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.
