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

An Adaptive Treatment Intervention for Depression and Engagement in HIV Care Among Latinos Living With HIV

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 Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Augment w/mHealth; Behavioral: Maintenance; Behavioral: Switch to CBT & mHealth; Behavioral: Augment w/BAT & mHealth

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Ward 86 HIV Clinic, Zuckerberg San Francisco General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite measure of feasibility for the adaptive treatment strategy (ATS)	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: Total number of participants screened, eligible and enrolled;; At least 80% of all BAT & CBT sessions completed;; 80% retention of participants across all "outcome groups".	4 months
Composite measure of acceptability for the adaptive treatment strategy (ATS)	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: Greater than 90% adherence to the BAT & CBT session schedule;; 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;; Acceptability responses coded from post-intervention exit interview transcripts;; Limited number of barriers to participation reported by participants in exit interviews;; Responses to a brief survey (to be developed) assessing clinic staff acceptability of the intervention.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Adherence to Antiretroviral Therapy (ART)	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.	12 months
Viral Load	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.	12 months
Patient Health Questionnaire-9 (PHQ-9)	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.	12 months
Engagement in HIV Care	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.	12 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: John A Sauceda, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• Pfeiffer PN, Bohnert KM, Zivin K, Yosef M, Valenstein M, Aikens JE, Piette JD. Mobile health monitoring to characterize depression symptom trajectories in primary care. J Affect Disord. 2015 Mar 15;174:281-6. doi: 10.1016/j.jad.2014.11.040. Epub 2014 Nov 28.
• Almirall D, Compton SN, Gunlicks-Stoessel M, Duan N, Murphy SA. Designing a pilot sequential multiple assignment randomized trial for developing an adaptive treatment strategy. Stat Med. 2012 Jul 30;31(17):1887-902. doi: 10.1002/sim.4512. Epub 2012 Mar 22.
• Hopko DR, Lejuez CW, Ruggiero KJ, Eifert GH. Contemporary behavioral activation treatments for depression: procedures, principles, and progress. Clin Psychol Rev. 2003 Oct;23(5):699-717. doi: 10.1016/s0272-7358(03)00070-9.
• Safren SA, O'Cleirigh C, Tan JY, Raminani SR, Reilly LC, Otto MW, Mayer KH. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected individuals. Health Psychol. 2009 Jan;28(1):1-10. doi: 10.1037/a0012715.
• Christopoulos KA, Riley ED, Tulsky J, Carrico AW, Moskowitz JT, Wilson L, Coffin LS, Falahati V, Akerley J, Hilton JF. A text messaging intervention to improve retention in care and virologic suppression in a U.S. urban safety-net HIV clinic: study protocol for the Connect4Care (C4C) randomized controlled trial. BMC Infect Dis. 2014 Dec 31;14:718. doi: 10.1186/s12879-014-0718-6.
• Murphy SA, Lynch KG, Oslin D, McKay JR, TenHave T. Developing adaptive treatment strategies in substance abuse research. Drug Alcohol Depend. 2007 May;88 Suppl 2(Suppl 2):S24-30. doi: 10.1016/j.drugalcdep.2006.09.008. Epub 2006 Oct 23.
• Dimidjian S, Barrera M Jr, Martell C, Munoz RF, Lewinsohn PM. The origins and current status of behavioral activation treatments for depression. Annu Rev Clin Psychol. 2011;7:1-38. doi: 10.1146/annurev-clinpsy-032210-104535.
• Simoni JM, Wiebe JS, Sauceda JA, Huh D, Sanchez G, Longoria V, Andres Bedoya C, Safren SA. A preliminary RCT of CBT-AD for adherence and depression among HIV-positive Latinos on the U.S.-Mexico border: the Nuevo Dia study. AIDS Behav. 2013 Oct;17(8):2816-29. doi: 10.1007/s10461-013-0538-5.
• McKleroy VS, Galbraith JS, Cummings B, Jones P, Harshbarger C, Collins C, Gelaude D, Carey JW; ADAPT Team. Adapting evidence-based behavioral interventions for new settings and target populations. AIDS Educ Prev. 2006 Aug;18(4 Suppl A):59-73. doi: 10.1521/aeap.2006.18.supp.59.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Actual): August 28, 2022
• Study Completion (Actual): August 28, 2022

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Depression; HIV; Latinos; Mobile health; Sequential multiple assignment randomized trial designs; Cognitive-behavioral therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: K01MH113475 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No