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Designing, Testing, and Adapting Behavioral and Social Interventions for Diverse Populations

Designing, Testing, and Adapting Behavioral and Social Interventions for Diverse Populations Nabila El- Bassel 2012 NIH Summer Institute on Social and Behavioral Intervention Research July 9-13, 2012. The Presentation Will Cover:. Definition of intervention research

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Designing, Testing, and Adapting Behavioral and Social Interventions for Diverse Populations

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  1. Designing, Testing, and Adapting Behavioral and Social Interventions for Diverse Populations Nabila El-Bassel 2012 NIH Summer Institute onSocial and Behavioral Intervention Research July 9-13, 2012

  2. The Presentation Will Cover: • Definition of intervention research • Stage model of intervention design and implementation (Rounsaville et al, 2001) • Process of designing and adapting theory-driven intervention research • Examples of stage 1a, 1b, and efficacy trials

  3. Scientific process/methods of producing evidence-based solutions for public health and social problems Operates at different levels: Individual, Couple, Group, Organization, Neighborhood, Community Tedious, but uses creativity & innovation Long process, but rewarding What is Intervention Research?

  4. Stage Model of Intervention Research • Consists of 4 stages (1a, 1b, efficacy, and effectiveness/implementation) • Uses a sequential process that leads from design to adaptation and implementation of contextually relevant interventions - from piloting to efficacy and implementation • Encourages innovation and underscores that one type of intervention does not fit all

  5. Hierarchy of Research Designs to Produce Practice/Intervention Evidence (Meta Analyses & Systematic Review of RCTs) META Gold Standard(Maximizes Internal Validity) Randomized Controlled Trials Stepped Wedge Designs Time Series Designs Cohort Case Pre and Post without Randomization

  6. Methods of Scientific Stages for Intervention Research • Does the intervention work? Is the intervention safe? • Identify mechanisms of change for when the intervention works • Controlled environment • Focus on internal validity • Does the intervention work in the real world? With what population? • More flexible than efficacy trial • Focus on external validity Marketing Dissemination/Implementation • Identify possible adverse events for proven interventions • Design and test feasibility of the study with small sample size • Determine effect size Effectiveness • Study the implementation (adoption) of proven effective interventions/practices and monitor them in a real-world setting Efficacy Pilot Stage & Safety

  7. Methods of Scientific Stages for Intervention Research Marketing Dissemination/Implementation Gold StandardRandomized Controlled Trial Hybrid Model Effectiveness Efficacy Pilot Stage & Safety

  8. Methods of Scientific Stages for Intervention Research The Hybrid Model ofIntervention Research • Flexible, less stringent inclusion criteria than efficacy trials • Focuses on internal and external validity • Includes multiple research populations, communities and comorbitities • Includes non-research staff (e.g., practitioners and counselors) to deliver interventions Marketing Dissemination/Implementation Hybrid Model Effectiveness Efficacy Pilot Stage & Safety

  9. Stage Ia • Empirically define the problem/s that the intervention is designed to address • Specify the theoretical rationale, aims, and hypotheses • Specify the mediators, moderators and mechanisms that lead to behavior change • Design/adapt a theory-driven intervention • Create a culturally-specific manualized treatment/intervention protocols • Develop training manuals (intervention and assessment)

  10. Stage Ia • Establish a Community Collaborative Board to ensure that participants’ worldviews are addressed; involve participants and the community in all stages of the research in order to make it “culturally congruent” • Identify systems/agencies that need to be included in the study • Define inclusion/exclusion criteria, strategies for recruitment and retention • Design process measures protocols for quality assurance and maintaining integrity of data

  11. Stage Ib: Feasibility • Pilot test the final version of the treatment/intervention (pilot randomized trial, n=15-20 in each condition) • Use a control condition (no treatment, wait list, treatment as usual, placebo, or “gold standard”) • Participants accept the new treatment/intervention • Ability to recruit a sufficient number of the target population and retain them in the intervention and follow-ups) • Feasibility of treatment delivery with the proposed types of therapists/facilitators • Improvement in at least one outcome

  12. Stage Ib: Feasibility • Conduct in-depth interviews with participants to capture their experiences in the intervention (pilot the intervention session and obtain feedback in Stage Ib)

  13. Stage II: Efficacy • Test the efficacy of the manualized, pilot-tested theory-driven treatment/intervention • The primary purpose is maximizing internal validity • Use a full randomized clinical trial with sufficient power • Control group (e.g., active condition targeting different outcomes and mediators, or “gold standard”) • Understanding the mechanisms that lead to change (i.e., role of mediators, moderators, facilitator effects/process measures, and dose-response

  14. Stage III: Dissemination/Transportability • Test the transportability of efficacious treatments/ interventions • This involves the issue of generalizability (e.g., Will this treatment maintain efficacy with different practitioners, clients, settings, etc.?) • Implementation issues (e.g., What kind of training by what type of trainers? How acceptable is the treatment or intervention?) • Cost-effectiveness issues (e.g., What are the savings, particularly in comparison to existing interventions or methods?)

