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An Adaptive Intervention for Depression Among Latinos Living With HIV. (Latino-SMART)

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ClinicalTrials.gov Identifier: NCT03668379
Recruitment Status : Not yet recruiting
First Posted : September 12, 2018
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
John Sauceda, University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Augment w/mHealth Behavioral: Maintenance Behavioral: Switch to CBT & mHealth Behavioral: Augment w/BAT & mHealth Not Applicable

Detailed Description:
This project proposes to use a SMART to build an adaptive treatment strategy (ATS) that has a mobile health (mHealth) tool (text-messaging) to improve adherence to the treatments for depression. The treatments being tested are a behavioral activation therapy (BAT) and cognitive-behavioral therapy (CBT). The outcomes are feasibility of the SMART and ATS in the HIV care site and acceptability of the SMART and ATS to patients and clinic staff. To achieve the overall goal, there are two aims. Aim 1 uses qualitative research methods for the conduct of focus groups and individual interviews with HIV+ Latinos in both English and Spanish. The goal of Aim 1 is to tailor the intervention to the cultural and linguistic needs of Latinos and the organization needs of the HIV clinic study site, which informs Aim 2. Aim 1 is guided by the CDCs Map of Adaptation tailoring framework, which consist of three Action Steps. Action Step 1-3 are to better understand and document: 1) expressions for depression in Spanish and barriers to care, 2) language issues in detecting and reporting depressive symptoms, 3) cultural perspectives of how depression presents as a barrier to care, and 4) attitudes (i.e., cognitive and emotional evaluations) toward BAT and CBT, and text-message preference and confidentiality concerns to promote adherence to the intervention activities. Aim 2 is to build and test a pilot SMART for an ATS - a set of decision rules that uses detectable changes in patient health status to inform the next course of treatment. Successful completion of the proposed study will yield pilot data on the feasibility and acceptability of an ATS for depression integrated into HIV primary care at the University of California San Francisco - Zuckerberg San Francisco General Hospital.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The study utilizes a Sequential Multiple Assignment Randomized Trial (SMART) design in order to guide a series of adaptive behavioral interventions. In a SMART, eligible participants will be randomized at baseline and assigned to "1st-stage treatments" consisting of either 1. Behavioral Activation Therapy (BAT) or 2. BAT & mHealth. During the first stage treatment, Patient Health Questionnaire-9 (PHQ-9) scores will be collected. At the follow-up period, the PHQ-9 will provide a cutoff score to determine whether a participant showed a clinically meaningful response ("responder/non-responder") to the "1st stage treatment." "Responder" indicates that patients successfully responded to the 1st stage treatment and will continue the treatment in maintenance mode. "Non-responder" indicates that the patient did not respond to the 1st-stage treatment and are re-randomized to either an augmented or "switched" intervention.
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: Medical providers of the patients enrolled in the study will be notified that their patient is in a study for depression but not told what intervention arm. At all follow-up outcome points, the assessor will be blind to all intervention arms the patient were randomized to.
Primary Purpose: Treatment
Official Title: An Adaptive Treatment Intervention for Depression and Engagement in HIV Care Among Latinos Living With HIV.
Estimated Study Start Date : December 2, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Behavioral Activation Therapy
During the initial stage treatment, the active comparator arm is the behavioral activation (BAT) program intervention. BAT is informed by behavioral theory and has been shown to be a highly efficacious treatment for depression. A total of five, 1-hour sessions will be delivered every two weeks. During Session 1, the focus will be on providing an introduction to BAT, as well as building "confianza" (mutual trust) between the patient and provider. Sessions 2 & 3 will review the initial session, introduce "high" value activities and barriers to BAT protocols. Sessions 4 & 5 will review progress, challenges & maintenance strategies.
Behavioral: Augment w/mHealth
"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.

Behavioral: Maintenance
"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.

Behavioral: Switch to CBT & mHealth
"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.

