Patient Experience Evaluation of the CMO-Based Pharmaceutical Care Model vs Usual Care in People Living with HIV

Figures & data

Table 1 Baseline Characteristics of Patients Included in the Study

	Total (n = 151)	Traditional Group (n = 64)	CMO Group (n = 87)	p- value
DEMOGRAPHIC DATA
Median age [IQR]	51.35 [14.2]	50.77 [12.3]	52.38 [15.3]	0.347
GENERAL DATA
Pregnancy during the study (n, %)	2 (1.3%)	1 (1.6%)	1 (1.1%)	0.627
Level of studies (n, %)				0.011
No studies	16 (10.7%)	2 (3.1%)	14 (16.3%)	-
Basic studies	87 (58.0%)	36 (56.2%)	51 (59.3%)	-
University studies	47 (31.3%)	26 (40.6%)	21 (24.4%)	-
Currently working (n, %)	92 (61.7%)	45 (71.4%)	47 (54.7%)	0.037
Lives alone	46 (30.7%)	29 (45.3%)	17 (19.8%)	0.001
SOCIAL AND HEALTHCARE DATA
Socioeconomic environment (n, %)				0.776
Very poor	4 (2.7%)	1 (1.6%)	3 (3.5 %)	-
Poor	13 (8.7%)	4 (6.2%)	9 (10.6 %)	-
Average	35 (23.5%)	17 (26.6%)	18 (21.2 %)	-
Good	78 (52.3%)	34 (53.1%)	44 (51.8 %)	-
Very good	19 (12.8%)	8 (12.5%)	11 (12.9 %)	-
Relationship with healthcare professionals (n, %)
Very poor	0 (0.0%)	0 (0.0%)	0 (0.0%)
Poor	0 (0.0%)	0 (0.0%)	0 (0.0%)
Average	7 (4.8%)	3 (4.7%)	4 (4.8%)
Good	73 (49.7%)	27 (42.2%)	46 (55.4%)
Very good	67 (45.6%)	34 (53.1%)	33 (39.8%)
Knowledge about the treatment and the disease (n, %)*				< 0.001
Very poor	1 (0.7%)	0 (0.0%)	1 (1.2%)	-
Poor	10 (6.9%)	0 (0.0%)	10 (12.0%)	-
Average	23 (15.9%)	5 (8.1%)	18 (21.7%)	-
Good	61 (42.1%)	22 (35.5%)	39 (47.0%)	-
Very good	50 (34.5%)	35 (56.5%)	15 (18.1%)	-
Toxic habits (n, %)**	71 (48.0%)	34 (53.1%)	37 (44.0%)	0.116
HIV DATA
Coinfection (n, %)	21 (14.3%)	7 (11.1%)	14 (16.7%)	0.025
Indetectable viral load (n, %)	114 (75.5%)	30 (46.9%)	84 (96.6%)	< 0.001
CD4 cell counts >200 cells/µL	132 (87.4%)	46 (71.9%)	86 (98.9%)	< 0.001
CD4/CD8 ratio <1 (n, %)	102 (70.8%)	43 (75.4%)	59 (67.8%)	0.326
CLINICAL VARIABLES
Cholesterol >250 mg/dL (n, %)	17 (11.3%)	10 (15.9%)	7 (8.0%)	0.863
Triglycerides >200 mg/dL (n, %)	23 (15.3%)	12 (19.0%)	11 (12.6%)	0.246
HDL (>45 mg/dL in males and >55 mg/dL in females) (n, %)	78 (53.1%)	36 (59.0%)	42 (48.8%)	0.224
Glycated haemoglobin >7% (n, %)	2 (3.7%)	1 (12.5%)	1 (2.2%)	0.022
Blood pressure >160/100 mm Hg (n, %)	8 (6.0%)	1 (1.8%)	7 (9.1%)	0.001
VACS index (median, IQR)	12 [21]	12 [17]	13 [28.75]	0.002
Cardiovascular risk (median, IQR)	6.5 [8.75]	2 [1]	7 [8.25]	0.124
PHARMACOTHERAPY
ART (n, %)				0.486
2 NRTI + 1 INI	53 (35.1%)	22 (34.4%)	31 (35.6%)
2 NRTI + 1 NNRTI	26 (17.2%)	8 (12.5%)	18 (20.7%)
2 NRTI + 1 boosted PI	17 (11.3%)	9 (14.1%)	8 (9.2%)
Other combinations	55 (36.4%)	25 (39.1%)	30 (34.5%)
Polypharmacy (n, %)	36 (24.2%)	11 (17.7%)	25 (28.7%)	0.177
Number of drugs (median, IQR)	4 [4]	3 [3]	4.5 [3]	0.023
Adherence to ART (n, %)	126 (85.7%)	56 (90.3%)	70 (82.4%)	0.173
Adherence to concomitant treatment (n, %)	68 (66.7%)	34 (87.2%)	34 (54.0%)	0.001
Primary adherence (n, %)	81 (77.9%)	38 (97.4%)	43 (66.2%)	<0.001
Secondary adherence (n, %)	73 (68.2%)	35 (83.3%)	38 (58.5%)	0.007

