Improving the Treatment of Depression Among Youth With HIV

NCT07211087 | Not Yet Recruiting

• 1 other identifier: R01MH137280
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

Depression is a common psychiatric condition among Youth with HIV (YWH), with prevalence as high as 25% in the United States. The treatment of depression is essential for improving both psychiatric and medical outcomes for YWH (e.g., adherence to antiretroviral treatment). Practice guidelines for the treatment of depression and substantial research (including for those with and without HIV), indicate that measured-care treatment (care decisions guided by systematic symptom measurement) and using a combination of a medication management algorithm (MMA) and cognitive behavioral therapy (CBT) that is tailored to the population is efficacious. Unfortunately, these methods are seldom fully implemented in practice, leading to markedly reduced intervention effectiveness. This proposed project will compare an enhanced version of combination treatment (COMBEX) to our previously tested combination treatment (COMB) in a Hybrid Type 2 Cluster Randomized Trial. COMBEX will be enhanced by five ERIC implementation strategies as suggested in our post-trial interviews from our efficacy trial and it will also continue to use the ERIC strategies used in COMB. It is hypothesized that these additional ERIC strategies will improve sustainability and depression outcomes at 48 and 72 weeks.

Conditions

Depression Disorders; HIV (Human Immunodeficiency Virus)

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire-9 (PHQ-9)

  Self-reported depression symptoms score

  Assessed at baseline and Weeks 12, 24, 36, 48, 60, and 72

Secondary Outcomes (1)

• HIV viral load

  Measured at baseline and Weeks 12, 24, 36, 48, 60, and 72

Other Outcomes (3)

• General Quality of Life

  Assessed at baseline and Weeks 12, 24, 36, 48, 60, and 72

• Antidepressant prescription

  Assessed at Weeks 12, 24, 36, 48, 60, and 72

• ART Prescription

  Assessed at Weeks 12, 24, 36, 48, 60, and 72

Study Arms (2)

COMBEX

EXPERIMENTAL

COMB + additional ERIC strategies

Behavioral: COMBEX

COMB

ACTIVE COMPARATOR

Combined approach to routine psychotherapy (including CBT and medication management)

Behavioral: COMB

Interventions

COMBEX BEHAVIORAL

The intervention (COMBEX) is a combined approach to routine psychotherapy (including CBT and medication management) with additional ERIC strategies incorporated.

COMBEX

COMB BEHAVIORAL

COMB is a combined approach to routine psychotherapy (including CBT and medication management).

COMB

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• aged 15- 24 years
• engaged in care at a participating HIV care site
• have documented HIV-1 confirmed by medical records
• a diagnosis as determined by a site clinician of nonpsychotic depression requiring treatment \[either Major Depressive Disorder (MDD), Depression not otherwise specified, or Dysthymia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
• significant symptomatology at Entry (as defined by the PHQ-9)
• aware of their HIV status as determined by site staff
• English-speaking
• able and willing to provide written informed assent/consent and written parental or guardian permission

You may not qualify if:

• by site review, have a history of any psychotic disorders and/or Bipolar I or II Disorder
• have of a severe alcohol or substance dependence according to DSM-V or had moderate symptoms and are experiencing withdrawal or dependence symptoms within the month prior to enrollment
• have depression and/or suicidal ideation requiring more intensive services
• intend to relocate from the study site; 5) are in therapy with a non-study therapist (unless willing to switch to a study-trained therapist)
• if they are in imminent danger to themselves or others. If wards of the state meet all eligibility requirements, they will be eligible if the state allows them to participate in research. Otherwise, they will be excluded.

Sponsors & Collaborators

• Rhode Island Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Larry K Brown, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larry K Brown, MD

CONTACT

(401)-793-8808; lkbrown@brownhealth.org

Graham Emslie, MD

CONTACT

214-456-5918; Graham.Emslie@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hybrid Type 2 Cluster Randomized Trial

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02