ADELANTE: A Randomized Controlled Trial to Improve Engagement in Care for Latinos With HIV

Part of paid clinical trials in Miami, Florida.

Sponsor
Massachusetts General Hospital
Study ID
NCT06274632
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ADELANTE — BEHAVIORAL
    A manualized problem-solving intervention that addresses barriers to viral suppression in Latinos with HIV. At the patient-level, CHWs use motivational interviewing to facilitate problem-solving skill development around attending HIV care and adherence and establish an individually tailored goal-setting plan. We target emotional well-being and self-management through a rapport with CHW and the integration of an HIV-centered telenovela to facilitate participant reflection on difficult topics for skill-building. The CHW will also link the participant to needed services.

Study Details

The goal of this study is to test the effectiveness of ADELANTE on viral suppression among Latinos with HIV and viral non-suppression. Participants will receive ADELANTE (5-session, community health worker-delivered, problem-solving intervention) or enhanced care condition (ECC, 5 reminder phone calls). We will evaluate the overall effectiveness of ADELANTE compared with ECC on rates of viral suppression and emergency room visits and hospitalizations. Our hypothesis is that ADELANTE participants will achieve higher rates of viral suppression and will have lower rates of emergency room visits and hospitalizations compared with ECC at 12 months post-randomization.

Key Dates

Start date
May 22, 2024
Status verified
Jan 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: ADELANTE
    Participants will receive 5, individualized problem solving sessions delivered by a community health worker over 6 months. The intervention content is framed around a bi-lingual film about HIV.
  • No Intervention: Enhanced Care Condition
    Participants in the enhanced care control group will receive 5 locator phone calls confirming contact information at the same interval as CHW sessions in the ADELANTE group. They will be offered routine HIV health promotion materials as is available in the clinic. If a participant requests support for navigation or case management, they will be encouraged to contact their HIV team

Primary Outcome Measure

12-month viral suppression [ Time Frame: month-12 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33146
Allan Rodriguez, MD
[email protected]
305-243-3711
Baylor College of MedicineHoustonTexas77030
Thomas P Giordano, MD
[email protected]
713-798-8918

Find similar trials in Miami, FL

By condition
HIV
By specialty
Infectious disease
By research site
University of Miami· Miami, FLBaylor College of Medicine· Houston, TX

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