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UCLA C-MORE Seminar Series May 21, 2013

UCLAGail E. Wyatt, Ph.D., Principal InvestigatorAlison B. Hamilton, Ph.D., M.P.H., Co-InvestigatorJohn K. Williams, M.D., Co-InvestigatorHector F. Myers, Ph.D., Co-InvestigatorHonghu Liu, Ph.D., Co-InvestigatorAlicia Eccles, M.P.H., Southern CA Project CoordinatorLouise Datu, Administrative Analyst

Alameda County, Department of Public HealthRon Kabir Hypolite, J.D., Co-Principal InvestigatorCraig Hutchinson, M.P.H., Northern CA Project Coordinator

ConsultantsBrian Mittman, Ph.D., Implementation Expert, Veterans Administration Thomas Coates, Ph.D., Statewide Sustainability Consultant, UCLANabila El-Bassel, D.S.W., Dissemination Consultant, Columbia University, NYDavid Holtgrave, Ph.D., Cost Effectiveness Expert, John Hopkins ExpertC. Hendricks Brown, Ph.D., Statistician, University of MiamiNan Laird, Ph.D., Biostatistician, Harvard University 2

• “Implementation imperative”• pressure/need for research to facilitate

implementation (and hence greater societal benefit) of research-developed practices

• Multiple challenges to uptake of research-developed practices

• barriers to implementation• limited interest among researchers and research

funders• limited guidance for study design and methods• limitations in the practices themselves (e.g.,

efficacy vs. effectiveness evidence)3

• To provide an example of a NIMH-funded “hybrid” effectiveness/implementation study to illustrate challenges in study design, methods and conduct, including

• sampling, power and outcome selection• measurement• complexities of community-based research in

current fiscal and policy environment (e.g., recruitment, retention, partnership)

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• HIV/AIDS epidemic disproportionately impacts African American communities

• Rates of new infections among African Americans are seven times higher than among Whites

• High rates of sexually transmitted infections among African Americans

• HIV infection rates in California rank 3rd in the U.S. • Los Angeles and Alameda Counties have the largest

concentrations of African Americans and highest proportion of African American HIV/AIDS cases

• City of Oakland has the highest and most rapidly growing incidence rate of diagnosed and undiagnosed HIV in the country

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• Few couples-based interventions focused on reducing risky sexual behaviors, increasing condom use, 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• NIMH-funded Eban (Yoruba for “fence”) risk reduction

intervention designed to fill gap• Guided by social cognitive and culturally-grounded

theories• Focused on building risk-reduction skills• 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

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• 8-week, standardized, manualized intervention facilitated by a male-female team

Components:• strategies that address individual, interpersonal, social, and

cultural factors influencing risk behavior• dyadic and group processes that take advantage of

relationship and group dynamics• educational and culturally appropriate sessions• discussions of the realities of urban African American

couples and focus on positive self-evaluations; cultural, gender, and ethnic pride; and risk avoidance

• culturally congruent video clips, games, brainstorming, role-playing, and skill-building activities, and small group discussions

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• Given established efficacy, appropriate to move Eban into practice in community-based organizations (CBOs)

• Shift requires reciprocal, multidirectional information and technology exchange between the research team and the collaborating CBOs

• Long-term goal to facilitate large-scale implementation of Eban II in CBOs that serve HIV-positive 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.

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• Goal: clinically meaningful, not just statistically significant, evidence-based practice

• Collect effectiveness data• Understand and overcome implementation barriers• Understand black box of implementation• Develop a sustainable intervention and implementation

strategy• Challenges:

• Rapid timeline• 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

From Curran et al.

ClinicalEffectiveness

ResearchImplementation

Research

Hybrid

Type I

Hybrid

Type IHybrid

Type II

Hybrid

Type IIHybrid

Type III

Hybrid

Type III

Hybrid Type I: test clinical intervention, observe/gather information on implementation

Hybrid Type II: test clinical intervention, study implementation intervention

Hybrid Type III: test implementation intervention, observe/gather information on clinical intervention and outcomes

Types of Hybrid Designs

From Curran et al.

Eban II

• To facilitate implementation of Eban II in 10 CBOs in California; specifically, to employ a theory-guided strategy to partner with the CBOs to expose providers to the intervention, facilitate its adoption and delivery with high fidelity, and sustain its use for nine months following the active implementation phase.

• Using mixed quantitative and qualitative methods, to document the implementation process and identify barriers and facilitators to adoption, fidelity, and sustainability.

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• 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) incident sexually transmitted infections (syphilis,

gonorrhea & Chlamydia)

Secondary Aim• To determine the cost-effectiveness of

implementation of the Eban II intervention based on implementation costs and potential cost savings. 13

• Protocol-based implementation approach • Mixed methods process evaluation • Conceptual guidance from the TCU Program

Change Model (Simpson et al.)• model of phased organizational change from

exposure to adoption, implementation, and sustainability

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• Multiple strategies and tools

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Table 1. Implementation Strategies & Tools by PCM Phase Purpose

Training Phase Tools Eban training manuals Provides instructions for intervention delivery

Eban videos Operationalizes intervention core elements

Eban Sharepoint Provides all training tools in accessible format

Adoption Tools HIV Fact Sheets (patient & provider versions)

Educates about HIV prevention

Adoption Strategies Project kick-off Engages sites in project, concretizes expectations

Site coordinators Serve as intervention champions & liaisons

Implementation Strategies

Monthly inter-agency calls Build sense of communal effort; sustain leadership support

Continual feedback on implementation Supports tailoring of implementation strategies

Technical assistance, especially during sustainability

Promotes collaboration & commitment to sustainability

Pre-sustainability workshops Increase likelihood of sustainability

Practice Improvement Project wrap-up retreat Promotes scale up and spread

• Effectiveness assessed using a randomized delayed enrollment (waitlist) control design to evaluate the impact of treatment on outcomes at posttest and 3-month follow-up

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Staff Survey•Web-based, individualized link to SurveyMonkey•Completed by staff (target n=200) who provide direct client care•One time only, at baseline; approx 30 min to complete•Assesses

• Organizational climate• Attitudes toward evidence-based practices• Burnout• 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 17

Effectiveness Aim: Eligibility Criteria

Couples screened as eligible if they:

•Self-identify as heterosexual

•One partner is HIV-positive, the other is HIV-negative & they know each other’s status

•At least one partner identifies as African American

•Age 18 – 60

•Have been a couple for at least 3 months & intend to stay together

•Had unprotected sex within the last 3 months

•No plans to relocate beyond a reasonable distance

•Willing to complete the study even if relationship ends 18

• Sustainability phase begins after the active implementation phase is completed

• 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

• Sustainability=two eight-week cycles of the intervention with 3-5 couples in each cycle, fidelity to the intervention core elements

• Pre-post couples-level measures will also be collected in order to examine outcomes

• Post-sustainability qualitative interviews with key stakeholders19

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• Held project kick-offs to generate enthusiasm, foster buy-in

• Trained ~25 staff members as facilitators and site coordinators

• Collected org survey from 88 staff members across 9 agencies (64% response rate as of 5/21/13)

• Initiated project at first 2 agencies (one in Oakland, one in Los Angeles)

• Held first State of California Implementation Network call in April

Key milestones met to date

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• Sampling, randomization, unit of analysis• organization/site for implementation;

couple for effectiveness• power limitations

• Balancing fidelity vs. adaptation to achieve feasibility

• Measurement burden: effectiveness outcomes, couple characteristics and adherence, staff characteristics, agency characteristics

Key challenges of design/methods

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• Addressing barriers at agency level• Staffing limitations• Funding limitations• Time limitations (burden)

• 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 in study conduct

Submit protocol manuscript to Implementation Science

Continue process evaluation at active sitesPhase in next pair of sites in Year 2 (July

2013)Analyze organizational readiness data

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Pursue mechanisms for dissemination of interventionSeek support (from CTSI?) for

packaging/branding of Eban intervention materials (e.g., training videos) 

Talk & ListenPursue funding for additional clinical

outcomes of interest

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Implications for:• Researchers: how to design and obtain funding

for this type of work; how to properly prepare for it

• Research institutions, programs, centers, academic leaders

• Funding agencies• Other policy, practice leaders and entities

For Discussion Today

Gail E. Wyatt, PhD (PI)email: gwyatt@mednet.ucla.eduphone: 310-825-0193

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