Clinical trial NCT05723653: Hybrid Type I Effectiveness-Implementation Trial of Project nGage
Official title: Harnessing Social Network Support to Improve Retention in Care and Viral Suppression Among Young Black Men in Chicago and Alabama: A Hybrid Type I Effectiveness-implementation Trial of Project nGage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Seropositivity
Keywords: HIV care engagement
HIV viral suppression
Social support
Social networks
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Tulane University
name: University of Alabama at Birmingham
name: Birmingham AIDS Outreach
name: Chicago Center for HIV Elimination
name: Howard Brown Health
name: Thrive Alabama
First posted: 2023-02-13
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Following study registration (at which a unique Study Identification (ID) will be assigned), Index participants will be randomized to either the nGage intervention group (n=300) or Treatment as Usual (TAU, n=300). Intervention arm Indexes will identify a Support Confidant (SC) (creating Index-SC dyads). Study staff will discuss pros and cons of TAU (equipoise induction) to balance the desirability of the two intervention conditions.

After the 12-month follow-up survey, we will re-randomize the 300 Index-SC dyads in the nGage condition with equal probability to continue receiving standard nGage mini-boosters \[referred to as Sustained nGage (n=150 Index-SC dyads)\] or a return to TAU (n=150 Index-SC dyads). Blocked randomization determined by recruitment site will be used to ensure balance across study arms. The randomization schedule will be prepared in advance, and treatment assignment will be obtained using the randomization module in REDCap.
Primary purpose: TREATMENT

Brief summary: The goal of this Hybrid Type I effectiveness-implementation trial is to test Project nGage, an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression among young Black men and women ages 18-49.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria for Index Participants:

* Identify as Black/African American
* Assigned male sex at birth and currently identify as either a cisgender man or as a transgender woman;
* 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.

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-SC relationship

Primary outcomes:
measure: Missed Visit Proportion
timeFrame: 24 months
measure: Viral Suppression
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham 1917 Clinic
state: Alabama
city: Birmingham
country: United States
facility: Birmingham AIDS Outreach
state: Alabama
city: Huntsville
country: United States
facility: Thrive Alabama
state: Alabama
city: Chicago
country: United States
facility: Howard Brown Health
state: Illinois
city: Chicago
country: United States
facility: Chicago Center for HIV Elimination
state: Illinois
city: Chicago
country: United States
facility: Crown Family School of Social Work, Policy, and Practice at the University of Chicago
state: Illinois
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
Study officials:
affiliation: University of Chicago
name: Alida Bouris, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tulane University
name: David S Batey, PhD
role: PRINCIPAL_INVESTIGATOR
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