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

Mass General Brigham

Status: Enrolling

Conditions: HIV/AIDS

Treatments: Behavioral: ADELANTE

Study type: Interventional

Funder types: Other

Identifiers

NCT06274632

2023P001913

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

250 participants in 2 patient groups

ADELANTE

Experimental group

Description:

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.

Treatment:

Behavioral: ADELANTE

Enhanced Care Condition

No Intervention group

Description:

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