Transcript Preliminary Findings From the CDC/HRSA Retention in Care Project Faye Malitz Health Services and Resources Administration HIV/AIDS Bureau Lytt Gardner Centers for Disease Control and Prevention Division.

Preliminary Findings From the CDC/HRSA
Retention in Care Project
Faye Malitz
Health Services and Resources Administration
HIV/AIDS Bureau
Lytt Gardner
Centers for Disease Control and Prevention
Division of HIV/AIDS Prevention
Mollie Jenckes, Antoinette McCray, & Melissa Otterbein
Johns Hopkins School of Medicine
Elana Desrivieres
SUNY Downstate Medical Center
This continuing education activity is managed and accredited
accredited by Professional Education Service Group. The
information presented in this activity represents the opinion of the
author(s) or faculty. Neither PESG, nor any accrediting organization
endorses any commercial products displayed or mentioned in
conjunction with this activity.
Commercial Support was not received for this activity.
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 Faye Malitz
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Has no financial interest or relationships to disclose
Lytt Gardner
Has no financial interest or relationships to disclose
Mollie Jenckes
Has no financial interest or relationships to disclose
Antoinette McCray
Has no financial interest or relationships to disclose
Melissa Otterbein
Has no financial interest or relationships to disclose
Elana Desrivieres
Has no financial interest or relationships to disclose
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At the conclusion of this activity, the participant will be
able to:
 Describe and discuss the results of the intervention trial
based on the first year of the intervention;
 Describe the types of activities performed by the retention
interventionists to promote retention in HIV primary care,
and activities that promote continuity of clinic services;
and
 Identify three commonly reported barriers to care or unmet
needs that were self-reported by study participants.
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6 HIV Clinics
Investigators
Boston University Medical Center, Center for Infectious
Diseases
Meg Sullivan
Mari-Lynn Drainoni
STAR Health Center, SUNY Downstate Medical Center,
Brooklyn, NY
Tracey Wilson
Moore HIV Clinic, Johns Hopkins University, Baltimore,
MD
Richard Moore
Jeanne Keruly
Jackson Memorial Hospital Adult HIV Clinic, Miami, FL
Allan Rodriguez
Lisa Metsch
1917 HIV Clinic, University of Alabama, Birmingham, AL Michael Mugavero
Michael Saag
Thomas Street Health Center, Baylor College of
Medicine, Houston, TX
Tom Giordano
Jessica Davila
 To identify clinic-based interventions to promote regular
attendance for primary care and prevent loss to care
Two Studies
Conducted in Two Phases
Characteristics of Intervention
Study 1 / Phase 1: low-dose,
• Provider messages, brochures, visual
low effort, clinic-wide intervention
cues (posters)
Study 2 / Phase 2:
3-arm randomized controlled
trial (~300 patients per clinic)
• Enhanced contact with patients across
time
• Improvement/reinforcement of patient
skills relevant for clinic attendance
6/09
6/10
6/11
6/12
|----------|----------|----------|-----------|-------------|------------|------------|
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PHASE 1 clinic-wide intervention
▼
PHASE 2 RCT enrollment
▼
12-month intervention period
begins, per enrollee, and
monitoring of attendance
▼
After intervention ends, monitor
attendance for 12 months, per enrollee
Phase 2
 Brief description of RCT design & intervention
components
 Findings during the 12-month intervention period
 Future analyses
 Phase 2 Intervention delivered by trained
interventionists hired for the study
 Involves ~ 300 patients per clinic
 Enrolled at a primary care visit
 Enrollees did not have “perfect” attendance in
prior 12 months
 Within each clinic, patients randomized to 3-arm
trial
1. Does attendance for primary care improve
through enhanced contact with patients across
time?
2. Does attendance improve even more when we
add a behavioral skills component relevant to
attending clinic?
Standard of Care
(n ~ 100 per clinic)
Enhanced Contact
(n ~ 100 per clinic)
Patients continue to Standard services
receive standard
+
services offered to all
patients
Enhanced contact with
patients across time
Enhanced Contact + Skills
(n ~ 100 per clinic)
Standard services
+
Enhanced contact with
patients across time
+
Modules to improve skills
relevant to clinic attendance
Problem solving
Communication
Organization
Note: patients in these two arms also received HIV
education from interventionist on importance of regular
care and association with CD4/VL
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Conducted by Interventionist
 Reminder calls 7 and 2 days before appointments
 Interim visit call (~half way between appointments)
 Missed visit call
 Brief face-to-face when patient returned to clinic for
primary care visit
Retention Risk Screener
 Administered by interventionist in semi-structured,
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conversational manner (probes, specific questions,
checkboxes)
Identify barriers to clinic attendance
Identify skill areas that need attention
Prioritize skill modules
Unmet/continuing needs, referral to case manager
 Three ~ 20 minute modules
 Problem solving skills for overcoming barriers to clinic
attendance
 Communication skills with providers
 Organizational skills
 Patients worked interactively with interventionist
 Not all patients needed all three modules
 Received a pocket guide summarizing essentials of all three
skill areas
Phase 2 Timeline of Intervention Activities
-Eligibility screen
-ACASI (all enrollees)
-Randomized
-Session 1 (EC, EC+)
Intro; HIV educ;
locator info.
Enrollment at
clinic
2-week
Interv.
visit
Session 2
(EC+ only;
97% received)
-Retention scrn
-Skill modules
Reminder calls
at 7 & 2 days
before primary
care appt.
Interim
phone call
Phone call to
patient who
missed appt.
Attend
primary
care visit
Interim
phone call
Miss primary
care appt
Brief F-to-F w/
interventionist
(EC, EC+)
EC :
Enhanced contact arm
EC+ : Enhanced contact + skills arm
Phase 2 Trial
Eligibility Criteria
I. Established patients met ONE of the following two
clinic attendance criteria:
 At least one no-show for an HIV primary care
appointment in the prior 12 months
 Not seen for HIV primary care at least once in each of
two consecutive 6-month periods
(Based on electronic attendance data already in hand)
II. All New patients were eligible.
• In addition, eligibility required meeting ALL of the
following criteria:
 18 years of age or older (at least 19 years of age in
Alabama)
 Currently receiving care at the clinic
 Ability to speak English or Spanish
 No plans to move out of area in next 12 months
 Ability to provide informed consent
Enrollment Data
Number approached
N
2671
Percent
100.0
Number screened
2090
78.2
Number eligible
2015
96.4
Number enrolled
1838
91.2
Data Sources
ACASI
Visit + Lab
(EMR)
Analysis Database
Intervention
delivery data
Demographics
Study Site
Houston
Baltimore
Boston
Brooklyn
Miami
Birmingham
Study Arm
Enhanced contact + Skills
Enhanced contact
Standard of care
Patient Type
New Patients
Established Patients
N
Percent
330
308
299
302
299
300
17.9
16.8
16.3
16.4
16.3
16.3
610
615
613
33.2
33.5
33.3
526
1312
28.6
71.4
Demographics
N
Percent
Sex
Males
Females
Transgender
1158
665
15
63.0
36.2
0.8
Race/ethnicity
Black/African American
Hispanic/Latino
White
Other (Asian, NH/PI, AI/AN, multi-race)
1262
288
235
53
68.7
15.7
12.8
2.9
Age at time of enrollment
1,835
Mean (median)
44.6 (45)
199
361
624
651
10.8
19.7
34.0
35.5
Age, categorical
18-29
30-39
40-49
50+
Demographics
HIV Risk Factor
MSM+ MSM/IDU
IDU
Heterosexual
Other (e.g., perinatal, blood transfusion)
Unknown/Undetermined
N
Percent
526
309
854
35
114
28.6
16.8
46.5
1.9
6.2
Clinical
N
Percent
Taking ART medication
Self-report (ACASI)
Medical records
1393
1437
76.0
78.2
Undetectable viral load
≤200 copies/mL
980
56.5
Comparability Among 3 Study Arms
Demographic & Behavioral Variables
Chi Square Result (df)
p-value
Site
0.50 (10)
0.99
Sex
4.57 (2)
0.10
Race/Ethnicity
7.58 (6)
0.27
HIV Risk Factor
4.00 (6)
0.68
Insurance Type (n=1780)
5.43 (6)
0.49
Age Category
3.09 (6)
0.80
Education level
2.71 (10)
0.99
Housing type
7.19 (8)
0.52
Employment status
2.79 (6)
0.84
Quality of health, self-report
6.58 (8)
0.58
Incarcerated in past 6 months
0.16 (2)
0.92
Alcohol binge drinking
0.55 (2)
0.76
Any drug use in past 3 months
1.74 (2)
0.42
Comparability among Study Arms
Unmet needs/barriers
Chi Square (df)
Any unmet needs (1+ vs. 0), past 6 months
2.68 (2)
Unmet needs (categorical): 0, 1, 2+
3.69 (4)
Structural and Financial
barriers: payment
0.90 (2)
barriers: transportation
1.40 (2)
Clinical Data
Baseline CD4 (<350 vs. ≥ 350 cells/mL)
2.06 (2)
Baseline VL (≤200 vs. >200 copies/mL)
3.81 (2)
Taking ART at baseline
2.05 (2)
Attendance in prior year (**established patients only**)
4-month visit constancy
No missed visits
>6 month gap in care
Appointment adherence (≥0.75 vs. <0.75)
1.48 (2)
0.66 (2)
0.07 (2)
0.18 (2)
p-value
0.26
0.45
0.64
0.50
0.36
0.15
0.36
0.48
0.72
0.97
0.92
Three PC outcomes assessed over the 12-month
intervention period:
 4-Month constancy : at least one visit in each of three
4-month periods (yes/no)
 Appointment Adherence: each participant’s
proportion of kept appointments divided by scheduled
appointments (mean of the proportions)
Outcome
Arm
Enhanced Contact
4-Month
Standard of Care
Constancy
Enhanced Contact
+ Skills
Standard of Care
* Log binomial
Percent
Success
55.7
Prevalence
Ratio
P-value*
1.22
0.0006
1.21
0.0008
45.8
55.5
45.8
Outcome
Arm
Enhanced Contact
Appt
Adherence
Mean
Prevalence
Proportion of
Ratio
Kept Appts
.718
Standard of Care
.662
Enhanced Contact
+ Skills
.702
Standard of Care
p-value
.662
1.08
0.0002
1.06
0.008
Outcome
Arms
Percent Prevalence
success
Ratio
EC vs.
EC + Skills
4-Month
EC
Constancy EC + Skills
55.7
Appt
EC
Adherence EC + Skills
.718
55.5
.702
p-value
1.00
0.94
1.02
0.29
Direct contacts with patient
 Face-to-face contacts (Session 1, Session 2,
return visits to clinic)
 Telephone contacts
 Appointment reminder contacts
 Missed visit contacts
 Interim contacts between PC visits
Contacts on behalf of patient
 Support service contacts (e.g., CM/SW)
 Medical team contacts
 Telephone Calls (EC and EC + skills arms pooled)
 Number of appointment reminders
 Number of Interim calls (half-way between PC visits)
Mean Appt Adherence
4-Month Visit
Constancy
(p-value*)
(p-value*)
# of Successful Interim Phone Contacts
0
1–2
3 or more
(n=234)
(n=547)
(n=439)
0.614
0.733
0.753
(<0.0001)
42.7%
57.2%
60.4%
(<0.0001)
# of Successful Appointment Reminder Contacts
0
1–2
3–6
7 or more
(n=181)
(n=320)
(n=423)
(n=300)
0.545
0.702
0.764
0.770
(<0.0001)
* Linear trend from chi-square for trend
30.3%
42.2%
62.1%
77.0%
(<0.0001)
Differences in retention by type of
module and number of modules
received?
Mean Appt
Adherence
4-Month Visit
Constancy
Organization Module (n=550)
0.724
57.3%
Problem-solving Module(n=232)
0.706
60.3%
Communication Module
(n=199)
0.684
54.8%
1 module (n=300)
0.750
54.7%
2 modules (n=189)
0.713
56.6%
All 3 modules (n=101)
0.672
61.4%
 Enhanced contact improved clinic attendance for
PC when compared to SOC practices at clinics
 As number of successful telephone reminders and
interim calls increased, attendance increased
 Skills modules delivered in the context of
enhanced contact activities did not further
improve attendance (but more analysis coming)
 Examining skills modules effects in more detail
 Examining whether other variables modified the
EC intervention effect (subgroups that did/did not
benefit)
 Examining whether we had an effect on viral load
of patients
 Analysis of longer-term effects in the 12-month
period after the intervention ended
If you would like to receive continuing education credit for
this activity, please visit:
http://www.pesgce.com/RyanWhite2012
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Faye E. Malitz
[email protected]
(301) 443-3259
Lytt Gardner
[email protected]
(404) 639-6163