University of Illinois at Chicago & Howard Brown Health Center Treatment Advocacy Program (TAP) Preliminary report, 7/18/06

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1 University of Illinois at Chicago & Howard Brown Health Center Treatment (TAP) Preliminary report, 7/18/06 David J. McKirnan Jenny Hopwood Principal Investigator Project Coordinator Staff: Charlene Avery-Lewis Jason Bird David Fingerhut Christine Holland Past Staff DJ Jacques Sonia Torres Patty Delaney Advocates: Joe Benjamin Keith Bussy Luis Bustamante Mark Hartfield Jeff Savage Luis Spraggins Interns: Nisha Gabriel Nikki Massey Kelly Meehan-Coussee Jenny Gonzalez Jorge Egal Brian Valasek TAP preliminary report, CDC, 7/18/06. 1

2 Study design 12 Month Randomized Controlled Trial of primary-care based counseling intervention v. standard of care. Intervention: : 4 90-minute free standing sessions, 3-3 month check in visits, 6 and 12 month coping follow-up counseling sessions. Contrast: : normal care, advocates available as needed. Assessments: : baseline, 6-months, 6 12-months. Key outcomes: Any unprotected anal sex Any unprotected anal sex with HIV-negative or HIV-unknown partner ( Transmission( risk ). Recent sexually transmitted disease Treatment adherence Clinical health indicators (Viral load, CD4). TAP preliminary report, CDC, 7/18/06. 2

3 TAP program; core elements Integrated coping & skills intervention Combine sexual safety with treatment adherence, HIV coping, disclosure skills. ongoing coping check-in in & support Behavioral assessment and feedback to primary care provider to patient Integrate measurement into intervention Primary care, continuous contact delivery model DCCT-like approach Para-professional peer model Clear, user friendly [para-professional] professional] protocol Strongly individually tailored plus highly structured TAP preliminary report, CDC, 7/18/06. 3

4 TAP program; ancillary elements Computer administration high stimulus value protocol and measurement fidelity maximized hot button structure of diverse modules Theory based motivational interviewing & cognitive behavioral behavioral funnel Eventual: web-based based ancillary programming TAP preliminary report, CDC, 7/18/06. 4

5 TAP Program: The behavioral funnel Most broad: Basic motivational interviewing approach More focused: Cognitive Behavioral techniques / skills Tailored feedback TAP preliminary report, CDC, 7/18/06. 5

6 TAP approach to coping: complete model Feelings & Moods TAP focuses on three key areas that affect HIV coping Disclosure & Support Coping with Sexuality & Treatment Health & Well Being Alcohol & Drug use TAP preliminary report, CDC, 7/18/06. 6

7 TAP Main Menu Enrollment: Entering the study Coping with HIV Medications Introduction: Welcome to TAP Module 1: Basic Medication Skills Module 2: Advanced Medication Skills Sexual Safety Sponsored By: The University of Illinois at Chicago Howard Brown Health Center, Chicago. Contact: Dr. David J. McKirnan, UIC, Focus topics: HIV Information Basic safety skills Module 1: Module 2: Intimacy & Sexuality Focused Safety Skills HIV communication Alcohol-Drugs Follow-up: Coping Visit Moods & feelings TAP preliminary report, CDC, 7/18/06. 7

8 Education: Sample: Demographics < High school diploma 11.2% High school 14.6% Some college / technical 39.2% College degree 23.5% Any post-college 11.5% Education by group, X 2 (5, n= 260) = 9.7, n.s. Employment Unemployed 51.9% Disability 34.6% Employment by group, X 2 (3, n= 260) <1, n.s. Income 10k 31.2% 10 30K 39.7% 30 60K 21.8% 60K 7.3% Currently employed: mode = 30 40K. Income by group, X 2 (5, n= 260) = 4.8, n.s. TAP preliminary report, CDC, 7/18/06. 8

9 Sample characteristics Ethnicity African-American American 35.4% (n = 102) Latino 14.4% (n = 54) White 47.5% (n = 149) Asian & other 2.7% (n = 11) Ethnicity by group X 2 (3, n= 316) =.9, n.s. Age (M = 40.5, SD = 8.9) % (n = 41) % (n = 94) % (n = 142) % (n = 41) Age by group X 2 (3, n= 318) = 1.6, n.s. TAP preliminary report, CDC, 7/18/06. 9

10 By ethnicity Time since diagnosis African-Americans Americans M = 9.2 Whites M = 7.1 F (2,299) = 3.86, p<.05). Latinos M = 7.2 By Intervention group % of participants Intervention in each time category group Contrast group Overall ½ 3 years 23.1% 36.8% 30.3% 4 9 years 36.7% 24.5% 30.3% 10 years 40.1% 38.7% 39.4% M time Group x time; X 2 (2, n= 310) = 8.6, p<.02. TAP preliminary report, CDC, 7/18/06. 10

11 Study retention Overall (6 months): M follow-up interval 5.8 months; 5-7 months. Retained 81.3% (n= 260 / 320) Not 6 mo. 18.3% 18.3% (n= 60) (12 mo. Retention > 90%) By group: Intervention group 80.4% Contrast group 82.8% Predictors of loss to follow-up: Age & SES n.s. Ethnicity X 2 (1, n=319) =.3, n.s. 80.4% (n= 135 / 168) 82.8% (n= 125 / 151) X 2 (2, n= 305) = 10.2, p<.00 Latino 31.5% LOF African-American American 10.8% White 18.1% Psychosocial vars. n.s. Alcohol & Drug use vars. n.s. Medication adherence n.s. overall TAP preliminary report, CDC, 7/18/06. 11

12 Study Retention: By Treatment Adherence & Group % retained at 6 mo., by group and baseline treatment adherence Intervention group Full adherence 77.7% Any non- adherence 87.2% Contrast group 87.9% 75% Intervention group by adherence, X2 (1, n=319) = 5.65, p<.02). Intervention group: X2 (1, n=168) = 1.2, n.s. Contrast group: X2 (1, n=151) = 4.23, p<.05. TAP preliminary report, CDC, 7/18/06. 12

13 Retention rates for each baseline sexual pattern. Any male partner Primary partner Study retention: By baseline sexual behavior Reported sexual pattern Yes 80.3% 72.7% No 90% 88.8% X 2 2.2, n.s. 13.7, p< 001 Any UPA 81% 81.9% < 1, n.s. Any HIV+ UPA 77.3% 83.7% 2.0, n.s. Transmission Risk % < 1, n.s. TAP preliminary report, CDC, 7/18/06. 13

14 Baseline & 6month characteristics: Medication history Baseline (denominator = complete sample): On Medication 71.2% Medication naïve 18.1% 6 Month: On medication 75.4% Initiated meds 4.7% (n=15 / 260) Stopped meds 1.3% (n=4) Consistent meds 56.6% (n=181) No meds 18.8% (n=60) TAP preliminary report, CDC, 7/18/06. 14

15 Baseline & 6 month characteristics: Sexual patterns % reporting each sexual pattern, by study wave. Baseline 6 Month X 2 (1, n=260) Any male partner 86% 75% 10.3, p<.01 Primary partner 38.8% 40% <1, n.s. Any UPA 47.7% 40% 3.1, n.s. Any HIV+ UPA 32.7% 31.2% <1, n.s. Transmission risk 28.5% 20.8% 4.1, p<.05 Non-adherence 33.1% 24.6% 4.53, p<.05 TAP preliminary report, CDC, 7/18/06. 15

16 Intervention characteristics Module completion: None 3% (n=5) 1 6.5% (n=11) 2 8.9% (n=15) % (n=23) % (n=114) TAP preliminary report, CDC, 7/18/06. 16

17 Intervention effects: Sexual risk Key variables: Any unprotected (receptive( / insertive) anal sex [UPA]. Transmission risk : : UPA with HIV- or HIV unknown partner(s). Binary; ; any partner Continuous; ; approx. # partners, truncated at 98% percentile. Data considerations Continuous variables subjected to square root transformation (raw data skewness >3, reduced to <2). Binary measures tested via General Estimating Equation [GEE] procedure in SAS. Continuous variables via GLM repeated measures in SPSS. All analyses tested intervention group x follow-up wave. SES, ethnicity, age, and follow-up time as covariates. All models tested twice: Full sample Men sexually active at baseline (86% of participants, n=224). TAP preliminary report, CDC, 7/18/06. 17

18 Any unprotected anal sex, complete and sexually active samples. % reporting UPA, by study wave, group, & sub- sample Contrast group Baseline 44% 52.9% Follow-up 42.4% 48.1% Sample Complete Sexually active Intervention group 51.1% 57.5% 37.8% 40% Complete Sexually active Complete sample, n=260, parameter estimate =.56, SE =.28, Z = 1.99, p=.047 Active sample, n = 224, parameter estimate =.60, SE =.30, Z = 2.01, p=.04 TAP preliminary report, CDC, 7/18/06. 18

19 Key covariates of UPA intervention effects Psychosocial and other risk variables were modeled as time-varying covariates of intervention effects Sexual self-efficacy efficacy showed a significant intervention effect F (1,252) = 4.32, p<.04 M sexual self-efficacy efficacy Contrast group Intervention group Baseline Follow- up as did drug use (M alcohol intoxication, use of club & hard drugs) F (1,252) = 5.12, p<.025. M drug use Contrast group Intervention group Baseline Follow- up TAP preliminary report, CDC, 7/18/06. 19

