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Hybrid Type I Effectiveness-Implementation Trial of Project nGage

Sponsor
University of Chicago (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05723653
Collaborator
Tulane University (Other), University of Alabama at Birmingham (Other), Birmingham AIDS Outreach (Other), Chicago Center for HIV Elimination (Other), Howard Brown Health (Other), 1917 Clinic at the University of Alabama at Birmingham (Other), Thrive Alabama (Other)
900
Enrollment
7
Locations
2
Arms
46.9
Anticipated Duration (Months)
128.6
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

Study Description

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 sexual minority men (YBSMM) aged 18-35.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Project nGage
 N/A

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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Masking Description:
Due to the nature of nGage, it is not possible to blind participants, interventionists, and investigators. However, we take the following steps to minimize bias, assess contamination, and enhance rigor: (1) collecting baseline data prior to randomization; (2) Treatment as Usual (TAU) providers are blinded to allocation; and (3) assessing contamination at follow-up surveys by identifying overlap between the networks of those in the nGage and TAU groups.
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Project nGage Condition

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
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.
Other Names:
  • nGage

    		•
    No Intervention: Treatment as Usual Condition

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Missed Visit Proportion [24 months]

      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.

    2. Viral Suppression [24 months]

      Viral load (suppressed or not) will be measured in RNA copies/mL, with ≤200 copies/mL defined as viral suppression.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham 1917 Clinic Birmingham Alabama United States 35205
    2 Birmingham AIDS Outreach Birmingham Alabama United States 35233
    3 Thrive Alabama Huntsville Alabama United States 65801
    4 Howard Brown Health Chicago Illinois United States 60613
    5 Chicago Center for HIV Elimination Chicago Illinois United States 60637
    6 Crown Family School of Social Work, Policy, and Practice at the University of Chicago Chicago Illinois United States 60637
    7 Tulane University New Orleans Louisiana United States 70118

    Sponsors and Collaborators

    • University of Chicago
    • Tulane University
    • University of Alabama at Birmingham
    • Birmingham AIDS Outreach
    • Chicago Center for HIV Elimination
    • Howard Brown Health
    • 1917 Clinic at the University of Alabama at Birmingham
    • Thrive Alabama

    Investigators

    • Principal Investigator: Alida Bouris, PhD, University of Chicago
    • Principal Investigator: David S Batey, PhD, Tulane University

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT05723653
    Other Study ID Numbers:
    • IRB22-0110
    First Posted:
    Feb 13, 2023
    Last Update Posted:
    Feb 13, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Chicago
    HIV care engagement
    HIV viral suppression
    Social support
    Social networks
    Additional relevant MeSH terms:
    HIV Seropositivity

    Study Results

    No Results Posted as of Feb 13, 2023