Abstract
Background: Adults seeking diagnosis and treatment for tuberculosis (TB) and HIV in low-resource settings face considerable barriers and have high pre-treatment mortality. Efforts to improve access to prompt TB treatment have been hampered by limitations in TB diagnostics, with considerable uncertainty about how available and new tests can best be implemented. Design and methods: The PROSPECT Study is an open, three-arm pragmatic randomised study that will investigate the effectiveness and cost-effectiveness of optimised HIV and TB diagnosis and linkage to care interventions in reducing time to TB diagnosis and prevalence of undiagnosed TB and HIV in primary care in Blantyre, Malawi. Participants (≥ 18 years) attending a primary care clinic with TB symptoms (cough of any duration) will be randomly allocated to one of three groups: (i) standard of care; (ii) optimised HIV diagnosis and linkage; or (iii) optimised HIV and TB diagnosis and linkage. We will test two hypotheses: firstly, whether prompt linkage to HIV care should be prioritised for adults with TB symptoms; and secondly, whether an optimised TB triage testing algorithm comprised of digital chest x-ray evaluated by computer-aided diagnosis software and sputum GeneXpert MTB/Rif can outperform clinician-directed TB screening. The primary trial outcome will be time to TB treatment initiation by day 56, and secondary outcomes will include prevalence of undiagnosed TB and HIV, mortality, quality of life, and cost-effectiveness. Conclusions: The PROSPECT Study will provide urgently-needed evidence under "real-life" conditions to inform clinicians and policy makers on how best to improve TB/HIV diagnosis and treatment in Africa. Clinical trial registration: NCT03519425 (08/05/2018).
Highlights
Tuberculosis (TB) is the leading infectious cause of death worldwide[1]
This article is included in the Malawi-Liverpool Wellcome Trust Clinical Research Programme gateway
In addition to low rates of TB screening, we have previously shown that only a small proportion (13%) of adults attending health facilities receive Human Immunodeficiency Virus (HIV) testing, despite World Health Organization (WHO) and Malawi guidelines recommending a strategy of universal providerinitiated HIV testing and counselling (HTC) for all individuals attending health centres, regardless of reason[8]
Summary
Tuberculosis (TB) is the leading infectious cause of death worldwide[1]. In 2016, there were an estimated 1.4 million deaths attributed to tuberculosis global, with an additional 0.4 million deaths from TB among people living with Human Immunodeficiency Virus (HIV) infection[1,2]. The expansion of coverage of effective antiretroviral therapy (ART) for treatment of HIV in many sub-Saharan countries has likely contributed to recent reductions in mortality, the pace of decline is unacceptably slow. New impetus has been given to efforts to improve tuberculosis control by the recent-agreed global End-TB Strategy[4]. This strategy, which was endorsed by WHO in 2015, demands global action and intensified research to address HIV-associated TB in 30-high HIV/TB burden countries that together comprise 87% of the global burden of TB2. The primary trial outcome will be time to TB treatment initiation by day 56, and secondary outcomes will include prevalence of undiagnosed TB and HIV, mortality, quality of life, and cost-effectiveness
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