Neisseria Gonorrheae InfectionGO-SANCT07530406
Performance, Acceptability, and Usability of a Novel Rapid Lateral Flow Test for Detecting Neisseria Gonorrhoeae in Pregnant and Symptomatic Women Attending Clinics in South Africa.
An observational study of Neisseria Gonorrheae Infection, run by Foundation for Professional Development (Pty) Ltd at 1 site in South Africa.
Trial summary
Previous studies of the Neisseria gonorrhoeae (NG) lateral flow assay (LFA) have shown promising results. In East London, South Africa, the LFA demonstrated a sensitivity of 80% in asymptomatic women. However, a study in Zimbabwe reported a lower sensitivity of 65% among pregnant women attending antenatal care (ANC). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neisseria Gonorrheae Infection
- What is being tested?
- Novel Lateral Flow Assay for Neisseria gonorrhoeae
- How many people
- 1,239 participants
- Where
- 1 siteSouth Africa
- Study dates
- 11 Sep 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Pregnant women 2. Symptomatic women 3. Healthcare workers (HCWs) population Systems Usability Score Survey \& TFA Acceptability Survey * HCWs using the NG LFA during month 3 of the study. Focus Group Discussions (FGD) * HCWs actively involved in conducting the study Focus Group Discussions (FGD) - Non-Study Participants * HCWs working at the study site but NOT directly involved in the NG LFA study procedures
Who may be able to join
- ANC population
- Women age ≥18 years
- Pregnant women
- Attending a study site for antenatal care
- Willingness to participate and signed informed consent form (ICF)
Who cannot join
- Self-reported use of antimicrobial therapy within 21 days preceding enrolment
- Use of vaginal douche or vaginal product in the previous 24 hours
- Unable to provide specimens for testing
- A medical condition, serious illness, or other condition that could interfer with study procedures or jeopardise participant safety Symptomatic population Inclusion -
- Non pregnant women age ≥18 years
- Diagnosis of VDS. Diagnosis of VDS will be based on self-reported presence ofsymptoms consistent with VDS, such as increased or abnormal vaginal discharge
Show all 11Show fewer
- Willingness to participate and sign ICF Exclusion -
- Self-reported use of antimicrobial therapy within 21 days preceding enrolment
- Use of vaginal douche or vaginal product in the previous 24 hours
- Unable to provide specimens for testing
- A medical condition, serious illness, or other condition that could interfere with study procedures or jeopardise participant safety
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
1. Nontyatyambo CHC 2. Empilweni Gompo CHC 3. Duncan Village Day Hospital 4. Grey Gateway Clinic 5. Ndevana Clinic
East London, Eastern Cape, 5247
Mandisa M Mdingi, +27 737069068, mandisam@foundation.co.za
About this study
Official title: Evaluation of Performance, Acceptability, and Usability of a Novel Lateral Flow Assay for Point-of-Care Detection of Neisseria Gonorrhoeae Infection Among Pregnant and Symptomatic Women in South Africa
Previous studies of the Neisseria gonorrhoeae (NG) lateral flow assay (LFA) have shown promising results. In East London, South Africa, the LFA demonstrated a sensitivity of 80% in asymptomatic women. However, a study in Zimbabwe reported a lower sensitivity of 65% among pregnant women attending antenatal care (ANC). This discrepancy raises important questions about the test's performance in pregnant women in the East London ANC population. Physiological changes during pregnancy may influence test accuracy, highlighting the need for further investigation in this specific population and setting.
This study aims to evaluate the performance, acceptability, and usability of the NG LFA among pregnant and symptomatic women attending clinics in East London. Participants will provide clinical samples that are tested using both the NG LFA and standard laboratory methods to assess diagnostic accuracy, including sensitivity and specificity. The study will specifically determine whether pregnancy affects the test's performance and whether the LFA is reliable for routine use in ANC clinics. Confirming its accuracy could enable wider implementation, improving case detection, treatment rates, and reducing the burden of gonorrhea in the community.
