Trial Outcomes & Findings for Trial of Collaborative Depression Care Management for HIV Patients (NCT NCT01372605)

NCT ID: NCT01372605

Last Updated: 2016-11-29

Results Overview

Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 304 participants
• Primary outcome timeframe: Six months post-enrollment
• Results posted on: 2016-11-29

Participant Flow

Participant milestones

Measure	Collaborative Depression Care Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications	Enhanced Usual Care Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
Overall Study STARTED	149	155
Overall Study COMPLETED	137	145
Overall Study NOT COMPLETED	12	10

Reasons for withdrawal

Measure	Collaborative Depression Care Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications	Enhanced Usual Care Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
Overall Study Death	1	2
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	4	7
Overall Study Moved	3	0
Overall Study Changed medical home	2	0

Baseline Characteristics

Trial of Collaborative Depression Care Management for HIV Patients

Baseline characteristics by cohort

Measure	Collaborative Depression Care n=149 Participants Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications	Enhanced Usual Care n=155 Participants Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.	Total n=304 Participants Total of all reporting groups
Age, Continuous	42.8 years STANDARD_DEVIATION 10.3 • n=5 Participants	44.9 years STANDARD_DEVIATION 9.9 • n=7 Participants	43.9 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex/Gender, Customized Male	112 participants n=5 Participants	100 participants n=7 Participants	212 participants n=5 Participants
Sex/Gender, Customized Female	35 participants n=5 Participants	52 participants n=7 Participants	87 participants n=5 Participants
Sex/Gender, Customized Transgender	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	140 Participants n=5 Participants	151 Participants n=7 Participants	291 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	86 Participants n=5 Participants	107 Participants n=7 Participants	193 Participants n=5 Participants
Race (NIH/OMB) White	58 Participants n=5 Participants	43 Participants n=7 Participants	101 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	149 participants n=5 Participants	155 participants n=7 Participants	304 participants n=5 Participants

PRIMARY outcome

Timeframe: Six months post-enrollment

Population: All those completing a 6-month pill count which resulted in a valid adherence measure

Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor

Outcome measures

Measure	Collaborative Depression Care n=86 Participants Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications	Enhanced Usual Care n=95 Participants Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
Antiretroviral Medication Adherence	89.2 observed pills taken as % of expected Standard Deviation 21.8	87.6 observed pills taken as % of expected Standard Deviation 22.9

SECONDARY outcome

Timeframe: Six months

Population: All those completing a 6-month outcomes interview which resulted in a valid HAMD measure

Hamilton Rating Scale for Depression (HAMD) symptom score at 6 months, assessed by blinded assessor. Possible score ranges from 0 to 50. Higher scores indicate worse depressive symptoms.

Outcome measures

Measure	Collaborative Depression Care n=92 Participants Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications	Enhanced Usual Care n=98 Participants Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
Depressive Symptoms	13.5 units on a scale Standard Deviation 7.6	17.2 units on a scale Standard Deviation 8.5

SECONDARY outcome

Timeframe: 12 months

Population: Includes all individuals who completed a 6-month pill count that could be linked to an earlier (usually, 5-month) pill count, so as to calculate adherence. Some individuals did not complete this data point but still continued in the study and contributed later data.

Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor

Outcome measures

Measure	Collaborative Depression Care n=69 Participants Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications	Enhanced Usual Care n=63 Participants Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
Antiretroviral Medication Adherence	86.3 Percentage of expected pills Standard Deviation 22.5	94.5 Percentage of expected pills Standard Deviation 12.4

SECONDARY outcome

Timeframe: 12 months

Population: All participants were analyzed using all available time points, with multiple imputation used to address missing data.

Total health care costs over 12 months

Outcome measures

Measure	Collaborative Depression Care n=149 Participants Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications	Enhanced Usual Care n=155 Participants Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
Health Care Costs	4611 dollars Standard Error 151	4535 dollars Standard Error 148

SECONDARY outcome

Timeframe: 12 months

Population: All participants with available medical chart data on appointment attendance were analyzed. Some participants did not complete the study but still contributed chart abstraction data.

Kept HIV appointments as a percentage of all kept or missed appointments during 12 months post-enrollment

Outcome measures

Measure	Collaborative Depression Care n=146 Participants Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications	Enhanced Usual Care n=151 Participants Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
Appointment Adherence	81.3 Percent of appts that were kept Standard Deviation 23.9	80.1 Percent of appts that were kept Standard Deviation 26.1

SECONDARY outcome

Timeframe: 6 months

Population: All participants with a viral load available at 6 months. Some individuals without a viral load at 6 months still continued in the study and provided later data.

