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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Depression

Treatments: Behavioral: Augment w/BAT & mHealth; Behavioral: Augment w/mHealth; Behavioral: Maintenance; Behavioral: Switch to CBT & mHealth

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03668379

K01MH113475

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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10 participants in 2 patient groups

Behavioral Activation Therapy

Active Comparator group

Description:

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.

Treatment:

Behavioral: Switch to CBT & mHealth

Behavioral: Maintenance

Behavioral: Augment w/mHealth

Behavioral Activation Therapy & mHealth

Experimental group

Description:

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.

Treatment:

Behavioral: Switch to CBT & mHealth

Behavioral: Maintenance

Behavioral: Augment w/BAT & mHealth