Outcomes and implementation challenges of using daily treatment regimens with an innovative adherence support tool among HIV-infected tuberculosis patients in Karnataka, India: a mixed-methods study

Figures & data

Table 1. Comparison of components of new and conventional care for HIV-infected TB patients in selected districts of Karnataka state, India between January and December 2016.

Components	New care package	Conventional care
Screening for TB	Four symptom-based intensified screening at ART centre	Four symptom-based intensified screening at ART centre
Diagnosis of TB	Using CBNAAT and sputum microscopy facilitated by ART staff	Using CBNAAT and sputum microscopy facilitated by ART staff; Sputum samples were collected and transported to the nearest CBNAAT facility, wherever applicable
TB Treatment Initiation	Immediately after TB diagnosis at the ART centre	Patient referred from ART centre after diagnosis for treatment initiation at a Peripheral Health Institution (PHI), near to patient’s residence
Type of Drugs	Fixed-dose combination (FDC) of 4FDC during intensive phase and 3FDC during continuation phase. The number of pills per patient per day ranges from 2 to 5 based on weight band	No FDC available. Individual drugs with fixed-dose for all adults. The number of pills per patient (thrice weekly) ranged from 7 during intensive phase to 5 during continuation phase
Dosing frequency	Daily	Thrice weekly (alternate days)
Adherence support and compliance monitoring	Self-administered treatment with 99DOTS (Technology-enabled adherence support)	Directly Observed Treatment, usually provided by community health worker/volunteer of general health system
Drug dispensing	Dispensed for 28 days from the ART centre during their routine scheduled visit to centre	Dispensed thrice weekly during intensive phase and once weekly during continuation phase of treatment by the DOT provider at a place convenient to the patient
Patient Follow-up	ART centre	Peripheral Health Institution
Treatment outcome ascertainment	By the ART medical Officer	By the Medical officer of PHI

Abbreviations: HIV- Human Immunodeficiency Virus; TB- Tuberculosis; ART- Antiretroviral Therapy; CBNAAT- Cartridge-Based Nuclei Acid Amplification Test; FDC- Fixed-Dose Combination; PHI- Peripheral Health Institution; DOT- Directly Observation Treatment

Figure 1. Map of study districts and ART centres delivering new care package in the state of Karnataka during January to December, 2016.

Table 2. Comparison of socio-demographic and clinical characteristics of HIV-infected TB patients registered for TB treatment with either new care package or conventional care package in selected districts of Karnataka between January 2016 and December 2016.

Characteristics	New care package, n (%)*	Conventional care, n (%)*	p Value^†
Total	870	961
Age in years
0–14	13 (1.5)	33 (3.4)	0.041
15–29	110 (12.6)	135 (14.1)
30–44	447 (51.4)	482 (50.2)
45 and above	300 (34.5)	311 (32.4)
Gender
Male	546 (62.8)	597 (62.1)	0.779
Female	324 (37.2)	364 (37.9)
District
Belgaum	226 (26.0)	558 (58.1)	< 0.001
Gulbarga	185 (21.7)	47 (4.9)
Bagalkot	425 (48.9)	144 (15.0)
Bangalore	34 (3.9)	212 (22.1)
Type of TB
Microbiologically confirmed	283 (32.5)	507 (52.8)	<0.001
Clinically diagnosed	587 (67.5)	454 (47.2)
Site of TB
Pulmonary TB	732 (84.1)	698 (79.5)	0.010
Extra Pulmonary TB	138 (15.9)	156 (20.5)
Category of TB Treatment
New	708 (81.4)	789 (82.1)	0.689
Previously treated	162 (18.6)	172 (17.9)
ART status
On ART	782 (89.9)	829 (86.3)	0.017
Not on ART	88 (10.1)	61 (13.7)
CD4 count (cells/mm3)
Less than 50	91 (10.5)	66 (6.9)	<0.001
50–199	384 (44.1)	353 (36.7)
200–349	168 (19.3)	215 (22.4)
350–499	83 (9.5)	94 (9.8)
More than 500	61 (7.0)	81 (8.4)
Not available	83 (9.5)	152 (15.8)
CD4 count (Median (IQR))	160 (83–280)	194 (100–315)	0.001^#

*Column Percentage, ^†Chi-square test, ^#Mann Whitney U test

Abbreviations: HIV- Human Immunodeficiency Virus; TB- Tuberculosis; ART- Antiretroviral Therapy; CD4- Cluster of Differentiation 4/CD4 + T helper cells

Table 3. Comparison of TB treatment outcomes among HIV-infected TB patients registered for TB treatment with either new or conventional care package in selected districts of Karnataka from January to December 2016.

