Colleen A. Redding, Ph.D.
Cancer Prevention Research Center
University of Rhode Island

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

 $9.3
–15.5 Billion per year in direct medical costs only
 8 STIs
(HIV, HPV, HSV2, HepB, Chlamydia,
Gonorrhea, Syphillis, Trichomoniasis)
 estimate is Y2000 $
 $6.5 Billion among 15-24 yr. olds
(Chesson et al., 2004)


Intentional Behavior Change
•
Stages of Change
•
Decisional Balance
•
Situational Efficacy / Temptations
•
Processes of Change

Different variables important for each stage transition

 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 Maintenance
Intermediate Level Tailored interventions
Individual LevelExpert system interventions

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

 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






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 Redding 1 , JO Prochaska 1 , JS Rossi 1 , K
Armstrong 2 , D Coviello 2 , UE Pallonen 1 , K
Evers 1 , WF Velicer 1 , & L Ruggiero 1
1 - Cancer Prevention Research Center, University of RI
2 - Family Planning Council, Philadelphia, PA

 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

 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

(N=831)
Race/Ethnicity
Black / African-American
White / European-American
Hispanic / Latina
Native American
Other / Multiracial
%
81.0
7.3
7.8
1.4
1.8

Age of sexual debut  13-14 y.o.
Hx. Chlamydia
Hx. Gonorrhea
Hx. HPV, Herpes, or Syphilis
Hx. Pregnancy (at least one)
%
62.7
20.5
10.3
9.4
36.0

(N=828)
35
30
25
20
15
10
5
0
PC C PR A M
13.6%
N=113
31.0%
N=257
15.0%
N=124
17.3%
N=143
23.1%
N=191

Weight of the positive and negative aspects of behavior change
PROS
BENEFITS
CONS
COSTS
REASONS
To use condoms NOT to use condoms

56
54
52
50
48
46
44
PC C PR A M
Pros
Cons

Baseline Sample - Pros & Cons of Condom
Use (T-scores) by Stage
55
Pros
50
Cons
45
40
PC n=113
C n=257
P n=124
N=828
A n=143
M n=191

55
50
45
60
Baseline Sample - Confidence in Condom
Use (T-scores) by Stage
40
PC n=113
C P n=257 n=124
N=828
A n=143
M n=191

 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)


Condom Use Promotion
Smoking Cessation OR Prevention
 Tailored feedback based on:




Stages of change
Pros & Cons
Confidence or Temptation
Processes of Change
 Stage-Matched Counseling


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.


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

• 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

Experiential
Processes
Behavioral
Processes
Thinking, Feeling or
Experiencing
Consciousness Raising
Dramatic Relief
Environmental Reevaluation
Self Reevaluation
Social Liberation
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
40
35
50
45
60
55
CR
DR
ER
SO
SR
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
50
45
40
35
P
N=113
C D
N=257
N=124
N=828
A
N=143
M
N=191
AS
CO
EC
PS

Assessment/ Intervention
Baseline
Time 2
Time 3
Time 4
12 months
18 months
N
833
470
437
442
530
500
%
100
56.4
52.5
53.1
63.6
60.0

% A/M - Condom Use in Baseline nonusers by Group by Time
50
25
20
15
10
5
0
45
40
35
30
Baseline 6 months 12 months 18 months
TTM
Std. Care

% A/M – ITT Condom Use by Group by Time
(N=494)
30
25
20
15
10
5
0
Baseline 6 months 12 months 18 months
TTM
Std. Care

% A/M - Baseline condom users by group by time
120
100
80
60
40
20
0
Baseline 6 months 12 months 18 months
TTM
Std. Care

Quit Rates in Smokers by Group at 18 months
(n=88, ns)
40
30
20
10
0
18 Months
TTM
SC

Smoking Uptake among Baseline
Nonsmokers by Group
20
15
10
5
0
TTM
Std. Care
18 months





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.


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 JF 1 , Redding CA 3 , Blume JD 2 ,
Allsworth JE 1 , Matteson KA 2,4 , Lozowski
F 2,4 , Mayer KH 2 , Morokoff PJ 3 , Rossi JS 3
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


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 (%)
Reported
Dual Method
Use
86 (32)
Reported
Consistent
Condom Use
124 (46)
Any STI or unintended pregnancy
95 (35)
Control
N=270 n (%)
71 (26)
124 (46)
93 (34)
Unadjusted
HRR
Adjusted for propensity score
(95% CI)
1.38
(1.00, 1.89)
1.70
(1.09, 2.66)
1.14
(0.89, 1.47)
1.26
(0.88, 1.79)
1.08
(0.81, 1.44)
1.19
(0.79, 1.79)


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

CA Redding 1 , PJ Morokoff 1 , JS Rossi 1 , KS Meier 1 ,
BB Hoppner 1 , K Mayer 2 , B Koblin 3 , P Brown-
Peterside 3
1 – Psychology Department & CPRC, University of RI
2 - Miriam Lifespan Hosp. & Brown Univ., Providence, RI
3 – New York Blood Center, Bronx, NY


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


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


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





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.


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

Hx. Of STI
Used injection drugs
Not use condom @ last sex
Age of sexual debut
# sex partners in past 30 days
%
46.4
18
72
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
41%
PR
14%
A
5% -
M


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.

Assessment/ Intervention
Baseline
2 months
4 months
6 months
12 months
18 months
N %
527 100
409 77.6
338 64.1
359 68.1
324 62.2
278 52.8

-
-
- 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
(N=292)
Any Stage Progress
(N=305)

9
7
5
3
1
15
13
11
Baseline to 6 Months X Group -
# times unprotected sex (N=267)
Treatment
Control
Baseline 6-Month

6 Mos. - % Time Being Safe
N=296
100%
80%
60%
40%
20%
0% treatment control
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.

(n=305)
60%
50%
40%
30%
20%
10%
0%
0.551
0.451
Treatment Control

10% more progress in Treatment than in Control

(N=448)
60%
50%
40%
30%
20%
10%
0%
0.357
0.287
Treatment Control

~ 7% more progress in Tx than in Control







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.








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

Focus Groups/ Formative Work
New questions?
Pilot Sample - Measurement work
Efficacy/effectiveness trials
Pilot test intervention