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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202409641377968 Date of Registration: 19/09/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Triple point of care testing for HIV, Syphilis and Hepatitis B virus versus Conventional Antenatal Screening A Comparative Study.
Official scientific title Triple point of care testing for HIV, Syphilis and Hepatitis B virus versus Conventional Antenatal Screening A Comparative Study.
Brief summary describing the background and objectives of the trial The triple infections of Human immunodeficiency virus (HIV), Syphilis, and Hepatitis B virus (HBV) constitute a group of epidemiologically interrelated infection that constitutes a global challenge, especially in the field of maternal and child health, contributing to most of the maternal and perinatal/infant morbidity and mortality. Strategies for prevention of mother-to-child transmission of HIV have been well-established and effective. Evidence however has shown that antenatal screening for Hepatitis B and Syphilis is lagging behind that of HIV. Several reasons could be responsible for this. Screening for these infections, however, has been made easier with the use of a rapid diagnostic test kit that could be applied at the point of care and even more with the recently introduced dual test kit for HIV and Syphilis. Objectives 1. To determine and compare the testing rates for HIV, Syphilis and Hepatitis B viral infections between the intervention and control group. 2. To determine the study participants' acceptability, uptake, and preference for the triple point of care test. 3. To determine the possible barriers to conventional antenatal screening among attendees in the booking clinic. 4. To determine the period prevalence of the triple infections among the study participants
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Comparing Triple point of care antenatal screening with Coventional antenatal screening method
Purpose of the trial Education /Training
Anticipated trial start date 01/11/2023
Actual trial start date 01/11/2023
Anticipated date of last follow up 29/02/2024
Actual Last follow-up date 29/02/2024
Anticipated target sample size (number of participants) 170
Actual target sample size (number of participants) 164
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
UATHHRECPR2023 10079 UATH HREC
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Triple point of care testing for HIV Hepatitis B and Syphilis once At a spot Using Skytec HIV, Hepatitis B, Hepatitis C, and Syphilis Combo test cassete to carry out HIV, but Hepatitis B, and Syphilis screening test at point of care, 85
Control Group Conventional antenatal screening Once At a spot Carrying out Rapid diagnostic test for HIV at antenatal clinic, then carrying out Hepatitis B and Syphilis test in the Laboratory 79 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women aged 18 years or older. Pregnant women with unknown or poor documentation of testing results for the triple infection were deemed eligible and were thus recruited into the study. Pregnant women with mental health disorders. Pregnant women who had already been screened in the index pregnancy for the triple infection with properly documented evidence in our facility. Pregnant women at a gestational age greater than 36weeks Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 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 20/10/2023 University of Abuja Teaching Hospital Health Research Ethical Committee UATH HREC
Ethics Committee Address
Street address City Postal code Country
Passo Road Gwagwalada, Abuja 902101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome proportion of participants successfully screened over the total number of consenting participants in a strategy Four weeks during intervention
Secondary Outcome 1.Uptake which was defined as the increase in the number of women screened for triple infections over and above screening rates for any triple infection documented at baseline 2.Preference for the strategy; Defined as whether participants preferred POCTs over conventional laboratory tests 3.Preference for turnaround time (TAT); is the time to complete the tests and receive results,4.The impact defined by the number of infections detected/confirmed relative to the total number of participants screened, Four weeks during intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Obstetrics and Gynaecology University of Abuja Teaching Hospital Gwagwalada AbujaFCT Passo Road Abuja Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Sponsored Passo road Gwagwalada Abuja 902101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Seff Passo Road Gwagwalada Gwagwalada Abuja 902101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator TSITERIMAM THOMAS SAMBO sambotsiterimam@gmail.com +2347067725266 Kwambal estate Passo road Phase3 Gwagwalada, Abuja- FCT
City Postal code Country Position/Affiliation
Gwagwalada AbujaFCT 902101 Nigeria Resident Doctor
Role Name Email Phone Street address
Public Enquiries Nneoma Nnaemeka anointin1675@gmail.com +2348063953869 Passo road
City Postal code Country Position/Affiliation
Gwagwalada Abuja 902101 Nigeria Laboratory Scientist
Role Name Email Phone Street address
Scientific Enquiries Denis Anthony Isah denisanthonyisah@yahoo.com +2348061109664 Passo Road Gwagwalada,
City Postal code Country Position/Affiliation
Gwagwalada Abuja 902101 Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Anyone who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 12/09/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 12/09/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information