The TRIple Elimination Model Of Mother-to-child Transmission Program (TRI-MOM) (TRI-MOM)
Primary Purpose
Hiv, Syphilis, HBV
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TRI-MOM intervention
Sponsored by

About this trial
This is an interventional health services research trial for Hiv focused on measuring maternal health, child health, HIV, Hepatitis B, Syphilis, prevention and control, pregnancy
Eligibility Criteria
Inclusion Criteria: Women attending a postnatal visit in one of the selected maternities (no maternal age limit) Exclusion Criteria: Refusal to participate in the study Unable to provide consent
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TRI-MOM
Arm Description
Women attending their first postnatal visit in one of the selected maternities (no maternal age limit) will be eligible to participate in the study
Outcomes
Primary Outcome Measures
Coverage of the strategy in the study maternities before its implementation
Proportion of women screened for HIV, Syphilis and HBV during pregnancy
Coverage of the strategy in the study maternities after its implementation
Proportion of women screened for HIV, Syphilis and HBV during pregnancy
Secondary Outcome Measures
Knowledge of the targeted infections before the strategy implementation
Proportion of women with a good level of knowledge (defined by a score) of the targeted infections (HIV, syphilis, and HBV) and of PMTCT
Knowledge of the targeted infections after the strategy implementation
Proportion of women with a good level of knowledge (defined by a score) of the targeted infections (HIV, syphilis, and HBV) and of PMTCT
Acceptability of the implemented strategy and PMTCT and preferences : screening refusal before the strategy implementation
Proportion of pregnant women who refuse the screening for any of the 3 targeted infections
Acceptability of the implemented strategy and PMTCT and preferences : screening refusal after the strategy implementation
Proportion of pregnant women who refuse the screening for any of the 3 targeted infections
Acceptability of the implemented strategy and PMTCT and preferences : treatment refusal before the strategy implementation
Proportion of positive pregnant women refusing treatment
Acceptability of the implemented strategy and PMTCT and preferences : treatment refusal after the strategy implementation
Proportion of positive pregnant women refusing treatment
Sensitivity of the hepatitis B core-related antigen rapid diagnostic test (HBcrAg-RDT) (PROTECT-B ancillary study)
Percentage of HBsAg-positive women with a high viral load (≥200,000 IU/mL) who are positive for HBcrAg-RDT
Specificity of the HBcrAg-RDT (PROTECT-B ancillary study)
Percentage of HBsAg-positive women with a low viral load <200,000 IU/mL who are negative for HBcrAg-RDT
Positive predictive value of the HBcrAg-RDT (PROTECT-B ancillary study)
Proportion of subjects with a positive HBcrAg test result who truly have a high viral load (≥200,000 IU/mL)
Negative predictive value of the HBcrAg-RDT (PROTECT-B ancillary study)
Proportion of subjects with a negative HBcrAg test result who truly do not have a high viral load (≥200,000 IU/mL)
Full Information
NCT ID
NCT05951751
First Posted
July 3, 2023
Last Updated
July 10, 2023
Sponsor
Institut de Recherche pour le Developpement
Collaborators
Centre Muraz, Medical Research Council, Institut Pasteur, REVS PLUS Burkina Faso, Young Gambian Mums Fund, National AIDS Control Program Gambia
1. Study Identification
Unique Protocol Identification Number
NCT05951751
Brief Title
The TRIple Elimination Model Of Mother-to-child Transmission Program (TRI-MOM)
Acronym
TRI-MOM
Official Title
Integrated Antenatal Screening for HIV, Syphilis, and Hepatitis B Virus (HBV) in Pregnant Women in Burkina Faso and The Gambia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherche pour le Developpement
Collaborators
Centre Muraz, Medical Research Council, Institut Pasteur, REVS PLUS Burkina Faso, Young Gambian Mums Fund, National AIDS Control Program Gambia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The TRI-MOM program aims to implement and evaluate a simplified (based on inexpensive rapid diagnostic tests), integrated (in governmental health facilities) and coordinated (between health care workers) strategy for the triple elimination of HIV, syphilis and HBV mother-to-child transmission (MTCT) in nine maternal and child health services, 5 in Burkina Faso and 4 in The Gambia.
The TRI-MOM program has two components:
an "intervention" component consisting of a pilot study to reinforce the antenatal screening and prevention of MTCT (PMTCT) capacities for the 3 targeted infections through the implementation of a simplified, integrated and coordinated strategy of triple elimination of MTCT.
an "evaluation" component which will assess the impact of the TRI-MOM strategy on PMTCT services, reduction of HBV MTCT and women empowerment.
Detailed Description
The TRI-MOM (TRIple elimination Model Of Mother-to-child transmission of HIV/Syphilis and HBV in Burkina Faso and The Gambia) program aims to implement and evaluate a simplified (based on inexpensive rapid diagnostic tests), integrated (in governmental health facilities) and coordinated (between health care workers) strategy for the triple elimination of HIV, syphilis and HBV MTCT in nine maternal and child health services, 5 in Burkina Faso and 4 in The Gambia. In The Gambia, the program will be conducted in collaboration with the national HIV, sexually transmitted infections (STI) and hepatitis programmes.
