Hybrid Type I Effectiveness-Implementation Trial of a Social Network Support Intervention

NCT05723653 | Recruiting DMC

• 1 other identifier: IRB22-0110
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 7

Brief Summary

The goal of this Hybrid Type I effectiveness-implementation trial is to test an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression among people living with HIV aged 18-49.

Conditions

HIV Seropositivity

Keywords

HIV care engagement; HIV viral suppression; Social support; Social networks

Outcome Measures

Primary Outcomes (2)

• 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.

  18 months

• Viral Suppression

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

  18 months

Study Arms (2)

Social Network Support Intervention Condition

EXPERIMENTAL

The intervention condition will be delivered by trained Intervention Case Managers to n=300 Index participants and their Support Confidant. The intervention consists of (1) selection and invitation of a Support Confidant, (2) a face-to-face intervention between the Intervention Case Manager and the Index and Support Confidant, and (3) quarterly interactive mini-booster sessions delivered to the Index and Support Confidant via text or telephone, based on participant preference. At 12 months, Index participants 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: Social Network Support Intervention

Treatment as Usual Condition

NO INTERVENTION

Treatment as Usual is comprehensive and follows Department of Health and Human Services 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.

Interventions

Social Network Support Intervention BEHAVIORAL

The Social Network Support Intervention is an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression among people living with HIV. The intervention consists of (1) selection and invitation of a Support Confidant, (2) a face-to-face intervention between the Intervention Case Manager and the Index and Support Confidant, and (3) quarterly interactive mini-booster sessions delivered to the Index and Support Confidant via text or telephone, based on participant preference.

Social Network Support Intervention Condition

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Resides in Chicagoland, Illinois or Alabama

You may not qualify if:

• 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
• Romantic/Sexual partners of Index participant
• Relationship strain or abuse present in Index-Support Confidant relationship

Sponsors & Collaborators

• University of Chicago: lead
• Tulane University: collaborator
• University of Alabama at Birmingham: collaborator
• Birmingham AIDS Outreach: collaborator
• Chicago Center for HIV Elimination: collaborator
• Howard Brown Health: collaborator
• Thrive Alabama: collaborator

Study Sites (7)

University of Alabama at Birmingham 1917 Clinic

Birmingham, Alabama, 35205, United States

NOT YET RECRUITING

Birmingham AIDS Outreach

Birmingham, Alabama, 35233, United States

RECRUITING

Thrive Alabama

Huntsville, Alabama, 65801, United States

RECRUITING

Howard Brown Health

Chicago, Illinois, 60613, United States

RECRUITING

Chicago Center for HIV Elimination

Chicago, Illinois, 60637, United States

RECRUITING

Crown Family School of Social Work, Policy, and Practice at the University of Chicago

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

Tulane University

New Orleans, Louisiana, 70118, United States

NOT YET RECRUITING

Related Publications (29)

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MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Alida Bouris, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• David S Batey, PhD

  Tulane University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alida Bouris, PhD

CONTACT

773-834-4304; abouris@uchicago.edu

David S Batey, PhD

CONTACT

504-862-3485; dsbatey@tulane.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, 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 each study arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Following study registration (at which a unique Study Identification (ID) will be assigned), Index participants will be randomized to either the intervention group (n=300) or Treatment as Usual (n=300). Intervention arm Indexes will identify a Support Confidant (SC) (creating Index-SC dyads). Study staff will discuss pros and cons of treatment as usual (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-Support Confidant dyads in the intervention condition with equal probability to continue receiving standard mini-boosters (n=150 Index-Support Confidant dyads) or a return to treatment as usual (n=150 Index-Support Confidant dyads). The randomization schedule will be prepared in advance, and treatment assignment will be obtained using the randomization module in REDCap.

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 13, 2023
• Study Start: February 13, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)