NCT02939131

IMPAACT 2002: Cognitive Behavioral Therapy and Medication Management for Treatment of Depression in US Youth With HIV

Completed NA Results posted Last updated 3 March 2021

What this trial tests

NA trial testing Health and Wellness Combined Cognitive Behavioral Therapy and a Medication Management Algorithm in HIV in 156 participants. Completed in 21 January 2020.

Timeline

6 March 2017

Primary endpoint
12 September 2019

21 January 2020

Quick facts

Lead sponsor	International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	156
Start date	6 March 2017
Primary completion	12 September 2019
Estimated completion	21 January 2020
Sites	13 locations across United States

Drugs / interventions tested

• Health and Wellness Combined Cognitive Behavioral Therapy and a Medication Management Algorithm
• Enhanced Standard of Care

Conditions studied

• HIV — all drugs for HIV →
• Depression — all drugs for Depression →

Sponsor

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Who can join

Adults 12 to 24, any sex, with HIV or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Depression Outcomes: Quick Inventory of Depression Symptomatology - Self Report (QIDS-SR) Score Primary · Week 24

The QIDS-SR ranges from 0-27 and assesses the severity and number of depression symptoms. Data completed through the Audio Computer Assisted Interview (ACASI) system are used for this outcome. A lower score indicates fewer depression symptoms and lower depression symptom severity. Scores for all participants at a site were averaged. The site-specific averages were then analyzed.

Group	Value	95% CI
COMB-R	6.7	3.7 – 9.7
Enhanced Standard of Care	10.6	8.8 – 12.3

Depression Outcomes: Response to Treatment, Defined as a Decrease in QIDS-SR Score by >50% Primary · Week 0 and Week 24

We are assessing the percentage of participants with a response to treatment.The percentage of participants at each site with a response was calculated. These percentages were averaged for each treatment and the treatment averages were compared. A response to treatment is considered a decrease in Quick Inventory of Depression Symptomatology, Self Report (QIDS-SR) from Study entry to Week 24 by more than 50%. The week 0 value is generally considered the entry value. Priority is given to the ACASI score at week 0. In certain cases, the week 1 ACASI value is used if there is no ACASI score at wee

Group	Value	95% CI
COMB-R	62.3	39 – 85.5
Enhanced Standard of Care	17.9	7.0 – 28.9

Depression Outcomes: Remission, Defined as a QIDS-SR Score <= 5 Primary · Week 24

We computed the percentage of participants at each site with remission and then compared the percentages. Remission is defined as a Quick Inventory of Depression Symptomatology, self-report (QIDS-SR) score \<= 5. ACASI data are used for this outcome. The QIDS-SR scale is from 0-27 with a lower score indicating tess symptomatology.

Group	Value	95% CI
COMB-R	47.9	22.7 – 73.0
Enhanced Standard of Care	17.0	7.2 – 26.8

Biological Outcomes: Cluster of Differentiation 4 (CD4) Cell Count at Week 24 Primary · Week 24

CD4 cell counts are cells/microL (uL). CD4 cell counts of all participants at a site were averaged. The averages were then analyzed.

Group	Value	95% CI
COMB-R	703	466 – 940
Enhanced Standard of Care	683	524 – 842

Biological Outcomes: Plasma HIV RNA Level at Week 24 Primary · Week 24

Plasma HIV RNA data are calculated on the log10 scale as log10(RNA copies/mL) For this analysis, HIV-1 RNA values (copies per mL) that were censored below the lower limit of quantification (LLQ) were imputed to be equal to the LLQ - 1. The LLQ was considered to be 40 copies/mL. Viral load was calculated on the log10 scale as log10(RNA copies/mL). Viral load suppression was also measured as copies \< 40. The log10 (RNA copies/mL) values were averaged by site and those averages were analyzed.

Group	Value	95% CI
COMB-R	2.23	1.48 – 2.97
Enhanced Standard of Care	2.06	1.47 – 2.65

Adherence Outcomes: Adherence to Anti-HIV Medications - Number of Days in Last 30 With Any Missed Doses Secondary · Weeks 24 and 48

Adherence to anti-HIV medications at each assessment for the first 24 weeks (during active treatment) and at 48 weeks, as measured by self-report. The first of three questions was to assess the number of days in the last 30 with any missed medication doses.The average number of days for all participants at a site were averaged. The site-specific averages were then analyzed.

week 24

Group	Value	95% CI
COMB-R	4.4	2.6 – 6.2
Enhanced Standard of Care	2.3	1.0 – 3.7

week 48

Group	Value	95% CI
COMB-R	4.8	1.1 – 8.5
Enhanced Standard of Care	4.7	0.4 – 9.0

Adherence Outcomes: Adherence to Anti-HIV Medications - How Good Participant Was at Taking Medicines as Instructed Secondary · Weeks 24 and 48

Adherence to anti-HIV medications at each assessment for the first 24 weeks (during active treatment) and at 48 weeks, as measured by self-report. The second of three questions was how good the participant is at taking his medication as instructed in the last 30 days. Response scales are Likert from 1 to 6, with a higher score indicating better adherence. 1=Very poor .... 6=Excellent. The average score for all participants at each site was computed and these site-level summaries were compared across treatments.

Week 24

Group	Value	95% CI
COMB-R	4.3	3.8 – 4.9
Enhanced Standard of Care	4.7	4.1 – 5.4

Week 48

Group	Value	95% CI
COMB-R	4.4	3.7 – 5.1
Enhanced Standard of Care	4.2	3.9 – 4.5

Adherence Outcomes: Adherence to Anti-HIV Medications - How Often Did Participant Take Medications as Instructed Secondary · Weeks 24 and 48

Adherence to anti-HIV medications at each assessment for the first 24 weeks (during active treatment) and at 48 weeks, as measured by self-report. The third of three questions was how often the participant took medication correctly in the last 30 days. Response scales are Likert from 1 to 6, with a higher score indicating better adherence. 1=Never ... 6=Always. The average score for all participants at a site was computed and these site-level summaries were compared across treatments.