Read more
In addition to evaluating performance, the study will investigate the feasibility of self-collected samples. Self-collection offers privacy, convenience, and may increase participation in testing, particularly for women who prefer this method. It may also reduce the workload for healthcare providers, especially in resource-limited settings. The study will compare the accuracy of self-collected samples with clinician-collected samples to determine whether self-collection is a viable option in ANC and symptomatic populations.
The findings will provide crucial evidence to guide implementation of the NG LFA in primary care and ANC clinics, supporting timely diagnosis and treatment. If successful, this approach could strengthen gonorrhea screening programs, enhance patient-centered care, and contribute to better sexual and reproductive health outcomes for women in South Africa.
Read the detailed description
Background and Rationale :
Gonorrhoea remains a significant public health challenge globally, particularly in South Africa, where it is considered endemic. Untreated gonorrhoea, which is now becoming more resistant to antibiotics, can lead to severe complications, including pelvic inflammatory disease, infertility, adverse pregnancy outcomes, and increased susceptibility to HIV. Pregnant women are especially vulnerable as untreated gonorrhoea can result in miscarriage, preterm birth, and neonatal infection. Early and accurate diagnosis is crucial for timely treatment and the prevention of these adverse outcomes.
Nucleic acid amplification tests (NAATs) are considered the most reliable diagnostic tool for gonorrhoea. However, their high cost, long turnaround time and demanding infrastructure requirements often render them inaccessible in resource-constrained environments. The NG LFA, a rapid, point-of-care test developed by FIND, offers a potential solution for these settings.
Previous NG LFA performance studies have shown promising results, with a sensitivity of 80% in asymptomatic women in East London1. However, a study in Zimbabwe found a lower sensitivity of 65% among pregnant women attending Antenatal Care (ANC). This discrepancy raises questions about the LFA's performance in this specific population and setting. The observed difference in sensitivity between asymptomatic women and pregnant women highlights the need to investigate the LFA's performance, specifically in the ANC population in East London. It has been hypothesised that pregnancy may induce physiological changes that affect the test's accuracy. Therefore, further investigation is needed to confirm this potential impact. If the NG LFA proves reliable and accurate in this setting, its widespread implementation in ANC clinics could significantly improve case detection and treatment rates, ultimately reducing the burden of gonorrhoea in the community.
This study will also investigate the potential for self-collected samples. Self-collection offers several benefits, such as increased privacy and convenience, which could encourage more women to get tested. Additionally, it may reduce the workload for healthcare providers, especially in areas with limited resources. We will evaluate the feasibility and accuracy of self-collected samples compared to those collected by clinicians in the ANC population and symptomatic women who may prefer this method.
Objectives:
Primary Objective
- To determine the diagnostic accuracy of the NG LFA for the detection of NG in provider-collected vaginal samples from pregnant women attending ANC when compared to Xpert® CT/NG as the reference standard. Secondary Objectives
- To determine the diagnostic accuracy of the NG LFA for the detection of NG in vaginal provider-collected samples among symptomatic non-pregnant women.
- To compare the diagnostic accuracy of the NG LFA for the detection of NG in vaginal self-collected and provider-collected samples from pregnant women attending ANC.
- To compare the diagnostic accuracy of the NG LFA for the detection of NG in vaginal self-collected and provider-collected samples from symptomatic non-pregnant women.
- To compare the safety of self-collection of vaginal swabs vs provider collection among pregnant women attending ANC and symptomatic non-pregnant women.
- To assess healthcare workers' acceptability, usability, and preferences regarding the NG LFA systems integration compared to the reference method.
- To assess the acceptability and preference for self-collected vaginal samples compared to provider-collected samples among pregnant ANC attendees and symptomatic non-pregnant women and healthcare workers.
- Conditions
- Neisseria Gonorrheae Infection
- Being tested
- Novel Lateral Flow Assay for Neisseria gonorrhoeae
- Keywords
- GO-SA
- Medical subject headings
- Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Lateral Flow Assay for Neisseria gonorrhoeaeDiagnostic test
The clinical claims for the NG LFA are centred around its potential to provide rapid, accurate, and accessible POC diagnosis for NG infection in non-pregnant and pregnant women. It is intended to be used for the detection of NG infections in vaginal swab specimens collected from both symptomatic non-pregnant women and women attending ANC. The NG LFA aims to offer several advantages over traditional testing, including:
- Rapid Results: The LFA is designed to provide results within 30 minutes, enabling faster diagnosis and treatment decisions compared to laboratory-based tests that may take hours or days.
- Ease of Use: The LFA is intended to be user-friendly, requiring minimal training and resources. This makes it suitable for use in various settings, including primary healthcare facilities and ANC clinics.
- Affordability: The LFA is expected to be more cost-effective than current molecular diagnostic methods, potentially expanding access to testing in resource-limited settings.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women Cohort and Symptomatic Women Cohort | This is a cross-sectional, single time-point study with a paired design to determine the diagnostic accuracy of the NG LFA against the Xpert® CT/NG as a reference standard in vaginal samples collected from pregnant women attending ANC and to compare the accuracy and safety of self-collected and provider-collected samples in both non-pregnant symptomatic and pregnant ANC attendees. Receives: Diagnostic Test: Novel Lateral Flow Assay for Neisseria gonorrhoeae |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the diagnostic accuracy of the NG LFA for the detection of NG in provider-collected vaginal samples from pregnant women attending ANC when compared to Xpert® CT/NG as the reference standard.
Point estimates of sensitivity and specificity with 95% confidence intervals (Wilson's score method) among pregnant ANC attendees.
Measured: Baseline
Secondary outcomes (6)
To determine the diagnostic accuracy of the NG LFA for the detection of NG in vaginal provider-collected samples among symptomatic non-pregnant women.
Point estimates of sensitivity and specificity with 95% confidence intervals (Wilson's score method) among symptomatic non-pregnant women.
Measured: Baseline
To compare the diagnostic accuracy of the NG LFA for the detection of NG in vaginal self-collected and provider-collected samples from pregnant women attending ANC.
Point estimates of the percentage differences with 95% confidence intervals (Tango's score method) of the diagnostic performance metrics between self-collected and provider-collected vaginal samples for the detection of NG in pregnant ANC attendees.
Measured: Baseline
To compare the diagnostic accuracy of the NG LFA for the detection of NG in vaginal self-collected and provider-collected samples from symptomatic non-pregnant women.
Point estimates of the percentage differences with 95% confidence intervals (Tango's score method) of the diagnostic performance metrics between self-collected and provider-collected vaginal samples for the detection of NG in non-pregnant symptomatic women.
Measured: Baseline
To compare the safety of self-collection of vaginal swabs vs provider collection among pregnant women attending ANC and symptomatic non-pregnant women.
The number of adverse events reported following self-collection of vaginal swabs or collection by health service providers among pregnant women attending ANC and symptomatic non-pregnant women.
Measured: Baseline
To assess healthcare workers' acceptability, usability, and preferences regarding the NG LFA systems integration compared to the reference method.
Mixed methods: Acceptability; distribution of acceptability questionnaire scores; usability; distribution of System Usability Scores; perceptions on acceptability, usability, and preferences of systems integration from qualitative semi-structured interviews and focus group discussions.
Measured: Systems usability score survey and the TFA acceptability survey relating to the NG LFA will be administered to all healthcare workers who are manipulating the NG LFA at month 3 (projected mid-point of participant enrolment) and at month 5.
To assess the acceptability and preference for self-collected vaginal samples compared to provider-collected samples among pregnant ANC attendees and symptomatic non-pregnant women and healthcare workers.
