Clinic-based evaluation of antigen-based point-of-care tests for genital trichomoniasis infection and bacterial vaginosis among women attending antenatal care facilities in Nchelenge, Zambia

Not Applicable

Recruiting

• Conditions: Trichomoniasis and bacterial vaginosis; Fertility-female

• Registration Number: PACTR202302766902029
• Lead Sponsor: Tropical Disease Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-13
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 1021

Inclusion Criteria

1.Pregnant women confirmed by ultrasound
2.Gestational age from Week 13 and 0 Days
3.Willing and able to provide written informed consent

Exclusion Criteria

1.History of using metronidazole or clindamycin during current pregnancy
2.Known allergy or contraindication to metronidazole
3.Unable to give written informed consent
4.Previously having participated in this study
5.Have (a) used a vaginal cream or ointment product, (b) douched, or (c) used spermicides, vaginal lubricants or feminine sprays within 72 hours of testing

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Performance of the TV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to NAAT among asymptomatic and symptomatic pregnant women combined.<br><br>2. Performance of the BV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to Nugent scoring among asymptomatic and symptomatic pregnant women combined.<br><br>We define symptomatic as having one or more of the following:<br>Unusual vaginal discharge, pain during urination, itching or burning of the vulva, sores, blisters, ulcers, warts or rashes in the genital area, lumps and bumps on the genitals, lower abdominal pain<br><br>3. The minimal operational characteristics of these POC tests and their acceptability to patients and healthcare providers