NCT07211087Not yet recruiting
Improving the Treatment of Depression Among Youth With HIV
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 29 Sept 2025
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Jul 2029
- Lead sponsor
- Rhode Island Hospital
- Diseases
- HIV
- NCT number
- NCT07211087
What you commit to
- Study type: Interventional
- Planned participants: 130
- From 1 Apr 2026 to the primary completion date, 1 Jul 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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)
Other illness
- by site review, have a history of any psychotic disorders and/or Bipolar I or II Disorder
Other
- have depression and/or suicidal ideation requiring more intensive services
- 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.
Who the study is looking for
- 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
Age in the registry: 15 years to 24 years · Sex: All · Does not accept healthy volunteers
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.