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.

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

Overview

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

1. 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 2. To determine the diagnostic accuracy of the NG LFA for the detection of NG in vaginal provider-collected samples among symptomatic non-pregnant women. 3. 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. 4. 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. 5. To compare the safety of self-collection of vaginal swabs vs provider collection among pregnant women attending ANC and symptomatic non-pregnant women. 6. To assess healthcare workers' acceptability, usability, and preferences regarding the NG LFA systems integration compared to the reference method. 7. 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.

Interventions

• Diagnostic test Novel Lateral Flow Assay for Neisseria gonorrhoeae
  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: 1\. Rapid Results: The LFA is designed to provide results within 30 minutes,

Primary outcome measures

• 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]

Secondary outcome measures (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. [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]

Eligibility criteria

Inclusion criteria

ANC population

• Women age ≥18 years
• Pregnant women
• Attending a study site for antenatal care
• Willingness to participate and signed informed consent form (ICF)

Exclusion criteria

• 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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Other

Study locations

South Africa · 1 center

• 1. Nontyatyambo CHC 2. Empilweni Gompo CHC 3. Duncan Village Day Hospital 4. Grey Gateway — East London

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 tran PMID 38485431
• Gleeson 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. PMID 38412465
• Peters 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. PMID 25118973
• Peters 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. PMID 38335982

Identifiers

NCT: NCT07530406 · GO-SA AM007 · DFATD-Canada

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