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

• Published in: BMJ open 2024-06, Vol.14 (6), p.e084806
• Main Authors: Serraino, Riccardo, Cesana, Bruno Mario, Morrone, Helen Linda, Marino, Gabriella Giuseppina, Cirillo, Maria, Olivadese, Vincenzo, Kyambadde, Peter, Biriwo, Lawrence Ssejjuko, Mutebi, Frederik, Trecarichi, Enrico Maria, Musinguzi, Patrick, Byakika-Kibwika, Pauline, Torti, Carlo
• Format: Article
• Language: English
• Subjects: Acids; Adolescent; Adult; Antibiotics; Antimicrobial agents; Chlamydia; Drug resistance; Female; Gonorrhea; Humans; infection control; Infections; Infectious Diseases; Laboratories; Low income groups; Male; Medical diagnosis; molecular diagnostics; Nucleic Acid Amplification Techniques - methods; Pathogens; Patients; Public health; Randomized Controlled Trials as Topic; sexually transmitted disease; Sexually transmitted diseases; Sexually Transmitted Diseases - diagnosis; Sexually Transmitted Diseases - therapy; Standard of care; STD; Teaching hospitals; Toxicity; Uganda; Ulcers; Vaginal Discharge - diagnosis; Vaginal Discharge - microbiology
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2024-084806

IntroductionSexually transmitted diseases (STDs) are a major cause of long-term disability. Urethral discharge syndrome (UDS), abnormal vaginal discharge (AVD) and genital ulcer disease (GUD) are very common in low-income and middle-income countries (LMICs), where, due to lack of resources, these infections are managed according to a syndromic approach. Although microbiological diagnosis using nuclear acid amplification tests (NAAT) is already a standard to prescribe targeted treatments in industrialised countries, no randomised clinical trials have been conducted to evaluate clinical usefulness and acceptability of NAAT in comparison with syndromic approach in LMICs. The results of this study could inform diagnostic guidelines since they may suggest an update of the current recommendation if microbiological diagnosis using NAAT in the management of STD is demonstrated to be both useful and acceptable in an LMIC context.Methods and analysisThe primary objective of this randomised, open-label trial is to evaluate the clinical usefulness of a NAAT and its acceptability in comparison with a clinical syndromic approach and to explore whether this test could replace the syndromic approach in the management of STDs at a national referral hospital in Uganda. 220 patients presenting to the STD clinic at Mulago Hospital in Kampala, Uganda with AVD, UDS or GUD will be randomised to either standard of care (syndromic management) or NAAT-based treatment with a 1:1 ratio. All the patients will be asked to return after 2 or 3 weeks for a control visit. Primary outcome will be therapeutic appropriateness.Ethics and disseminationThis trial was approved by the Mulago Hospital Research and Ethical Committee (MHREC2023-97) and the Uganda National Council for Science and Technology (HS31000ES). Patients will give informed consent to participate before taking part in the study. Results will be published in peer-reviewed journals in open-access formats and data made available in anonymised form.Trial registration number NCT05994495.