An Adaptive Treatment Intervention for Depression and Engagement in HIV Care Among Latinos Living With HIV
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- University of California, San Francisco
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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
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
Outcomes
Primary Outcomes
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: 1. Total number of participants screened, eligible and enrolled; 2. At least 80% of all BAT \& CBT sessions completed; 3. 80% retention of participants across all "outcome groups".
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: 1. Greater than 90% adherence to the BAT \& CBT session schedule; 2. 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; 3. Acceptability responses coded from post-intervention exit interview transcripts; 4. Limited number of barriers to participation reported by participants in exit interviews; 5. Responses to a brief survey (to be developed) assessing clinic staff acceptability of the intervention.
Secondary Outcomes
- Self-reported Adherence to Antiretroviral Therapy (ART)(12 months)
- Viral Load(12 months)
- Patient Health Questionnaire-9 (PHQ-9)(12 months)
- Engagement in HIV Care(12 months)