Mixed methods: Distribution of acceptability questionnaire score, perceptions on acceptability and preference from qualitative focus group discussions. The proportion of participants in each group who prefer self-collected samples over provider-collected samples.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start11 Sep 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neisseria Gonorrheae InfectionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,239 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation for Professional Development (Pty) Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Innovative New Diagnostics, Switzerland
- Responsible party
- Sponsor
- Investigators
- Mandisa M Mdingi, Master of Public Health, Principal investigator, Foundation for Professional DevelopmentDr Birgitta Gleeson, PhD, Principal investigator, Foundation for Innovative New Diagnostics, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530406
- Sponsor's protocol ID
- GO-SA AM007
- Other IDs
- DFATD-Canada
- Acronym
- GO-SA
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Riddell MA, Vallely LM, Mengi A, Badman SG, Low N, Wand H, Bolnga JW, Babona D, Mola GDL, Wiseman V, Kelly-Hanku A, Homer CSE, Morgan C, Luchters S, Whiley DM, Robinson LJ, Au L, Pukai-Gani I, Laman M, Kariwiga G, Toliman PJ, Batura N, Tabrizi SN, Rogerson SJ, Garland SM, Guy RJ, Peeling RW, Pomat WS, Kaldor JM, Vallely AJB; WANTAIM study group. Point-of-care testing and treatment of sexually transmitted and genital infections to improve birth outcomes in high-burden, low-resource settings (WANTAIM): a pragmatic cluster randomised crossover trial in Papua New Guinea. Lancet Glob Health. 2024 Apr;12(4):e641-e651. doi: 10.1016/S2214-109X(24)00004-4.
PubMed 38485431Gleeson B, Piton J, Mazzola L, McHugh S, Bender J, Lear M, Gavrikova T, Van Der Pol B, Daniels B, Osborn J, Dailey P, Ferreyra C. Development of a Novel Fluorescent-Based Lateral Flow Assay for the Detection of Neisseria gonorrhoeae at the Point of Care. Sex Transm Dis. 2024 Mar 1;51(3):186-191. doi: 10.1097/OLQ.0000000000001913. Epub 2023 Dec 19.
PubMed 38412465Peters RP, Dubbink JH, van der Eem L, Verweij SP, Bos ML, Ouburg S, Lewis DA, Struthers H, McIntyre JA, Morre SA. Cross-sectional study of genital, rectal, and pharyngeal Chlamydia and gonorrhea in women in rural South Africa. Sex Transm Dis. 2014 Sep;41(9):564-9. doi: 10.1097/OLQ.0000000000000175.
PubMed 25118973Peters RPH, Klausner JD, Mazzola L, Mdingi MM, Jung H, Gigi RMS, Piton J, Daniels J, de Vos L, Adamson PC, Gleeson B, Ferreyra C. Novel lateral flow assay for point-of-care detection of Neisseria gonorrhoeae infection in syndromic management settings: a cross-sectional performance evaluation. Lancet. 2024 Feb 17;403(10427):657-664. doi: 10.1016/S0140-6736(23)02240-7. Epub 2024 Feb 6.
PubMed 38335982
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance, Acceptability, and Usability of a Novel Lateral Flow Assay for Point-of-Care Detection of Neisseria Gonorrhoeae Infection Among Pregnant and Symptomatic Women in South Africa
- ClinicalTrials.gov ID
- NCT07530406
- Acronym / sponsor ID
- GO-SA / GO-SA AM007
- Conditions
- Neisseria Gonorrheae Infection
- Keywords
- GO-SA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,239 participants (estimated)
- Lead sponsor
- Foundation for Professional Development (Pty) LtdUniversity, hospital or other
- Collaborators
- Foundation for Innovative New Diagnostics, Switzerland
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Apr 2026 (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.
