Recruiting

Engagement in Care

Sponsor:

Massachusetts General Hospital

Code:

NCT06274632

Conditions

HIV/AIDS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ADELANTE

Study Details

Brief 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.

Conditions

HIV/AIDS

Study ID

NCT06274632

Start date

May 22, 2024

Status verified date

Jan, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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; 3 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.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Julie H Levison, MD

617-724-4698jlevison@mgb.org

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33146

Contacts

Allan Rodriguez, MD

305-243-3711arodriguez2@miami.edu

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Thomas P Giordano, MD

713-798-8918tpg@bcm.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Keywords

  • Latino
  • Hispanic
  • HIV/AIDS
  • health outcomes
  • community health worker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-01-09.