Hybrid Type I Effectiveness-Implementation Trial of a Social Network Support Intervention

Official title

Harnessing Social Network Support to Improve Retention in Care and Viral Suppression Among People Living With HIV in Chicago and Alabama: A Hybrid Type I Effectiveness-implementation Trial

Overview

The goal of this Hybrid Type I effectiveness-implementation trial is to test 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 aged 18-49.

Detailed description

This study is a Hybrid Type I effectiveness-implementation trial of an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression. The study will be conducted in Chicago, Illinois and Alabama, two high burden priority areas in the National Ending the HIV Epidemic Plan. Both retention in care and viral suppression are critical targets in ongoing efforts to eliminate HIV, as persons adherent to antiretrovirals are unlikely to transmit HIV, and retention in care allows for ongoing monitoring of viral load and the delivery of other important services, e.g., case management, mental health, and substance use treatment.

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.

Interventions

• Behavioral 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 Suppor

Primary outcome measures

• Missed Visit Proportion [Time frame: 18 months]
• Viral Suppression [Time frame: 18 months]

Eligibility criteria

Inclusion Criteria for Index Participants:

• Aged 18-49 years old, inclusive
• 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

Exclusion Criteria for Index Men:

• If a participant fails to meet all inclusion criteria

Inclusion Criteria for Support Confidants:

• 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

• Romantic/Sexual partners of Index participant
• Relationship strain or abuse present in Index-Support Confidant relationship

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 7 centers

• University of Alabama at Birmingham 1917 Clinic — Birmingham
• Birmingham AIDS Outreach — Birmingham
• Thrive Alabama — Huntsville
• Howard Brown Health — Chicago
• Chicago Center for HIV Elimination — Chicago
• Crown Family School of Social Work, Policy, and Practice at the University of Chicago — Chicago
• Tulane University — New Orleans

Publications

• Bouris A, Jaffe K, Eavou R, Liao C, Kuhns L, Voisin D, Schneider JA. Project nGage: Results of a Randomized Controlled Trial of a Dyadic Network Support Intervention to Retain Young Black Men Who Have Sex With Men in HIV Care. AIDS Behav. 2017 Dec;21(12):3618-3629. doi: 10.1007/s10461-017-1954-8. PMID 29079949
• 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. PMID 24404408
• Cabral HJ, Tobias C, Rajabiun S, Sohler N, Cunningham C, Wong M, Cunningham W. Outreach program contacts: do they increase the likelihood of engagement and retention in HIV primary care for hard-to-reach patients? AIDS Patient Care STDS. 2007;21 Suppl 1:S59-67. doi: 10.1089/apc.2007.9986. PMID 17563291
• Centers for Disease Control and Prevention. Estimated HIV incidence and prevalence in the United States, 2010-2015. HIV Surveillance Supplemental Report 2018;23(No. 1). http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published March 2018. Accessed [1 Dec 2022].
• Craw JA, Gardner LI, Marks G, Rapp RC, Bosshart J, Duffus WA, Rossman A, Coughlin SL, Gruber D, Safford LA, Overton J, Schmitt K. Brief strengths-based case management promotes entry into HIV medical care: results of the antiretroviral treatment access study-II. J Acquir Immune Defic Syndr. 2008 Apr 15;47(5):597-606. doi: 10.1097/QAI.0b013e3181684c51. PMID 18285714
• Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. PMID 22310560
• Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50. PMID 19664226
• Department of Health and Human Services. Ending the HIV Epidemic: A Plan for America. 2019; https://www.hhs.gov/sites/default/files/ending-the-hiv-epidemic-fact-sheet.pdf.

Identifiers

NCT: NCT05723653 · IRB22-0110

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