  15. Use of a Stage Model to Design and Adapt Culturally Congruent Interventions

  16. Adaptation in Stage I and II • Intervention adaptation: Process of modifying an intervention without competing with or contradicting the theory that guides the intervention and the intervention’s core elements • Major reasons for adaptation: • Simplifying complex innovation (intervention) to increase its effectiveness and adoption • Expanding or addressing other issues such as cultural and local contexts

  17. Adaptation Process Step I: • Understand the population and the scope of the problem • Review the epidemiology • Incidence • Prevalence • Risk and protective factors • Identify key behaviors and social and structural drivers of the problem

  18. Adaptation Process Step II: Identify and understand: • Core elements of the original intervention • Theoretical base of the core elements of the intervention • Mediators and mechanisms of change

  19. Adaptation Process • Mediation: What factors caused the change? (Internal Validity) • Mechanisms: How did the change occur? What was the process of change? (Construct Validity) Moderators: For whom or under what conditions did the intervention work? • Determine which participants are more responsive to the intervention • Help define subpopulations that may gain from the intervention

  20. Adaptation Process Step III: Identify and understand: • Evidence of the intervention’s effectiveness • Key characteristics (structure, length of sessions, modality, delivery style, delivery place, qualifications of facilitators) • Cultural relevance of all aspects of the intervention (theory, core elements and key characteristics)

  21. Culturally and Contextually Congruent Interventions Scientific Advisory Board Community Based Organizations Researchers Consumers Multi-disciplinaryResearchers Agency Study Site CommunityCollaborative Board

  22. Culturally Congruent Interventions: Community Collaborative Board • Assists in developing study protocols • Provides recommendations on recruitment, retention, and content of the intervention and all the protocols • Ensures human protection, clarifying ethical obligations in participating in research and providing suggestions on consent forms

  23. Culturally Congruent Interventions CCB members must: • Be representative of the community • Endorse the research • Have a serious interest in helping the community and be willing to invest in the project • Understand their roles

  24. Adaptation Process Step IV: Formative work for the adaptation of the core elements to inform the design and implementation of the intervention: • In-depth interviews • Focus group(s) Constituencies: • Key informants, consumers, and staff who comment on the core elements of the intervention and study procedures

  25. Adaptation Process • Step V: In collaboration with CCB and others • Define what needs to be changed in the intervention’s core elements • Define what cannot be changed • Revise the core elements and protocols through feedback from all of the consistencies

  26. Adaptation Process • Step VI: Pre pilot – mixed methods (pre/post design and process measures) • Step VII: Revise the intervention based on the findings from the pre pilot and finalize intervention and study protocols with the CCB and consumers (up to this step is stage 1a) • Step VIII: Conduct small feasibility trial (stage 1b ) • Step IX: Efficacy trial

  27. Couple-based Social Network Structural HIV Prevention Individual Group Community Advances in HIV Behavioral Prevention: Our “Toolbox” Multilevel

  28. HIV Couple-Based Gender-Specific Approach Addresses the context of gender and power in the relationship Provides a supportive environment that enables intimate partners to feel safe disclosing highly personal information (extra-dyadic relationships, STIs, sharing needles, etc.) and to learn effective couple communication and negotiation of condom use together

  29. Project Connect (Stage 1a, 1b, efficacy) NIMH funded study completed in 2001 improving communication skills about sexual safety increasing the proportion of protected sexual acts reducing unprotected acts 217 couples recruited from primary care settings 30% had a history of drug use (intervention not designed to address drug use and risks)

  30. Theory Guiding the Intervention • Social Cognitive Theory • Ecological Framework • Couple Therapy Skills

  31. Key Concepts from Cognitive-Behavioral Theory • Behavior is mediated by cognitions • Knowledge is necessary but not enough for behavioral change • Perceptions, motivations, skills and the social environment are key influences on behavior Fishbein, M (2000) The Role of Theory in HIV Prevention. AIDS Care, 12(3):273-278.

