This study is a Hybrid Type I effectiveness-implementation trial of Project nGage
("nGage"), 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 (IL) and Alabama (AL), two high burden priority areas
in the National Ending the HIV Epidemic (EHE) Plan. Nationwide, Black men and women bear
the highest incidence of HIV and experience the poorest outcomes in the HIV Continuum of
Care. Both retention in care and viral suppression are critical targets in the EHE Plan,
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 in men's networks who
can offer the types of social support that can help to navigate life's complexities,
including the stressors of living with HIV. The nGage intervention uses sociograms,
highly engaging social network diagrams, to identify an ideally positioned SC. Once a SC
is identified, the Index and their SC 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-SC 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 nGage (n=300) or
treatment as usual (TAU) (n=300). In addition, 300 SCs also will be enrolled. At
12-months post-intervention, we will re-randomize nGage dyads to continue receiving
mini-boosters (Sustained nGage: n=150) or return to TAU (n=150). Data collection at
baseline, 12, and 24 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, AL. To study implementation
in each setting and geographic context, we will use the Consolidated Framework for
Implementation Research (CFIR) as the determinant framework and Reach, Effectiveness,
Adoption, Implementation, and Maintenance (RE-AIM) as the evaluation framework. The
specific aims of the study are to:
Aim 1: Evaluate the (a) effectiveness of nGage vs. TAU over 12 months in N=600
participants aged 18-49 and (b) value of continuing nGage over another 12 months
(Sustained nGage). The primary outcomes are retention in care and viral suppression, as
measured by EMR data on missed visit proportion (MVP) and viral load.
Aim 2: Examine if intervention effects (a) vary between Chicago and Alabama (AL), (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 abuse at the
Index level.
Aim 3: Evaluate the implementation of nGage using the CFIR and the RE-AIM framework.
Guided by CFIR, 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 that influence implementation. We will use RE-AIM to assess
Reach, Adoption, Implementation, and Maintenance, including implementation costs in each
clinical setting and geographic context.
If effective, nGage 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.