Previous studies of the Neisseria gonorrhoeae (NG) lateral flow assay (LFA) have shown promising results. In East London, South Africa, the LFA demonstrated a sensitivity of 80% in asymptomatic women. However, a study in Zimbabwe reported a lower sensitivity of 65% among pregnant women attending antenatal care (ANC). This discrepancy raises important questions about the test's performance in pregnant women in the East London ANC population. Physiological changes during pregnancy may influence test accuracy, highlighting the need for further investigation in this specific population and setting.
This study aims to evaluate the performance, acceptability, and usability of the NG LFA among pregnant and symptomatic women attending clinics in East London. Participants will provide clinical samples that are tested using both the NG LFA and standard laboratory methods to assess diagnostic accuracy, including sensitivity and specificity. The study will specifically determine whether pregnancy affects the test's performance and whether the LFA is reliable for routine use in ANC clinics. Confirming its accuracy could enable wider implementation, improving case detection, treatment rates, and reducing the burden of gonorrhea in the community.
In addition to evaluating performance, the study will investigate the feasibility of self-collected samples. Self-collection offers privacy, convenience, and may increase participation in testing, particularly for women who prefer this method. It may also reduce the workload for healthcare providers, especially in resource-limited settings. The study will compare the accuracy of self-collected samples with clinician-collected samples to determine whether self-collection is a viable option in ANC and symptomatic populations.
The findings will provide crucial evidence to guide implementation of the NG LFA in primary care and ANC clinics, supporting timely diagnosis and treatment. If successful, this approach could strengthen gonorrhea screening programs, enhance patient-centered care, and contribute to better sexual and reproductive health outcomes for women in South Africa.
Detailed description
Background and Rationale :
Gonorrhoea remains a significant public health challenge globally, particularly in South Africa, where it is considered endemic. Untreated gonorrhoea, which is now becoming more resistant to antibiotics, can lead to severe complications, including pelvic inflammatory disease, infertility, adverse pregnancy outcomes, and increased susceptibility to HIV. Pregnant women are especially vulnerable as untreated gonorrhoea can result in miscarriage, preterm birth, and neonatal infection. Early and accurate diagnosis is crucial for timely treatment and the prevention of these adverse outcomes.
Nucleic acid amplification tests (NAATs) are considered the most reliable diagnostic tool for gonorrhoea. However, their high cost, long turnaround time and demanding infrastructure requirements often render them inaccessible in resource-constrained environments. The NG LFA, a rapid, point-of-care test developed by FIND, offers a potential solution for these settings.
Previous NG LFA performance studies have shown promising results, with a sensitivity of 80% in asymptomatic women in East London1. However, a study in Zimbabwe found a lower sensitivity of 65% among pregnant women attending Antenatal Care (ANC). This discrepancy raises questions about the LFA's performance in this specific population and setting. The observed difference in sensitivity between asymptomatic women and pregnant women highlights the need to investigate the LFA's performance, specifically in the ANC population in East London. It has been hypothesised that pregnancy may induce physiological changes that affect the test's accuracy. Therefore, further investigation is needed to confirm this potential impact. If the NG LFA proves reliable and accurate in this setting, its widespread implementation in ANC clinics could significantly improve case detection and treatment rates, ultimately reducing the burden of gonorrhoea in the community.
This study will also investigate the potential for self-collected samples. Self-collection offers several benefits, such as increased privacy and convenience, which could encourage more women to get tested. Additionally, it may reduce the workload for healthcare providers, especially in areas with limited resources. We will evaluate the feasibility and accuracy of self-collected samples compared to those collected by clinicians in the ANC population and symptomatic women who may prefer this method.
Objectives:
Primary Objective
- To determine the diagnostic accuracy of the NG LFA for the detection of NG in provider-collected vaginal samples from pregnant women attending ANC when compared to Xpert® CT/NG as the reference standard. Secondary Objectives
- To determine the diagnostic accuracy of the NG LFA for the detection of NG in vaginal provider-collected samples among symptomatic non-pregnant women.
