ADELANTE: a Randomized Controlled Trial to Improve Engagement in Care for Latinos with HIV
- Conditions
- HIV/AIDS
- Interventions
- Behavioral: ADELANTE
- Registration Number
- NCT06274632
- Lead Sponsor
- Massachusetts General Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ADELANTE 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.
- Primary Outcome Measures
Name Time Method 12-month viral suppression month-12 Viral suppression is defined as number of participants with HIV RNA less than 200 cpm. Response determined by viral load values in the medical record closest to the scheduled 12-month date, allowing for a range of three months before or after the scheduled 12-month date.
- Secondary Outcome Measures
Name Time Method Number of Hospitalizations 12 months All-cause hospitalizations defined as number of different times stayed in any hospital overnight or longer
Retention in care 12 months A dichotomized outcome (yes/no) with yes defined as at least one visit to the clinic providing HIV treatment at both time periods (months 0-6 and months 7-12) with the two visits at least 90 days apart and no defined as no HIV visit from at least one time period. Attendance determined by review of the medical record.
Number of Emergency department visits 12 months All-cause emergency department visits
6-month viral suppression month-6 Viral suppression is defined as number of participants with HIV RNA less than 200 cpm. Response determined by viral load values in the medical record closest to the scheduled 6-month date, allowing for a range between 4 and 8 months.
Trial Locations
- Locations (2)
University of Miami
🇺🇸Miami, Florida, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States