Utility and Acceptability of a Molecular Test in the Management of Sexually Transmitted Diseases in Uganda

NCT05994495 | Completed

• 1 other identifier: MHREC2023-97
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess utility and acceptability of a molecular test in comparison with clinical syndromic approach in the management of sexually transmitted diseases (STD) at STD clinic of Mulago National Referral Hospital in Uganda. The main questions it aims to answer are:

• Does new molecular test improve appropriateness of therapy compared with the clinical syndromic approach without or with limited laboratory tests in the management of STDs?
• Are new molecular tests both clinically useful and acceptable in a Low-Middle Income Country for the management of STDs? Participants will be put into two groups ("A" or "B"):
• Participants in group "A" will have a pus swab collected from urethra or vagina or a urine sample. After the result of the test, patients will be prescribed a specific drug.
• Participants in group "B" will have a pus swab collected from urethra or vagina or a urine sample, but participants in group "B" and their doctor will not know the results of the test. So, participants in group "B" will be given treatment in the standard way, according to the current clinical practice.

Conditions

Sexually Transmitted Diseases

Keywords

Sexually transmitted diseases; STDs; Low-Middle Income Country; Molecular Test; NUCLEIC ACID AMPLIFICATION TEST; NAAT; Clinical Syndromic Approach; LMIC

Outcome Measures

Primary Outcomes (1)

• Clinical Usefulness

  Proportion of patients with appropriate therapy in each arm. Appropriate therapy will be defined (either as study intervention during consultation in Arm "A" or post-hoc in Arm "B") as the use of a recommended drug or drug combinations which are recommended against the pathogen(s) diagnosed by the molecular test.

  minutes 210

Secondary Outcomes (4)

• Microbiological and clinical cure

  weeks 3

• Concordance

  Minutes 210

• Acceptability

  Minutes 210

• Prevalence

  Months 2

Study Arms (2)

ARM A Molecular test

EXPERIMENTAL

Patients randomized to Arm "A" will be subjected to a microbiological test (either swabs or urine testing by NAAT). After having obtained the result of the molecular test, patients will be prescribed a targeted treatment

Diagnostic Test: nuclear acid amplification tests

ARM B Clinical Syndromic Approach

ACTIVE COMPARATOR

Patients randomized to Arm "B" will be subjected to a molecular test, but they will be treated according to the current guidelines and the best practice using the clinical syndromic approach. So, patients randomized to Arm "B" and their physician also will be blinded to the results of the molecular test

Other: Clinical Syndromic Approach

Interventions

nuclear acid amplification tests DIAGNOSTIC_TEST

The NAAT test will be performed with Bosch Vivalytic STI test. It is a qualitative Polymerase Chain Reaction-based assay for simultaneous detection of 10 common sexually transmitted pathogens: Herpes simplex virus 1 (HSV 1)- Herpes simplex virus 2 (HSV 2)- Chlamydia trachomatis (CT) - Haemophilus ducreyi (HD)- Mycoplasma genitalium (MG) - Mycoplasma hominis (MH) - Neisseria gonorrhoeae (NG) - Treponema pallidum (TP)- Ureaplasma urealyticum (UU) - Trichomonas vaginalis (TV)

Also known as: Bosch Vivalytic STI test

ARM A Molecular test

Clinical Syndromic Approach OTHER

Physical examination

ARM B Clinical Syndromic Approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and females with UDS, AVD and GUD diagnosed as per the current National STD Management Guidelines 201616, who have given informed, written, and signed consent.

You may not qualify if:

• All patients presenting with UDS, AVD and GUD who decline informed and written consent.
• All patients living farther than a 20 km radius from Mulago National Referral Hospital
• All patients presenting with any syndromes not listed above.
• Female patients in their menstrual period.
• Pregnant patients.
• Patients with a previous infection presenting with recurrence or relapse.

Sponsors & Collaborators

• Riccardo Serraino: lead
• Societa' Italiana Di Malattie Infettive E Tropicali: collaborator

Study Sites (1)

Mulago National Referral Hospital

Kampala, 7051, Uganda

Location

Related Publications (1)

• Serraino R, Cesana BM, Morrone HL, Marino GG, Cirillo M, Olivadese V, Kyambadde P, Biriwo LS, Mutebi F, Trecarichi EM, Musinguzi P, Byakika-Kibwika P, Torti C. 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. BMJ Open. 2024 Jun 11;14(6):e084806. doi: 10.1136/bmjopen-2024-084806.

  PMID: 38862220 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlo Torti

  Magna Graecia University of Catanzaro, Italy

  PRINCIPAL INVESTIGATOR

• Patrick Musinguzi

  Mulago National Referral Hospital, Kampala, Uganda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Fellow

Model Details: This is an operational, randomized, open-label trial to assess appropriateness of therapy, diagnostic accuracy, clinical and microbiological outcomes, and acceptability of an etiology approach using a molecular test (NAAT) versus a clinical syndromic approach for the management of STDs in patients followed by a STD clinic of a National Referral Hospital in Kampala, Uganda.

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 16, 2023
• Study Start: January 15, 2024
• Primary Completion: January 30, 2025
• Study Completion: March 30, 2025
• Last Updated: April 29, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)