Trial Outcomes & Findings for Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings (NCT NCT01735708)
NCT ID: NCT01735708
Last Updated: 2022-10-13
Results Overview
Title: Brief Pain Inventory Interference Scale. Abbreviation: BPI-I. Measures: self-report of interference due to pain. Scale range: 0-10. Higher scores represent a worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
187 participants
Primary outcome timeframe
3 months
Results posted on
2022-10-13
Participant Flow
Participant milestones
| Measure |
Health Education
Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
|
HIVPASS Intervention
Participants in the HIVPASS intervention arm will receive 7 individual sessions with the study interventionist, the first of which is a collaborative meeting with the PCP. Sessions will focus on pain interference and depression management.
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
92
|
|
Overall Study
Month 3 Assessment
|
79
|
79
|
|
Overall Study
COMPLETED
|
84
|
79
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings
Baseline characteristics by cohort
| Measure |
Health Education
n=95 Participants
Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
|
HIVPASS Intervention
n=92 Participants
Participants in the HIVPASS intervention arm will receive 7 individual sessions with the study interventionist, the first of which is a collaborative meeting with the PCP. Sessions will focus on pain interference and depression management.
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
51.4 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
37 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
56 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Non-binary
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
83 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
162 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
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Brief Pain Inventory - Interference Scale
|
6.44 units on a scale
STANDARD_DEVIATION 2.15 • n=5 Participants
|
6.16 units on a scale
STANDARD_DEVIATION 1.98 • n=7 Participants
|
6.30 units on a scale
STANDARD_DEVIATION 1.56 • n=5 Participants
|
|
Worst pain severity, past week
|
8.27 units on a scale
STANDARD_DEVIATION 1.52 • n=5 Participants
|
8.14 units on a scale
STANDARD_DEVIATION 1.61 • n=7 Participants
|
8.21 units on a scale
STANDARD_DEVIATION 2.07 • n=5 Participants
|
|
Average pain severity, past week
|
6.37 units on a scale
STANDARD_DEVIATION 1.88 • n=5 Participants
|
6.48 units on a scale
STANDARD_DEVIATION 1.87 • n=7 Participants
|
6.43 units on a scale
STANDARD_DEVIATION 1.87 • n=5 Participants
|
|
Quick Inventory of Depressive Symptoms
|
14.4 units on a scale
STANDARD_DEVIATION 2.93 • n=5 Participants
|
14.0 units on a scale
STANDARD_DEVIATION 3.04 • n=7 Participants
|
14.2 units on a scale
STANDARD_DEVIATION 2.99 • n=5 Participants
|
|
PROMIS Anxiety
|
24.5 units on a scale
STANDARD_DEVIATION 6.44 • n=5 Participants
|
24.5 units on a scale
STANDARD_DEVIATION 6.63 • n=7 Participants
|
24.5 units on a scale
STANDARD_DEVIATION 6.39 • n=5 Participants
|
|
Antiretroviral therapy (ART) adherence
|
91.5 % Adherence
STANDARD_DEVIATION 18.4 • n=5 Participants
|
95.1 % Adherence
STANDARD_DEVIATION 0.5 • n=7 Participants
|
93.3 % Adherence
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Detectable viral load
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
SF-36 Physical Health component
|
-1.67 units on a scale
STANDARD_DEVIATION 0.94 • n=5 Participants
|
-1.42 units on a scale
STANDARD_DEVIATION 1.07 • n=7 Participants
|
-1.55 units on a scale
STANDARD_DEVIATION 1.01 • n=5 Participants
|
|
SF-36 Mental Health component
|
-1.83 units on a scale
STANDARD_DEVIATION 1.09 • n=5 Participants
|
-1.77 units on a scale
STANDARD_DEVIATION 1.21 • n=7 Participants
|
-1.80 units on a scale
STANDARD_DEVIATION 1.15 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsTitle: Brief Pain Inventory Interference Scale. Abbreviation: BPI-I. Measures: self-report of interference due to pain. Scale range: 0-10. Higher scores represent a worse outcome.
