Effectiveness of screening for tuberculosis in HIV: a pragmatic clinical trial

Santos, Marcela Lopes; Batista, Joanna d’Arc Lyra; Braga, Cynthia; Silva, Adriana Paula da; Maruza, Magda; Souza, Wayner Vieira; Carvalho, Maria Rosimery de; Siqueira-Filha, Noemia Teixeira de; Albuquerque, Maria de Fátima Pessoa Militão de

doi:10.11606/s1518-8787.2021055002936

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Original Article • Rev. Saúde Pública 55 • 2021 • https://doi.org/10.11606/s1518-8787.2021055002936 copy

Effectiveness of screening for tuberculosis in HIV: a pragmatic clinical trial

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

OBJECTIVE:

To verify the effectiveness of screening for tuberculosis (TB) on all-cause mortality and tuberculosis cases in newly diagnosed HIV-infected patients through a clinical algorithm based on recommendations of the World Health Organization.

METHODS:

From March 2014 to April 2016, a pragmatic randomized clinical trial was conducted with newly diagnosed and TB-free HIV-infected adults undergoing antiretroviral therapy for up to one month at a major tertiary hospital for HIV in the state of Pernambuco, Brazil. Participants were randomized into intervention and control groups using an automatically-generated random list, and followed-up for at least 6 months. The intervention group was screened for TB at hospital admission and at every follow-up visit through a series of questions addressing TB-related symptoms (cough, fever, night sweating, and weight loss). Patients presenting with any of these symptoms were referred to a pulmonologist and underwent sputum smear microscopy, sputum culture, and rapid molecular testing (GeneXpert). When at least one test result came back positive, TB treatment was initiated. In turn, if patients tested negative but presented with severe clinal symptoms, TB preventive treatment was initiated. Screening for TB was not performed systematically in the control group. The primary outcome assessed in this study was death from all causes, and secondary outcomes included sensitivity and specificity of this screening test, as well as its detection time.

RESULTS:

This study evaluated 581 patients, 377 in the intervention group (64.9%) and 204 in the control group (35.1%). In total, 36 patients died during the follow-up period. Of these, 26 (6.9%) were from the intervention group, reaching a cumulative mortality coefficient of 69 per 1,000 inhabitants, and 10 (4.9%) from the control group (p = 0.341), with a cumulative mortality coefficient of 49 per 1,000 inhabitants (p = 0.341).

DESCRIPTORS:
HIV Infections; Tuberculosis, diagnosis; Mass Screening; Clinical Trial

