Hybrid Type I Effectiveness-Implementation Trial of Project nGage

Study Overview
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Brief Summary
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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 sexual minority men (YBSMM) aged 18-35.

Detailed Description
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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 among young Black sexual minority men (YBSMM) aged 18-35. The study will be conducted in Chicago, IL and Alabama, two high burden priority areas in the National Ending the HIV Epidemic (EHE) Plan. Nationwide, YBSMM 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 for YBSMM 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 YBSMM 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 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 YBSMM aged 18-35 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 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 YBSMM, strengthening the public health impact of Treatment as Prevention. Thus, the research holds significant promise for addressing racial and geographic health disparities among YBSMM and will result in a sustainable, scalable program and implementation strategy that can be disseminated in HIV clinics nationwide.

Official Title
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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

Conditions
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HIV Seropositivity

Intervention / Treatment
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* Behavioral: Project nGage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Index Men: Identify as Black Assigned male sex at birth and currently identify as a cisgender man Age 18-35-years-old, inclusive Same gender anal/oral sex in the past six months Have at least one SC in their network Speak English Own a cell phone not shared with anyone else Have missed at least one HIV care scheduled visit in the past 12 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 young man. Exclusion Criteria: Romantic/Sexual partners of Index Men Relationship strain or abuse present in Index-SC relationship

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Following study registration (at which a unique Study 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Project nGage Condition<br>The Project nGage condition will be delivered by trained Intervention Case Managers to n=300 men (referred to as Index men) and their Support Confidant (SC). The Project nGage intervention consists of (1) selection and invitation of a SC, (2) a face-to-face intervention between the Intervention Case Manager and the Index and SC, and (3) quarterly interactive mini-booster sessions delivered to the Index and SC via text or telephone, based on participant preference. At 12 months, Index men 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. | Behavioral: Project nGage<br>* Project nGage (nGage) is an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression among young Black sexual minority men. The nGage intervention consists of (1) selection and invitation of a Support Confidant (SC), (2) a face-to-face intervention between the Intervention Case Manager and the Index and SC, and (3) quarterly interactive mini-booster sessions delivered to the Index and SC via text or telephone, based on participant preference.<br>* Other names: nGage;|
| No Intervention: Treatment as Usual Condition<br>Treatment as Usual (TAU) is comprehensive and follows DHHS 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Missed Visit Proportion | We count visits as scheduled (non-acute) visits to an antiretroviral prescribing provider. Missed Visit Proportion (MVP) is calculated as the proportion of total scheduled visits that are missed during the follow-up period. To permit longitudinal analyses, we shall also split the two-year follow-up period into eight three-month quarters and record, for each participant, whether he completed or missed his scheduled appointment during that quarter. Appointment and visit history to calculate MVP will be collected from each clinic's electronic medical record data. | 24 months | 
| Viral Suppression | Viral load (suppressed or not) will be measured in RNA copies/mL, with ≤200 copies/mL defined as viral suppression. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV care engagement, HIV viral suppression, Social support, Social networks