Experimental: Behavioral Activation Therapy & mHealth
During the initial stage treatment, the experimental arm will deliver a BAT program identical to the active comparator arm, as well as a mobile health (mHealth) component in the form of one-way and two-way SMS text-messages. Direct personalized text-messages will be delivered twice a week to facilitate engagement with the BAT intervention activities. One-way messages will be sent as appointment and BAT adherence reminders. Two-way messages will be sent once a week during a set block of protected hours, creating a "mobile drop-in clinic" where messages can be sent and received.
Behavioral: Maintenance
"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.

Behavioral: Switch to CBT & mHealth
"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.

Behavioral: Augment w/BAT & mHealth
"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.




Primary Outcome Measures :
  1. Composite measure of feasibility for the adaptive treatment strategy (ATS) [ Time Frame: 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".

  2. Composite measure of acceptability for the adaptive treatment strategy (ATS) [ Time Frame: 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 direct benefit from one-way text messages;
    3. Acceptability responses coded from post-intervention exit interview transcripts;
    4. Limited number of barriers to participation reported by participants in exit interviews;
    5. Responses to a brief survey (to be developed) assessing clinic staff acceptability of the intervention.


Secondary Outcome Measures :
  1. Self-reported Adherence to Antiretroviral Therapy (ART) [ Time Frame: 12 months ]
    Self-reported adherence will be measured using the the visual analog scale (VAS), a 10-cm line on which participants indicate the percentage of doses (intervals of 10 percentage points indicated from 0% to 100%) of all HIV medications taken in the past 30 days (Amico et al., 2006). This measure will be used for descriptive purposes.

  2. Viral Load [ Time Frame: 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.

  3. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 12 months ]
    The PHQ-9 is a survey tool used to screen, diagnose, monitor and measure self-reported depressive symptoms. The tool rates the frequency of symptoms in order to score the severity of symptoms. Changes in PHQ-9 scores from baseline will be used for descriptive purposes.

  4. Engagement in HIV Care [ Time Frame: 12 months ]
    Engagement in care will be measured utilizing the multidimensional index of engagement in HIV care, a 10-item unit-dimensional patient-centered scale that assesses provider, clinic, and patient-level characteristics associated with being engaged in HIV care. This measure will be used for descriptive purposes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HIV positive
  • 18 years of age and older
  • Self identifies as Latino/Hispanic
  • Fluent in English or Spanish
  • Receives HIV care at study site clinic
  • Has a moderate depression severity score or higher (Patient Health Questionnaire-9 score >9; PHQ)
  • Agrees to discuss depression, treatment preferences, and mobile health
  • Owns a mobile phone that can send/receive short-message service (SMS) text messages
  • Agrees to participate in the intervention that lasts three months
  • Agrees to have medical and clinical data abstracted one year after baseline
  • Able and willing to consent to participate

Exclusion Criteria:

  • Not HIV positive
  • Under 18 years of age
  • Does not self-identify as Latino/Hispanic
  • Not fluent in English or Spanish
  • Does not receive primary HIV care at the study site
  • Has a less than moderate depression severity score (Patient Health Questionnaire-9 score ≤9; PHQ)
  • Does not agree to discuss depression, treatment preferences, and mobile health
  • Does not owns a mobile phone that can send/receive short-message service (SMS) text messages
  • Does not agree to participate in the intervention that lasts three months
  • Does not agree to have medical and clinical data abstracted one year after baseline
  • Not able and willing to consent to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668379


Contacts
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Contact: John Sauceda, PhD (415) 502-1000 ext 17172 john.sauceda@ucsf.edu

Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: John A Sauceda, PhD University of California, San Francisco

Publications:

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Responsible Party: John Sauceda, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03668379     History of Changes
Other Study ID Numbers: K01MH113475 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John Sauceda, University of California, San Francisco:
Depression
HIV
Latinos
Sequential multiple assignment randomized trial designs
Mobile health
Cognitive-behavioral therapy
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders