Transcript Recommending a Strategy - University of Connecticut

Population-based
Interventions to
Improve Sexual
Health: Development
and Evaluation
Colleen A. Redding, Ph.D.
Cancer Prevention Research Center
University of Rhode Island
How many people get new
STI’s in the U.S. every year?
Disease
All STI’s
HPV (Genital warts)
Trichomoniasis
Chlamydia
HSV (Genital herpes)
Gonorrhea
Syphilis
HIV
New cases/year
18.9 million
5.5 million
5 million
3 million
1 million
650,000
70,000
>40,000
Public Health Cost?
 $9.3–15.5
Billion per year in direct
medical costs only
8
STIs (HIV, HPV, HSV2, HepB, Chlamydia,
Gonorrhea, Syphillis, Trichomoniasis)
 estimate
 $6.5
is Y2000 $
Billion among 15-24 yr. olds
(Chesson et al., 2004)
The Transtheoretical Model
Intentional Behavior Change
• Stages of Change
• Decisional Balance
• Situational Efficacy / Temptations
• Processes of Change
Different variables important for each
stage transition
What are Expert
Systems?
 A computer software program that
codifies the reasoning of human
experts into decision rules or
algorithms
 Integrates assessment and feedback
consistently using decision rules
Different Levels of Targeting/Tailoring
Group Level - Same intervention for all
Stage Level - Targeted interventions
Precontemplation
Contemplation
Preparation
Action
Intermediate Level - Tailored interventions
Individual Level-Expert system interventions
Maintenance
Stage-targeted vs. TTM-Tailored
univariate
group feedback
clinical decisions
5 different types
multivariate (10-15)
individual feedback
empirical decisions
normative comparison
ipsative comparison
thousands of types
interactive
algorithms vary by Stg
Benefits of Expert System
Interventions
Provide highly individualized feedback
 Appropriate for those at all stages of change,
(not only prepared to change)
 Potentially cost-effective
 Integrate multiple risk behaviors
 Multimedia components
 Confidentiality
 Force explicit (testable) decision rules
 High Fidelity

Efficacy of TTM-Tailored Interventions
for Single Health Behaviors








Smoking Cessation
Healthy Diet
Physical Activity
Sun Protection
Medication Adherence
Stress/Depression Management
Mammography screening
School Bullying
Efficacy of TTM-Tailored Tx with
Multiple Behaviors
Smoking, Diet, Sun Protection
 Smoking, Diet, Sun, Mammography
 Smoking, Diet, Blood Glucose Monitoring
 Smoking, Diet, Physical Activity, Stress
 Diet, Physical Activity

Steps in the Intervention
Development Process

Focus Groups


Learn language and how participants think
about the area.
Pilot Sample
Validate measurement structure of constructs
 Normative database
 Assess variables that differentiate stages

Develop Prototype – test - retest
 Pilot test intervention
 Efficacy/effectiveness trial (s)

CA Redding1, JO Prochaska1, JS Rossi1, K
Armstrong2, D Coviello2, UE Pallonen1, K
Evers1, WF Velicer1, & L Ruggiero1
1 - Cancer Prevention Research Center, University of RI
2 - Family Planning Council, Philadelphia, PA
Human Papillomavirus - HPV

The most prevalent STI in the U.S.
 Prevalence highest among 18-24 year old
women (14% - 50%) (men not studied well)
 Some HPV subtypes cause genital cancers
 > 99% of cervical cancers have HPV DNA
detected within the tumor
 HPV associated with penile, anal, and oral
cancers
 New HPV vaccine protects against 4 types
Step By Step: Steppin’ for
Healthier Teens
4 urban family planning clinics –
Philadelphia metropolitan area
 About 75% participation rate among
eligible adolescents
 833 female nonpregnant 14-17 y.o.
 Teens - informed assent/consent parental consent not needed
 Randomized clinical trial