- To compare the diagnostic accuracy of the NG LFA for the detection of NG in vaginal self-collected and provider-collected samples from pregnant women attending ANC.
- To compare the diagnostic accuracy of the NG LFA for the detection of NG in vaginal self-collected and provider-collected samples from symptomatic non-pregnant women.
- To compare the safety of self-collection of vaginal swabs vs provider collection among pregnant women attending ANC and symptomatic non-pregnant women.
- To assess healthcare workers' acceptability, usability, and preferences regarding the NG LFA systems integration compared to the reference method.
- To assess the acceptability and preference for self-collected vaginal samples compared to provider-collected samples among pregnant ANC attendees and symptomatic non-pregnant women and healthcare workers.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women Cohort and Symptomatic Women Cohort | – | Diagnostic Test: Novel Lateral Flow Assay for Neisseria gonorrhoeaeThis is a cross-sectional, single time-point study with a paired design to determine the diagnostic accuracy of the NG LFA against the Xpert® CT/NG as a reference standard in vaginal samples collected from pregnant women attending ANC and to compare the accuracy and safety of self-collected and provider-collected samples in both non-pregnant symptomatic and pregnant ANC attendees. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Pregnant women 2. Symptomatic women 3. Healthcare workers (HCWs) population Systems Usability Score Survey \& TFA Acceptability Survey * HCWs using the NG LFA during month 3 of the study. Focus Group Discussions (FGD) * HCWs actively involved in conducting the study Focus Group Discussions (FGD) - Non-Study Participants * HCWs working at the study site but NOT directly involved in the NG LFA study procedures
Key inclusion criteria (5 listed)
- ANC population
- Women age ≥18 years
- Pregnant women
- Attending a study site for antenatal care
- Willingness to participate and signed informed consent form (ICF)
Key exclusion criteria (11 listed)
- Self-reported use of antimicrobial therapy within 21 days preceding enrolment
- Use of vaginal douche or vaginal product in the previous 24 hours
- Unable to provide specimens for testing
- A medical condition, serious illness, or other condition that could interfer with study procedures or jeopardise participant safety Symptomatic population Inclusion -
- Non pregnant women age ≥18 years
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 |
|---|---|---|
| Novel Lateral Flow Assay for Neisseria gonorrhoeaeThe clinical claims for the NG LFA are centred around its potential to provide rapid, accurate, and accessible POC diagnosis for NG infection in non-pregnant and pregnant women. It is intended to be used for the detection of NG infections in vaginal swab specimens collected from both symptomatic non-pregnant women and women attending ANC. The NG LFA aims to offer several advantages over traditional testing, including: 1. Rapid Results: The LFA is designed to provide results within 30 minutes, enabling faster diagnosis and treatment decisions compared to laboratory-based tests that may take hours or days. 2. Ease of Use: The LFA is intended to be user-friendly, requiring minimal training and resources. This makes it suitable for use in various settings, including primary healthcare facilities and ANC clinics. 3. Affordability: The LFA is expected to be more cost-effective than current molecular diagnostic methods, potentially expanding access to testing in resource-limited settings. | Diagnostic test | Pregnant Women Cohort and Symptomatic Women Cohort |
Primary outcome
To determine the diagnostic accuracy of the NG LFA for the detection of NG in provider-collected vaginal samples from pregnant women attending ANC when compared to Xpert® CT/NG as the reference standard.
Time frame: Baseline
Point estimates of sensitivity and specificity with 95% confidence intervals (Wilson's score method) among pregnant ANC attendees.
6 secondary outcomes
To determine the diagnostic accuracy of the NG LFA for the detection of NG in vaginal provider-collected samples among symptomatic non-pregnant women.
Time frame: Baseline
To compare the diagnostic accuracy of the NG LFA for the detection of NG in vaginal self-collected and provider-collected samples from pregnant women attending ANC.
Time frame: Baseline
To compare the diagnostic accuracy of the NG LFA for the detection of NG in vaginal self-collected and provider-collected samples from symptomatic non-pregnant women.
