Clinical trial NCT03668379: An Adaptive Intervention for Depression Among Latinos Living With HIV
Official title: An Adaptive Treatment Intervention for Depression and Engagement in HIV Care Among Latinos Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
HIV
Latinos
Sequential multiple assignment randomized trial designs
Mobile health
Cognitive-behavioral therapy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-09-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS)
timeFrame: 4 months
measure: Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS)
timeFrame: 4 months
Secondary outcomes:
measure: Self-reported Adherence to Antiretroviral Therapy (ART)
timeFrame: 12 months
measure: Viral Load
timeFrame: 12 months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12 months
measure: Engagement in HIV Care
timeFrame: 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Ward 86 HIV Clinic, Zuckerberg San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: John A Sauceda, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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citation: 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.
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 Dia study. AIDS Behav. 2013 Oct;17(8):2816-29. doi: 10.1007/s10461-013-0538-5.
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