Hybrid Type I Effectiveness-Implementation Trial of a Social Network Support Intervention
NCT ID: NCT05723653
Last Updated: 2025-09-17
Study Results
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Basic Information
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RECRUITING
NA
900 participants
INTERVENTIONAL
2023-02-13
2027-12-31
Brief Summary
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Detailed Description
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Most clinic-based strategies to improve Continuum of Care outcomes focus on newly created network members, e.g., support groups, peer navigators, or case managers. In contrast, we identify and activate organic Support Confidants (SC)-those people who can offer the types of social support that can help to navigate life's complexities, including the stressors of living with HIV. The intervention uses sociograms, highly engaging social network diagrams, to identify an ideally positioned Support Confidant. Once a Support Confidant is identified, the Index and their Support Confidant attend a single session, in-person intervention with a trained interventionist. The intervention uses the Information Motivation Behavioral Skills Model, Motivational Interviewing, and Cognitive Behavioral Theory to promote Continuum of Care-specific support in the Index-Support Confidant relationship.
This study will conduct a Hybrid Type I randomized controlled trial with N=600 participants living with HIV, who will be randomized to receive the intervention (n=300) or treatment as usual (n=300). In addition, 300 Support Confidants also will be enrolled. At 12-months post-intervention, we will re-randomize dyads to continue receiving mini-boosters (n=150) or return to treatment as usual (n=150). Data collection at baseline, 12, and 18 months will include surveys and electronic medical record (EMR) data. The study will be implemented in community-based clinics and academic-affiliated health centers in Chicago and in Birmingham and Huntsville, Alabama. To study implementation in each setting and geographic context, we will use the Consolidated Framework for Implementation Research as the determinant framework and Reach, Effectiveness, Adoption, Implementation, and Maintenance as the evaluation framework. The specific aims of the study are to:
Aim 1: Evaluate the (a) effectiveness of a social support intervention versus treatment as usual over 12 months with 600 people living with HIV ages 18-49 and (b) value of continuing to offer social support over another 6 months. The primary outcomes are retention in care and Viral Suppression, as measured by electronic medical record data on missed visit proportion and viral load.
Aim 2: Examine if intervention effects (a) vary between Chicago and Alabama, (b) are mediated by changes in the Index's level of motivational readiness, self-efficacy, and stigma expectancies, and (c) are moderated by mental health and substance use at the Index level.
Aim 3: Evaluate the implementation of the intervention using the Consolidated Framework for Implementation Research and the Reach, Evaluation, Adoption, Implementation and Maintenance frameworks. We will conduct surveys and focus groups with key stakeholders to assess the inner and outer settings, implementer and intervention characteristics, and multi-level process factors within the Consolidated Framework for Implementation Research. We will assess the following implementation outcomes for the study in each clinical setting and geographic context: Reach, Adoption, Implementation, and Maintenance.
If effective, the intervention has the potential to reduce HIV incidence by harnessing existing social support in the lives of people living with HIV, strengthening the public health impact of Treatment as Prevention. Thus, the research holds significant promise for addressing racial and geographic health disparities and will result in a sustainable, scalable program and implementation strategy that can be disseminated in HIV clinics nationwide.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
After the 12-month follow-up survey, we will re-randomize the 300 Index-Support Confidant dyads in the intervention condition with equal probability to continue receiving standard mini-boosters (n=150 Index-Support Confidant dyads) or a return to treatment as usual (n=150 Index-Support Confidant dyads). The randomization schedule will be prepared in advance, and treatment assignment will be obtained using the randomization module in REDCap.
TREATMENT
NONE
Study Groups
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Social Network Support Intervention Condition
The intervention condition will be delivered by trained Intervention Case Managers to n=300 Index participants and their Support Confidant.
The intervention consists of (1) selection and invitation of a Support Confidant, (2) a face-to-face intervention between the Intervention Case Manager and the Index and Support Confidant, and (3) quarterly interactive mini-booster sessions delivered to the Index and Support Confidant via text or telephone, based on participant preference.
At 12 months, Index participants in the experimental condition will be re-randomized to either continue receiving quarterly interactive mini-booster sessions or to stop receiving mini-boosters and return to treatment as usual.
Social Network Support Intervention
The Social Network Support Intervention is an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression among people living with HIV. The intervention consists of (1) selection and invitation of a Support Confidant, (2) a face-to-face intervention between the Intervention Case Manager and the Index and Support Confidant, and (3) quarterly interactive mini-booster sessions delivered to the Index and Support Confidant via text or telephone, based on participant preference.
Treatment as Usual Condition
Treatment as Usual is comprehensive and follows Department of Health and Human Services guidelines and local protocols on the provision of HIV primary care, which include scheduling one HIV primary care visit and lab tests (including viral load) once every six months, i.e., two HIV primary care visits per year. In addition, all sites provide standard case management and mental health and psychosocial support services to all patients.
No interventions assigned to this group
Interventions
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Social Network Support Intervention
The Social Network Support Intervention is an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression among people living with HIV. The intervention consists of (1) selection and invitation of a Support Confidant, (2) a face-to-face intervention between the Intervention Case Manager and the Index and Support Confidant, and (3) quarterly interactive mini-booster sessions delivered to the Index and Support Confidant via text or telephone, based on participant preference.
Eligibility Criteria
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Inclusion Criteria
* Speak English
* Own a cell phone not shared with anyone else
* Have missed at least one HIV care scheduled visit or have not been virally suppressed in the past 24 months.
* Resides in Chicagoland, Illinois or Alabama
* Index agrees to engage the Support Confidant
* Age 18 years or older
* Speaks English
* Owns a cell phone not shared with others
* Is not a romantic/sexual partner of the Index participant
Exclusion Criteria
* Relationship strain or abuse present in Index-Support Confidant relationship
18 Years
49 Years
ALL
Yes
Sponsors
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Tulane University
OTHER
University of Alabama at Birmingham
OTHER
Birmingham AIDS Outreach
UNKNOWN
Chicago Center for HIV Elimination
UNKNOWN
Howard Brown Health
UNKNOWN
Thrive Alabama
UNKNOWN
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Alida Bouris, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
David S Batey, PhD
Role: PRINCIPAL_INVESTIGATOR
Tulane University
Locations
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University of Alabama at Birmingham 1917 Clinic
Birmingham, Alabama, United States
Birmingham AIDS Outreach
Birmingham, Alabama, United States
Thrive Alabama
Huntsville, Alabama, United States
Howard Brown Health
Chicago, Illinois, United States
Chicago Center for HIV Elimination
Chicago, Illinois, United States
Crown Family School of Social Work, Policy, and Practice at the University of Chicago
Chicago, Illinois, United States
Tulane University
New Orleans, Louisiana, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Bouris A, Voisin D, Pilloton M, Flatt N, Eavou R, Hampton K, Kuhns LM, Eder M, Schneider JA. Project nGage: Network Supported HIV Care Engagement for Younger Black Men Who Have Sex with Men and Transgender Persons. J AIDS Clin Res. 2013 Aug 31;4:10.4172/2155-6113.1000236. doi: 10.4172/2155-6113.1000236.
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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IRB22-0110
Identifier Type: -
Identifier Source: org_study_id
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