An Adaptive Intervention for Depression Among Latinos Living With HIV

Depression Clinical Trial

— Latino-SMART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03668379
• Other study ID #: K01MH113475
• Secondary ID: K01MH113475
• Status: Completed
• Phase: N/A
• Start date: February 26, 2020
• Est. completion date: August 28, 2022

Study information

• Verified date: August 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 28, 2022
• Est. primary completion date: August 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Ward 86 HIV Clinic, Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

Dimidjian S, Barrera M Jr, Martell C, Muñoz 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. Review. — View Citation

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. — View Citation

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. — View Citation

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:S24-30. Epub 2006 Oct 23. — View Citation

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. — View Citation

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. — View Citation

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 Día study. AIDS Behav. 2013 Oct;17(8):2816-29. doi: 10.1007/s10461-013-0538-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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