DOI: 10.5061/dryad.ffbg79ctb
title: Data from: Computer-aided X-ray screening for tuberculosis and HIV testing among adults with cough in Malawi (the PROSPECT study): a randomized trial and cost-effectiveness analysis

description: Suboptimal tuberculosis (TB) diagnostics and HIV contribute to the high
 global burden of TB. We investigated costs and yield from systematic
 HIV-TB screening, including computer-aided digital chest X-ray (DCXR-CAD).
 Suboptimal tuberculosis (TB) diagnostics and HIV contribute to the high
 global burden of TB. We investigated costs and yield from systematic
 HIV-TB screening, including computer-aided digital chest X-ray (DCXR-CAD).
 In this open, three-arm randomised trial, adults (≥18 years) with cough
 attending acute primary services in Malawi were randomised (1:1:1) to
 standard-of-care (SOC); oral HIV testing (HIV screening) and linkage to
 care; or HIV testing and linkage to care plus DCXR-CAD with sputum Xpert
 for high CAD4TBv5 scores (HIV-TB screening). Participants and study staff
 were not blinded to intervention allocation, but investigator blinding was
 maintained until final analysis. The primary outcome was time to TB
 treatment. Secondary outcomes included proportion with same-day TB
 treatment; prevalence of undiagnosed/untreated bacteriologically-confirmed
 TB on day 56; and undiagnosed/untreated HIV. Analysis was done on an
 intention to treat basis. Cost-effectiveness analysis used a
 health-provider perspective. Between 15/11/2018-27/11/2019, 8236 were
 screened for eligibility, with 473, 492, and 497 randomly allocated to
 SOC, HIV, and HIV-TB screening arms; 53 (11%), 52 (9%), and 47 (9%) were
 lost to follow-up, respectively. At 56 days, TB treatment had been started
 in 5 (1.1%) SOC, 8 (1.6%) HIV-screening, and 15 (3.0%) HIV-TB screening
 participants. Median (IQR) time to TB treatment was 11 (6.5-38), 6 (1-22)
 and 1 (0-3) days (hazard ratio for HIV-TB vs. SOC: 2.86, 1.04-7.87), with
 same-day treatment of 0/5 (0%) SOC, 1/8 (12.5%) HIV, and 6/15 (40.0%)
 HIV-TB screening arm TB patients (p=0.03). At day 56, 2 SOC (0.5%), 4 HIV
 (1.0%), and 2 HIV-TB (0.5%) participants had undiagnosed
 microbiologically-confirmed TB. HIV screening reduced the proportion with
 undiagnosed or untreated HIV from 10 (2.7%) in the SOC arm to 2 (0.5%) in
 the HIV-screening arm (risk ratio [RR]: 0.18, 0.04-0.83), and 1 (0.2%) in
 the HIV-TB screening arm (RR: 0.09, 0.01-0.71). Incremental costs were
 US$3.58 and US$19.92 per participant screened for HIV and HIV-TB; the
 probability of cost-effectiveness at a US$1200/quality-adjusted life-year
 (QALY) threshold were 83.9% and 0%. Main limitations were the lower than
 anticipated prevalence of tuberculosis and short participant follow-up
 period; cost and quality of life benefits of this screening approach may
 accrue over a longer time horizon. DCXR-CAD with universal HIV screening
 significantly increased the timeliness and completeness of HIV and TB
 diagnosis. If implemented at scale this has potential to rapidly and
 efficiently improve TB and HIV diagnosis and treatment.
description: Adults aged 18 years attending acute primary care services with
 symptoms of tuberculosis (cough of any duration) and who provided informed
 consent were recruited to the trial and underwent baseline questionnaire,
 and were randomly allocated to one of three trial arms: standard of care;
 HIV testing; or HIV testing plus digital chest x-ray screening using
 CAD4TBv5 (DCXR-CAD), with TB confirmatory testing by sputum Xpert.
 Participants were followed for 56 days after recruitment for outcome
 assessment. The primary outcome was time to TB treatment. Secondary
 outcomes were proportion with same-day TB treatment; prevalence of
 undiagnosed/untreated bacteriologically-confirmed TB on day 56; and
 undiagnosed/untreated HIV.
description: This dataset contains individual-level data for participants who
 took part in the PROSPECT Study (clinicaltrials.gov: NCT03519425
 https://clinicaltrials.gov/ct2/show/NCT03519425), a three-arm randomised
 trial of computer-aided chest-xray screening and HIV testing in primary
 care in Malawi. The dataset is in .csv file
 format. There are a total of 1462 records, each
 containing data on an individual trial participant.
 There are a total of 21 variables, which are defined
 below. group: trial arm participant was
 randomly allocated to: SOC: standard of care; HIV: HIV testing; HIV-TB:
 HIV testing plus DCXR-CAD cough: did participant
 report cough at recruitment? yes; no
 duration_of_cough_weeks: duration of cough in weeks
 night_sweats: did participant report night sweats? yes;
 no weight_loss: did participant report weight loss?
 yes; no fever: did participant report fever? yes;
 n0 reported_hiv_status: participant's
 self-reported HIV status at baseline: HIV-positive; HIV-negative; never
 tested taking_antiretoviral_therapy: was participant
 was taking antiretroviral therapy for treatment of HIV? yes; no
 euro_qol_5q_5d_3l_zimbabwe_tariff: EuroQol EQ5D3L score
 (Zimbabwe tariff), measured at baseline cxr_done:
 among participants allocated to the HIV-TB arm, was a chest x-ray done?
 yes; no cad4tbv5_score: CAD4TBv5 score on digital
 chest x-ray (range 0-100, with higher score indicating greater probability
 of pulmonary TB) cad4tbv5_above_threshold: was the
 CAD4TBv5 score on chest x-ray above the threshold for sputum testing
 (greater than or equal to 45); yes; no
 sputum_xpert_done: for participants with CAD4TBv5 scores above
 the threshold, was a sputum Xpert test done? yes; no
 sputum_xpert_result: for participants where a sputum Xpert test
 was done, what was the result of the Xpert test (mtb detected: Xpert
 showed presence of Mycobaterium tuberculosis)
 primary_outcome_tb_treatment_initiation: primary trial outcome.
 Was TB treatment initiated within 56 days of recruitment? 1=yes,
 0=no primary_outcome_days_to_tb_initiation: primary
 trial outcome. Days from recruitment to initiation of TB treatment, or
 completion of follow-up/censoring if didn't initiate TB
 treatment secondary_outcome_undiagnsed_tb: secondary
 trial outcome. Did participant have undiagnosed/untreated
 microbiologically-confirmed TB on sputum smear, culture or Xpert on sample
 taken at Day 56 outcome assessment? yes; no
 secondary_outcome_same_day_tb_treatment: Secondary trial
 outcome. Did participant initiate TB treatment on the same day as
 recruitment? yes; no
 secondary_outcome_undiagnosed_hiv: Secondary outcome. Did
 participant have undiagnosed or untreated HIV at Day 56 outcome
 assessment? yes; no secondary_outcome_mortality: did
 participant die during follow-up period? yes; no
 secondary_outcome_eq5d: EuroQol EQ5D3L score (Zimbabwe tariff),
 measured at Day 56 outcome assessment visit