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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Chicago
Study ID
NCT05723653
Status
Recruiting

Conditions

  • HIV Seropositivity

Eligibility Criteria

Sex
ALL
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Feb 13, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Social Network Support Intervention Condition
    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.
  • No Intervention: Treatment as Usual Condition
    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.

Primary Outcome Measure

Missed Visit Proportion [ Time Frame: 18 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Birmingham AIDS OutreachBirminghamAlabama35233
Emma S Kay, PhD
Emma S Kay, PhD (PRINCIPAL_INVESTIGATOR)
University of Alabama at Birmingham 1917 ClinicBirminghamAlabama35205
Kathy Gaddis
Kathy Gaddis, MSW (PRINCIPAL_INVESTIGATOR)
Thrive AlabamaHuntsvilleAlabama65801
Jitesh Parmar (PRINCIPAL_INVESTIGATOR)
Chicago Center for HIV EliminationChicagoIllinois60637
Rebecca Eavou
John Schneider, MD (PRINCIPAL_INVESTIGATOR)
Crown Family School of Social Work, Policy, and Practice at the University of ChicagoChicagoIllinois60637
Alida Bouris, PhD
773-834-4304
Howard Brown HealthChicagoIllinois60613
Kelly Ducheny, PsyD (PRINCIPAL_INVESTIGATOR)
Tulane UniversityNew OrleansLouisiana70118
David S Batey, PhD
David S Batey, PhD (PRINCIPAL_INVESTIGATOR)

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