Recommending Strategy by mikesanye

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									 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                New cases/year
All STI’s                 18.9 million
HPV (Genital warts)        5.5 million
Trichomoniasis               5 million
Chlamydia                    3 million
HSV (Genital herpes)         1 million
Gonorrhea                     650,000
Syphilis                       70,000
HIV                           >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             is Y2000 $

  $6.5       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      Maintenance




                    Intermediate Level - Tailored interventions




                   Individual Level-Expert system interventions
Stage-targeted vs. TTM-Tailored
univariate           multivariate (10-15)
group feedback       individual feedback
clinical decisions   empirical decisions
                     normative comparison
                     ipsative comparison
5 different types    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      C       PR     A      M

       13.6%   31.0%   15.0%   17.3%   23.1%
       N=113   N=257   N=124   N=143   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
46                             Cons

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        A       M
      n=113   n=257     n=124   n=143   n=191


                      N=828
     Baseline Sample - Confidence in Condom
              Use (T-scores) by Stage
60


55


50


45


40
          PC         C       P       A       M

          n=113   n=257    n=124   n=143   n=191

                          N=828
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)
       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
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                 Behavioral
      Processes                    Processes



   Thinking, Feeling or
                                      Doing
      Experiencing

 Consciousness Raising        Counterconditioning
 Dramatic Relief              Helping Relationships
 Environmental Reevaluation   Reinforcement Management
 Self Reevaluation            Self Liberation
 Social 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
50
                                              DR
                                              ER
                                              SO
45
                                              SR


40



35
      P       C       D      A       M

     N=113   N=257   N=124   N=143   N=191   N=828
     Interpersonal Processes
       of Change By Stage
60



55

                                                 AS
50                                               CO
                                                 EC
                                                 PS
45



40



35
     P        C          D       A        M

     N=113   N=257       N=124   N=143   N=191
                     N=828
     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
                                                 TTM
  25
                                                 Std. Care
  20
  15
  10
   5
   0
       Baseline   6 months 12 months 18 months
% A/M – ITT Condom Use by Group
by Time (N=494)

  30

  25

  20
                                                 TTM
  15
                                                 Std. Care
  10

  5

  0
       Baseline   6 months 12 months 18 months
% A/M - Baseline condom users by
group by time

    120

    100

     80
                                                    TTM
     60
                                                    Std. Care
     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
  20
                                 SC

  10


  0
              18 Months
Smoking Uptake among Baseline
Nonsmokers by Group
  20


  15

                           TTM
  10
                           Std. Care

  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 dual-
method 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        Control    Unadjusted   Adjusted for
                                     HRR          propensity
               N=272      N=270
                                                  score
               n (%)      n (%)      (95% CI)
 Reported      86 (32)    71 (26)    1.38         1.70
 Dual Method
 Use                                 (1.00, 1.89) (1.09, 2.66)

 Reported      124 (46)   124 (46)   1.14         1.26
 Consistent
 Condom Use                          (0.89, 1.47) (0.88, 1.79)

 Any STI or    95 (35)    93 (34)    1.08         1.19
 unintended
 pregnancy                           (0.81, 1.44) (0.79, 1.79)
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 Brown-
Peterside3


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              15.25
# sex partners in past 30 days     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   C      PR     A     M
       40%   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    N      %
       Baseline           527    100
       2 months           409   77.6
       4 months           338   64.1
       6 months           359   68.1
      12 months           324   62.2
      18 months           278   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      (N=292)
- Any Stage Progress (N=305)
      Baseline to 6 Months X Group -
     # times unprotected sex (N=267)
15
13
11
9                              Treatment
7                              Control
5
3
1
         Baseline    6-Month
  6 Mos. - % Time Being Safe
                  N=296
100%

80%

60%                             treatment
40%                             control

20%

 0%
       Baseline       6-Month
                  % A/M at 6 months
                      (n=292)

    30%                0.246
    25%
    20%                                            0.14
    15%
    10%
     5%
     0%
                  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%                0.162
     15%                                            0.091
     10%
      5%
      0%
                   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)

                    0.551
    60%
                                              0.451
    50%
    40%
    30%
    20%
    10%
     0%
                Treatment                  Control

    10% more progress in Treatment than in Control
ITT Analysis of Stage Progress
(N=448)


    60%
    50%
                   0.357
    40%                                        0.287
    30%
    20%
    10%
     0%
               Treatment                  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

								
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