Abstracts Vol. 1 [International Conference on AIDS (11th: 1996: Vancouver, Canada)]

Tu.B.172 - Tu.B.180

Tuesday, July 9, 1996

Tu.B. 172
A SUCCESSFUL COMMUNITY-BASED RESEARCH MODEL FOR REACHING
UNDERSERVED POPULATIONS
Kunches, Laureen M*, DeCristofaro J*, DeMaria A**, Landers S*, Werner B**. and the gp
160 Working Group. *JSI Research & Training; **Massachusetts Dept. of Public Health,
Boston, MA, USA
Issue: Equitable access to HIV clinical trials has been logistically difficult, and most trials have
not had appropriate representation of women, IDUs and minority populations.
Project: Through a collaborative process involving consumers, scientists and activists, state
funding for clinical research was prioritized to support a Phase /11 therapeutic vaccine trial
(gp I 60, VoxSyn, MicroGeneSys, Inc.) with two main goals: 1) to provide local access to a
promising therapy and 2) to serve a population closely resembling the local geographic and
demographic characteristics of PWA's. A multidisciplinary working group developed the
protocol to complement other ongoing trials; CD4 lymphocyte count (under 400/mm3)
and other entry criteria were minimally restrictive.
Results: After widely publicizing the trial, 142 participants were selected in a weighted lottery
from over 500 interested individuals.Women (30%), IDU's (26%), and racial minorities (37%)
were well-represented, and 32% were on no antiretroviral therapy at entry Communitybased clinical sites statewide cooperated by referring eligible patients and providing exam
room space for monthly visits. Appointment scheduling, data management, and logistics were
coordinated centrally; part-time nurses and nurse practitioners traveled to the sites, performing physical assessment, phlebotomy vaccine administration and data collection.The overall
cost per patient (approx. $2100/yr) is lower than many other research approaches.
Lessons Learned: This cost-effective model is a "user-friendly" approach to providing high
quality clinical data while reaching underserved populations.
Laureen M. Kunches, JSI Research & Training, 44 Farnsworth St., Boston, MA 02210 USA
Tel. [phone]; Fax [phone] email: laurie [email protected]
Tu.B. 173
RECRUITMENT AND RETENTION OF WOMEN AND MINORITIES IN HIV CLINICAL
RESEARCH AT COOK COUNTY HOSPITAL, CHICAGO, 1994-5
Sherer Renslow, Cohen M, Pulvirenti J, Weber K, Barker D, Boyer K, Henry-Reid L, Lubin B,
Luskin-Hawk R*, Weinstein R.
HIV Centenr, Division of ID, CCH, & Rush Medical College; *ARAC, Chicago, Illinois, USA
Objective: To describe the 1994 & 1995 recruitment & retention (R&R) experience of
women and minorities in clinical trials and epidemiologic studies at Cook County Hospital
(CCH), Chicago.
Methods: We reviewed I1994&5 patient contact, accrual, and retention data for the following research studies at CCH: CPCRA (5 protocols, 132 pts), pediatric ACTG (5 prot., 45
pts), ACTG (10 prot., 49 pts), WITS (82 pts),WIHS (150 pts),Vaccine Prepare (53 pts),
Adolescent (I 0 pts), & proprietary (3 prot.s, 37 pts).
Results: Of I 8,595 visits to CCH in I1994&5, 3,280 (I8%) were research-related, and of
3,598 patients, 558 (1I6%) were enrolled in research. Of these 558: 354 (63%) were
women; 45 (8%) children age 0-13; 76% African American, 10% nwHispanic. 12% white, &
2% other; & 169 (30%) were IDU. Retention rates in 1994-5 were 93% overall (7% lost to
F/U) & ranged from 78%-98%. By trial: CPCRA 94%; peds ACTG 98%; ACTG 94%; WITS
9 l%;WIHS 96%;VPS 93%; proprietary 78%. In 3 evaluable groups, missed visit rate was 8%
(range 7%- I 2%). R&R strategies included: trial integration into HIV primary care clinic; support services, including case management & groups; transportation; on-site child care; dedicated clinical & clerical research space; bilingual staff & cultural sensitivity training; peer
retention specialists; Community Advisory Board work in trial design & conduct; anonymous
client feedback forms & satisfaction surveys; community outreach; nursing outreach & education in clinic; 800 # with voicemail for homeless subjects; cash incentives; food provision;
frequent non-study contacts; & drug treatment. Obstacles included overly complex protocols; provider indifference & heavy care loads; pt work schedules; pt fear of exploitation;
mistrust of research; homelessness; drug use & lack of treatment.
Conclusions: Clinical trial participation in urban public hospitals is feasible with creative
strategies which support the dignity of people living with HIV and attend to their expressed
needs. Staff cultural sensitivity training is essential. Clinical trials are central to state-of-the-art
HIV primary care & support in public hospital HIV clinics.
Renslow Sherer, M.D. 1835 W Harrison Street, Chicago, Illinois 60612, USATeI: 312-633-3005
Fax: [phone] email: [email protected]
Tu.B. 174
"SOFT" AND "HARD" MEASURES OF ENERGY/FATIGUE IN HIV TRIALS
Doob, Penelope Reed*, Johnson KM, St Cyr J**, MacFadden DK**. *York University North
York, ON, Canada; **University ofToronto,Toronto, ON, Canada
Objective: To examine potential "hard" endpoints for change in HIV-related fatigue and their
relation to "soft" health-related quality of life (HRQL) measures.
Methods: 15 HIV + patients with severe fatigue and CD4 counts <200 were enrolled in an
exploratory open label study of Peptide T (8.5mg/d s.c.).Tests included the 6-Minute Walk
Test (6MVVT) and Borg Perceived Exertion Scale (0, 3, 6 wks), grip strength and neuropsychological tests (0, 6 wks), and HRQL measures (MOS-HIV Psychological General WellBeing [PGWB], Beck Depression Inventory [BDI], and a symptom severity checklist [SSC])
at wks 0, 3, 6, 9, 12, I5. Electronic personal activity monitors (PAMs) were worn for I wk
pre-baseline and at wks 3 and 6.
Results: Objective meosures: Patients improved on the 6MVT (paired t test, mean 52.6m,
p-0.02. at wk 3 and 56.9m, p-0.0004, at wk 6) while Borg perceived exertion declined (I.6, p=0.009, wk 3; -2.4, p=.0006, wk 6). Grip strength improved (p=.005 dom, p-. I nondom), as did other NP tests including FAS/CFL verbal fluency and finger-tapping (dom).
Results from PAMs, used for the first time n HIV trials, were inconclusive, with collection
and analysis of PAM data problematic.
HRQL measures: MOS-HIV Energy-Fatigue and PGWB Vitality subscales showed significant
improvement (>2 baseline s.d. for the MOS-HIV, p ranging from.0002 to.013), as did SSC
items fatigue and weakness and a MOS summary score. Measures of depression generally
did not show significant improvement.
Correlation analyses between and within types of tests indicated high inter-correlation of
change in HRQL but at best (Fatigue) a correlation of only.4708 (Pearson; p=.089) with