HIV RNA viral load below the limit of detection at 6 months

Outcome measures

Measure	Collaborative Depression Care n=79 Participants Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications	Enhanced Usual Care n=98 Participants Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
Number of Participants With Viral Load Below Detection	68 participants	75 participants

SECONDARY outcome

Timeframe: 6 months

Population: All participants who completed a 6-month research interview contributed data to this endpoint. Some participants did not complete the 6-month interview but still continued in the study and contributed later data.

Short Form-12 Mental Composite score. Scores range from 0-100, with 50 corresponding to the mean and 10 points to the standard deviation in a normative US population. Higher scores indicate better health.

Outcome measures

Measure	Collaborative Depression Care n=92 Participants Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications	Enhanced Usual Care n=98 Participants Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
Quality of Life	41.6 units on a scale Standard Deviation 12.4	37.6 units on a scale Standard Deviation 12.6

SECONDARY outcome

Timeframe: 6 months

Population: All participants completing the 6-month interview and currently on antiretrovirals contributed to this analysis. Some participants did not complete the 6-month interview but still continued in the study and contributed to later data.

Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).

Outcome measures

Measure	Collaborative Depression Care n=92 Participants Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications	Enhanced Usual Care n=98 Participants Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
Self Reported Adherence	92.7 units on a scale Standard Deviation 12.3	93.9 units on a scale Standard Deviation 15.0

SECONDARY outcome

Timeframe: 12 months

Population: All participants completing the 12-month interview contributed data to this analysis. Some participants did not complete the 12-month interview but still completed the study and contributed other data.

Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).

Outcome measures

Measure	Collaborative Depression Care n=69 Participants Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications	Enhanced Usual Care n=81 Participants Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
Self-reported Adherence	91.6 units on a scale Standard Deviation 16.4	94.1 units on a scale Standard Deviation 14.7

SECONDARY outcome

Timeframe: 12 months

Psychiatric hospitalizations

Outcome measures

Measure	Collaborative Depression Care n=149 Participants Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications	Enhanced Usual Care n=155 Participants Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
Safety Endpoint	2 participants	4 participants

SECONDARY outcome

Timeframe: 12 months

Population: All participants with at least one depression measure contributed to this analysis.

Total depression-free days over 12 months as calculated from Hamilton Rating Scale for Depression scores at baseline and 3, 6, 9, and 12 months

Outcome measures

Measure	Collaborative Depression Care n=143 Participants Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications	Enhanced Usual Care n=137 Participants Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
Depression-free Days	160 days Standard Deviation 9.9	136 days Standard Deviation 9.3

Adverse Events

Collaborative Depression Care

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Enhanced Usual Care

Serious events: 2 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Measure	Collaborative Depression Care n=149 participants at risk Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications	Enhanced Usual Care n=155 participants at risk Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
Immune system disorders Death	0.67% 1/149 • Number of events 1 Adverse events were collected without classification by specific Adverse Event Terms. Per protocol, hospitalizations were considered other adverse events in this study.	1.3% 2/155 • Number of events 2 Adverse events were collected without classification by specific Adverse Event Terms. Per protocol, hospitalizations were considered other adverse events in this study.

Other adverse events

Measure	Collaborative Depression Care n=149 participants at risk Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications	Enhanced Usual Care n=155 participants at risk Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
Immune system disorders Medical hospitalization	23.5% 35/149 • Number of events 63 Adverse events were collected without classification by specific Adverse Event Terms. Per protocol, hospitalizations were considered other adverse events in this study.	21.3% 33/155 • Number of events 51 Adverse events were collected without classification by specific Adverse Event Terms. Per protocol, hospitalizations were considered other adverse events in this study.
Psychiatric disorders Psychiatric hospitalization	1.3% 2/149 • Number of events 2 Adverse events were collected without classification by specific Adverse Event Terms. Per protocol, hospitalizations were considered other adverse events in this study.	2.6% 4/155 • Number of events 4 Adverse events were collected without classification by specific Adverse Event Terms. Per protocol, hospitalizations were considered other adverse events in this study.

Additional Information

Dr. Brian Pence

University of North Carolina-Chapel Hill

Phone: 9199667446

Email: bpence@unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place