HIV/STD Safer Skills Groups For Women In Methadone Maintenance or Psychosocial Outpatient Treatment: A NIDA Clinical Trials Network Trial A parallel study to: HIV/STD Safer Skills Groups For Men In Methadone Maintenance or Drug-Free Outpatient Treatment Supported by: NIDA U10 DA CU-Partners/Long Island Node Edward Nunes, MD (P.I.) New York State Psychiatric Institute

Effect Of HIV/STD Safer Skills Groups on Condom Use Self Efficacy and Carrying Condoms: Secondary Outcome Results

Long Island Node Lead Team Susan Tross – Lead Investigator: Don Calsyn – Lead Investigator CTN0018-Men’s Study Aimee Campbell – Co-Project Director Jennifer Manuel – Co-Project Director Lisa Cohen – Co-Project Director Megan Ghiroli – Assistant Project Director Gloria Miele – Training Director Mary Hatch-Maillette – Project Director CTN0018-Men’s Study Edward Nunes – Co-Investigator Jennifer Lima – Regulatory Director Jim Robinson – Director, Data Management Center Martina Pavlicova, Mei-Chen Hu, Weijin Gan, Nancy Nugent, Eva Petkova – Statisticians Karen Loncto – QA Director Nabila El-Bassel – Intervention Specialist

Community Treatment Program (CTP) Partners Methadone Maintenance (N=7) Thomas Jefferson (Philadelphia, PA) Consortium (Philadelphia, PA) Hartford Dispensary (New Britain, CT) Staten Island University Hospital (Staten Island, NY) SouthLight (Raleigh, NC) Bay Area Addiction, Research & Treatment (La Puente, CA) Evergreen Treatment Services (Seattle, WA) Outpatient Psychosocial (N=5) SouthLight (Raleigh, NC) Alcohol and Drug Services (Greensboro, NC) Compass (Toledo, OH) Prestera Center (Huntington, WV) Lexington/Richland Alcohol and Drug Abuse Council (Columbia, SC)

Background & Rationale Heterosexual women are among the fastest growing subgroups of people with AIDS in the US While female AIDS cases due to injection drug use have declined (32%), cases due to heterosexual transmission have increased (66%) Partner risk factors in heterosexual transmission: partner that is an IDU (19.8%) Condom use self-efficacy is a factor commonly associated with sexual risk reduction behavior * Having condoms can be a key factor in condom use Centers for Disease Control and Prevention, 2004

Skills Underlying Safer Sex Sense of self-efficacy about trying safer sex (Marin et al., 1998) Problem-solving skills Negotiation and refusal skills – in as much as male condoms are controlled by men Skills for acquiring and using male and female condoms Eroticizing safer sex skills Partner abuse risk assessment and safety planning

Theory Social Cognitive Learning Theory: Behavior is learned through the social processes of observation, modeling, skill rehearsal, and feedback, especially with one’s peer group, and sustained by the self-efficacy arising from these Empowerment Theory: Individuals are empowered to action by the processes of: skill mastery; peer support; and ability to impact on one’s world

Study Aims To assess the effectiveness of an evidence-based safer sex skills group intervention for women in 12 CTN community treatment programs on: –Primary Outcome: Number of unprotected (vaginal and anal) sex occasions (USO) in past 3 months –Secondary Outcomes: –Condom Use Self-Efficacy – to be presented today –Proportion of sex-with-drug-or-alcohol-occasions of all sex occasions –Proportion of protected sex occasions of all sex occasions --Carrying condoms – to be presented today --Gender role beliefs

Study Design Baseline Assessment Eligibility HIV Education (HE) (1 Session) Safer Sex Skills Building (SSB) (5 Session) Cohort Randomization 3 Month FU 6 Month FU Post Treatment

Sample Inclusion Criteria Participating in CTP drug treatment Unprotected vaginal or anal sex occasion (USO) in past 6 months Willing to participate in randomized trial Understand and speak English Exclusion Criteria Immediately planning pregnancy Cognitive impairment affecting participation (MMSE Score)

Methods Repeated measures assessment at baseline and 3- and 6- month follow-up of two secondary outcomes: –Condom Use Self Efficacy Scale (Marin, Tschann, Gomez, & Gregorich 1998) score: 11 (5-point Likert scale) items (Range: 0 – 44) --Carrying Condoms (Yes/No) dichotomous rating

Intervention Outlines

Baseline Characteristics* *No significant differences between SSB and HE on any characteristic

Primary Outcome Results (Tross et al., 2008) Reduced frequency of USO was observed in both SSB and HE intervention conditions at 3- month follow-up However, at 6 month follow-up, whereas this decline held in the SSB intervention, there was an increase in USO in the HE condition (F=67.2, p<.0001)(Effect Size=.42)

Observed (Baseline) and Predicted Means (3- and 6-Months) For USO

Secondary Outcome Question: Does Intervention Affect Condom Use Self-Efficacy (CUSE)? Approach: Random Effects Modeling Of Time X Intervention Effects Covariates: Baseline CUSE score, monogamy status

Analysis of Condom Use Self- Efficacy: 2-Way Interaction Model EffectBetaSEF ValuePr>F Baseline CUSE <.0001 Monogamy.68, Intervention Time Time*Intervention

Modeled Intervention Effect On Condom Use Self-Efficacy Score (CUSE)

Intervention Effect At 6-month follow-up, there was a trend toward significance in CUSE increase, favoring the SSB condition (p<.06) *There was no significant monogamy effect on CUSE score (p =.12)

Secondary Outcome Analysis: Does intervention affect carrying condoms? Approach: Logistic regression model Covariates: Baseline probability of not carrying condoms, monogamy status, methadone versus psychosocial treatment program

Analysis of Probability of Not Carrying Condoms Effect AOR C.I. F Value P Baseline probability <.0001 Monogamy Drug Treatment Type – Intervention Time

Modeled Intervention Effect On Probability Of Not Carrying Condoms

Intervention Effect There was a significant intervention effect on probability of not carrying condoms at 3-month and 6-month follow- up (p =.002). But, there was no significant change between these differences over time (p=.29). *There was no monogamy effect on probability of not carrying condoms (p =.16) *There was no type-of-drug-treatment effect on probability of not carrying condoms (p =.12)

Conclusion While SSB, as compared to HE, was associated with significant decrease in unprotected sexual occasions at 6-month follow-up, It was associated only with a trend toward significant improvement in condom use self- efficacy, and It was associated with significant differences in probability of not carrying condoms at 3- and 6- month follow-up; but, these differences did not significantly change over time.

Implications Safer sexual behavior is the result of a diverse cluster of factors – variably impacted by a skills building intervention It is possible that self-efficacy requires more emphasis on psychological empowerment, and less on interpersonal and behavioral skill Especially among women who have access to condoms (e.g. as might those in drug treatment), obtaining and carrying condoms is an instrumental step in the chain of behavior leading to safer sex