20 Any UPA: Mediating analyses Sexual efficacy & drug use were modeled as time- varying covariates in the GEE analysis of UPA Efficacy was a substantial predictor of UPA over time (parameter estimate =.55, SE =.13, Z = 4.24, p<.000) as was drug use (parameter estimate = 1.07, SE =.33, Z = 3.2, p=001). The addition of efficacy and drug use as covariates reduced the intervention effect to a non-significant level (parameter estimate =.47, SE = 31, Z =.151, p= 13). These results were essentially the same for the sexually active sub-sample. sample. TAP preliminary report, CDC, 7/18/06. 20

21 Any Transmission risk, complete and sexually active samples. % reporting transmission risk, by study wave, group, & sub-sample sample Contrast group Baseline 23% 27.9% Follow-up 23% 26.9% Sample Complete Sexually active Intervention group 33% 37.5% 18.5% 20% Complete Sexually active Complete sample, n=260, parameter estimate =.886, SE =.35, Z = 2.52, p=.012 Active sample, n = 224, parameter estimate =.93, SE =.37, Z = 2.55, p =.011 TAP preliminary report, CDC, 7/18/06. 21

22 Transmission risk: mediating analyses Sexual self-efficacy efficacy had substantial direct effects on transmission risk over time, Parameter estimate =.38, SE =.12, Z = 3.2, p=001 as did drug use, Parameter estimate = 1.16, SE =.30, Z = 3.8, p=.001 Intervention effects on transmission risk was lessened, but still significant with these variables in the model, Parameter estimate =.82, SE =.37, Z = 2.23, p=.026). These results were similar among men who were sexually active at baseline. Efficacy and drug use predicted risk over time, but only partially mediated the intervention effect. TAP preliminary report, CDC, 7/18/06. 22

23 Intervention effects: Number of UPA and Transmission risk partners. Complete sample M # risky partners, by risk index, complete sample. Baseline Follow-up Risk type Contrast group UPA Transmission risk Intervention group UPA Transmission risk # UPA partners, F (1, 242) = 4.95, p =.027 # Transmission risk partners:, F (1, 243) = 5.44, p =.021 TAP preliminary report, CDC, 7/18/06. 23

24 Mediating analyses: continuous measures of risk. UPA partners: : sexual efficacy & drug covariates reduced the intervention effect to a non-significant level, F(1, 248) = 1.66, p=.2. Transmission risk partners: : The covariates also attenuated intervention effects: F (1, 248) = 3.16, p=.08. Sub-sample effects: Intervention effects were the same for the sub-sample sample who were sexually active at baseline. Analyses of covariance showed almost identical results for both samples. TAP preliminary report, CDC, 7/18/06. 24

25 Intervention effects: Treatment adherence (missed visits & medications) % reporting any non-adherence, by adherence index. Baseline Follow-up Adherence index Contrast group 36% 30.7% 31.2% 38.6% Visit or med. Medication Intervention group 30.4% 23.7% 18.5% 19.4% Visit or med. Medication Any missed provider visit or > rare medication miss, n=260, parameter estimate =.47, SE =.34, p=.16 Any > rare medication miss, n = 181 (71% of participants), parameter estimate =.65, SE =.39, p=.10 TAP preliminary report, CDC, 7/18/06. 25

26 Summary At 6 months TAP had modest, but significant effects on sexual activity. Effects are consistent across binary and continuous measures Effects are stronger for transmission risk,, that disregards sero- concordant HIV+ partners Effects somewhat stronger for men who were sexually active at baseline. Intervention effects on risk are mediated by changes in sexual self-efficacy efficacy and drug use. Both measures were modified by the intervention Both measures strongly control overall changes in risk The measures mediate intervention effects. TAP preliminary report, CDC, 7/18/06. 26

27 Summary, cont. Trend toward intervention effects on treatment efficacy Adherence generally high Medication adherence more strongly affected, consistent with intervention content. No effect on: STIs, clinical outcomes STIs common (17% baseline, 13% 6mo.) Time frame may be too short to show change Clinical status generally good for this sample. TAP preliminary report, CDC, 7/18/06. 27

28 Ongoing 12 month data almost done Baseline / modeling papers still on drawing board McKirnan & Fingerhut, expand Fingerhut s s MA thesis: adherence & risk controlled by separate variables Adherence: concrete barriers, efficacy, coping Risk: more MH measures, depression, drug use May require more targeted interventions Holland: qualitative description of active ingredients in session, using SOAP notes & session tapes McKirnan & Tolou-Shams: Interaction of Depression by drug use on risk. Key: dissemination and intervention uptake Applicability in prevention case management context Use of WEB as adjunct or core intervention resource TAP preliminary report, CDC, 7/18/06. 28