Outcome measures
| Measure |
HIVPASS Intervention
n=79 Participants
Participants in the HIVPASS intervention arm will receive 7 individual sessions with the study interventionist, the first of which is a collaborative meeting with the PCP. Sessions will focus on pain interference and depression management.
|
Health Education
n=79 Participants
Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
|
|---|---|---|
|
Brief Pain Inventory Interference Scale at 3 Months
|
4.23 score on a scale
Standard Deviation 2.84
|
5.03 score on a scale
Standard Deviation 2.98
|
SECONDARY outcome
Timeframe: 12 monthsTitle: Brief Pain Inventory Interference Scale. Abbreviation: BPI-I. Measures: self-report of interference due to pain. Scale range: 0-10. Higher scores represent a worse outcome.
Outcome measures
| Measure |
HIVPASS Intervention
n=79 Participants
Participants in the HIVPASS intervention arm will receive 7 individual sessions with the study interventionist, the first of which is a collaborative meeting with the PCP. Sessions will focus on pain interference and depression management.
|
Health Education
n=84 Participants
Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
|
|---|---|---|
|
Brief Pain Inventory Interference Scale at 12 Months
|
4.95 score on a scale
Standard Deviation 3.01
|
4.74 score on a scale
Standard Deviation 3.12
|
SECONDARY outcome
Timeframe: 3 monthsQuick Inventory of Depressive Symptoms. Abbreviation: QIDS. Measures: clinician-based assessment of depression symptom severity. Scale range: 0-27. Higher scores represent a worse outcome.
Outcome measures
| Measure |
HIVPASS Intervention
n=79 Participants
Participants in the HIVPASS intervention arm will receive 7 individual sessions with the study interventionist, the first of which is a collaborative meeting with the PCP. Sessions will focus on pain interference and depression management.
|
Health Education
n=79 Participants
Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
|
|---|---|---|
|
Quick Inventory of Depression Symptoms at 3 Months
|
10.25 score on a scale
Standard Deviation 4.81
|
10.35 score on a scale
Standard Deviation 4.81
|
SECONDARY outcome
Timeframe: 12 monthsQuick Inventory of Depressive Symptoms. Abbreviation: QIDS. Measures: clinician-based assessment of depression symptom severity. Scale range: 0-27. Higher scores represent a worse outcome.
Outcome measures
| Measure |
HIVPASS Intervention
n=79 Participants
Participants in the HIVPASS intervention arm will receive 7 individual sessions with the study interventionist, the first of which is a collaborative meeting with the PCP. Sessions will focus on pain interference and depression management.
|
Health Education
n=84 Participants
Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
|
|---|---|---|
|
Quick Inventory of Depression Symptoms at 12 Months
|
9.80 score on a scale
Standard Deviation 5.60
|
10.18 score on a scale
Standard Deviation 5.05
|
Adverse Events
Health Education
Serious events: 39 serious events
Other events: 40 other events
Deaths: 2 deaths
HIVPASS Intervention
Serious events: 21 serious events
Other events: 35 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Health Education
n=95 participants at risk
Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
|
HIVPASS Intervention
n=92 participants at risk
Participants in the HIVPASS intervention arm will receive 7 individual sessions with the study interventionist, the first of which is a collaborative meeting with the PCP. Sessions will focus on pain interference and depression management.