Sample Diversity (N=831)
Race/Ethnicity
Black / African-American
%
81.0
White / European-American
7.3
Hispanic / Latina
7.8
Native American
1.4
Other / Multiracial
1.8
Sexual Risks
%
Age of sexual debut 13-14 y.o.
62.7
Hx. Chlamydia
20.5
Hx. Gonorrhea
10.3
Hx. HPV, Herpes, or Syphilis
9.4
Hx. Pregnancy (at least one)
36.0
Urban Female Teens (N=828)
Stages of Condom Adoption
35
30
25
20
15
10
5
0
PC
13.6%
N=113
C
31.0%
N=257
PR
15.0%
N=124
A
17.3%
N=143
M
23.1%
N=191
Pros and Cons
of Condom Use
Weight of the positive and negative aspects of behavior change
PROS
CONS
BENEFITS
COSTS
REASONS
To use condoms
NOT to use condoms
Functional Relationship
Stages & Pros + Cons
56
54
52
50
48
Pros
Cons
46
44
PC
C
PR
A
M
Baseline Sample - Pros & Cons of Condom
Use (T-scores) by Stage
55
Pros
50
Cons
45
40
PC
C
P
n=113
n=257
n=124
N=828
A
M
n=143
n=191
Baseline Sample - Confidence in Condom
Use (T-scores) by Stage
60
55
50
45
40
PC
n=113
C
n=257
P
n=124
N=828
A
n=143
M
n=191
TTM-Tailored Expert Systems
for Condom Use & Smoking
For use in Family Planning Clinics
 Mouse input (no keyboard!)
 On-screen and printed feedback
 Printed feedback for both participant
and her clinic counselor
 Smoking system appropriate for both
smokers (cessation) and nonsmokers
(prevention)

TTM Tailored Intervention
Package

Interactive assessment and expert
system feedback (onscreen & printed)



Tailored feedback based on:





Condom Use Promotion
Smoking Cessation OR Prevention
Stages of change
Pros & Cons
Confidence or Temptation
Processes of Change
Stage-Matched Counseling
Standard Care Intervention
Package
Identical computer-delivered
assessment and generic feedback to
use condoms, condom tips, and
advise to either quit smoking or avoid
starting to smoke.
 Standard family planning counseling
on birth control and condom use.

Stage-matched Counseling
Can be used with teens at all stages of
change, not only those ready for action
 Comparable to Motivational Interviewing
 Counselors match Process exercises to
stage using Manual
 Counselor received printed output from
computer with client’s stage of change
and processes to work on

Processes of Change
• HOW
people change
• cognitive, emotional, behavioral,
interpersonal strategies/techniques used
to change behavior
• different processes mediate transitions
between stages
• process-to-outcome research
• foundation of intervention design
Processes of Change
Experiential
Processes
Thinking, Feeling or
Experiencing
Consciousness Raising
Dramatic Relief
Environmental Reevaluation
Self Reevaluation
Social Liberation
Behavioral
Processes
Doing
Counterconditioning
Helping Relationships
Reinforcement Management
Self Liberation
Stimulus Control
Newer Interpersonal
Processes


Condom Communication - talking about condom
use
Condom Assertiveness - insisting on condom
use

Eroticizing Condoms - finding ways of making
using condoms more enjoyable

Partner Support - getting partner’s support for
condom use

Interpersonal Systems Control - avoidance of
challenging people and/or social/sexual
situations
Experiential Processes of Change
For Condom Use By Stage
60
55
CR
DR
ER
SO
SR
50
45
40
35
P
N=113
C
N=257
D
N=124
A
N=143
M
N=191
N=828
Interpersonal Processes
of Change By Stage
60
55
AS
CO
EC
PS
50
45
40
35
P
N=113
C
N=257
D
N=124
N=828
A
N=143
M
N=191
Retention Rates
Assessment/Intervention
N
%
Baseline
833
100
Time 2
470
56.4
Time 3
437
52.5
Time 4
442
53.1
12 months
530
63.6
18 months
500
60.0
% A/M - Condom Use in Baseline
nonusers by Group by Time
50
45
40
35
30
25
20
15
10
5
0
TTM
Std. Care
Baseline
6 months 12 months 18 months
% A/M – ITT Condom Use by Group
by Time (N=494)
30
25
20
TTM
Std. Care
15
10
5
0
Baseline
6 months 12 months 18 months
% A/M - Baseline condom users by
group by time
120
100
80
TTM
Std. Care
60
40
20
0
Baseline
6 months 12 months 18 months
Quit Rates in Smokers by Group
at 18 months (n=88, ns)
40
30
TTM
SC
20
10
0
18 Months
Smoking Uptake among Baseline
Nonsmokers by Group
20
15
TTM
Std. Care
10
5
0
18 months
Step by Step Conclusions
Results support the efficacy of the TTM Tailored
expert system intervention & stage matched
counseling package to increase condom use and
reduce condom relapse in this high risk sample
 Despite lack of statistical significance, smoking
cessation results at 18 months replicated prior
results with adults and adolescents.
 No support for effectiveness of the smoking
prevention intervention.
 Significant initial increases in condom use were
sustained over 18 months, however, control group
caught up.

Remaining Questions?
Would these results generalize to at risk
adults?
 Would condom use results hold up without
the counseling component?

Tailored intervention to increase dualmethod use: an RCT to reduce unintended
pregnancies and STIs
Peipert JF1, Redding CA3, Blume JD2,
Allsworth JE1, Matteson KA2,4, Lozowski
F2,4 , Mayer KH2, Morokoff PJ3, Rossi JS3
1- Washington University, School of Medicine, St. Louis, MO
2 - Brown University, Providence, RI
3 - University of Rhode Island, Kingston, RI
4 - Women and Infants Hospital, Providence, RI
5 - Rhode Island Hospital, Providence, RI
Project PROTECT Study
Dual Method Use
Recruited N=542 at risk women (13-35)
 59% of eligibles recruited
 Tested for STIs before enrollment


If +, treatment & test of cure before enrollment
English speaking
 Avoid pregnancy X 2 years
 < 13 y.o. required parental consent
 RCT

PROTECT Study Timepoints

Baseline – full exam
TTM group - 1 + 2 months sessions
Standard Care – no additional sessions
6 & 18 months phone survey
 12 & 24 months – full survey & exam

PROTECT Baseline Sample
Characteristics (N=542)









Median Age = 22 years
90% Single
25% < H.S. Education (*unbalanced)
22% Black & 17% Hispanic
47% History STI (*unbalanced)
49% History unplanned pregnancy
34% No contraceptive use
33% Hormonal contraceptive use
48% smokers
PROTECT Study Outcomes
TTM
N=272
n (%)
Control
N=270
n (%)
Unadjusted
HRR
Reported
Dual Method
Use
86 (32)
71 (26)
1.38
1.70
(1.00, 1.89) (1.09, 2.66)
Reported
Consistent
Condom Use
124 (46)
124 (46)
1.14
1.26
(0.89, 1.47) (0.88, 1.79)
Any STI or
unintended
pregnancy
95 (35)
93 (34)
1.08
1.19
(0.81, 1.44) (0.79, 1.79)
Adjusted for
propensity
score
(95% CI)
PROTECT Conclusions
TTM Tailored Expert system increased
reported dual method use (~ 70%)
 Smaller effect on condom use (~ 30%
increase) – not significant
 No effect on incident STIs and
unplanned pregnancies

RI Project RESPECT
CA Redding1, PJ Morokoff1, JS Rossi1, KS Meier1,
BB Hoppner1, K Mayer2, B Koblin3, P BrownPeterside3
1 – Psychology Department & CPRC, University of RI
2 - Miriam Lifespan Hosp. & Brown Univ., Providence, RI
3 – New York Blood Center, Bronx, NY
RI Project RESPECT

9 local sites in urban areas

Drug Tx. Programs, STD Clinics
1 site in the Bronx, NY Blood Center
 RCT
 TTM-Tailored ES Feedback compared to
Generic feedback alone
 Intervention at Baseline, 2, 4 months
 Follow-up at 6, 12, 18 months

Participation Criteria
18 - 44 years old & English speaking
 Heterosexually active in past 3 months

unprotected vaginal or anal sex
 At least one opposite sex partner

Not pregnant or trying to get pregnant
 Self report - HIV Negative

Participation Criteria continued

One of the following in the past year:
 3 sexual partners
 diagnosed with an STI (other than HIV)
 a sex partner with 3 sex partners
 a sex partner who is a bisexual male
 a sex partner who has injected drugs
 exchanged sex for money or drugs
Baseline Sample (n=315)
Age mean = 32.2 years (s.d. = 8.1)
 Gender



28% Male
Employment
65% Unemployed
 21% Full-time work
 11% Part-time work
 3% Other
 Education


42.5% < H.S.
More Sample Description

Diversity (matches rates of HIV in RI)
38% White
 33% African American
 23% Hispanic


Relationship Status
86% Unmarried/Separated/Divorced/Widowed
 14% Married or Living With Partner


85% Sexually Active in past 2 months
Behavioral Risks
%
Hx. Of STI
46.4
Used injection drugs
18
Not use condom @ last sex
72
Age of sexual debut
# sex partners in past 30 days
15.25
3.2
Baseline Stages of Condom Adoption
(N=315) At-Risk Sample of M + F
45
40
35
30
25
20
15
10
5
0
PC
40%
C
PR
A
M
41%
14%
5%
-
Expert System Enhancements
New background pictures +
recorded new adult male and
female audio.
 Gender-matched systems
 Added new sections for main and
other partner readiness to use
condoms.

Respect Retention Rates
Assessment/Intervention
Baseline
2 months
4 months
6 months
12 months
18 months
N
%
527
409
338
359
324
278
100
77.6
64.1
68.1
62.2
52.8
Outcomes
- DVs:


# times unprotected sex in past 30
days (n = 267)
% of times safe (includes those not
sexually active in past 30 days)
(n=296)
-
% A/M consistent condom use
Any Stage Progress (N=305)
(N=292)
Baseline to 6 Months X Group # times unprotected sex (N=267)
15
13
11
9
Treatment
Control
7
5
3
1
Baseline
6-Month
6 Mos. - % Time Being Safe
N=296
100%
80%
60%
treatment
control
40%
20%
0%
Baseline
6-Month
% A/M at 6 months
(n=292)
30%
25%
20%
15%
10%
5%
0%


0.246
0.14
Treatment
Control
Includes only Pre-Action Stages at Baseline (PC, C, PR)
10% more progress to A/M in Tx than in Control
Intent to Treat (ITT) Analysis of
% A/M at 6 months (n=448)
30%
25%
20%
15%
10%
5%
0%



0.162
0.091
Treatment
Control
All baseline pre-action S’s included.
Assumes no progress among lost-to-follow-up participants.
Reduces effect from 10% to 7%, still statistically significant.
Any Stage Progress at 6 months
(n=305)
60%
50%
40%
30%
20%
10%
0%

0.551
0.451
Treatment
Control
10% more progress in Treatment than in Control
ITT Analysis of Stage Progress
(N=448)
60%
50%
40%
30%
20%
10%
0%

0.357
Treatment
0.287
Control
~ 7% more progress in Tx than in Control
RI Project RESPECT
Conclusions






We were able to recruit a high risk sample of men
and women from different sites.
We were able to get good proportions (78%) of
the sample to come back for at least 2 sessions.
Retention was a concern.
Results support the 6 month efficacy of the TTM
Tailored expert system to increase condom use in
this high risk sample.
Longer term outcomes look like Step X Step…
Durability of these effects over time?
Differences Across Studies?
Condom use
STI
Study
N d [95% CI]
d [95% CI]
Protect
346 0.140 [0.07–0.35] 0.154 [0.06–0.36]
RI Respect
292 0.461 [0.23–0.69]
Step By Step 622 0.477 [0.32–0.64]
Noar SM, Black HG, Pierce LB. (2009). Efficacy of computer technology-based
HIV prevention interventions: a meta-analysis. AIDS, 23, 107–15.
What’s next?
Process to outcome research
 Compare cross-sectional to longitudinal findings
 Examine predictors of changes over time
 Enhance intervention outcomes


(More sessions? New variables? New behaviors?
More ? )
Enhance retention
 Generalize to additional at risk samples +
settings
 Dissemination & Translation

Useful Intervention Refinement
Process
Focus Groups/ Formative Work
New questions?
Pilot Sample - Measurement work
Efficacy/effectiveness trials
Pilot test intervention