TB-related Symptoms	Prevalence in the population	Prevalence among TB cases	Sensitivity	Specificity	PPV	PNV
Cough	30 (25.4–34.9)	71 (52.5–84.9)	70.6 (53.9–83.2)	74.1 (69.2–78.4)	21.2 (14.7–29.7)	96.2 (93.2–97.9)
Fever	18.9 (15.1–23.)	50 (32.4–67.6)	50 (34.1–65.9)	84.2 (80.0–87.7)	23.9 (15.5–35.0)	94.4 (91.3–96.5)
Night sweats	12.8 (9.6–16.6)	29.4 (15.1–47.5)	29.4 (16.8–46.2)	88.9 (85.1–91.8)	20.8 (11.7–34.3)	92.7 (89.3–95.0)
Weight loss	47.9 (42.7–53.1)	82.4 (65.5–93.2)	82.4 (66.5–91.7)	55.6 (50.3–60.7)	15.6 (11.0–21.6)	96.9 (93.5–98.6)
WHO's Screening	56.5 (51.3–61.3)	85.3 (68.9–95.0)	85.3 (69.9–93.6)	46.4 (41.2–51.6)	13.6 (9.7–18.9)	97.0 (93.1–98.7)
Other TB-related symptoms
Shortness of breath	18.4 (14.6–22.6)	35.3 (19.7–53.5)	35.3 (21.5–52.1)	83.3 (79.0–86.9)	17.4 (10.2–28.0)	92.8 (89.4–95.2)
Weakness	38.6 (33.6–43.7)	70.6 (52.5–84.9)	70.6 (53.8–83.2)	64.6 (59.4–69.5)	16.6 (11.4–23.5)	95.7 (92.2–97.6)
Chest or back pain	20.7 (16.8–25.2)	44.1 (27.2–62.1)	44.1 (28.9–60.6)	81.6 (77.1–85.3)	19.2 (12.0–29.3)	93.6 (90.3–95.9)
Lump	15.7 (12.2–19.8)	26.5 (12.9–44.4)	26.5 (14.6–43.1)	85.4 (81.2–88.7)	15.3 (8.2–26.5)	92.1 (88.6–94.6)
Other symptoms combination
WHO's screening + chest X-ray	58.6 (53.5–63.6)	85.3 (68.9–95.0)	85.3 (69.9–93.6)	44.0 (38.9–49.3)	13.1 (9.3–18.2)	96.8 (92.7–98.6)
At least 2 WHO's screening	33.0 (28.2–38.0)	82.4 (65.5–93.2)	82.4 (66.5–91.7)	71.9 (66.9–76.4)	22.6 (16.1–30.7)	97.6 (94.9–98.9)
At least 3 WHO's screening	15.4 (11.9–19.5)	54.9 (35.1–70.2)	52.9 (36.7–68.6)	88.3 (84.5–91.3)	31.0 (20.6–43.8)	95.0 (92.0–96.9)
At least 4 WHO's screening	4.8 (2.9–7.5)	8.8 (1.9–23.7)	8.8 (3.0–23.0)	95.6 (92.9–97.3)	16.7 (5.8–39.2)	91.3 (88.0–93.8)
Cough + Fever	1.3 (0.4–3.1)	0 (0–10.3)	0 (0–1.2)	98.5 (96.6–99.4)	0 (0–43.5)	89.6 (86.1–92.3)
Cough + Night sweats	0.5 (0–1.9)	0 (0–10.3)	0 (0–1.2)	99.4 (97.9–99.8)	0 (0–65.8)	90.9 (87.6–93.4)
Cough + Weight loss	9.3 (6.6–12.7)	17.6 (6.7–34.5)	17.7 (8.3–33.5)	91.5 (88.1–94.0)	17.1 (8.1–32.7)	91.8 (88.4–94.3)
Fever + Night sweats
Fever + Weight loss	4.5 (2.7–7.1)	5.9 (0.7–19.7)	5.9 (1.6–19.1)	95.6 (92.9–97.3)	11.8 (3.3–34.3)	91.1 (87.7–93.6)
Night sweating + Weight loss	1.9 (0.7–3.8)	5.9 (0.7–19.7)	5.9 (1.6–19.1)	98.5 (96.6–99.4)	28.6 (8.2–64.1)	91.3 (88.0–93.8)
Cough + Fever + Night sweats	0.2 (0–1.4)	2.9 (0–15.3)	2.9 (0.5–14.9)	100 (98.9–100)	100 (20.7–100)	91.2 (87.9–93.7)
Cough + Fever + Weight loss	5.6 (3.5–8.4)	29.4 (15.1–47.5)	29.4 (16.8–46.2)	96.8 (94.3–98.2)	47.6 (28.3–67.6)	93.2 (90.1–95.4)
Cough + Night sweats + Weight loss	2.4 (1.1–4.5)	2.9 (0–15.3)	2.9 (0.5–14.9)	97.7 (95.5–98.8)	11.1 (2.0–43.5)	91.0 (87.6–93.5)
WHO's screening + Shortness of breath	15.4 (11.9–19.5)	32.4 (17.4–50.5)	32.4 (19.1–49.1)	86.2 (82.2–89.5)	19.0 (10.9–30.9)	92.8 (89.4–95.1)
WHO's screening + Weakness	32.2 (27.5–37.2)	64.7 (46.5–80.3)	64.7 (47.9–78.5)	71.1 (66.0–75.6)	18.2 (12.3–26.0)	95.3 (92.0–97.3)
WHO's screening + Chest or back pain	18.4 (14.6–22.6)	44.1 (27.2–62.1)	44.1 (28.9–60.6)	84.2 (80.0–87.7)	21.7 (13.6–32.8)	93.8 (90.5–96.0)
WHO's screening + Lump	10.6 (7.7–14.2)	23.5 (10.7–41.2)	23.5 (12.4–40.0)	90.6 (87.1–93.3)	20 (10.5–34.8)	92.3 (88.9–94.7)
WHO's screening + Shortness of breath + Weakness + Chest or back pain + Lump	2.4 (1.1–4.5)	11.8 (3.3–27.5)	11.8 (4.7–26.6)	98.5 (96.6–99.4)	44.4 (18.9–73.3)	91.8 (88.6–94.2)
WHO's screening + At least one signal (shortness of breath or weakness or pain or lump)	41.8 (36.7–46.9)	67.6 (49.5–82.6)	67.7 (50.8–80.9)	60.8 (55.6–65.8)	14.7 (10.0–21.0)	95.0 (91.2–97.2)
WHO's screening considering only cough for more than 2 months	52.4 (47.2–57.5)	85.3 (68.9–95.0)	85.3 (69.9–93.6)	50.9 (45.6–56.1)	14.7 (10.5–20.3)	97.2 (93.6–98.8)

