Study Title
Utility, acceptability and applicability of a nucleic acid amplification test in comparison with a syndromic approach in the management of sexually transmitted diseases at Mulago National Referral Hospital in Uganda (ASTRHA): protocol for an open-label, randomised controlled trial
Abstract
Sexually transmitted diseases (STDs) are common in low-income and middle-income countries (LMICs) and are currently managed using a syndromic approach due to limited resources. This study aims to evaluate the clinical usefulness and acceptability of a nucleic acid amplification test (NAAT) compared to the syndromic approach in LMICs. The results may inform diagnostic guidelines and update recommendations for STD management in LMICs.
Methods and Analysis
The trial will compare the clinical usefulness and acceptability of NAAT with the syndromic approach in managing STDs at Mulago Hospital in Uganda. 220 patients will be randomly assigned to receive either standard syndromic management or NAAT-based treatment. The primary outcome will be therapeutic appropriateness.
Ethics and Dissemination
The trial has been approved by the Mulago Hospital Research and Ethical Committee and the Uganda National Council for Science and Technology. Patients will provide informed consent to participate, and the results will be published in peer-reviewed journals and made available in anonymised form.
Trial Registration
TRIAL REGISTRATION NUMBER: NCT05994495
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