The TRI-MOM program has two components:
an "intervention" component consisting of a pilot study to reinforce the antenatal screening and PMTCT capacities for the 3 targeted infections through the implementation of a simplified, integrated and coordinated strategy of triple elimination of MTCT. This pilot study will be conducted in 9 selected maternities.
an "evaluation" component which will assess the impact of the TRI-MOM strategy on PMTCT services, reduction of HBV MTCT and women empowerment.
Intervention component :
The TRI-MOM strategy includes 4 main activities:
Training of healthcare professionals in charge of maternal health (nurses, midwives and doctors in charge of maternal health services)
Triple screening of HIV, Syphilis and HBV by rapid diagnostic tests
Assessment and treatment of women positive for any of the 3 targeted infections
Raising awareness on MTCT among pregnant women visiting antenatal services and empowering women infected with at least one of the three infections
Evaluation component :
The TRI-MOM program will include three studies :
A quantitative and qualitative cross-sectional study before and after the implementation of the strategy.
A cohort study of pregnant women positive for any of the three infections.
Cost and cost-effectiveness analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv, Syphilis, HBV
Keywords
maternal health, child health, HIV, Hepatitis B, Syphilis, prevention and control, pregnancy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TRI-MOM
Arm Type
Experimental
Arm Description
Women attending their first postnatal visit in one of the selected maternities (no maternal age limit) will be eligible to participate in the study
Intervention Type
Other
Intervention Name(s)
TRI-MOM intervention
Intervention Description
The TRI-MOM strategy includes 4 main activities:
Training of healthcare professionals in charge of maternal health (nurses, midwives and doctors in charge of maternal health services)
Triple screening of HIV, Syphilis and HBV by rapid diagnostic tests
Assessment and treatment of women positive for any of the 3 targeted infections
Raising awareness on MTCT among pregnant women visiting antenatal services and empowering women infected with at least one of the three infections
Primary Outcome Measure Information:
Title
Coverage of the strategy in the study maternities before its implementation
Description
Proportion of women screened for HIV, Syphilis and HBV during pregnancy
Time Frame
Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy)
Title
Coverage of the strategy in the study maternities after its implementation
Description
Proportion of women screened for HIV, Syphilis and HBV during pregnancy
Time Frame
Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)
Secondary Outcome Measure Information:
Title
Knowledge of the targeted infections before the strategy implementation
Description
Proportion of women with a good level of knowledge (defined by a score) of the targeted infections (HIV, syphilis, and HBV) and of PMTCT
Time Frame
Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy)
Title
Knowledge of the targeted infections after the strategy implementation
Description
Proportion of women with a good level of knowledge (defined by a score) of the targeted infections (HIV, syphilis, and HBV) and of PMTCT
Time Frame
Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)
Title
Acceptability of the implemented strategy and PMTCT and preferences : screening refusal before the strategy implementation
Description
Proportion of pregnant women who refuse the screening for any of the 3 targeted infections
Time Frame
Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy)
Title
Acceptability of the implemented strategy and PMTCT and preferences : screening refusal after the strategy implementation
Description
Proportion of pregnant women who refuse the screening for any of the 3 targeted infections
Time Frame
Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)
Title
Acceptability of the implemented strategy and PMTCT and preferences : treatment refusal before the strategy implementation
Description
Proportion of positive pregnant women refusing treatment
Time Frame
Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy)
Title
Acceptability of the implemented strategy and PMTCT and preferences : treatment refusal after the strategy implementation
Description
Proportion of positive pregnant women refusing treatment
Time Frame
Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)
Title
Sensitivity of the hepatitis B core-related antigen rapid diagnostic test (HBcrAg-RDT) (PROTECT-B ancillary study)
Description
Percentage of HBsAg-positive women with a high viral load (≥200,000 IU/mL) who are positive for HBcrAg-RDT
Time Frame
Data collected at cohort inclusion
Title
Specificity of the HBcrAg-RDT (PROTECT-B ancillary study)
Description
Percentage of HBsAg-positive women with a low viral load <200,000 IU/mL who are negative for HBcrAg-RDT
Time Frame
Data collected at cohort inclusion
Title
Positive predictive value of the HBcrAg-RDT (PROTECT-B ancillary study)
Description
Proportion of subjects with a positive HBcrAg test result who truly have a high viral load (≥200,000 IU/mL)
Time Frame
Data collected at cohort inclusion
Title
Negative predictive value of the HBcrAg-RDT (PROTECT-B ancillary study)
Description
Proportion of subjects with a negative HBcrAg test result who truly do not have a high viral load (≥200,000 IU/mL)
Time Frame
Data collected at cohort inclusion
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women attending a postnatal visit in one of the selected maternities (no maternal age limit)
Exclusion Criteria:
Refusal to participate in the study
Unable to provide consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Perieres, PhD
Phone
+33 4.91.32.46.00
Email
lauren.perieres@inserm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie Boyer, PhD
Organizational Affiliation
UMR 1252 SESSTIM
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
To be completed
Learn more about this trial
The TRIple Elimination Model Of Mother-to-child Transmission Program (TRI-MOM)
We'll reach out to this number within 24 hrs