NIMH/NIAIDSeptember 2013

Co-Investigators:Alison B. Hamilton, Ph.D., M.P.H.,

UCLADavid Holtgrave, Ph.D., Johns HopkinsHonghu Liu, Ph.D., UCLABrian Mittman, Ph.D., VA & KaiserHector F. Myers, Ph.D., UCLA &

VanderbiltJohn K. Williams, M.D., UCLA

Consultants:C. Hendricks Brown, Ph.D.,

University of MiamiThomas Coates, Ph.D., UCLANabila El-Bassel, D.S.W.,

Columbia University, NYNan Laird, Ph.D., Harvard

University

Community Partners:AIDS Healthcare FoundationAIDS Project Los AngelesSpectrum/O.A.S.I.S.CAL PEPWORLDHEPPACEBACAllen Temple Baptist ChurchTarzana Treatment CenterT.H.E. Clinic

Project Coordinators:Alicia Eccles, M.P.H. (Southern CA)Craig Hutchinson, M.P.H. (Northern CA)

Administrative Support:Louise Datu

Eban II Research TeamPI: Gail E. Wyatt, Ph.D., UCLA

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• 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

Objectives

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• 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)

Background

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• 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.

Moving Eban into Practice (Eban II)

R01 MH093230

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• 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 processFrom Curran et al., Med Care. 2012

“Hybrid” Study Design

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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:

a) incidents of protected sexb) proportion of condom usec) 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

Eban II Aims

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• 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

Design Overview

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• 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.

Phase 1: Training & Pre-Implementation

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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 couplesSemi-Structured Interviews•Pre- & post-implementation, and post-sustainability•Key stakeholders (n~50) at participating CBOs

Implementation Aim: Organizational Survey

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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 higherEmployment characteristics•Years at job: 47% 3-5 years•Years working in HIV/AIDS: 65% over 5 years•# of clients on caseload: 38% >40 clients

Organizational Survey: Preliminary Results

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Statement % Agree/Strongly Agree

I know how to ask a client if they are in a relationship with an HIV negative partner of the opposite sex.

82

I know how to ask a client about their HIV sero status without violating their confidentiality.

81

I know how to assess the level of risk for HIV transmission that sero discordant couples experience in their relationship.

76

I know what to say to individuals if they do not qualify for services.

78

I know how to counsel two people in a relationship about how to reduce HIV risk behaviors.

76

I know how to ask clients about their past and current sexual and physical abuse histories.

77

Organizational Survey: preliminary results (cont.)

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Eban II Aarons 2004 Aarons et al. 2007

Mean Mean Mean

Requirement 2.92 2.47 2.66

Appeal 2.98 2.90 2.99

Openness 2.79 2.49 2.66

Divergence 1.45 1.34 1.22

Total 2.80 2.30 2.77

Scale: 0-4 (Not at allA very great extent)Requirement: extent to which provider would adopt an EBP if it were required by an agency, supervisor, or stateAppeal: 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 itOpenness: extent to which provider is generally open to trying new interventions and would be willing to try or use more structured or manualized interventionsDivergence: extent to which provider perceives EBPs as not useful and less important than clinical experience

Evidence-Based Practices Attitudes Scale (EBPAS): 15 items

Organizational Survey: preliminary results (cont.)

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Low Medium High

Burnout: emotional exhaustion 64% 27% 9%

Burnout: personal accomplishment 76% 13% 10%

Burnout: depersonalization 84% 13% 3%

Maslach Burnout Inventory (22 items)

Scale: 0-6 (Neverevery 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.”

Organizational Survey: preliminary results (cont.)

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Phase 2: Adoption & Implementation

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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

Effectiveness Aim: Eligibility Criteria

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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 17

Phase 3: Sustainability

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• 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

Novel Effectiveness Aim: Sustainability

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• 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 agenciesAIDS Healthcare Foundation CAL-PEPAIDS Project Los Angeles HEPPAC

Key milestones met to date

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• 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

Key challenges of design/methods

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Advantages Challenges

Negative partners have to get HIV/STI tested.

Some negative partners don’t want to know their status and need counseling.Stigma of being with a positive partner remains huge, especially in certain communities.Misinformation and myths abound.

HIV serodiscordant couples are being served.

Transgender and same-sex couples feel left out.

The program focuses on high-risk heterosexual couples.

There are very few other resources so referrals are not likely to be made.

Recruitment Advantages & Challenges

• 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.

Lessons Learned To Date

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• 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

Implications

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*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

Next Steps

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*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

THANK YOU!

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*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