E. Bell 1 , S. Tross 2 , A.N.C. Campbell 1,3 , M. Hu 3 , M. Pavlicova 4 , E.V. Nunes 1,3

1. Race/Ethnicity as a Moderator of HIV/STD Sexual Risk Reduction Groups for Women in Substance Abuse Treatment • E. Bell 1, S. Tross2, A.N.C. Campbell1,3, M. Hu 3, M. Pavlicova 4, E.V. Nunes 1,3 • New York State Psychiatric Institute, Columbia University; (2) HIV Center for Clinical and Behavioral Studies, Columbia University; (3) Department of Psychiatry, Columbia University; (4) Department of Biostatistics, • Columbia University. BACKGROUND High-risk sexual behavior is an important vector of the HIV/AIDS epidemic (1), particularly among female substance abusers (2). Effective interventions to reduce unprotected sexual occasions (USO) and increase condom skills in this population are needed (3). Literature suggests race/ethnicity may influence risk behavior and participant response to intervention (4). We therefore performed a secondary analysis on a gender specific randomized controlled multi-site trial of a 5-session HIV/STD risk reduction intervention, Safer Sex Skills Building (SSB), compared to a 1-session Health Education (HE) control (5). SSB was skills-oriented but not ethnically tailored (6). It was hypothesized that race/ethnicity would moderate the intervention effects of SSB: reducing USO and increasing condom use skills among Caucasians but not minorities given the limited emphasis on the role of race, ethnicity, and culture in the intervention. METHODS Participants 515 women enrolled in the National Institute for Drug Abuse (NIDA) Clinical Trials Network (CTN) Safer Sex for Women study. The multi-site randomized trial compared a 5-session gender-specific safer sex skills building (SSB) intervention to a single session HIV/STD health education (HE) group. Seven methadone maintenance and five psychosocial outpatient treatment programs participated. Eligible patients were ≥ 18 years old and reported at least one unprotected vaginal or anal sexual occasion with a male partner within the 6 months prior to study entry. Procedures Following study consent, participants were assessed for sexual risk behavior, psychosocial information, safer sex attitudes and skills, substance use and severity. Participants were then randomized in cohorts of three to eight women to SSB or HE. Measures The primary outcome variable was sexual risk behavior, assessed using the Sexual Experiences and Risk Behavior Assessment Schedule (SERBAS). The SERBAS assesses the number of unprotected vaginal and anal intercourse occasions (USO). Trained research assistants observed and rated male(0-14) and female(0-11) condom skills. Condom use self-efficacy was assessed on the Condom Use Self-Efficacy Scale (0-4). The scale measures beliefs in the ability to protect oneself during sex and to negotiate safer sex. Age, education, and race/ethnicity were collected during the demographic assessment. Data Analysis Four outcome measures were analyzed: unprotected sexual occasions (USO); male and female condom use skills; and condom use self-efficacy. To assess the effect of race/ethnicity and covariates, longitudinal mixed effect models with random effects and fixed effects were used. PROC GLIMMIX in SAS was used for all analyses. Racial/ethnic groups were comprised of Caucasian (n=298), African American/Black (n=125), Hispanic/Latina (n=46), multiracial (n=38), American Indian/Alaska Native (n=6), and Asian/Pacific Islanders (n=1), with one missing case. Due to sample size constraints, it was necessary to combine ethnic groups for analysis. Thus, analyses were completed on comparisons of two groups: (1) Caucasians (n=298) and Non-Caucasian (n=217). (2) For outcomes that yielded significant differences between Caucasians and Non-Caucasians, we conducted further analyses comparing African Americans to Caucasians to help identify whether the African American subgroup was responsible for the initial difference. RESULTS Table 1 displays baseline demographic and clinical characteristics by racial/ethnic subgroup. Table 2 displays model outcomes for each of the four outcome variables. For the primary outcome USO, there was a significant main effect of treatment, reflecting lower USO in the SSB group, but no race/ethnicity by treatment interaction. On the male condom skill outcome, there was a significant interaction between race/ethnicity and time (F(1, 267) = 4.58, p = .033) suggesting that male condom use skill scores among the Non-Caucasian group were significantly higher than Caucasian counterparts at the 6-month follow-up (b=.67, s.e.