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Completed

NCT Number: NCT03668379

An Adaptive Intervention for Depression 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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ward 86 HIV Clinic, Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Augment w/mHealth

Behavioral

"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

Behavioral

"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

Behavioral

"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

Behavioral

"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.

Primary outcomes

  1. Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS)

    Time frame: 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:

    • 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".

  2. Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS)

    Time frame: 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:

    • 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.

Secondary outcomes

  1. Self-reported Adherence to Antiretroviral Therapy (ART)

    Time frame: 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.

  2. Viral Load

    Time frame: 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.

  3. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 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.

  4. Engagement in HIV Care

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: Latino-SMART

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 12, 2018
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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