Designing Testing and Adapting Behavioral and Social Interventions

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 • Stage model of intervention design and implementation (Rounsaville et al, 2001) • Process of designing and adapting theorydriven intervention research • Examples of stage 1 a, 1 b, and efficacy trials

What is Intervention Research? • 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

Stage Model of Intervention Research • Consists of 4 stages (1 a, 1 b, 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

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

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

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

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

Stage Ia • Empirically define the problem/s that the intervention is designed to address • Specify 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)

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

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

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)

Stage II: Efficacy • Test the efficacy of the manualized, pilot-tested theorydriven 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

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? )

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

Adaptation in Stage I and II • Intervention adaptation: Process of modifying an intervention without competing with or contradicting 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

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

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

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

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)

Culturally and Contextually Congruent Interventions Scientific Advisory Board Community Collaborative Board Community Based Organizations Researchers Consumers Multi-disciplinary Researchers Agency Study Site

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

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

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

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

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 1 a) • Step VIII: Conduct small feasibility trial (stage 1 b ) • Step IX: Efficacy trial

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

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

Project Connect (Stage 1 a, 1 b, 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)

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

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.

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

Session 1 • Information about HIV Perceived HIV • Personal and couple vulnerability Risk 2 3 • Review of last session • HIV/STI 101 • Myth/facts on HIV/STIs • Personal vulnerability • Alternatives to unsafe • Speaker/listener intro sex • Goal-setting • Pros/cons of • Protecting ourselves participating in the and protecting our Outcome intervention as a couple relationship SCT Construct Skills • Couples-based Social Support approach • Speaker/listener intro • Speaker/listener practice … … Expectancies • Practicing skills and • Speaker/listener empowering couples to practice make change • Taking control of life Self-Efficacy • Communicating about safer sex • Goal-setting • Overcoming barriers to Communication participating . . . 6 • Recap & review • Social support network map • Relapse prevention & contingency planning • Speaker/listener review • Condom use skills • Goal-setting • Relapse prevention & contingency planning • Rewarding behaviors, … ourselves, & relationship • Taking control of life • Communicating about sex … • Relapse prevention & contingency planning • Communicating about sex • Commitment to relationship • Social support network map … • Relapse prevention & contingency planning

Intervention: Connect

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)

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

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

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 accept the roles of the CAB as defined in Eban CCB protocol

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

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

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

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

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

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

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”

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

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

Central Asia Source: Russia-Ukraine-Travel. com

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

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

Project Renaissance In-depth interviews and focus group on intervention elements, recruitment strategies, and assessment protocols • IDU couples (interviewed together and individually) • Stakeholders: medical and non-medical staff, needle exchange programs, pharmacists, police department Finalized the intervention protocol using feedback from all constituencies

Findings from the Focus Group • Definition of a main partner • Couples expressed being strongly motivated to participate in the research • Both male and female IDUs indicated that they would feel more comfortable discussing sensitive sexual issues in same gender groups before talking with their partners • Prefer female facilitator to conduct the intervention sessions informing the police about their visit to NEP

Project Renaissance – Pilot Trial Developmental Activities • Reduced sessions to 4 instead of 6 • Female facilitator instead of male • Use mixed modality instead of couple-alone • Skills-building starts with non-HIV content then HIV • Adding content on gender inequalities in drug risks

Study Design - Main Phase 4 -Session HIV Risk Reduction Intervention (20) Visit 1 Visit 2 Visit 3 Screen Eligible Randomization Baseline STI (n=120 (n=40 couples) participants) (n=40 couples) Visit 7 3 -Month Follow-up (n=38 couples) 4 -Session Wellness Promotion Intervention (20)

Project Renaissance Screened 966 Individuals Baseline 732 Individuals (367 Couples) Randomization 300 Couples (600) Couple Overdose and HIV Risk Reduction 5 Sessions (151 Couples) • Immediately Post. Treatment (IPT) • 6 -Month Follow-Up • 12 -Month Follow-Up Couple Overdose and Wellness Promotion 5 Sessions (141 Couples) • Immediately Post. Treatment (IPT) • 6 -Month Follow-Up • 12 -Month Follow-Up

Conclusion • Using scientific process/methods to produce evidence -based solutions to public health and social problems –Long process • Tedious, but rewards creativity & innovation • Requires collaboration • Involves good science • Stage model is used to develop, test and adapt culturally and contextually congruent interventions 56

Acknwoledgments Louisa Gilbert (Ph. D) Columbia University Assel Terlikbayeva (MD, MSW) Global Health Research Center Susan Witte (Ph. D) Columbia University Elwin Wu (Ph. D) Columbia University Mingway Chang (Ph. D) Columbia University Robert Remien (Ph. D) Columbia University Sholpan Primbetova (MD, MSW) Global Health Research Center Chris Beyer (MD, MPH) John Hopkins University National Institute on Drug Abuse (NIDA) National Institute of Mental Health

Team in Kazakhstan