the 6MVVT. In the NP group, FAS/CFL was correlated with SSC Fatigue and Weakness
(r=.6675 and.5950, p=.02 and.05), while finger tapping (dom) showed a trend towards
correlation with the WalkTest (.5873, p=0.07).
Conclusions: Identifying appropriate "hard" measures of change in HIV-related fatigue
remains problematic. While many measures indicated substantial improvement. correlations
between "soft" and "hard" measures were weak, perhaps because HRQL measures demand
a 4 wk retroactive assessment while "hard" measures are taken on a single dayThe PAM,
difficult to use and analyze, may not be well suited to HIV trials.
P R. Doob, I Fenwick Ave.,Toronto, ON, Canada M4K 3H2 Tel: 4 I 6-465-8845
Fax: 4 I 6-465-2695 email: [email protected]
Tu.B. 175
REGARDING RESEARCH: HIV + WOMEN CONSIDER CLINICAL TRIALS
Parks, Virginia E. ACT UP Golden Gate, Women Organized to Respond to Life-Threatening
Disease (WORLD), Community Constituency Group of the ACTG, AIDS Clinical Research
Center; San Francisco, CA, USA
Issues: Historically, women of childbearing age have been excluded from clinical research.
Although HIV has dramatically affected this population, only in the last few years have HIV+
women and activists successfully begun to eliminate gender-based exclusions. Despite these
efforts, the percentage of women enrolling in clinical research is still relatively low.
Assumptions are made by researchers and advocates alike, however nobody has simply
asked HIV+ women what they perceive as their barriers to research.
Project: As an HIV negative treatment advocate for women and children, I wanted to ascertain what factors encourage or discourage the enrollment of women in trials.Through personal contacts and announcements in community based newsletters, a convenience sampling of 100 HIV+ women currently residing in the United States were recruited for a survey regarding clinical trials.The survey includes demographic information, questions regarding factors thought to encourage/discourage enrollment, as well as opportunities for
women to express in their own words their opinions regarding research.
Results: Preliminary data suggest multiple barriers for women who do not participate in
clinical research including obvious ones such as time, transportation, and child care. Some
women also cite more complicated reasons: preference of alternative or traditional medicine, mistrust of research, and concerns regarding experimental drugs. Women who decide
to participate in research also do so for varied reasons including disease progression, a
desire to contribute to our knowledge, access to therapies or healthcare.
Lessons Learned: Whether researcher or advocate, to successfully encourage the enrollment of women in research, one must actively listen to the needs and concerns of women.
While some barriers to research can be easily addressed, others will be more difficult to
resolve--but should still be considered in the enrollment, informed consent, and design of
clinical trials.
Virginia E. Parks, 1735C Dolores, San Francisco, CA 94 I I0;Tel/fax 4 I15/648-2758
Tu.B. 176
SELF REPORTED SYMPTOMS IN HIV INFECTION
Neidig, Judith L, Nickel J, Smith B, Brashers D, Para M, Fass, R. The Ohio State University
Columbus, Ohio, USA
Objective: To determine patterns of self-reported symptoms by persons infected with HIV
at various stages of disease.
Methods: Data on self-reported symptoms were prospectively collected from research volunteers during screening for clinical trials at an AIDS Clinical Trials Unit. Subjects selected symptoms from a written checklist and reports of 992 adults at their initial visit were analyzed.
Results: Mean numbers of reported symptoms were 4.8 (CD4 < 200); 3.8 (CD4 200-499);
and 3.5 (CD4 > 500).