Week 24

Group	Value	95% CI
COMB-R	4.8	4.3 – 5.3
Enhanced Standard of Care	5.2	4.7 – 5.7

Week 48

Group	Value	95% CI
COMB-R	4.8	3.9 – 5.6
Enhanced Standard of Care	4.5	3.9 – 5.1

Adherence Outcomes: Adherence to Psychiatric Medications - Number of Days in Last 30 With Any Missed Doses Secondary · Weeks 24 and 48

Adherence to depression medications at each assessment for the first 24 weeks (during active treatment) and at 48 weeks, as measured by self-report for those participants taking depression medications. Three questions were asked; The first of the three questions was to assess the number of days in the last 30 with any missed medication doses.The average number of days for all participants at a site were averaged. The site-specific averages were then analyzed.

week 24

Group	Value	95% CI
COMB-R	3.4	0.9 – 5.9
Enhanced Standard of Care	1.2	0.1 – 2.2

week 48

Group	Value	95% CI
COMB-R	3.6	1.1 – 6.2
Enhanced Standard of Care	6.4	-3.4 – 16.1

Adherence Outcomes: Adherence to Psychiatric Medications - How Good Participant Was at Taking Medications as Instructed Secondary · Weeks 24 and 48

Adherence to depression medications at each assessment for the first 24 weeks (during active treatment) and at 48 weeks, as measured by self-report tor those participants taking depression medications. The second of three questions was how good the participant is at taking his medication as instructed during the last 30 days. Response scales are Likert from 1 to 6, with a higher score indicating better adherence.1=Very poor .... 6=Excellent. The average score for all participants at each site was computed and these site-level summaries were compared across treatments.

week 24

Group	Value	95% CI
COMB-R	4.5	4.0 – 5.1
Enhanced Standard of Care	5.2	4.4 – 5.9

week 48

Group	Value	95% CI
COMB-R	4.5	3.8 – 5.2
Enhanced Standard of Care	4.0	2.6 – 5.5

Adherence Outcomes: Adherence to Psychiatric Medications - How Often Did Participant Take Medicines as Instructed Secondary · Weeks 24 and 48

Adherence to depression medications at each assessment for the first 24 weeks (during active treatment) and at 48 weeks, as measured by self-report for those participants taking depression medications. The third of three questions was how often the participant took medication correctly in the past 30 days. Response scales are Likert from 1 to 6, with a higher score indicating better adherence: 1=Never .... 6=Always. The average score for all participants at each site was computed and these site-level summaries were compared across treatments.

Week 24

Group	Value	95% CI
COMB-R	4.8	4.1 – 5.5
Enhanced Standard of Care	5.4	5.0 – 5.8

Week 48

Group	Value	95% CI
COMB-R	5.1	4.5 – 5.6
Enhanced Standard of Care	4.3	2.7 – 5.9

Adherence Outcomes: Adherence to Psychotherapy Sessions Secondary · Weeks 1, 6, 12 and 24

We computed the number of scheduled counseling sessions attended. The average number of sessions was computed for all participants at each site and these site-level averages were compared across treatments.Where study visits for weeks 0 and 1 were held on the same day, the counseling session for week 1 would have been administered at week 0.

Group	Value	95% CI
COMB-R	3.5	3.3 – 3.8
Enhanced Standard of Care	3.7	3.3 – 4.0

Adverse events — posted to ClinicalTrials.gov

Time frame: The adverse event data were collected over the 48 weeks of the study duration.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

COMB-R

Serious: 6/81 (7%)

Deaths: 0/81

Enhanced Standard of Care (ESC)

Serious: 6/75 (8%)

Deaths: 0/75

Serious adverse events (8 terms)

Reaction	System	COMB-R	Enhanced Standard of Care …
Suicide attempt	Psychiatric disorders	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—
Appendicitis	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Depression	Psychiatric disorders	—	—
Major depression	Psychiatric disorders	—	—
Mental disorder	Psychiatric disorders	—	—
Substance-induced psychotic disorder	Psychiatric disorders	—	—

Other adverse events (15 terms — click to expand)

Reaction	System	COMB-R	Enhanced Standard of Care …
Depression	Psychiatric disorders	—	—
Major depression	Psychiatric disorders	—	—
Depressed mood	Psychiatric disorders	—	—
Irritability	Psychiatric disorders	—	—
Disturbance in attention	Nervous system disorders	—	—
Insomnia	Psychiatric disorders	—	—
Persistent depressive disorder	Psychiatric disorders	—	—
Lethargy	Nervous system disorders	—	—
Fatigue	General disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Anxiety	Psychiatric disorders	—	—
Suicidal ideation	Psychiatric disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Pneumonia bacterial	Infections and infestations	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—

Most-reported serious reactions: Suicide attempt, Cholecystitis acute, Appendicitis, Pneumonia, Depression, Major depression, Mental disorder, Substance-induced psychotic disorder.

Data from ClinicalTrials.gov NCT02939131 adverse events section.

Sponsor's own description

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 and medical outcomes for HIV-infected youth in the United States (US) compared to enhanced standard care (ESC).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Participant acceptability and clinician satisfaction of cognitive behavioural therapy and medication management algorithm compared with enhanced standard care for treatment of depression among youth with HIV.
   Barr EA, Baltrusaitis K, Kennard BD, Emslie GJ, et al · · 2025 · cited 2× · PMID 39550758 · DOI 10.2989/17280583.2024.2387632