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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Texas
Baylor College of Medicine
RECRUITING
Houston
Contact Information
Primary
Julie H Levison, MD
jlevison@mgb.org
617-724-4698
Time Frame
Start Date: 2024-05-22
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 250
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: University of Miami, Baylor College of Medicine
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov