Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375135
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-04-16
Brief Title:
mHealth e-Navigator Stepped Care on ART Adherence in Latino MSM
Sponsor:
Florida International University
Organization:
Florida International University
Study Overview
Official Title:
Efficacy of an mHealth e-Navigator Stepped Care Intervention for ART Adherence Among Latino MSM
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Project STEP
Brief Summary:
The goal of this study is to evaluate the efficacy of stepped care strategies to improve ART adherence among adult Latino MSM 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 MSM 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 MSM 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 MSM 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
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 MSM 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 MSM 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 MSM 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None