NIMH/NIAID September 2013

1. Studying Effectiveness and Implementation of Evidence-Based, Research-Developed Programs in Routine Care Settings:The NIMH Eban II Study(R01 MH093230)Gail E. Wyatt, Ph.D.Professor, Dept. of Psychiatry & Biobehavioral Sciences UCLA Semel Institute for Neuroscience and Human Behavior Director, UCLA Sexual Health Program Director, Center for Culture, Trauma and Mental Health DisparitiesCo-Director, HIV/AIDS, Substance Abuse and Trauma Training Program (HA-STTP)Associate Director, UCLA AIDS Institute Director, UCLA HIV/AIDS Translational Training Program (HATT) Clinical Psychologist Sex TherapistSenior Cobb Fellow in Health Disparities NIMH/NIAID September 2013

2. Eban II Research TeamPI: Gail E. Wyatt, Ph.D., UCLA Consultants: C. Hendricks Brown, Ph.D., University of Miami Thomas Coates, Ph.D., UCLA Nabila El-Bassel, D.S.W., Columbia University, NY Nan Laird, Ph.D., Harvard University Community Partners: AIDS Healthcare Foundation AIDS Project Los Angeles Spectrum/O.A.S.I.S. CAL PEP WORLD HEPPAC EBAC Allen Temple Baptist Church Tarzana Treatment Center T.H.E. Clinic Co-Investigators: Alison B. Hamilton, Ph.D., M.P.H., UCLA David Holtgrave, Ph.D., Johns Hopkins Honghu Liu, Ph.D., UCLA Brian Mittman, Ph.D., VA & Kaiser Hector F. Myers, Ph.D., UCLA & Vanderbilt John K. Williams, M.D., UCLA Project Coordinators: Alicia Eccles, M.P.H. (Southern CA) Craig Hutchinson, M.P.H. (Northern CA) Administrative Support: Louise Datu

3. Objectives • To provide an example of a NIMH-funded “hybrid” implementation/effectiveness study in order to illustrate challenges associated with study design & methods, including: • complexities of community-based settings in the current fiscal environment • novel features of the hybrid approach and how it fills the need for multiple foci on prevention

4. Background • HIV/AIDS epidemic disproportionately impacts African American communities • High rates of sexually transmitted infections among African Americans • HIV infection rates in California rank 3rd in the U.S. • Few couples-based interventions focused on reducing risky sexual behaviors, increasing condom use, and reducing STI/HIV transmission • Interventions have not focused specifically on heterosexual African Americans and their disproportionate HIV risk • Uneven sustainability of evidence-based practices in CBOs • The NIMH-funded Eban (Yoruba for “fence”) risk reduction intervention was designed to fill the gap • RCT with 535 couples demonstrated efficacy in reducing rates of unprotected sex and increased rates of condom use at post-test, 6- and 12-month follow-ups (El-Bassel et al., Arch Intern Med. 2010)

5. Moving Eban into Practice (Eban II) R01 MH093230 • Given established efficacy, it was appropriate to move Eban into practice in community-based organizations (CBOs) • This shift requires reciprocal, multidirectional information and technology exchange between the research team and the collaborating CBOs • The long-term goal is to facilitate large-scale implementation of Eban II in CBOs that serve HIV-positive populations and at-risk African Americans • need to understand barriers and facilitators to adoption and implementation of Eban with high fidelity • need to obtain preliminary evidence of the effectiveness of specific strategies to facilitate adoption • Our goal: To reduce HIV and STI transmission among African American HIV sero-discordant couples.

6. “Hybrid” Study Design • Goal: clinically beneficial outcomes, not just statistically significant, evidence-based practice • Understand black box of implementation • Identify outstanding research questions • Use implementation strategy to achieve/assess Eban’s potential • Develop a sustainable intervention • Challenges: • Rapid timeline and limited resources • Real-time focus on potential and actual influences on the progress and effectiveness of implementation efforts • Activities during the study to refine implementation efforts, resolve mutable barriers, and enhance available facilitators • Rigidity of the IRB process From Curran et al., Med Care. 2012

7. Eban II Aims • Implementation Aims: • To facilitate implementation of Eban II in 10 CBOs in California • employ a theory-guided strategy to partner with CBOs that will expose providers to the intervention • facilitate its adoption and delivery with high fidelity • sustain use for 9months following the active implementation phase • Using mixed methods to: • document the implementation process and process evaluation • identify barriers and facilitators to adoption, fidelity, and sustainability. • Effectiveness Aim: • To evaluate the effect of Eban II on the following behavioral and biological outcomes among 180 couples: • incidents of protected sex • proportion of condom use • Incidents of STIs (syphilis, gonorrhea & Chlamydia) • Novel Secondary Aims: • To determine the cost-effectiveness of the Eban II intervention based on implementation costs and potential cost savings • To monitor how effectively agencies sustain the Eban II intervention within the context of real-world realities

8. Design Overview • Protocol-based implementation approach • Conceptual guidance from the Program Change Model (Simpson & Flynn, J Subst Abuse Treat. 2007) • model of phased organizational change from exposure to adoption, implementation, and sustainability • Novel Culturally Congruent Design • Eban is attractive because it is a unique program developed specifically for African American heterosexual couples with cultural messages and tools that were tailored to address the realities of urban African American couples affected by HIV. • Collectivism & Cohesion complement implementation theory.

