IMPAACT 2002: Combined Cognitive Behavioral Therapy and a Medication Management Algorithm for Treatment of Depression Among US Youth With HIV

IMPAACT 2002 is a prospective, multi-site, two-arm, cluster-randomized study to evaluate
whether a health and wellness Cognitive Behavioral Therapy and Medication Management (COMB-R)
intervention for depression demonstrates improved depression outcomes (e.g., decreased
depressive symptoms and greater remission and response rates) and medical outcomes (e.g.,
increased CD4 T-cell count, decreased HIV RNA level) among HIV-infected youth in the US
compared to enhanced standard care (ESC). Youth enrolled in the study will attend a
Screening/Entry Visit and study visits at Weeks 1, 6, 12, and 24. They will have two
additional follow-up visits at Weeks 36 and 48 for the study team to evaluate if observed
effects of the intervention are maintained. The intervention is a treatment for depression
that includes manualized Health and Wellness Cognitive Behavioral Therapy and
algorithm-driven Medication Management designed to address the unique challenges faced by
this population.

Inclusion Criteria:

- Receiving mental health or HIV-related care at participating US IMPAACT site

- Confirmed of HIV-1 Infection

- Aware of his or her HIV infection

- Per clinician assessment, primary diagnosis of nonpsychotic depression, including
Major Depressive Disorder, Depression NOS, or Dysthymia, as defined by DSM-IV or DSM-V
criteria

- Current depressive symptoms that warrant intervention as determined by a score of ≥ 11
on the Quick Inventory of Depressive Symptomatology - Clinician (QIDS-C)

- Able to communicate in spoken and written English

- Able and willing to provide written informed assent/consent and able to obtain written
parental or guardian permission (if required, as specified in site SOP, by State law,
and/or IRB policy) to be screened for and to enroll in IMPAACT 2002

Exclusion Criteria:

- Known or self-reported history of any psychotic disorder and/or bipolar I or II
disorder

- Severe disorders (more than 6 symptoms) based on DSM-V criteria) related to alcohol,
cannabis or other substances; or those with moderate symptoms (4 or 5 symptoms) who
are also currently experiencing withdrawal or dependence symptoms; within the past
month prior to enrollment

- Per clinician assessment at screening, depression and/or suicidal ideation requiring
more intensive treatment than the study provides or at immediate risk of being a
danger to themselves or others

- Per participant report at screening, intends to relocate away from the study site
during study participation

- Currently in therapy with a non-study provider, unless willing to switch to a
study-trained provider

- Has any other condition that, in the opinion of the Investigator of Record
(IoR)/designee, would preclude informed assent/consent, make study participation
unsafe, complicate interpretation of study outcome data, or otherwise interfere with
achieving the study objectives