Improving the Treatment of Depression Among Youth With HIV

NCT ID: NCT07211087

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-15
• Study Completion Date: 2030-03-31

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.

Detailed Description

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.

The specific co-primary aims of this proposed study are to:

1. Test the effectiveness COMBEX (with its additional ERIC strategies) compared to COMB on the implementation outcomes of adoption, fidelity, and sustainability.

2. Evaluate, using a cluster randomized design, the impact of COMBEX compared to COMB in improving real-world effectiveness of reducing indices of depression (e.g., symptoms, treatment response, remission) and decreasing the viral load (VL) among 130 YWH in eight HIV care clinics over 72 weeks.

3. Use an explanatory, sequential, mixed-method approach to evaluate the context of implementation, for both COMB and COMBEX, guided by the sustainability framework with data from staff/clinicians (n=64).

Conditions

Depression Disorders; HIV (Human Immunodeficiency Virus)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

COMBEX

COMB + additional ERIC strategies

Group Type: EXPERIMENTAL

COMBEX

Intervention Type: BEHAVIORAL

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

COMB

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

Group Type: ACTIVE_COMPARATOR

COMB

Intervention Type: BEHAVIORAL

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

Interventions

COMBEX

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

Intervention Type: BEHAVIORAL

COMB

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larry K Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Central Contacts

Larry K Brown, MD

Role: CONTACT

lkbrown@brownhealth.org

(401)-793-8808

Graham Emslie, MD

Role: CONTACT

Graham.Emslie@UTSouthwestern.edu

214-456-5918

Other Identifiers

R01MH137280

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH137280

Identifier Type: NIH

Identifier Source: org_study_id

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