I
0

Most C
CD4<200
n-340

ommonly Reported Symptoms by CD4 Subgroups

Fatigue
Cough
Chills
Headache
Depression

(70%)
(47%)
(37%)
(35%)
(33%)

CD4 200 - 499
n=437
Fatigue (48
Depression (40
Cough (37
Headache (33
Memory Loss (29. v,

%)
%)
%)
3%)

CD4>500
n= 305
Fatigue (43%)
Depression (38%)
Cough (33%)
Headache (33%)
Memory Loss (28%)

Conclusions: Persons with HIV infection reported being symptomatic regardless of disease
stage.This descriptive study provides an empirical foundation for designing interventional
symptom management studies for this population.
Judith Neidig, AIDS Clinical Trials Unit,The Ohio State University Hospitals, 4725 University
Hospitals Clinic, 456 W. 10th Avenue, Columbus, OH 4321I0 Tel: [phone]
Fax: [phone] email Neidig. [email protected]
Tu.B. 180
RISK OF HOSPITALIZATION FOR SERIOUS BACTERIAL INFECTION (SBI) ASSOCIATED WITH NEUTROPENIA SEVERITY IN PATIENTS WITH HIV
Jacobson, Mark A*, Cohen PT*, Liu RCC**,Wong R***, Rich W***. *UCSF & San
Francisco General Hospital (SFGH),** Dixon Statistical Assoc., ***Amgen Inc.
Objectives: To determine if severity of neutropenia is associated with increased risk of hospitalization for SBI in patients with HIV
Methods: We examined data from 10/I/92- I 1/30/93, including: I) demographics of all
patients (N=2047) attending the SFGH AIDS clinic, 2) all absolute CD4 and neutrophil
counts performed in the SFGH Clinical Lab, 3) all ICD-9 SFGH discharge diagnosis codes,
We categorized ANC's (cells/uL) into 9 strata (see table below).We then analyzed a single
risk window for each patient encompassing the first time period that lowest strata ANC's
occurred for that patient. Random complete medical chart review of 5% of patients verified
that ICD-9 codes for SBI's had 98% positive and 96% negative predictive values for meeting
NIAID DAIDS clinical endpoint definitions for SBI's.

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