Background: TB in HIV-infected pregnant women is a leading cause of maternal and infant morbidity and mortality. Currently-recommended symptom-based screening of HIV-infected pregnant women may be insensitive.
Methods: We conducted a cluster-randomized trial to compare universal sputum TB testing of HIV-infected pregnant women against standard symptom-based testing. Sixteen public-sector antenatal clinics in two health districts were assigned to either strategy by constrained randomization. HIV-infected pregnant women without currently diagnosed TB were eligible. In universal testing clinics (UC), all HIV-positive pregnant women were asked to produce a sputum sample. In symptom clinics (SC), only those with WHO criteria for TB testing (cough, fever, night sweats, or weight loss) were asked to produce sputum. Sputa were tested by Xpert MTB/RIF and midway through the study liquid MGIT culture was added. Women and infants were followed through 2 months postpartum. Cluster-adjusted results are shown.
Results: From 5/2015 through 3/2017, 937 and 1095 HIV-infected pregnant women were enrolled in the UCs and SCs, respectively. Median age was 30 years, median gestational age 24 months, 11% had prior TB, 90% were on ART, with no significant differences by arm. At baseline 17% of UC women and 22% of SC women had >1 TB symptom (p=0.40).
In UCs and SCs, respectively, 35 and 4 women were diagnosed with TB during pregnancy (UC prevalence = 3.7%, SC 0.37%, adjusted p=0.01). Two months post-partum, infant mortality in UCs was 0.9% vs. 2.1% in SCs (adjusted p= 0.06). Miscarriages and stillbirths were similar in both arms and two women died in the SCs .
MGIT culture identified more TB than Xpert: 25/487 samples (5%) were MGIT+ vs 19/1400 (1.4%) Xpert+ (p< 0.05). 440 samples were tested with both assays, 4 were Xpert+/MGIT+, 412 negative for both, 3 Xpert+/MGIT-, and 21 Xpert-/MGIT+.
Conclusions: Universal TB screening of all HIV-infected pregnant women increased case detection 10-fold and was associated with reduced early infant mortality. MGIT identified more TB than Xpert in women whose pregnancy may mask TB symptoms. Our data support sputum testing all HIV-infected pregnant women for TB in high burden areas such as South Africa. Cost-effectiveness studies of universal testing are needed.