Notes: *By asking the question “In general, which of these categories define best your level of knowledge about HIV?” At the beginning of the study (no useful validated tool or scale was found); **Alcohol abuse, smoking or substance abuse. Percentages are based on the valid cases (total number of cases minus missing cases). Statistically significant p-values are indicated in bold.

Abbreviations: ART, antiretroviral therapy; CMO, Capacity- Motivation-Opportunity model; HDL, high-density lipoproteins; INI, integrase inhibitors; IQR, interquartile range; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; VACS, Veterans Aging Cohort Study.

Table 2 Comparison of Clinical Outcomes Before and After the Implementation of the Traditional PC Model or the CMO-Based PC Model

	Traditional		CMO		Time p-value		Group p-value		*Interaction p- value
	Baseline	Week 24	Baseline	Week 24	Traditional	CMO	Baseline	Week 24
CHOLESTEROL (n, %)
Low (<175 mg/dl)	17 (27.0%)	6 (17.6%)	19 (21.8%)	17 (23.0%)	0.651	0.300	0.863	0.109	0.332
Normal (175–250 mg/dl)	36 (57.1%)	24(70.6%)	61 (70.1%)	57 (77.0%)
High (>250 mg/dl)	10 (15.9%)	4 (11.8%)	7 (8.0%)	0 (0.0%)
TRIGLYCERIDES (n, %)
Low (<150 mg/dl)	36 (57.1%)	17 (51.5%)	36 (41.4%)	25 (33.8%)	0.888	0.844	0.246	0.264	0.974
Normal (150–200 mg/dl)	15 (23.8%)	12 (36.4%)	40 (46.0%)	46 (62.2%)
High (>200 mg/dl)	12 (19.0%)	4 (12.1%)	11 (12.6%)	3 (4.1%)
HDL (n, %)
Low (<45 mg/dl for men; <55mg/dl for women)	25 (41.0%)	15 (48.8%)	44 (51.2%)	43 (58.1%)	0.499	0.380	0.224	0.362	0.972
High (>45 mg/dl for men; >55mg/dl for women)	36 (59.0%)	16 (51.6%)	42 (48.8%)	31 (41.9%)
HbA1c (n, %)
Low (<6%)	4 (50.0%)	0 (0.0%)	3 (6.5%)	0 (0.0%)	0.107	0.137	0.022	0.387	0.036
Normal (6–7%)	3 (37.5%)	6 (85.7%)	42 (91.3%)	37 (94.9%)
High (>7%)	1 (12.5%)	1 (14.3%)	1 (2.2%)	2 (5.1%)
Blood pressure (n, %)
Low (<140/90 mm Hg)	21 (37.5%)	3 (10.3%)	10 (13.0%)	6 (8.7%)	0.020	0.657	0.001	0.661	0.036
Medium (140/90–160/100 mm Hg)	34 (60.7%)	26 (89.7%)	60 (77.9%)	62 (89.9%)
High (>160/100 mm Hg)	1 (1.8%)	0 (0.0%)	7 (9.1%)	1 (1.4%)

Notes: *Time p-value compares the baseline vs end of treatment scores within each group, group p-value compares baseline and traditional groups at each time. Interaction p-value compares if the temporal change in a group is different from the temporal change in the other group. Statistically significant p-values are indicated in bold.

