N. gonorrhoeae among antenatal women and men and women attending sexual health services Infections and Infestations
Conditions
Interventions
This mixed methods cross-sectional, single-time-point study will determine the clinical performance of the point-of-care NG-LFA compared with the Xpert® CT/NG test as the reference standard in differe
Sponsors
Papua New Guinea Institute of Medical Research
Eligibility
Sex/Gender
All
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: Antenatal Clinic (ANC): 1. Asymptomatic and symptomatic pregnant women will be eligible to participate if aged 16 years or over. 2. They must be attending a study site for antenatal care. 3. They must be willing to participate. 4. They must be able to complete informed consent procedures. 5. Women attending their first ANC visit (a ‘booking’ visit) will be eligible. 6. Women attending an ANC follow-up visit during their current pregnancy will also be eligible. Sexual Health Clinic (SHC): 1. Women and men attending for sexual health services will be eligible to participate if aged 18 years or over. 2. They must be presenting with genital symptoms (vaginal discharge syndrome in women; urethral discharge syndrome in men; see Table 2). 3. They may also be presenting with anorectal symptoms (MSM/TG people). 4. They must be willing to participate. 5. They must be able to complete informed consent procedures.
Exclusion criteria
Exclusion criteria: 1. Genital symptoms that are not consistent with vaginal discharge syndrome (VDS) or urethral discharge syndrome (UDS), e.g. genital ulcer disease. 2. Currently taking treatment for Neisseria gonorrhoeae infection. 3. Neisseria gonorrhoeae treatment taken within two weeks before enrolment. 4. Received antibiotics (e.g. broad-spectrum) within 21 days prior to enrolment. 5. Use of vaginal douche or vaginal product in the previous 24 hours (all women). 6. Use of anal douche or anal product in the previous 24 hours (MSM/TG people only). 7. A medical condition, serious illness, or other condition that could interfere with study procedures or jeopardise participant safety. 8. Unable to provide specimens for testing. 9. Unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical performance characteristics of the NG-LFA (sensitivity, specificity, positive and negative predictive values) compared with the Xpert® CT/NG test as the reference standard. These will be calculated and reported as proportions and estimated with 95% confidence intervals (95% CI) using standard statistical methods. Samples will be collected at enrolment with all testing at the pint of care, and treatment as necessary. 2. Acceptability, usability and preference characteristics of the point of care screen and treta approach from health worker and participant perspectives. Measured using quantitative and qualitative data, collected via an exit survey among all participants and semi structured interviews among a sub-set of participants | — |
Secondary
| Measure | Time frame |
|---|---|
| Inhibitory concentrations and calculate the proportion of N. gonorrhoeae isolates which are susceptible, intermediate or resistant (or show reduced susceptibility) to antimicrobials, according to European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints, and present estimates with 95% CI. For those testing positive for N. gonorrhoeae, an additional sample will be requested prior to treatment being provided for microbiological evaluation using standardised antimicrobial susceptibility testing by culture (AST). Genomic materials will be extracted from these samples and tested for NG using two different genetic markers by PCR. The testing in the latter serves two purposes, to confirm NG positivity and to assess NG bacterial load in the samples. Samples that tested positive and had sufficient bacterial load will be further tested for the presence of genes (by PCR) and mutations (by genotyping PCR) that are predictive for resistance against the antimicrobials used for treating NG. Sequencing will be performed, and the sequences will be analysed using different tools including Multi-antigen sequence typing (MAST), Sequence typing for antimicrobial resistance (STAR), and Multi-locus sequence typing (MLST). | — |
Countries
Papua New Guinea
Contacts
Public ContactLisa Vallely
Outcome results
None listed