9. Phase 1: Training & Pre-Implementation

10. Implementation Aim: Organizational Survey • Staff Survey • Web-based, individualized link to SurveyMonkey • Completed by staff (target n=100) who provide direct client care • One time only, at baseline; approx 30 min to complete • Assesses • Organizational climate (Simpson) • Attitudes toward evidence-based practices (Aarons) • Burnout (Maslach) • Familiarity with treatment of couples • Helps to understand organizational settings where Eban II will be delivered to couples • Semi-Structured Interviews • Pre- & post-implementation, and post-sustainability • Key stakeholders (n~50) at participating CBOs

11. Organizational Survey: Preliminary Results • Ongoing (open through Sept 2013) • Sample to date • n=96 non-clerical staff members (representing 12 agencies) • Demographics • Mean age: 43 • Gender: 55% female • Ethnicity: 41% African American, 39% White, 9% Alaskan Native, 5% multiethnic, 3% Mexican, 3% Asian/Pacific Islander • Education: 52% BA or higher • Employment characteristics • Years at job: 47% 3-5 years • Years working in HIV/AIDS: 65% over 5 years • # of clients on caseload: 38% >40 clients

12. Organizational Survey: preliminary results (cont.)

13. Organizational Survey: preliminary results (cont.) Evidence-Based Practices Attitudes Scale (EBPAS): 15 items Scale: 0-4 (Not at allA very great extent) Requirement: extent to which provider would adopt an EBP if it were required by an agency, supervisor, or state Appeal: extent to which provider would adopt an EBP if it were intuitively appealing, could be used correctly, or was being used by colleagues who were happy with it Openness: extent to which provider is generally open to trying new interventions and would be willing to try or use more structured or manualized interventions Divergence: extent to which provider perceives EBPs as not useful and less important than clinical experience

14. Organizational Survey: preliminary results (cont.) Maslach Burnout Inventory (22 items) Scale: 0-6 (Neverevery day) Emotional exhaustion example: “I feel frustrated by my job.” Personal accomplishment example: “I feel I’m positively influencing other people’s lives through my work.” Depersonalization example: “I don’t really care what happens to some of my patients.”

15. Phase 2: Adoption & Implementation

16. Effectiveness Aim: Eligibility Criteria • Eligibility of couples: • Heterosexual • HIV serodiscordant • At least one partner identifies as African American • Age 18 – 60 • In a relationship for ≥ 3 months • Unprotected sex within the last 3 months • No plans to relocate beyond a reasonable distance • Willing to complete the study even if relationship ends • English speakers • Not pregnant/planning a pregnancy • Willing to fully participate for ≥ 8 months

17. Progress to Date • Recruited 39 couples • 20 couples were ineligible due to • homosexual/transgender • domestic violence • break-ups • 6 couples are scheduled for eligibility screening • 6 couples have completed screening and await confirmation of HIV/STI status to complete enrollment • 7 couples have completed enrollment

18. Phase 3: Sustainability

19. Novel Effectiveness Aim: Sustainability • Sustainability phase begins after the active implementation phase is completed • Sustainability=two eight-week cycles of the intervention with 3-5 couples in each cycle, fidelity to the intervention core elements • Reliance on grant funds ends and sites will be encouraged to integrate Eban II into their usual services • Pre-sustainability workshop will be provided • Technical assistance (including quality assurance) will be provided • retraining in the intervention • sharing resources • offering suggestions on lessons learned • review of session tapes to assess fidelity • Pre-post couples-level measures will also be collected in order to examine outcomes • Post-sustainability qualitative interviews with key stakeholders

20. Key milestones met to date • Held regional introductory meetings in Los Angeles and Oakland to meet the Eban team members (directors, facilitators, site coordinators, other stakeholders, etc.) to generate enthusiasm, foster buy-in, and discuss timing. • Held Eban Training and Project Kick-Off in Oakland for all Eban team members. • Collected organizational survey from 96 staff members • Initiated project at first 4 agencies • AIDS Healthcare Foundation CAL-PEP • AIDS Project Los Angeles HEPPAC

21. Key challenges of design/methods • Addressing barriers at agency level • Staffing, funding, time, and recruitment limitations • Lack of infrastructure for couples • Phasing in agencies rather than starting all at same time • Maintaining enthusiasm at non-active agencies • Fostering spirit of collaboration in competitive economic times Recruitment Advantages & Challenges

22. Lessons Learned To Date • STI testing is not well-integrated into HIV care and can be expensive and inconvenient. • Eban I was conducted when there were resources for HIV prevention activities. • Agencies that once provided prevention information and psycho-sexual counseling or case management have lost substantial funding. Clients then revert to their own understanding of risks. • Agency staff need support to deal with HIV-negative partners. • Reduced HIV prevalence has resulted in lower perceptions of risk in American society in general.

23. Implications • Implications for researchers: how to design and obtain funding for this type of work; how to properly prepare for it • Implications for research institutions, IRBs, programs, centers, academic leaders • Implications for funding agencies: need to require implementation studies in newly funded research • Implications for other policy and practice leaders: need to be aware that some of their decisions are alienating community partners • “Moving target” research: understanding the context of implementation efforts is essential to capture what is changing

24. Next Steps • Investigating extensions and adaptations • Seeking support for other supplementary work • Publishing results (protocol paper, org survey results) • Branding and packaging Eban online to expedite training and implementation

25. THANK YOU! • Chris Gordon, PhD, our NIMH Project Officer • Our partner agencies • AIDS Healthcare Foundation • AIDS Project Los Angeles • Spectrum/O.A.S.I.S. • CAL PEP • WORLD • Our investigative team • Participating couples • HEPPAC • EBAC • Allen Temple Baptist Church • Tarzana Treatment Center • T.H.E. Clinic For more information, please contact: • Gail E. Wyatt, PhD (PI) email: gwyatt@mednet.ucla.edu phone: 310-825-0193 fax: 310-206-9137