|
|---|---|---|
|
Metabolism and nutrition disorders
Acidosis
|
1.1%
1/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Infections and infestations
Appendicitis
|
1.1%
1/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/95 • 12 months
|
1.1%
1/92 • 12 months
|
|
Infections and infestations
Bacteremia
|
0.00%
0/95 • 12 months
|
1.1%
1/92 • 12 months
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/95 • 12 months
|
1.1%
1/92 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer diagnosis
|
2.1%
2/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Cardiac disorders
Chest pain
|
1.1%
1/95 • 12 months
|
2.2%
2/92 • 12 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.1%
1/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Gastrointestinal disorders
Colonic obstruction
|
1.1%
1/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/95 • 12 months
|
1.1%
1/92 • 12 months
|
|
Eye disorders
Cranial nerve palsy
|
0.00%
0/95 • 12 months
|
1.1%
1/92 • 12 months
|
|
Injury, poisoning and procedural complications
Deep vein thrombosis
|
1.1%
1/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Psychiatric disorders
Depression
|
1.1%
1/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Metabolism and nutrition disorders
Detox
|
2.1%
2/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Nervous system disorders
Dizziness
|
1.1%
1/95 • 12 months
|
1.1%
1/92 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.3%
5/95 • 12 months
|
3.3%
3/92 • 12 months
|
|
General disorders
Edema in limbs
|
2.1%
2/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
2.1%
2/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.1%
1/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Gastrointestinal disorders
GI bleed
|
1.1%
1/95 • 12 months
|
1.1%
1/92 • 12 months
|
|
Cardiac disorders
Heart failure
|
1.1%
1/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
General disorders
Hospitalization/reason unknown
|
4.2%
4/95 • 12 months
|
2.2%
2/92 • 12 months
|
|
Vascular disorders
Hypertension
|
2.1%
2/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Vascular disorders
Hypotension
|
1.1%
1/95 • 12 months
|
1.1%
1/92 • 12 months
|
|
Infections and infestations
Kidney infection
|
1.1%
1/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Infections and infestations
Lung infection
|
1.1%
1/95 • 12 months
|
3.3%
3/92 • 12 months
|
|
Infections and infestations
Meningitis
|
0.00%
0/95 • 12 months
|
1.1%
1/92 • 12 months
|
|
Gastrointestinal disorders
Nausea/vomiting/GI pain
|
2.1%
2/95 • 12 months
|
1.1%
1/92 • 12 months
|
|
Renal and urinary disorders
Nephrotic syndrome
|
1.1%
1/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/95 • 12 months
|
1.1%
1/92 • 12 months
|
|
Infections and infestations
Otitis media externa
|
1.1%
1/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
1/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Psychiatric disorders
Psychosis
|
1.1%
1/95 • 12 months
|
2.2%
2/92 • 12 months
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/95 • 12 months
|
1.1%
1/92 • 12 months
|
|
Renal and urinary disorders
Renal insufficiency
|
1.1%
1/95 • 12 months
|
1.1%
1/92 • 12 months
|
|
Nervous system disorders
Seizure
|
4.2%
4/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/95 • 12 months
|
1.1%
1/92 • 12 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/95 • 12 months
|
1.1%
1/92 • 12 months
|
|
Psychiatric disorders
Suicide attempt
|
1.1%
1/95 • 12 months
|
1.1%
1/92 • 12 months
|
|
Psychiatric disorders
Suicide ideation
|
2.1%
2/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Surgical and medical procedures
Surgical or medical procedure
|
5.3%
5/95 • 12 months
|
2.2%
2/92 • 12 months
|
|
Nervous system disorders
Syncope
|
2.1%
2/95 • 12 months
|
0.00%
0/92 • 12 months
|
|
Vascular disorders
Thromboembolic event
|
1.1%
1/95 • 12 months
|
0.00%
0/92 • 12 months
|
Other adverse events
| Measure |
Health Education
n=95 participants at risk
Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
|
HIVPASS Intervention
n=92 participants at risk
Participants in the HIVPASS intervention arm will receive 7 individual sessions with the study interventionist, the first of which is a collaborative meeting with the PCP. Sessions will focus on pain interference and depression management.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
5/95 • 12 months
|
6.5%
6/92 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
10/95 • 12 months
|
7.6%
7/92 • 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
10.5%
10/95 • 12 months
|
6.5%
6/92 • 12 months
|
|
Gastrointestinal disorders
Nausea, vomiting, and/or GI pain
|
9.5%
9/95 • 12 months
|
10.9%
10/92 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.4%
7/95 • 12 months
|
4.3%
4/92 • 12 months
|
|
Surgical and medical procedures
Surgical or medical procedure
|
7.4%
7/95 • 12 months
|
3.3%
3/92 • 12 months
|
|
Infections and infestations
Upper respiratory infection
|
5.3%
5/95 • 12 months
|
8.7%
8/92 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place