Sexually Transmitted DiseasesASTRHANCT05994495
Utility and Acceptability of a Molecular Test in the Management of Sexually Transmitted Diseases in Uganda
A study testing nuclear acid amplification tests and Clinical Syndromic Approach in people with Sexually Transmitted Diseases, run by Riccardo Serraino at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sexually Transmitted Diseases
- What is being tested?
- nuclear acid amplification tests and Clinical Syndromic Approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUganda
- Study dates
- 15 Jan 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
- 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.
Read the 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
- Conditions
- Sexually Transmitted Diseases
- Being tested
- nuclear acid amplification tests, Clinical Syndromic Approach
- Keywords
- Sexually transmitted diseases, STDs, Low-Middle Income Country, Molecular Test, NUCLEIC ACID AMPLIFICATION TEST, NAAT, Clinical Syndromic Approach, LMIC
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nuclear acid amplification testsDiagnostic test
Also called Bosch Vivalytic STI 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)
Clinical Syndromic ApproachOther
Physical examination
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Clinical Syndromic Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: minutes 210
Secondary outcomes (4)
Microbiological and clinical cure
Microbiological cure measured as the percentage of patients who will achieve success at the test of cure performed after two-three weeks from the end of therapy in both arms. For the clinical outcome, we will consider the percentage of patients who will recover from signs and symptoms of the STDs in both arms at the same time-point.
Measured: weeks 3
Concordance
Percentage of concordant results between the syndromic approach and the NAAT. The diagnosis is considered concordant when at least one pathogen responsible for a specific syndrome (Table 1) diagnosed through the syndromic approach is detected by a molecular testing. The diagnosis is considered not concordant when one or more pathogens responsible for syndromes other than those identified by the syndromic approach, are detected by molecular testing.
Measured: Minutes 210
Acceptability
Percentage of patients who will be sent home the same day with the treatment prescribed according to the molecular test result (Arm "A") or with the treatment according to the syndromic approach (Arm "B"). Patients will not be able to wait for the result of the test and for the targeted therapy will be considered as failure for the primary endpoint. In addition, patients who will drop out from the study will be considered as failure.
Percentage of patients who will be sent home the same day with the treatment prescribed according to the molecular test result (Arm "A") or with the treatment according to the syndromic approach (Arm "B"). Patients will not be able to wait for the result of the test and for the targeted therapy will be considered as failure for the primary endpoint. In addition, patients who will drop out from the study will be considered as failure.
Measured: Minutes 210
Prevalence
Prevalence of detected pathogens' genome at the molecular test (overall population).
Measured: Months 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start15 Jan 2024
- Primary completion30 Jan 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riccardo Serraino
- Sponsor type
- University, hospital or other
- Collaborators
- Societa' Italiana Di Malattie Infettive E Tropicali
- Responsible party
- Sponsor-investigator, Riccardo Serraino, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
- Investigators
- Carlo Torti, Principal investigator, Magna Graecia University of Catanzaro, ItalyPatrick Musinguzi, Principal investigator, Mulago National Referral Hospital, Kampala, Uganda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994495
- Sponsor's protocol ID
- MHREC2023-97
- Acronym
- ASTRHA
- Status last verified
- May 2024
- First submitted
- 6 Aug 2023
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38862220
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05994495
- Acronym / sponsor ID
- ASTRHA / MHREC2023-97
- Conditions
- Sexually Transmitted Diseases
- Keywords
- Sexually transmitted diseases, STDs, Low-Middle Income Country, Molecular Test, NUCLEIC ACID AMPLIFICATION TEST, NAAT, Clinical Syndromic Approach, LMIC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Riccardo SerrainoUniversity, hospital or other
- Collaborators
- Societa' Italiana Di Malattie Infettive E Tropicali
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ARM A Molecular test | Experimental | Diagnostic Test: nuclear acid amplification testsPatients 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 |
| ARM B Clinical Syndromic Approach | Active comparator | Other: Clinical Syndromic ApproachPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- All patients presenting with UDS, AVD and GUD who decline informed and written consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nuclear acid amplification testsAlso: Bosch Vivalytic STI testThe 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) | Diagnostic test | ARM A Molecular test |
| Clinical Syndromic ApproachPhysical examination | Other | ARM B Clinical Syndromic Approach |
Primary outcome
Clinical Usefulness
Time frame: minutes 210
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.
4 secondary outcomes
Microbiological and clinical cure
Time frame: weeks 3
Concordance
Time frame: Minutes 210
Acceptability
Time frame: Minutes 210
Prevalence
Time frame: Months 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Derived from this study: PubMed 38862220Serraino 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Torti principal investigator
Magna Graecia University of Catanzaro, Italy
Patrick Musinguzi principal investigator
Mulago National Referral Hospital, Kampala, Uganda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nuclear acid amplification tests and Clinical Syndromic Approach in people with Sexually Transmitted Diseases, run by Riccardo Serraino at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Usefulness (time frame: minutes 210). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05994495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.