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Population-based Interventions to Improve Sexual Health: Development and Evaluation Colleen A. Redding, Ph.D. Cancer Prevention Research Center University.

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Presentation on theme: "Population-based Interventions to Improve Sexual Health: Development and Evaluation Colleen A. Redding, Ph.D. Cancer Prevention Research Center University."— Presentation transcript:

1 Population-based Interventions to Improve Sexual Health: Development and Evaluation Colleen A. Redding, Ph.D. Cancer Prevention Research Center University of Rhode Island

2 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 ,000 70,000 >40,000

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

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

5 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

6 Group Level - Same intervention for all Stage Level - Targeted interventions PrecontemplationContemplationPreparationActionMaintenance Intermediate Level - Tailored interventions Individual Level-Expert system interventions Different Levels of Targeting/Tailoring

7 Stage-targeted vs. TTM-Tailored

8 Benefits of Expert System Interventions l Provide highly individualized feedback l Appropriate for those at all stages of change, (not only prepared to change) l Potentially cost-effective l Integrate multiple risk behaviors l Multimedia components l Confidentiality l Force explicit (testable) decision rules l High Fidelity

9 Efficacy of TTM-Tailored Interventions for Single Health Behaviors Smoking Cessation Smoking Cessation Healthy Diet Healthy Diet Physical Activity Physical Activity Sun Protection Sun Protection Medication Adherence Medication Adherence Stress/Depression Management Stress/Depression Management Mammography screening Mammography screening School Bullying School Bullying

10 Efficacy of TTM-Tailored Tx with Multiple Behaviors Smoking, Diet, Sun Protection Smoking, Diet, Sun Protection Smoking, Diet, Sun, Mammography Smoking, Diet, Sun, Mammography Smoking, Diet, Blood Glucose Monitoring Smoking, Diet, Blood Glucose Monitoring Smoking, Diet, Physical Activity, Stress Smoking, Diet, Physical Activity, Stress Diet, Physical Activity Diet, Physical Activity

11 Steps in the Intervention Development Process Focus Groups Focus Groups Learn language and how participants think about the area. Learn language and how participants think about the area. Pilot Sample Pilot Sample Validate measurement structure of constructs Validate measurement structure of constructs Normative database Normative database Assess variables that differentiate stages Assess variables that differentiate stages Develop Prototype – test - retest Develop Prototype – test - retest Pilot test intervention Pilot test intervention Efficacy/effectiveness trial (s) Efficacy/effectiveness trial (s)

12 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 Cancer Prevention Research Center, University of RI 2 - Family Planning Council, Philadelphia, PA

13 Human Papillomavirus - HPV The most prevalent STI in the U.S. The most prevalent STI in the U.S. Prevalence highest among year old women (14% - 50%) (men not studied well) Prevalence highest among year old women (14% - 50%) (men not studied well) Some HPV subtypes cause genital cancers Some HPV subtypes cause genital cancers > 99% of cervical cancers have HPV DNA detected within the tumor > 99% of cervical cancers have HPV DNA detected within the tumor HPV associated with penile, anal, and oral cancers HPV associated with penile, anal, and oral cancers New HPV vaccine protects against 4 types New HPV vaccine protects against 4 types

14 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 y.o. Teens - informed assent/consent - parental consent not needed Randomized clinical trial

15 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

16 Sexual Risks % Age of sexual debut  y.o Hx. Chlamydia 20.5 Hx. Gonorrhea 10.3 Hx. HPV, Herpes, or Syphilis 9.4 Hx. Pregnancy (at least one) 36.0

17 Urban Female Teens (N=828) Stages of Condom Adoption 13.6% N= % N= % N= % N= % N=191

18 Pros and Cons of Condom Use PROSCONS BENEFITSCOSTS NOT to use condoms To use condoms REASONS Weight of the positive and negative aspects of behavior change

19 Functional Relationship Stages & Pros + Cons

20 Baseline Sample - Pros & Cons of Condom Use (T-scores) by Stage n=113n=257n=124n=143n=191 N=828 Pros Cons

21 Baseline Sample - Confidence in Condom Use (T-scores) by Stage n=113n=257n=124n=143n=191 N=828

22 TTM-Tailored Expert Systems for Condom Use & Smoking n For use in Family Planning Clinics n Mouse input (no keyboard!) n On-screen and printed feedback n Printed feedback for both participant and her clinic counselor n Smoking system appropriate for both smokers (cessation) and nonsmokers (prevention)

23 TTM Tailored Intervention Package Interactive assessment and expert system feedback (onscreen & printed) Interactive assessment and expert system feedback (onscreen & printed)  Condom Use Promotion  Smoking Cessation OR Prevention Tailored feedback based on: Tailored feedback based on:  Stages of change  Pros & Cons  Confidence or Temptation  Processes of Change Stage-Matched Counseling Stage-Matched Counseling

24 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. 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. Standard family planning counseling on birth control and condom use.

25 Stage-matched Counseling Can be used with teens at all stages of change, not only those ready for action Can be used with teens at all stages of change, not only those ready for action Comparable to Motivational Interviewing Comparable to Motivational Interviewing Counselors match Process exercises to stage using Manual 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 Counselor received printed output from computer with client’s stage of change and processes to work on

26 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

27 Processes of Change Consciousness Raising Dramatic Relief Environmental Reevaluation Self Reevaluation Social Liberation Counterconditioning Helping Relationships Reinforcement Management Self Liberation Stimulus Control Experiential Processes Doing Behavioral Processes Thinking, Feeling or Experiencing

28 Newer Interpersonal Processes Condom Communication - talking about condom use Condom Communication - talking about condom use Condom Assertiveness - insisting on condom use Condom Assertiveness - insisting on condom use Eroticizing Condoms - finding ways of making using condoms more enjoyable Eroticizing Condoms - finding ways of making using condoms more enjoyable Partner Support - getting partner’s support for condom use Partner Support - getting partner’s support for condom use Interpersonal Systems Control - avoidance of challenging people and/or social/sexual situations Interpersonal Systems Control - avoidance of challenging people and/or social/sexual situations

29 Experiential Processes of Change For Condom Use By Stage N=113N=257N=124N=143N=191 N=828

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

31 Retention Rates Assessment/Intervention N% Baseline Time Time Time months months

32 % A/M - Condom Use in Baseline nonusers by Group by Time

33 % A/M – ITT Condom Use by Group by Time (N=494)

34 % A/M - Baseline condom users by group by time

35 Quit Rates in Smokers by Group at 18 months (n=88, ns)

36 Smoking Uptake among Baseline Nonsmokers by Group

37 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 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. 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. 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. Significant initial increases in condom use were sustained over 18 months, however, control group caught up.

38 Remaining Questions? Would these results generalize to at risk adults? Would these results generalize to at risk adults? Would condom use results hold up without the counseling component? Would condom use results hold up without the counseling component?

39 Tailored intervention to increase dual- method 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

40 Project PROTECT Study Dual Method Use Recruited N=542 at risk women (13-35) Recruited N=542 at risk women (13-35) 59% of eligibles recruited 59% of eligibles recruited Tested for STIs before enrollment Tested for STIs before enrollment If +, treatment & test of cure before enrollment If +, treatment & test of cure before enrollment English speaking English speaking Avoid pregnancy X 2 years Avoid pregnancy X 2 years < 13 y.o. required parental consent < 13 y.o. required parental consent RCT RCT

41 PROTECT Study Timepoints Baseline – full exam Baseline – full exam TTM group months sessions Standard Care – no additional sessions 6 & 18 months phone survey 6 & 18 months phone survey 12 & 24 months – full survey & exam 12 & 24 months – full survey & exam

42 PROTECT Baseline Sample Characteristics (N=542) Median Age = 22 years Median Age = 22 years 90% Single 90% Single 25% < H.S. Education (*unbalanced) 25% < H.S. Education (*unbalanced) 22% Black & 17% Hispanic 22% Black & 17% Hispanic 47% History STI (*unbalanced) 47% History STI (*unbalanced) 49% History unplanned pregnancy 49% History unplanned pregnancy 34% No contraceptive use 34% No contraceptive use 33% Hormonal contraceptive use 33% Hormonal contraceptive use 48% smokers 48% smokers

43 [1][1] All main effects of variables in Table 3 and most 2-way interactions TTM N=272 n (%) Control N=270 n (%) Unadjusted HRR (95% CI) Adjusted for propensity score Reported Dual Method Use 86 (32)71 (26)1.38 (1.00, 1.89) 1.70 (1.09, 2.66) Reported Consistent Condom Use 124 (46) 1.14 (0.89, 1.47) 1.26 (0.88, 1.79) Any STI or unintended pregnancy 95 (35)93 (34)1.08 (0.81, 1.44) 1.19 (0.79, 1.79) PROTECT Study Outcomes

44 PROTECT Conclusions TTM Tailored Expert system increased reported dual method use (~ 70%) TTM Tailored Expert system increased reported dual method use (~ 70%) Smaller effect on condom use (~ 30% increase) – not significant Smaller effect on condom use (~ 30% increase) – not significant No effect on incident STIs and unplanned pregnancies No effect on incident STIs and unplanned pregnancies

45 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 RI Project RESPECT

46 9 local sites in urban areas 9 local sites in urban areas Drug Tx. Programs, STD Clinics Drug Tx. Programs, STD Clinics 1 site in the Bronx, NY Blood Center 1 site in the Bronx, NY Blood Center RCT RCT TTM-Tailored ES Feedback compared to Generic feedback alone TTM-Tailored ES Feedback compared to Generic feedback alone Intervention at Baseline, 2, 4 months Intervention at Baseline, 2, 4 months Follow-up at 6, 12, 18 months Follow-up at 6, 12, 18 months

