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ADELANTE: A Randomized Controlled Trial to Improve Engagement in Care for Latinos With HIV

ConditionHIV/AIDS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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, University of Miami's Continuity Clinic, or another HIV primary care clinic in Miami/Dade County; 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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • ADELANTE

    Behavioral

    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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: ADELANTEExperimental treatment 1 intervention
Group B: Enhanced Care ConditionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

12-month viral suppression

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.

Time frame
month-12

Secondary outcomes

1

Number of Emergency department visits

All-cause emergency department visits

Time frame
12 months
2

Number of Hospitalizations

All-cause hospitalizations defined as number of different times stayed in any hospital overnight or longer

Time frame
12 months
3

6-month viral suppression

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.

Time frame
month-6
4

Retention in care

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Baylor College of Medicine

Collaborator

University of Miami

Collaborator

Source ClinicalTrials.gov
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