Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202302766902029 Date of Approval: 01/02/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title 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
Official scientific title 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
Brief summary describing the background and objectives of the trial Sexually transmitted infections and reproductive tract infection (STIs/RTIs) can adversely impact pregnancy outcomes, especially in sub-Saharan countries where the burden is high. A meta-analysis reported that Trichomonas vaginalis (TV) infection during pregnancy is associated with an increased risk of preterm birth and small for gestational age infants. Bacterial vaginosis (BV) during pregnancy is associated with preterm birth and spontaneous abortion. Meta-analysis suggests that three of every ten pregnant women attending antenatal care (ANC) in East and Southern Africa have TV and one half have BV. Diagnosing TV and BV requires access to laboratory infrastructure and expertise, which can be challenging in resource-poor settings. Point-of-care (POC) tests for TV and BV are now available and have moderate to high sensitivity and specificity among symptomatic individuals. These tests enable the rapid identification of cases and provision of treatment at the same consultation. However, very few studies of POC tests for TV and BV have been conducted among pregnant women in the antenatal setting. In this study we plan to evaluate antigen/enzyme-based POC tests for TV and BV (OSOM® Trichomonas Rapid Test and OSOM® BVBlue®) among pregnant women attending antenatal care.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female,Trichomoniasis and bacterial vaginosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/02/2023
Actual trial start date 15/02/2023
Anticipated date of last follow up 31/05/2023
Actual Last follow-up date 26/05/2023
Anticipated target sample size (number of participants) 1021
Actual target sample size (number of participants) 1021
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TV and BV POC test Women will receive TV and BV point-of-care (POC) test. If the result of one or both of these tests is positive, women will receive 2g dose of metronidazole. One time dose. Women will receive TV and BV point-of-care (POC) test. If the result of one or both of these tests is positive, women will receive 2g dose of metronidazole. 1021
Control Group TV NAAT and BV Nugent Scoring If women haven't received treatment for TV/BV yet and found to be positive of either of these tests, they will be given 2g dose of metronidazole. One time dose. Reference test will be conducted, which is NAAT for TV and Nugent Scoring for BV. These tests will be performed to the same group to whom experimental intervention (TV and BV POC test) is conducted. 1021 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Pregnant women confirmed by ultrasound 2. Gestational age from Week 13 and 0 Days 3. Willing and able to provide written informed consent 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 Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 60 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/05/2022 TDRC Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
6th and 7th Floors, Ndola Central Hospital Building Corner Nkana Road /Broadway Ndola 71769 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/06/2022 National Health Research Authority
Ethics Committee Address
Street address City Postal code Country
Kasama Road Zambia 30075 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/09/2022 London School of Hygiene Tropical Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E7HT United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/12/2022 The World Health Organization Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
20 Avenue Appia, 1211 Geneva, Switzerland Geneva 1211 Switzerland
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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. 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. We define symptomatic as having one or more of the following: 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 3. The minimal operational characteristics of these POC tests and their acceptability to patients and healthcare providers At the end of the study
Secondary Outcome 1. Performance of the TV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to NAAT among asymptomatic only pregnant women. 2. Performance the TV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to NAAT among symptomatic only pregnant women. 3. Performance of the BV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to Nugent scoring among asymptomatic only pregnant women. 4. Performance of the BV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to Nugent scoring among symptomatic only pregnant women. 5. Performance of the TV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to NAAT among pregnant women grouped by gravidae and parity. 6. Performance of the BV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to Nugent scoring among pregnant women grouped by gravidae and parity. 7. Performance of the TV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to NAAT among pregnant women of different age groups: <25, 25-34, >35 and <20, 20-24, 25-29, 30-34, >35. 8. Performance of the BV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to Nugent scoring among pregnant women of different age groups: <25, 25-34, >35 and <20, 20-24, 25-29, 30-34, >35. 9. Performance of the TV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to NAAT among pregnant women of different gestational age groups: <20 weeks, >20 10. Performance of the BV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to Nugent scoring among pregnant women of different gestational age At the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nchelenge health centre Nchelenge Nchelenge Zambia
Kabuta health centre Nchelenge Nchelenge Zambia
Kafutuma health centre Nchelenge Nchelenge Zambia
Kashikishi health centre Nchelenge Nchelenge Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Ministry of Education Culture Sports Science and Technology of Japan 3-2-2 Kasumigaseki, Chiyoda-ku Tokyo 1008959 Japan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tropical Disease Research Centre 6th and 7th Floors / Main Building Ndola Teaching Hospital Ndola, Zambia Ndola 71769 Zambia Hospital
COLLABORATORS
Name Street address City Postal code Country
Tropical Disease Research Centre 6th and 7th Floors / Main Building Ndola Zambia
London School of Hygiene and Tropical Medicine Keppel Street London WC1E7HT United Kingdom
Nagasaki University 1 chome 12-4 Sakamoto Nagasaki 8528523 Japan
Orebro University Hospital Sodra Grev Rosengatan Orebro 70185 Sweden
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Matthew Chico matthew.chico@lshtm.ac.uk +442079272841 Keppel street
City Postal code Country Position/Affiliation
London WC1E7HT United Kingdom Associate professor at London School of Hygiene and Tropical Medicine
Role Name Email Phone Street address
Public Enquiries Enesia Chaponda enesia.chaponda@gmail.com +26011291531 University of Zambia Great East Road Campus
City Postal code Country Position/Affiliation
Lusaka Zambia Senior lecturer and a researcher
Role Name Email Phone Street address
Scientific Enquiries Sumire Sorano sumire.sorano1@lshtm.ac.uk +81958197000 1Chome 12-4 Sakamoto
City Postal code Country Position/Affiliation
Nagasaki 8528102 Japan PhD Student in Nagasaki University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonymised study data will be shared for future research with controlled access. After original study report is published, individual participant data will be shared on request. Data sharing requests will be considered with supporting documentation including a formal research proposal. A data Use Agreement will be signed before any data are made available. Statistical Analysis Plan,Study Protocol 10 years Anonymised study data will be shared for future research keeping with good practice guidelines produced by the Medical Research Council Hubs for Trials Methodology Research (MRC HTMR). Data sharing requests will be considered with supporting documentation including a formal research proposal. Approval will be required from the TDRC ethics committee, the NHRA in Zambia, the ethics committee of LSHTM, and the research ethics committee of the WHO. A data Use Agreement will be signed before any data are made available.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information