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

Phase

N/A

Condition

Aids And Aids Related Infections

Hiv Infections

Hiv/aids

Treatment

ADELANTE

Clinical Study ID

NCT06274632

2023P001913

Ages > 18
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Self-identify as Latino/Latina/Latinx/Hispanic; adults 18 years and over; with HIVinfection confirmed by standard laboratory results available in the medical record; 3 or more months from initial entry into care with a medical provider who canprescribe HIV antiretroviral treatment; receiving HIV primary care at JacksonMemorial Hospital or Thomas Street at Quentin Mease Health Center/Harris HealthSystem; and medical record evidence with last viral load (VL) indicating viralnon-suppression (HIV RNA ≥200 cpm) within 12 months prior to assessment ofeligibility, as it is typical for providers to obtain laboratories prior to a clinicvisit in preparation for counseling.

Exclusion

Exclusion Criteria:

Lacks capacity to consent (measured by a validated screener), plans to move out ofthe county in the next 6 months, or currently participating in an HIV interventionstudy with ongoing follow-up.

Study Design

ADELANTE

May 22, 2024

February 28, 2027

Study Description

Participants will be Latinx/Hispanic individuals age ≥18 years who are at least 3 months since initiation of HIV treatment and have evidence of viral non-suppression (HIV RNA ≥200 cpm). Participants will be recruited from two Ryan White-funded clinics in geographic priority areas in the US Ending the HIV Epidemic (EHE) Plan due to high HIV incidences and prevalence. In the intervention, a bilingual (English-Spanish speaking) community health worker (CHW) will deliver a manualized problem-solving intervention that is framed around an HIV-focused telenovela, or drama-based film. The CHW will deliver five sessions within 6 months. The CHW will assist in problem-solving to improve behavioral activation and self-management skills and help participants adhere to HIV treatment and attend medical appointments. The CHW will also link patients to resources. In the enhanced care condition, participants will receive 5 phone calls. They will not receive the intervention or access to navigation beyond routine care. Measurements will occur at baseline, month-3, month-6, and month-12 post randomization by study staff blinded to the allocation status of participants. Participants will be remunerated for each assessment.

Connect with a study center

University of Miami
Miami, Florida 33146
United States
Site Not Available
University of Miami
Miami 4164138, Florida 4155751 33146
United States
Active - Recruiting
Baylor College of Medicine
Houston, Texas 77030
United States
Site Not Available
Baylor College of Medicine
Houston 4699066, Texas 4736286 77030
United States
Active - Recruiting

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