Clinical trial NCT05994495: Utility and Acceptability of a Molecular Test in the Management of Sexually Transmitted Diseases in Uganda
Official title: Utility, Acceptability and Applicability of a Nucleic Acid Amplification Test (NAAT) in Comparison With Syndromic Approach in the Management of Sexually Transmitted Diseases at Mulago National Referral Hospital in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Diseases
Keywords: Sexually transmitted diseases
STDs
Low-Middle Income Country
Molecular Test
NUCLEIC ACID AMPLIFICATION TEST
NAAT
Clinical Syndromic Approach
LMIC
Lead sponsor: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Sponsor class: OTHER
Collaborators: name: Societa' Italiana Di Malattie Infettive E Tropicali
First posted: 2023-08-16
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

Detailed description: Sexually 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 syndromes in low- and middle-income countries where, due to lack of resources, these syndromes are managed according to a syndromic approach. Appropriate STD diagnosis and treatment are crucial to prevent the transmission and sequelae. No randomized trials have been conducted so far to evaluate clinical usefulness and acceptability of microbiological diagnosis using NAAT in comparison with syndromic approach.

The aims of the study is to evaluate the clinical usefulness of a NAAT in terms of appropriateness of therapy, clinical and microbiological outcomes, diagnostic accuracy, and acceptability in comparison with 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. At last, to estimate the actual prevalence of causative agents of STDs in this setting.

In summary final aim is that the results could inform diagnostic guidelines since they may suggest an update of the current recommendations. Investigators speculate that the change in approach would allow a significant improvement in terms of appropriateness of therapy, reduction of the collateral damage, toxicity, and pharmacoeconomics costs.

This is an operational, randomized, open-label trial. Patients will be randomized (using block computerized method) into two Arms ("A" or "B"). 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. 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. All the patients randomized to Arm "A" or to Arm "B" will be asked to return after two-three weeks for a control visit. The NAAT test will be performed with Bosch Vivalytic Sexually Transmitted Infection test.

STUDY POPULATION Adults aged 18 years and above presenting with signs and symptoms of STDs at the Mulago Hospital STDs clinic during the study period, who provide written consent to the participation to the study and are diagnosed with UDS, AVD and GUD. Persons belonging to special populations (i.e., female sex workers, MSM) will be analyzed separately.

SAMPLE SIZE Eighty-seven patients (rounded to 90) in each treatment arm are necessary for demonstrating a difference of 0.20 by means of the Fisher's exact test carried out at a significance level of 0.05 (two tailed). The sample size will be increased to 110 patients in each treatment arm for allowing a drop- out rate of about 20%.

SAMPLING METHOD Two groups will be created by a random process and a blinded intervention. The intended sample will be composed by all sequential patients presenting with signs or symptoms suggestive for STDs at the time of screening for inclusion into the trial. Only patients who will satisfy the inclusion and exclusion criteria will be randomized after signing the informed consent. The randomization process will be carried out according to a complete block model. In addition, randomization will be stratified by gender. Any efforts will be put into improving the internal and external validity of the trial.

Data will be collected in an anonymized form: an Identification number will be assigned to each patients. Data will be analyzed by statistical team which will be led by a senior statistician

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Clinical Usefulness
timeFrame: minutes 210
Secondary outcomes:
measure: Microbiological and clinical cure
timeFrame: weeks 3
measure: Concordance
timeFrame: Minutes 210
measure: Acceptability
timeFrame: Minutes 210
measure: Prevalence
timeFrame: Months 2
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago National Referral Hospital
Study officials:
affiliation: Magna Graecia University of Catanzaro, Italy
name: Carlo Torti
role: PRINCIPAL_INVESTIGATOR
affiliation: Mulago National Referral Hospital, Kampala, Uganda
name: Patrick Musinguzi
role: PRINCIPAL_INVESTIGATOR
References: