Recruiting

HIV Intervention

Sponsor:

University of Chicago

Code:

NCT05723653

Conditions

HIV Seropositivity

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Interventions

Social Network Support Intervention

Study Details

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

Study ID

NCT05723653

Start date

Feb 13, 2023

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Inclusion Criteria for Index Participants:

  • 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

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-Support Confidant relationship

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Social Network Support Intervention

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.

Primary outcome measure

  • Missed Visit Proportion [ Time Frame: 18 months ]
  • Viral Suppression [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Locations

Birmingham AIDS Outreach

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Emma S Kay, PhD

emma@mcwc-bao.org

Principal Investigator:

Emma S Kay, PhD

Thrive Alabama

Recruiting

Huntsville, Alabama, United States, 65801

Contacts

Principal Investigator:

Jitesh Parmar

Howard Brown Health

Recruiting

Chicago, Illinois, United States, 60613

Contacts

Principal Investigator:

Kelly Ducheny, PsyD

Chicago Center for HIV Elimination

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

John Schneider, MD

More Information

Sponsor

University of Chicago

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-04-08.