CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Augment w/mHealth +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03668379
NCT03668379N/ACompleted
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An Adaptive Treatment Intervention for Depression and Engagement in HIV Care Among Latinos Living With HIV

University of California, San Francisco·interventional·Posted Sep 12, 2018·Updated Oct 21, 2024

In Brief

A clinical study evaluating Augment w/mHealth, Maintenance, and 2 other interventions for Depression. Completed, enrolled 10 participants across 1 site.

Detailed Summary

This study will use a pilot sequential multiple assignment randomized trial (SMART) design to build an adaptive treatment strategy (ATS) for depression and engagement in HIV among Latinos living with HIV. The ATS is the sequencing of treatments, which are a behavioral activation therapy (BAT), a cognitive-behavioral therapy (CBT), and mobile health (mHealth) tool. The outcomes are to assess the feasibility of the SMART and ATS in the HIV care site and acceptability of the SMART and ATS to patients and clinic staff.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 12, 2018
Enrollment StartFeb 26, 2020
Primary CompletionAug 28, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.8 years ago

Interventions

Augment w/mHealthbehavioral

"Non-responders" to the first stage treatment of BAT alone may be re-randomized to this augmented intervention to receive text-message support in addition to the BAT intervention.

Maintenancebehavioral

"Responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth will continue in maintenance mode. These participants will not receive any additional interventions during the 2nd-stage treatment.

Switch to CBT & mHealthbehavioral

"Non-responders" to the 1st-stage treatment of either 1. BAT or 2. BAT \& mHealth may be re-randomized to "switch" interventions in the form of an intensified "dose" of Cognitive Behavioral Therapy (CBT). CBT is eight sessions long and covers five modules that can be re-arranged to fit patient needs. Sessions will be scheduled once a week to facilitate more contact with participants. An identical text-messaged tool will be used.

Augment w/BAT & mHealthbehavioral

"Non-responders" to the BAT \& mHealth intervention may be re-randomized to receive an additional "dose" of BAT \& mHealth in the form of an additional session of BAT.