Designing, Testing, and Adapting Behavioral and Social Interventions for Diverse Populations Nabila El-Bassel 2012 NIH Summer Institute on Social and Behavioral

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

• 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

The Presentation Will Cover:

• 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?

• 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

Stage Model of Intervention Research

Hierarchy of Research Designs to Produce Practice/Intervention Evidence

Pre and Post without RandomizationPre and Post without Randomization

Cohort CaseCohort Case

Time Series DesignsTime Series Designs

Stepped Wedge Stepped Wedge DesignsDesigns

RandomizedRandomized Controlled Trials Controlled Trials

(Meta Analyses & Systematic Review of

RCTs)METAMETA

Gold StandardGold Standard (Maximizes Internal

Validity)

Methods of Scientific Stages for Intervention Research

Pilot Stage & Safety

Efficacy

Effectiveness

Dissemination/Implementation

Marketing

• Design and test feasibility of the study with small sample size

• Determine effect size

• 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

• Study the implementation (adoption) of proven effective interventions/practices and monitor

them in a real-world setting

• Identify possible adverse events for proven interventions



Efficacy

Effectiveness


Marketing

Gold StandardGold Standard Randomized Randomized

Controlled TrialControlled Trial

Hybrid Hybrid ModelModel



Efficacy

Effectiveness


Marketing

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

Hybrid Hybrid ModelModel

• 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)

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

Stage Ia

• 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 Ib: Feasibility

• 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

Stage II: Efficacy

• 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?)

Stage III: Dissemination/Transportability

Use of a Stage Model to Design and Adapt Culturally Congruent

Interventions

• 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

Adaptation in Stage I and II

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)

Adaptation Process

Agency Study Site

Consumers

Community Based

Organizations

Scientific AdvisoryBoard

CommunityCollaborative

Board

Multi-disciplinary Researchers

Culturally and Contextually Congruent Interventions

ResearchersResearchers

• 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: Community Collaborative Board

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

Culturally Congruent Interventions

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 1a)

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

• Step IX: Efficacy trial

Adaptation Process

Advances in HIV Behavioral Prevention:

Our “Toolbox”

Group

Community

Social Network

Individual

Couple-based

Multilevel

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 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)

Theory Guiding the Intervention

• Social Cognitive Theory

• Ecological Framework

• Couple Therapy Skills

• 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

Key Concepts from Cognitive-Behavioral Theory

Fishbein, M (2000) The Role of Theory in HIV Prevention. AIDS Care, 12(3):273-278.

Social Cognitive Theory and Ecological Framework

Sexual & Drug Risk Behavior

Sexual & Drug Risk Behavior

• Perceived risk-perception

• Outcome expectancies

• Self-efficacy

• Intention/motivation/rewards

• Couples’communication, negotiation, problem-solving skills

• Sexual pleasure and dysfunction

• Couple drug habits, couple dependencies, and commitment

• Social support, social network

• Male and female gender norms and expectations

• Homelessness, access to resources, employment

• Community norms

InterventionIntervention

CognitiveIndividualCognitiveIndividual

Interpersonal & Relationship Interpersonal

& Relationship

Environmental Macro

Structural

Environmental Macro

StructuralSubstance Substance AbuseAbuse

Substance Substance AbuseAbuse

1 2 3 ... 6

Perceived HIV Risk

•Information about HIV•Personal and couple vulnerability

•Review of last session •HIV/STI 101•Personal vulnerability•Speaker/listener intro•Goal-setting

•Review of last session•Myth/facts on HIV/STIs•Alternatives to unsafe sex …

•Recap & review•Social support network map

Outcome Expectancies

•Pros/cons of participating in the intervention as a couple

•Protecting ourselves and protecting our relationship …

•Relapse prevention & contingency planning

Self-Efficacy

•Practicing skills and empowering couples to make change

•Speaker/listener practice

•Taking control of life•Communicating about safer sex

•Goal-setting

•Speaker/listener review•Condom use skills•Goal-setting …


•Rewarding behaviors, ourselves, & relationship

Communication Skills

•Overcoming barriers to participating

•Taking control of life•Communicating about sex …


Social Support•Couples-based approach

•Speaker/listener intro•Speaker/listener practice

•Communicating about sex

•Commitment to relationship

…

•Social support network map


Session

SC

T C

on

stru

ct

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

Eban HIV/STD Eban HIV/STD Risk Reduction InterventionRisk 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


• 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


• 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

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, KazakhstanStudy Site: Shu, Kazakhstan

Map: GoogleEarth

• 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

• Unemployment rate is very high

• No access to drug treatment for IDUs, no NGOs

• One primary care clinic and one Needle Exchange Program

ShuShu

ShuShuShuShu

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

Visit 2Eligible

Baseline STI (n=40 couples)

Visit 1Screen (n=120

participants)

Visit 3Randomization(n=40 couples)

4-Session HIVRisk Reduction

Intervention(20)

4-SessionWellness Promotion

Intervention(20)

Visit 73-Month Follow-up

(n=38 couples)

Project RenaissanceScreened

966 Individuals

Couple Overdose and HIV Risk Reduction

5 Sessions (151 Couples)

Couple Overdose and Wellness Promotion

5 Sessions (141 Couples)

• Immediately Post-Treatment (IPT)

• 6-Month Follow-Up


• Immediately Post-Treatment (IPT)



Baseline732 Individuals (367 Couples)

Randomization 300 Couples (600)

56

•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

Conclusion

AcknwoledgmentsLouisa Gilbert (PhD) Columbia University

Assel Terlikbayeva (MD, MSW) Global Health Research Center

Susan Witte (PhD) Columbia University

Elwin Wu (PhD) Columbia University

Mingway Chang (PhD) Columbia University

Robert Remien (PhD) 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

Documents

Designing, Testing, and Adapting Behavioral and Social Interventions for Diverse Populations Nabila El-Bassel 2012 NIH Summer Institute on Social and Behavioral