		Intervention group	Control group	p
		n (%)	n (%)	p
Tuberculosis
	No	343 (91.0)	185 (90.7)	0.906
	Yes	34 (9.0)	19 (9.3)
	Total	377	204
Form of TB
	Pulmonary	18 (52.9)	8 (42.1)
	Extrapulmonary	9 (26.5)	6 (31.6)	0.748
	Disseminated	7 (20.6)	5 (26.3)
	Total	34	19
Confirmed Tuberculosis
	Yes	7 (20.6)	6 (31.6)	0.372
	No	27 (79.4)	13 (68.4)
	Total	34	19
TB Outcome
	Cure	10 (30.3)	9 (50.0)	0.164
	Others	23 (69.7)	9 (50.0)
	Total	33	18
Death
	No	351 (93.1)	194 (95.1)	0.341
	Yes	26 (6.9)	10 (4.9)
	Total	377	204
TB cases Characteristics
	Time in days of diagnosis (mean)	49.9	54.6	0.967
Exams performed
	Sputum smear	17 (81.0)	4 (19.0)	0.228^a a p-value of the chi-square test or exact Person test.
	GeneXpert	3 (60.0)	2 (40.0)	0.400^a a p-value of the chi-square test or exact Person test.
	Culture	7 (87.5)	1 (12.5)	0.875^a a p-value of the chi-square test or exact Person test.
	Chest X-ray	11 (64.7)	6 (35.3)	0.353^a a p-value of the chi-square test or exact Person test.
	Total	38	13
Positive exams
	Sputum smear	2 (50.0)	2 (50.0)	0.228^a a p-value of the chi-square test or exact Person test.
	GeneXpert	3 (100.0)	0 (0.0)	0.400^a a p-value of the chi-square test or exact Person test.
	Culture	1 (100.0)	0 (0.0)	0.875^a a p-value of the chi-square test or exact Person test.
	Chest X-ray	5 (31.3)	1 (16.7)	0.353^a a p-value of the chi-square test or exact Person test.
	Total	11	3
Diagnostic site
	CPH	26 (68.4)	12 (31.6)	0.358^a a p-value of the chi-square test or exact Person test.
	Other services	5 (55.6)	4 (44.4)
	Total	31	16
Location of diagnosis in CPH
	Outpatient care	17 (70.8)	7 (29.2)	0.602^a a p-value of the chi-square test or exact Person test.
	Inpatient care	9 (69.2)	4 (30.8)
	Total	26	11
ART
	Yes	28 (66.7)	14 (33.3)	0.342^a a p-value of the chi-square test or exact Person test.
	No	6 (54.6)	5 (45.5)
	Total	34	19

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[1] Correspondence: Marcela L Santos, EQN 410/411, Bloco A, Apto 21, Asa Norte, 70865-405, Brasília, DF, Brasil. Email: lopessantosmarcela@gmail.com