Time frame: Baseline
To compare the safety of self-collection of vaginal swabs vs provider collection among pregnant women attending ANC and symptomatic non-pregnant women.
Time frame: Baseline
To assess healthcare workers' acceptability, usability, and preferences regarding the NG LFA systems integration compared to the reference method.
Time frame: Systems usability score survey and the TFA acceptability survey relating to the NG LFA will be administered to all healthcare workers who are manipulating the NG LFA at month 3 (projected mid-point of participant enrolment) and at month 5.
To assess the acceptability and preference for self-collected vaginal samples compared to provider-collected samples among pregnant ANC attendees and symptomatic non-pregnant women and healthcare workers.
Time frame: Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 38485431Riddell MA, Vallely LM, Mengi A, Badman SG, Low N, Wand H, Bolnga JW, Babona D, Mola GDL, Wiseman V, Kelly-Hanku A, Homer CSE, Morgan C, Luchters S, Whiley DM, Robinson LJ, Au L, Pukai-Gani I, Laman M, Kariwiga G, Toliman PJ, Batura N, Tabrizi SN, Rogerson SJ, Garland SM, Guy RJ, Peeling RW, Pomat WS, Kaldor JM, Vallely AJB; WANTAIM study group. Point-of-care testing and treatment of sexually transmitted and genital infections to improve birth outcomes in high-burden, low-resource settings (WANTAIM): a pragmatic cluster randomised crossover trial in Papua New Guinea. Lancet Glob Health. 2024 Apr;12(4):e641-e651. doi: 10.1016/S2214-109X(24)00004-4.
- Background: PubMed 38412465Gleeson B, Piton J, Mazzola L, McHugh S, Bender J, Lear M, Gavrikova T, Van Der Pol B, Daniels B, Osborn J, Dailey P, Ferreyra C. Development of a Novel Fluorescent-Based Lateral Flow Assay for the Detection of Neisseria gonorrhoeae at the Point of Care. Sex Transm Dis. 2024 Mar 1;51(3):186-191. doi: 10.1097/OLQ.0000000000001913. Epub 2023 Dec 19.
- Background: PubMed 25118973Peters RP, Dubbink JH, van der Eem L, Verweij SP, Bos ML, Ouburg S, Lewis DA, Struthers H, McIntyre JA, Morre SA. Cross-sectional study of genital, rectal, and pharyngeal Chlamydia and gonorrhea in women in rural South Africa. Sex Transm Dis. 2014 Sep;41(9):564-9. doi: 10.1097/OLQ.0000000000000175.
- Background: PubMed 38335982Peters RPH, Klausner JD, Mazzola L, Mdingi MM, Jung H, Gigi RMS, Piton J, Daniels J, de Vos L, Adamson PC, Gleeson B, Ferreyra C. Novel lateral flow assay for point-of-care detection of Neisseria gonorrhoeae infection in syndromic management settings: a cross-sectional performance evaluation. Lancet. 2024 Feb 17;403(10427):657-664. doi: 10.1016/S0140-6736(23)02240-7. Epub 2024 Feb 6.
- Individual participant dataSharing planned: Undecided
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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.
Mandisa M Mdingi, Master of Public Health principal investigator
Foundation for Professional Development
Dr Birgitta Gleeson, PhD principal investigator
Foundation for Innovative New Diagnostics, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neisseria Gonorrheae Infection, run by Foundation for Professional Development (Pty) Ltd at 1 site in South Africa.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. 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 South Africa. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mandisa M Mdingi, Master of Public Health (+27 73 706 9068, mandisam@founadtion.co.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the diagnostic accuracy of the NG LFA for the detection of NG in provider-collected vaginal samples from pregnant women attending ANC when compared to Xpert® CT/NG as the reference standard. (time frame: Baseline). 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 NCT07530406, which also lists 4 linked publications.
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 15 Apr 2026.