An Adaptive Intervention for Depression Among Latinos Living With HIV

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Augment w/mHealth; Behavioral: Maintenance; Behavioral: Switch to CBT & mHealth; Behavioral: Augment w/BAT & mHealth

• Registration Number: NCT03668379
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-09-10
• Study First Posted: 2018-09-12
• Study Start: 2020-02-26
• Primary Completion: 2022-08-28
• Study Completion: 2022-08-28
• Results First Submitted: 2024-05-24
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-18
• Last Update Submitted: 2024-10-18
• Results First Posted: 2024-10-21
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Behavioral Activation Therapy	Augment w/mHealth	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 Activation Therapy & mHealth	Maintenance	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 Activation Therapy	Maintenance	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 Activation Therapy	Switch to CBT & mHealth	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 Activation Therapy & mHealth	Switch to CBT & 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 Activation Therapy & mHealth	Augment w/BAT & 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.

Primary Outcome Measures

Name	Time	Method
Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS)	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".
Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS)	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

Name	Time	Method
Self-reported Adherence to Antiretroviral Therapy (ART)	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). Higher percentage indicates greater adherence to HIV medications. This measure will be used for descriptive purposes.
Viral Load	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.
Patient Health Questionnaire-9 (PHQ-9)	12 months	Patient Health Questionnaire-9 is a self-report measure of depression with a range from 0-27, with higher score indicating greater severity of depression symptoms.
Engagement in HIV Care	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. Mean scores are the sum of all 10 items divided by 10 with a range of 1-5, and higher scores indicate better engagement in care.

Trial Locations

Locations (1)

Ward 86 HIV Clinic, Zuckerberg San Francisco General Hospital; 🇺🇸 San Francisco, California, United States