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ADELANTE: a Randomized Controlled Trial to Improve Engagement in Care for Latinos with HIV

NCT ID: NCT06274632

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-22

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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Participants will be Latinx/Hispanic individuals age ≥18 years who are at least 6 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.

Conditions

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HIV/AIDS

Keywords

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Latino Hispanic HIV/AIDS health outcomes community health worker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

ADELANTE

Intervention Type 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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ADELANTE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Self-identify as Latino/Latina/Latinx/Hispanic; adults 18 years and over; with HIV infection confirmed by standard laboratory results available in the medical record; 6 or more months from initial entry into care with a medical provider who can prescribe HIV antiretroviral treatment; receiving HIV primary care at Jackson Memorial Hospital or Thomas Street at Quentin Mease Health Center/Harris Health System; and medical record evidence with last viral load (VL) indicating viral non-suppression (HIV RNA ≥200 cpm) within 12 months prior to assessment of eligibility, as it is typical for providers to obtain laboratories prior to a clinic visit in preparation for counseling.

Exclusion Criteria

* Lacks capacity to consent (measured by a validated screener), plans to move out of the county in the next 6 months, or currently participating in an HIV intervention study with ongoing follow-up.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Julie H Levison

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Miami

Miami, Florida, United States

Site Status RECRUITING

Baylor College of Medicine

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Julie H Levison, MD

Role: CONTACT

Phone: 617-724-4698

Email: [email protected]

Facility Contacts

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Allan Rodriguez, MD

Role: primary

Thomas P Giordano, MD

Role: primary

Other Identifiers

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2023P001913

Identifier Type: -

Identifier Source: org_study_id