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 — BEHAVIORALThe 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 ConditionThe 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 ConditionTreatment 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
- Alida Bouris, PhD773-834-4304
- David S Batey, PhD504-862-3485
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Birmingham AIDS Outreach | Birmingham | Alabama | 35233 | Emma S Kay, PhD Emma S Kay, PhD (PRINCIPAL_INVESTIGATOR) |
| University of Alabama at Birmingham 1917 Clinic | Birmingham | Alabama | 35205 | Kathy Gaddis Kathy Gaddis, MSW (PRINCIPAL_INVESTIGATOR) |
| Thrive Alabama | Huntsville | Alabama | 65801 | Erin Bortel Jitesh Parmar (PRINCIPAL_INVESTIGATOR) |
| Chicago Center for HIV Elimination | Chicago | Illinois | 60637 | Rebecca Eavou John Schneider, MD (PRINCIPAL_INVESTIGATOR) |
| Crown Family School of Social Work, Policy, and Practice at the University of Chicago | Chicago | Illinois | 60637 | |
| Howard Brown Health | Chicago | Illinois | 60613 | Juan Rivera Kelly Ducheny, PsyD (PRINCIPAL_INVESTIGATOR) |
| Tulane University | New Orleans | Louisiana | 70118 | David S Batey, PhD David S Batey, PhD (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Birmingham, AL
By research site
Birmingham AIDS Outreach· Birmingham, ALUniversity of Alabama at Birmingham 1917 Clinic· Birmingham, ALThrive Alabama· Huntsville, ALChicago Center for HIV Elimination· Chicago, ILCrown Family School of Social Work, Policy, and Practice at the University of Chicago· Chicago, ILHoward Brown Health· Chicago, IL
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