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The TRIple Elimination Model Of Mother-to-child Transmission Program (TRI-MOM) (TRI-MOM)

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ClinicalTrials.gov Identifier: NCT05951751
Recruitment Status : Not yet recruiting
First Posted : July 19, 2023
Last Update Posted : July 19, 2023
Sponsor:
Collaborators:
Centre Muraz
Medical Research Council
Institut Pasteur
REVS PLUS Burkina Faso
Young Gambian Mums Fund
National AIDS Control Program Gambia
Information provided by (Responsible Party):
Institut de Recherche pour le Developpement

Study Description
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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:

  1. 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.
  2. an "evaluation" component which will assess the impact of the TRI-MOM strategy on PMTCT services, reduction of HBV MTCT and women empowerment.

Condition or disease Intervention/treatment Phase
Hiv Syphilis HBV Other: TRI-MOM intervention Not Applicable

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:

  1. 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.
  2. 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:

  1. Training of healthcare professionals in charge of maternal health (nurses, midwives and doctors in charge of maternal health services)
  2. Triple screening of HIV, Syphilis and HBV by rapid diagnostic tests
  3. Assessment and treatment of women positive for any of the 3 targeted infections
  4. 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 :

  1. A quantitative and qualitative cross-sectional study before and after the implementation of the strategy.
  2. A cohort study of pregnant women positive for any of the three infections.
  3. Cost and cost-effectiveness analysis.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2800 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Integrated Antenatal Screening for HIV, Syphilis, and Hepatitis B Virus (HBV) in Pregnant Women in Burkina Faso and The Gambia
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV Syphilis

Arms and Interventions
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Arm Intervention/treatment
Experimental: TRI-MOM
Women attending their first postnatal visit in one of the selected maternities (no maternal age limit) will be eligible to participate in the study
 Other: TRI-MOM intervention

The TRI-MOM strategy includes 4 main activities:

  1. Training of healthcare professionals in charge of maternal health (nurses, midwives and doctors in charge of maternal health services)
  2. Triple screening of HIV, Syphilis and HBV by rapid diagnostic tests
  3. Assessment and treatment of women positive for any of the 3 targeted infections
  4. Raising awareness on MTCT among pregnant women visiting antenatal services and empowering women infected with at least one of the three infections


Outcome Measures
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Primary Outcome Measures :
  1. Coverage of the strategy in the study maternities before its implementation [ Time Frame: Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy) ]
    Proportion of women screened for HIV, Syphilis and HBV during pregnancy

  2. Coverage of the strategy in the study maternities after its implementation [ Time Frame: Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy) ]
    Proportion of women screened for HIV, Syphilis and HBV during pregnancy


Secondary Outcome Measures :
  1. Knowledge of the targeted infections before the strategy implementation [ Time Frame: Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy) ]
    Proportion of women with a good level of knowledge (defined by a score) of the targeted infections (HIV, syphilis, and HBV) and of PMTCT

  2. Knowledge of the targeted infections after the strategy implementation [ Time Frame: Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy) ]
    Proportion of women with a good level of knowledge (defined by a score) of the targeted infections (HIV, syphilis, and HBV) and of PMTCT

  3. Acceptability of the implemented strategy and PMTCT and preferences : screening refusal before the strategy implementation [ Time Frame: Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy) ]
    Proportion of pregnant women who refuse the screening for any of the 3 targeted infections

  4. Acceptability of the implemented strategy and PMTCT and preferences : screening refusal after the strategy implementation [ Time Frame: Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy) ]
    Proportion of pregnant women who refuse the screening for any of the 3 targeted infections

  5. Acceptability of the implemented strategy and PMTCT and preferences : treatment refusal before the strategy implementation [ Time Frame: Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy) ]
    Proportion of positive pregnant women refusing treatment

  6. Acceptability of the implemented strategy and PMTCT and preferences : treatment refusal after the strategy implementation [ Time Frame: Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy) ]
    Proportion of positive pregnant women refusing treatment

  7. Sensitivity of the hepatitis B core-related antigen rapid diagnostic test (HBcrAg-RDT) (PROTECT-B ancillary study) [ Time Frame: Data collected at cohort inclusion ]
    Percentage of HBsAg-positive women with a high viral load (≥200,000 IU/mL) who are positive for HBcrAg-RDT

  8. Specificity of the HBcrAg-RDT (PROTECT-B ancillary study) [ Time Frame: Data collected at cohort inclusion ]
    Percentage of HBsAg-positive women with a low viral load <200,000 IU/mL who are negative for HBcrAg-RDT

  9. Positive predictive value of the HBcrAg-RDT (PROTECT-B ancillary study) [ Time Frame: Data collected at cohort inclusion ]
    Proportion of subjects with a positive HBcrAg test result who truly have a high viral load (≥200,000 IU/mL)

  10. Negative predictive value of the HBcrAg-RDT (PROTECT-B ancillary study) [ Time Frame: Data collected at cohort inclusion ]
    Proportion of subjects with a negative HBcrAg test result who truly do not have a high viral load (≥200,000 IU/mL)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05951751


Contacts
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Contact: Lauren Perieres, PhD +33 4.91.32.46.00 lauren.perieres@inserm.fr

Sponsors and Collaborators
Institut de Recherche pour le Developpement
Centre Muraz
Medical Research Council
Institut Pasteur
REVS PLUS Burkina Faso
Young Gambian Mums Fund
National AIDS Control Program Gambia
Investigators
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Principal Investigator: Sylvie Boyer, PhD UMR 1252 SESSTIM
More Information
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Responsible Party: Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT05951751    
First Posted: July 19, 2023    Key Record Dates
Last Update Posted: July 19, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: To be completed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de Recherche pour le Developpement:
maternal health
child health
HIV
Hepatitis B
 Syphilis
prevention and control
pregnancy
Additional relevant MeSH terms:
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Syphilis
Communicable Diseases
Infections
Treponemal Infections
Spirochaetales Infections
Gram-Negative Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Genital Diseases
Urogenital Diseases