N/A
N=10
An Adaptive Intervention for Depression Among Latinos Living With HIV
Depression
Bottom Line
View on ClinicalTrials.gov: NCT03668379 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS) — 5; 5; 4; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Augment w/mHealth (Behavioral); Maintenance (Behavioral); Switch to CBT & mHealth (Behavioral); Augment w/BAT & mHealth (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Measure of Feasibility for the Adaptive Treatment Strategy (ATS) |
5; 5; 4; 3; 0; 0 | — |
| PRIMARY Composite Measure of Acceptability for the Adaptive Treatment Strategy (ATS) |
3; 1; 0; 0; 0; 0 | — |
| SECONDARY Self-reported Adherence to Antiretroviral Therapy (ART) |
— | — |
| SECONDARY Viral Load |
3; 4; 1; 1 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
— | — |
| SECONDARY Engagement in HIV Care |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03668379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.