Abbreviations: CMO, Capacity- Motivation-Opportunity model; HbA1c, glycated haemoglobin A1c; HDL, high-density lipoproteins.

Figure 1 Global and conditional IEXPAC at baseline and week 24. (A) Global IEXPAC. (B) Conditional IEXPAC.

Notes: Dots representing the means. ****p < 0.005.

Abbreviations: CMO, Capacity- Motivation-Opportunity model; N.S., non-significant; p.adj, adjusted p-value; p.adj.sig, significant adjusted p-value; SD, standard deviation.

Table 3 Evaluation of Adherence to Treatment in the Two Intervention Groups After 24 Weeks

Adherence (n, %)*	Traditional		CMO		Time		Group		Interaction
					p-value		p-value		p-value
	Baseline	Week 24	Baseline	Week 24	Traditional	CMO	Baseline	Week 24
ART adherence	56 (90.3%)	33 (94.3%)	70 (82.4%)	68 (91.9%)	1.000	0.034	0.173	1.000	0.748
Adherence to concomitant treatment	34 (87.2%)	23 (92.0%)	34 (54.0%)	55 (91.7%)	-	<0.001	0.001	1.000	0.095
Primary adherence	38 (97.4%)	25 (92.6%)	43 (66.2%)	56 (94.9%)	-	<0.001	<0.001	0.647	0.017
Secondary adherence	35 (83.3%)	23 (85.2%)	38(58.5%)	53 (89.8%)	0.317	<0.001	0.007	0.718	0.045

Notes: *Percentages are based on the valid cases (total number of cases subtracting the lost cases). Time p-value compares the baseline and week 24 scores in each group. Baseline time p-value among the “adherence to concomitant treatment” group and the “primary adherence” group could not be calculated because of the number of missing values. Group p-value compares baseline and traditional groups at each time. Interaction p-value compares if the temporal change in a group is different to the temporal change in the other group. Percentages are based on the valid cases (total number of cases minus missing cases). Statistically significant p-values are indicated in bold.

Abbreviation: CMO, Capacity- Motivation-Opportunity model.

Table 4 Viro-Immunological Control

Variable	Traditional		CMO		Time		Group		Interaction
					p-value		p-value		p-value*
	Baseline	Week 24	Baseline	Week 24	Traditional	CMO	Baseline	Week 24
CD4 cell counts
< 200 cells/µL	18 (28.1%)	3 (8.1%)	1 (1.2%)	1 (1.4%)	0.002	0.997	<0.001	0.229	0.043
>200 cells/µL	46 (71.9%)	34 (91.9%)	86 (98.9%)	73 (98.7%)
CD4/CD8 ratio
<1	43 (75.4%)	23 (76.7%)	59 (67.8%)	41 (55.4%)	0.899	0.107	0.326	0.048	0.339
≥1	14 (24.6%)	7 (23.3%)	28 (32.2%)	33 (44.6%)
Viral load
Indetectable (<50 copies/mL)	30 (46.9%)	33 (89.2%)	84 (96.6%)	73(98.6%)	<0.001	0.405	<0.001	0.052	0.329
Detectable (>50 copies/mL)	34 (53.1%)	4 (10.8%)	3 (3.6%)	1(1.4%)

Notes: *Time p-value compares the baseline vs end of treatment scores within each group, group p-value compares baseline and traditional groups at each time. Interaction p-value compares if the temporal change in a group is different to the temporal change in the other group. Percentages are based on the valid cases (total number of cases minus missing cases). Statistically significant p-values are indicated in bold.

Abbreviation: CMO, Capacity- Motivation-Opportunity model.

Figure 2 Evaluation of patient satisfaction using the EVASAF questionnaire.

Note: Dots representing the means.

Abbreviation: CMO, Capacity- Motivation-Opportunity model.