  32. Social Cognitive Theory and Ecological Framework • Perceived risk-perception • Outcome expectancies • Self-efficacy • Intention/motivation/rewards CognitiveIndividual • Couples’communication, negotiation, problem-solving skills • Sexual pleasure and dysfunction • Couple drug habits, couple dependencies, and commitment Sexual & Drug Risk Behavior Interpersonal & Relationship Intervention • Social support, social network • Male and female gender norms and expectations • Homelessness, access to resources, employment • Community norms Environmental Macro Structural Substance Abuse

  33. Session SCT Construct

  34. Intervention: Connect

  35. Eban - HIV/STI Intervention • First and largest HIV RCT trial for serodiscordant African American couples • Funded by NIMH • Multi-site efficacy trial implemented in four U.S. cities • Columbia - School of Social Work (PI - Nabila El-Bassel) • Emory - School of Public Health (PI - Gina Wingood) • UCLA - Department of Psychiatry (PI - Gail Wyatt) • U Penn - Annenberg School of Communications (PI - John Jemmott)

  36. Project Eban (2010, NIMH) 535 serodiscordant African American couples (4 sites in US) 30% had a history of drug use (intervention did not address drug use and risks) Outcomes: sexual HIV risk reduction

  37. Project Eban • Design: Stage Ia & Ib (18 months) • Adapted the intervention from an existing couple-based study (Project Connect) • Created intervention and training protocols • Created measurement protocols (some new measures are driven by the Afro-centric paradigm) • Each site piloted the intervention with a small sample size • Revised the intervention and piloted it again to ensure its feasibility

  38. Project Eban: CCB Each of the four sites formed a local CCB • The CCB consisted of 10-12 stakeholders (leaders from minority hospital-based HIV/AIDS services, HIV/AIDS community networks, consumers) • CCB member inclusion criteria: 1) identify as black, or work in an organization that serves African American individuals, 2) be older than 18 years of age, 3) express a strong commitment to sustaining and strengthening black communities, 4) be willing to help reduce the spread of the HIV/AIDS pandemic in these communities, 5) endorse Project Eban research, 6) understand and accept the roles of the CAB as defined in Eban CCB protocol

  39. Eban HIV/STD Risk Reduction Intervention • Social Cognitive Theory • Ecological Framework • Couple Therapy Skills • Afro-centric Paradigm

  40. Afro-Centric Paradigm • This Afro-centric paradigm uses the seven principles of Nguzo Saba (Karenga,1980), best known in their application to Kwanzaa, the winter holiday • The principles are linked to traditional African value systems and provide a blueprint for good conduct and good health

  41. Principles of Nguzo Saba • Unity • Self-determination • Collective work and responsibility • Purpose • Creativity • Faith • Economic Cooperation

  42. Principles of Nguzo Saba • Unity:Striving for and maintaining unity in the family, community, nation, and race • Encouraging couples to unite in their efforts to stay safe, reduce HIV risk, and protect each other and their community from the devastating HIV pandemic • When couples unite against this pandemic, they gain the power to fight personal, cultural and societal barriers

  43. Principles of Nguzo Saba • Faith: • Uses proverbs, rituals, and poems to impart knowledge needed to help couples protect themselves and to provide a feeling of pride, unity, and respect for their cultural heritage • Includes discussion on what it means to be African American in today’s world and to fight the AIDS pandemic

  44. Project Eban: Facilitation • Ethnically matched facilitators leads to a greater sense of credibility, enhances rapport and trust, and allows participants to share sensitive issues without feeling misunderstood or stigmatized • HIV prevention messages are more accepted when delivered by African American facilitators • Discussions of historical and political issues, such as slavery, discrimination, and racism, are more accepted when ethnic matching is employed

  45. Project Eban: Feedback • Qualitative feedback from participants on intervention: • “Liked Blackness” • “Felt comfortable discussing sensitive issues” • “Did not feel stigmatized by facilitators” • “Increased motivation to use protection”

  46. Project Connect: Real World Settings Study purpose: • Adoption of a couple-based behavioral HIV intervention (NIMH funded, 2009) • 80 CBOs across New York State (<5 are located within HIV clinic/hospital settings) • 253 providers were trained in the CBOs

  47. International Implementation of Project Connect • Connect intervention recommended by CDC as “best practice” • Being tested for stage II in: • Central Asia • South Africa • Ukraine • Kenya • Colombia

  48. Central Asia Source: Russia-Ukraine-Travel.com

  49. Study Site: Shu, Kazakhstan Shu • Strategically located near Kazakhstan’s border with Kyrgyzstan and a major entry point for the drug trade • 34,000 population and, among adults, an estimated 3,000 are IDUs Shu • Unemployment rate is very high • No access to drug treatment for IDUs, no NGOs • One primary care clinic and one Needle Exchange Program Map: GoogleEarth

  50. Project Renaissance • Established CCB to provide feedback on the intervention elements and study protocols • The CCB consisted of the Deputy Mayor of Shu and representatives from the primary care center, the district attorney’s office, and the police department as well as community leaders • CCB members were trained in IRB, quality control, and intervention research

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