Recruiting

TRIDENT

Sponsor:

Florida International University

Code:

NCT05136703

Conditions

Depression

HIV-1-infection

Inflammation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)

Antiretroviral Therapy (ART) Adherence Counseling

Study Details

Brief summary:

The purpose of this randomized controlled trial is to understand how a cognitive-behavioral treatment (a form of psychological treatment) for depression changes the gut microbiome (micro-organisms that regulate the health of the gut), immune system, and the brain functioning in people living with HIV.

Conditions

Depression

HIV-1-infection

Inflammation

Study ID

NCT05136703

Start date

Aug 30, 2022

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18 or older
2. Speaks and reads English
3. Verified HIV+ status with antiretroviral medications bearing his/her name
4. Current diagnosis on Major Depressive Disorder (MDD) using a structured clinical interview (DIAMOND) or Hamilton Rating Scale for Depression scores of 7 or greater
5. If prescribed antidepressants, on a stable regimen and dose for at least 2 months
6. Suppressed HIV viral load (< 200 copies/mL)
7. Able to complete Functional Magnetic Resonance Imaging (fMRI) scans (i.e., no claustrophobia, no metal implants, no pacemaker, and BMI < 40)

Exclusion Criteria:

1. Unable to provide informed consent
2. Active, untreated major mental illness
3. Pregnancy at baseline
4. Received CBT for depression in the past 2 years
5. 5\. Otherwise eligible but does not complete the run-in period that includes the baseline assessment, biospecimen collection, the fMRI visit, and a separately scheduled randomization visit

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)

Participants randomized to receive CBT-AD immediately will complete up to 15 individual sessions (12 session with 3 booster sessions) focused on depression and one session of ART Adherence counseling during the four months following randomization.

experimental: Wait-List Control (WLC)

Participants randomized to the WLC condition will receive one session of ART adherence counseling immediately following randomization. After six months, WLC participants will have the opportunity to receive 15 individually delivered CBT-AD sessions (12 sessions and 3 booster sessions) focused on depression.

Interventions

Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)

CBT-AD is a behavioral intervention administered either in person or via Zoom. Each session lasts approximately 50 minutes. Participants will receive up to 12 individually delivered sessions over 4 months. Participants receive up to three individually delivered booster sessions through 6 months.

Antiretroviral Therapy (ART) Adherence Counseling

This treatment involves a single session integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.

Primary outcome measure

  • Change in resting state activation of the negative valence system [ Time Frame: 6 Months ]
  • Change in connectivity of the negative valence system [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Adam W Carrico, PhD

(305) 348-7887acarrico@fiu.edu

Locations

University of Miami Neuroimaging Facility

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Roger McIntosh, PhD

305-243-2047r.mcintosh@miami.edu

Care Resource - Midtown Miami

Recruiting

Miami, Florida, United States, 33137

Contacts

Adam W Carrico, PhD

(305) 348-7887acarrico@fiu.edu

More Information

Sponsor

Florida International University

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

  • Depression
  • Microbiome
  • HIV
  • CBT-AD
  • Gut
  • Brain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Florida International University on 2026-02-06.