47 Participation Criteria years old & English speaking years old & English speaking Heterosexually active in past 3 months Heterosexually active in past 3 months unprotected vaginal or anal sex unprotected vaginal or anal sex At least one opposite sex partner At least one opposite sex partner Not pregnant or trying to get pregnant Not pregnant or trying to get pregnant Self report - HIV Negative Self report - HIV Negative

48 Participation Criteria continued One of the following in the past year: One of the following in the past year: 3 sexual partners 3 sexual partners diagnosed with an STI (other than HIV) diagnosed with an STI (other than HIV) a sex partner with 3 sex partners a sex partner with 3 sex partners a sex partner who is a bisexual male a sex partner who is a bisexual male a sex partner who has injected drugs a sex partner who has injected drugs exchanged sex for money or drugs exchanged sex for money or drugs

49 Baseline Sample (n=315) Age mean = 32.2 years (s.d. = 8.1) Age mean = 32.2 years (s.d. = 8.1) Gender Gender 28% Male 28% Male Employment Employment 65% Unemployed 65% Unemployed 21% Full-time work 21% Full-time work 11% Part-time work 11% Part-time work 3% Other 3% Other Education Education 42.5% < H.S. 42.5% < H.S.

50 More Sample Description Diversity (matches rates of HIV in RI) Diversity (matches rates of HIV in RI) 38% White 38% White 33% African American 33% African American 23% Hispanic 23% Hispanic Relationship Status Relationship Status 86% Unmarried/Separated/Divorced/Widowed 86% Unmarried/Separated/Divorced/Widowed 14% Married or Living With Partner 14% Married or Living With Partner 85% Sexually Active in past 2 months 85% Sexually Active in past 2 months

51 Behavioral Risks % Hx. Of STI 46.4 Used injection drugs 18 Not use last sex 72 Age of sexual debut # sex partners in past 30 days 3.2

52 Baseline Stages of Condom Adoption (N=315) At-Risk Sample of M + F 40%41%14%5%-

53 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.

54 Respect Retention Rates Assessment/Intervention N% Baseline months months months months months

55 Outcomes - DVs: # times unprotected sex in past 30 days (n = 267) # times unprotected sex in past 30 days (n = 267) % of times safe (includes those not sexually active in past 30 days) (n=296) % 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)

56 Baseline to 6 Months X Group - # times unprotected sex (N=267)

57 6 Mos. - % Time Being Safe N=296

58 % A/M at 6 months (n=292) Includes only Pre-Action Stages at Baseline (PC, C, PR) Includes only Pre-Action Stages at Baseline (PC, C, PR) 10% more progress to A/M in Tx than in Control 10% more progress to A/M in Tx than in Control

59 Intent to Treat (ITT) Analysis of % A/M at 6 months (n=448) All baseline pre-action S’s included. All baseline pre-action S’s included. Assumes no progress among lost-to-follow-up participants. Assumes no progress among lost-to-follow-up participants. Reduces effect from 10% to 7%, still statistically significant. Reduces effect from 10% to 7%, still statistically significant.

60 Any Stage Progress at 6 months (n=305) 10% more progress in Treatment than in Control 10% more progress in Treatment than in Control

61 ITT Analysis of Stage Progress (N=448) ~ 7% more progress in Tx than in Control ~ 7% more progress in Tx than in Control

62 RI Project RESPECT Conclusions We were able to recruit a high risk sample of men and women from different sites. 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. We were able to get good proportions (78%) of the sample to come back for at least 2 sessions. Retention was a concern. 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. 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… Longer term outcomes look like Step X Step… Durability of these effects over time? Durability of these effects over time?

63 Condom use STI Study N d [95% CI] d [95% CI] Protect [0.07–0.35] [0.06–0.36] RI Respect [0.23–0.69] Step By Step [0.32–0.64] Differences Across Studies? Noar SM, Black HG, Pierce LB. (2009). Efficacy of computer technology-based HIV prevention interventions: a meta-analysis. AIDS, 23, 107–15.

64 What’s next? Process to outcome research Process to outcome research Compare cross-sectional to longitudinal findings Compare cross-sectional to longitudinal findings Examine predictors of changes over time Examine predictors of changes over time Enhance intervention outcomes Enhance intervention outcomes (More sessions? New variables? New behaviors? More ? ) (More sessions? New variables? New behaviors? More ? ) Enhance retention Enhance retention Generalize to additional at risk samples + settings Generalize to additional at risk samples + settings Dissemination & Translation Dissemination & Translation

65 Focus Groups/ Formative Work Pilot Sample - Measurement work Pilot test intervention Efficacy/effectiveness trials Useful Intervention Refinement Process New questions?


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