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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
Institut de Recherche pour le Developpement
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    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
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    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)

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