Efficacy of mHealth + e-Navigator Stepped Care Intervention for ART Adherence Among Latino Men With HIV (Project STEP)

Florida International University (FIU)

Status: Enrolling

Conditions: ART Adherence

Treatments: Behavioral: e-Navigation; Behavioral: TXTXT; Behavioral: Ecological Momentary Assessment (EMA) supported e-Navigation.

Study type: Interventional

Funder types: Other

Identifiers

NCT06375135

R1MD017205

Details and patient eligibility

About

The goal of this study is to evaluate the efficacy of stepped care strategies to improve ART adherence among adult Latino men with HIV using a sequential, multiple assignment, randomized trial (SMART). The trial will compare a stepped care strategy of delivering TXTXT ("Treatment Text") first and stepping up to remote patient navigation for non-responders vs. a stepped care strategy of delivering TXTXT + e-Navigation first and stepping up to EMA-supported e-Navigation for non-responders. Both TXTXT and the foundations of the e-Navigation interventions are CDC evidence-based interventions (EBI). We propose to use a SMART design which explicitly allows building, testing, and optimizing stepped care strategies without compromising rigor or randomization. We propose three specific aims:

Aim 1. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two static (non-stepped) treatment regimens (TXTXT alone vs. TXTXT + e-Navigation) on ART adherence and viral suppression among Latino men with HIV. Hypothesis 1a. TXTXT + e-Navigation will be more efficacious than TXTXT alone. Aim 2. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two stepped care strategies (TXTXT with added e-Navigation for non-responders vs. TXTXT + e-Navigation with added EMA support for non-responders) on ART adherence and viral suppression among Latino men with HIV. Hypothesis 2a: TXTXT + e-Navigation with added EMA support for non-responders at the 3-month follow-up will be more efficacious than TXTXT with added e-Navigation for non-responders at the 3-month follow-up. Aim 3. Identify baseline and time-varying moderators on the association between stepped care strategy and ART adherence and viral suppression among Latino men with HIV. Hypotheses 3a-c: TXTXT with added e-Navigation for non-responders will be less efficacious than TXTXT + e-Navigation with added EMA support for non-responders for individuals who are: (a) older at baseline, or report (b) substance use, or (c) symptoms of depression between baseline and the 3-month follow-up.

Enrollment: 250 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Latino or Hispanic
2. Self-report male sex
3. Age 18 or older
4. Diagnosed with HIV and prescribed ART least 1 month prior to study screening and enrollment
5. Suboptimal adherence defined as (1) laboratory evidence of at least one detectable viral load in the past 12 months (≥20 copies/mL), (2) electronic medical record of at least one <90% 30-day adherence period in the past 12 months, or (3) self-reported <90% past 30-day adherence.
6. Cell phone ownership and SMS use: Participants must own a personal cell phone for the intervention.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Arm 1 (starts on TXTXT only)

Experimental group

Description:

Arm 1 will begin with TXTXT only. ART adherence will be assessed at 3 months. If they are 90% adherent or above, they will continue with TXTXT only for an additional 3 months. If they are less than 90% adherent, they will be re-randomized (1:1) into staying only with TXTXT, or into receiving TXTXT plus e-Navigation for an additional 3 months. At 6 months, all interventions will end. Participants in this arm will be followed for 6 months after interventions cease.

Treatment:

Behavioral: TXTXT

Behavioral: e-Navigation

Arm 2 (starts with TXTXT and e-Navigation)

Experimental group

Description:

Arm 2 will begin with TXTXT and e-Navigation. ART adherence will be assessed at 3 months. If they are 90% adherent or above, they will continue with TXTXT and e-Navigation only for an additional 3 months. If they are less than 90% adherent, they will be re-randomized into staying only with TXTXT and e-Navigation, or into receiving TXTXT, e-Navigation plus EMA support for an additional 3 months. At 6 months, all interventions will end. Participants in this arm will be followed for 6 months after interventions cease.

Treatment:

Behavioral: Ecological Momentary Assessment (EMA) supported e-Navigation.

Behavioral: TXTXT

Behavioral: e-Navigation