They are advised
on a healthy diet for better nutrition. PRESICA participates in the payment of
transportation for those who come for systematic control. The counselor goes for
those who do not turn-out. A very important fact is the involvement at all levels,
of a PLWHIV/AIDS.
Results: During the year 1997, 675 persons were tested, 520 (77%) tested
positive. 155 (23%) tested negative. Within the same period 162 of the positive
ones were selected and enrolled in the follow-up cohort. After search, 19 of them
(12%) did not show-up and, 19 (12%) passed away. 1/3 of their partners are
informed of their HIV status, and amongst them 95% went for a test and 69%
tested positive. During home visits (done with the consent of the subjects) or in
thecase of death their families were sensitized.
Conclusion: The PRESICA is an innovation in cameroon and certainly in
Africa. By associating research and care the quality of life of PLWHIV/AIDS is
improved through constant medical and psycho-social care. This will account for
the encouraging turn-out of subjects participating in research Projects.
42247 The use of logic and a "rapid screening tool (RST)" to
determine eligibility for HIV clinical research treatment
trials
Susan Ray', M.F. Giordano1, T. Sarracco2. 1Cornell University Medical School,
Cornell Clinical Trials Unit, 525 East 68th Street, Box 566 NY NY 10021; 2The
New York Hospital, New York, NY, USA
Objective: 1) Develop and assess the usefulness and efficiency of a "rapid
screening tool (RST)" in performing preliminary chart reviews to identify HIVinfected subjects (S) who qualify for multiple research trials. 2) Describe factors
associated with those who are ineligible or who do not enroll for a trial at the time
of review.
Methods: We reviewed the eligibility criteria for 20 clinical trials. Of these, 8
primary criteria were identified to use for rapid chart review. These included: CD4,
HIV RNA, and yes/no answers to: protease inhibitor naive, NNRTI/NRTI naive,
stable antiviral therapy, weight loss greater than 5%, thrush within the previous
6 months, and CMV disease. Charts from an academic medical practice were
reviewed. Studies for which S was potentially eligible were recorded. A RN or MD
performed a subsequent comprehensive second review in which all necessary
and sufficient eligibility criteria for the particular study were assessed. Eligible S
were invited to participate in the clinical study for which they qualified.
Results: 116 (110 M, 6 F) charts were reviewed using RST (8 days/20 hrs). 79
(68.1%) were possibly eligible for trial(s) using the 8 criteria. Following second
review, 45 were ineligible for trial(s) [10 geographically unable, 2 deceased, 4
too ill, 7 already on a study, 2 lost to F/U, 20 did not meet eligibility criteria]. 34
remained eligible and 14 enrolled in studies [20 uninterested/non-compliant].

Conclusion: The RST modestly reduces the number of charts requiring time
consuming comprehensive review. The 8 criteria may be modified to perform
computer based screening for multiple clinical trials through the use of logic. An
estimated 380 hrs of work was saved by reviewing each chart for all enrolling
trials (20 hrs/charts/study).