TB treatment Outcome	New care package, N = 870, n (%)*	Conventional care package, N = 961, n (%)*	p Value^#
Successful	605 (69.5)	736 (76.6)	<0.001
Cured	95 (10.9)	293 (30.5)	<0.001
Treatment Completed	510 (58.6)	443 (46.1)	<0.001
Unsuccessful	265 (30.5)	225 (23.4)	<0.001
Failure	2 (0.2)	0 (0.0)	-
Lost to follow up	79 (9.1)	55 (5.7)	0.005
Died	174 (20.0)	152 (15.8)	0.019
Shift to Cat IV	1 (0.1)	6 (0.6)	0.083
Transfer Out	9 (1.0)	12 (1.3)	0.549

^*Percentage calculated with total number of individuals in each group as denominator

^#Chi-square test

Abbreviations: HIV- Human Immunodeficiency Virus; TB- Tuberculosis; Cat IV- Drug regimen used to treat Multi Drug Resistant TB patients

Table 4. Association of socio-demographic, clinical and treatment-related factors with unsuccessful outcomes among HIV-infected TB patients registered for TB treatment in selected districts of Karnataka from January to December 2016.

Characteristic	Total	Unsuccessful outcome, n (%)*	Unadjusted RR (95% CI)	Adjusted RR (95% CI)^#	p value
Total	1831	490 (26.7)
Age (in years)
0–14	46	9 (19.6)	1	1
15–29	245	57 (23.3)	1.2 (0.6–2.2)	1.2 (0.7–2.1)	0.501
30–44	929	246 (26.5)	1.4 (0.7–2.5)	1.3 (0.7–2.3)	0.354
45 and above	611	178 (29.1)	1.5 (0.8–2.7)	1.4 (0.8–2.3)	0.254
Gender
Male	1143	329 (28.8)	1.2 (1.0–1.4)	1.1 (0.9–1.4)	0.171
Female	688	143 (23.4)	1	1
Type of TB
Microbiologically confirmed	790	215 (27.2)	1.0 (0.9–1.2)	1.1 (0.8–1.4)	0.562
Clinically diagnosed	1041	275 (26.4)	1	1
Site of TB
Pulmonary TB	1496	401 (26.8)	1	1
Extra Pulmonary TB	335	89 (26.6)	1.0 (0.8–1.2)	1.1 (0.9–1.3)	0.336
Category of Treatment
New	1497	395 (26.4)	1	1
Previously treated	334	95 (28.4)	1.1 (0.9–1.3)	1.1 (0.9–1.5)	0.330
District
Bangalore	246	48 (19.5)	1	1
Belgaum	784	218 (27.8)	1.4 (1.1–1.9)	1.4 (0.9–2.1)	0.094
Bagalkot	569	154 (27.1)	1.4 (1.0–1.8)	1.1 (0.7–1.7)	0.743
Gulbarga	232	70 (30.2)	1.5 (1.1–2.1)	1.4 (0.9–2.2)	0.142
ART status
On ART	1611	358 (23.7)	1	1
Not on ART	220	109 (49.6)	2.1 (1.8–2.5)	2.1 (1.6–2.9)	<0.001
CD4 count (cells/mm3)
Less than 50	157	59 (37.6)	2.1 (1.4–3.2)	2.0 (1.4–2.9)	<0.001
50–199	737	209 (28.4)	1.6 (1.1–2.3)	1.6 (1.1–2.3)	0.010
200–350	383	81 (21.2)	1.2 (0.8–1.8)	1.2 (0.8–1.8)	0.292
350–500	177	33 (18.6)	1.1 (0.7–1.7)	1.1 (0.6–1.8)	0.756
More than 500	142	25 (17.6)	1	1
Not available	235	83 (35.3)	2.0 (1.4–3.0)	1.6 (1.0–2.5)	0.062
TB treatment regimen
New care package	870	265 (30.5)	1.3 (1.1–1.5)	1.3 (1.1–1.7)	0.014
Conventional care package	961	225 (23.4)	1	1

*Row percentage

^#Model adjusted for clustering at 38 Tuberculosis Units included in the study

Abbreviations: HIV- Human Immunodeficiency Virus; TB- Tuberculosis; RR- Relative Risk; CI- Confidence Interval; ART- Antiretroviral Therapy; CD4- Cluster of Differentiation 4/CD4 + T helper cells

Figure 2. Challenges in implementation of new care package among HIV-infected TB patients in selected districts of Karnataka from January to December 2016.