=0.23, t=2.88, p<.01) (see Figure 1). Restricting the analysis to Caucasians vs. the African Americans subsample, significantly higher male condom use skill scores were found among African Americans compared with Caucasians at the 6-month follow-up (b=.73, s.e.=0.28, t=2.56, p=.01). For the outcome female condom use skills, there was a significant interaction between ethnicity and treatment (F(1,257)=6.94,p<.01). Non-Caucasian women in SSB showed significant increases in female condom use skill scores (b = -0.89, s.e.=0.31, t = -2.87, p<0.01). An analysis restricted to African American and Caucasian subgroups was conducted. The result was a significant race/ethnicity by intervention interaction (F(1, 204)=7.70, p=.006), indicating greater benefit from SSB, compared to HE, among African Americans. (see Figures 2 and 3). For the condom use self-efficacy outcome, there were no significant main effects or interactions found. CONCLUSIONS There was a significant race/ethnicity by intervention interaction for the outcome of female condom use skills. However, it was in the opposite direction to that hypothesized. Non-Caucasian participants in SSB, compared to those in HE, showed significant increases in female condom skill; no intervention differences were detected among Caucasian women. Further, for the outcome of male condom use skills, there was an interaction of race/ethnicity by time, such that at the 6-month follow up, Non-Caucasian participants had greater male condom use skills compared to Caucasian women. The findings suggest a greater response to condom skill building in the Non-Caucasian participants. In addition, these findings may also be a function of the age difference between the Non-Caucasian and the Caucasian participants. Future analyses will address the role of age as a moderator of intervention effects. Larger percentages of the Non-Caucasian group were over 40 years old.Older women may be more experienced, open, as well as interested, in the feasibility of the female condoms.Among women in substance abuse treatment, HIV prevention interventions offering skills building, group support, and empowerment can be effective in promoting safer sexual behavioral change. Tailoring interventions to racial/ethnic values, norms and experiences may enhance efficacy REFERENCES (1) O'Leary A (2000). Women at risk for HIV from a primary partner: Balancing risk and intimacy. Annual Review of Sex Research, 11, 191–234. (2) Wingood G M, DiClemente R J (1998). The influence of psychosocial factors, alcohol, drug use on African American women's high risk sexual behavior. Am J Preventive Medicine, 15, 54–59. (3) Strathdee SA, et al.(2010). HIV and risk environment for injecting drug users: the past, present, and future, Lancet 2010; 376: 268–84. (4) Morrill AC, et al. (1996). Safer sex: Social and psychological predictors of behavioral maintenance and change among heterosexual women. Journal of Consulting and Clinical Psychology, Vol 64(4), 819-828. (5) Tross S, et al. (2008). Effectiveness of HIV/STD Sexual Risk Reduction Groups for Women in Substance Abuse Treatment Programs: Results of a NIDA Clinical Trials Network Trial. J Aquir Immune Defic Syndr. 48(5):581-589. (6) Valdiserri RO, et al. (1992). Structuring HIV prevention service delivery systems on the basis of social science theory. J Community Health.17(5):259-69. AKNOWLEDGMENTS This research was supported by grants from the National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN), 2U10 DA13035 ( Nunes & Rotrose) and K24 DA022412 ( Nunes), T32 DA007294 (Levin). We acknowledge and thank the efforts of research staff at participating treatment programs, and participants who took part in the study. In the preceding 24 months, Dr. Nunes has served on the Lilly advisory board and has received medication from Alkermes/Cephalon, Inc. for research study. Inquiries should be directed to the lead author: Elijah Bell, Ph.D. | Phone: 212-740-3507 | Email: belleli@nyspi.columbia.edu