Clinical trial NCT06274632: ADELANTE: a Randomized Controlled Trial to Improve Engagement in Care for Latinos with HIV
Official title: ADELANTE: a Randomized Controlled Trial of an Intervention to Improve Engagement in Care for Latinos with HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
Keywords: Latino
Hispanic
HIV/AIDS
health outcomes
community health worker
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
name: University of Miami
First posted: 2024-02-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 12-month viral suppression
timeFrame: month-12
Secondary outcomes:
measure: Number of Emergency department visits
timeFrame: 12 months
measure: Number of Hospitalizations
timeFrame: 12 months
measure: 6-month viral suppression
timeFrame: month-6
measure: Retention in care
timeFrame: 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: