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NCT03668379: Latino-SMART

An Adaptive Intervention for Depression Among Latinos Living With HIV

Completed NA Results posted Last updated 21 October 2024
What this trial tests

NA trial testing Augment w/mHealth in Depression in 10 participants. Completed in 28 August 2022.

Timeline
26 February 2020
Primary endpoint
28 August 2022
28 August 2022

Quick facts

Lead sponsorUniversity of California, San Francisco
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingdouble
Primary purposetreatment
Enrollment10
Start date26 February 2020
Primary completion28 August 2022
Estimated completion28 August 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS) Primary · 4 months

This is one composite measure. Feasibility of the adaptive treatment strategy (ATS) will be measured to assess whether the ATS is appropriate for further testing, relevant and sustainable. Feasibility of the ATS will be reported as a composite score of the following measures taken at the end of the second-stage treatment: 1. Total number of participants screened, eligible and enrolled; 2. At least 80% of all BAT \& CBT sessions completed; 3. 80% retention of participants across all "outcome groups".

Enrolled
GroupValue95% CI
Behavioral Activation Therapy Maintenance5
Behavioral Activation Therapy & mHealth Maintenance5
Completion Percentage
GroupValue95% CI
Behavioral Activation Therapy Maintenance4
Behavioral Activation Therapy & mHealth Maintenance3
Retention Percentage
GroupValue95% CI
Behavioral Activation Therapy Maintenance0
Behavioral Activation Therapy & mHealth Maintenance0
Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS) Primary · 4 months

This is one composite measure. Acceptability of the adaptive treatment strategy will be measured to determine the tolerability or appropriateness of the SMART intervention from the perspective of both participants and clinicians.Acceptability of the ATS will be reported as a composite score of the following measures taken at the end of the second-stage treatment: 1. Greater than 90% adherence to the BAT \& CBT session schedule; 2. Responsiveness to text-messages: a) \>80% of all two-way messages replied back to study line during the set of blocked hours; b) \>90% of participants reporting dir

90% Adherence
GroupValue95% CI
Behavioral Activation Therapy Maintenance3
Behavioral Activation Therapy & mHealth Maintenance1
Two-Way Text-Message Response
GroupValue95% CI
Behavioral Activation Therapy Maintenance0
Behavioral Activation Therapy & mHealth Maintenance0
One-Way Text-Message Response
GroupValue95% CI
Behavioral Activation Therapy Maintenance0
Behavioral Activation Therapy & mHealth Maintenance0
Acceptability Responses
GroupValue95% CI
Behavioral Activation Therapy Maintenance0
Behavioral Activation Therapy & mHealth Maintenance0
Barriers
GroupValue95% CI
Behavioral Activation Therapy Maintenance0
Behavioral Activation Therapy & mHealth Maintenance0
Responses
GroupValue95% CI
Behavioral Activation Therapy Maintenance0
Behavioral Activation Therapy & mHealth Maintenance0
Viral Load Secondary · 12 months

Viral load measures the amount of HIV virus in the blood. Viral load data abstracted from patient medical records will act as a descriptive measure of HIV-related clinical outcomes. A detectable viral load is a measurement of the amount of HIV in the blood, and an indication that HIV is replicating in the body. Undetectable viral load means that there is not enough of the virus to be detected.

Undetectable viral load
GroupValue95% CI
Behavioral Activation Therapy Maintenance3
Behavioral Activation Therapy & mHealth Maintenance4
Detectable viral load
GroupValue95% CI
Behavioral Activation Therapy Maintenance1
Behavioral Activation Therapy & mHealth Maintenance1

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Depression

Currently open trials in the same condition.

Other University of California, San Francisco trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03668379.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing