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

June 17, 2024 updated by: Institut de Recherche pour le Developpement

Integrated Antenatal Screening for HIV, Syphilis, and Hepatitis B Virus (HBV) in Pregnant Women in Burkina Faso and The Gambia

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 5 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 5 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 Type

Interventional

Enrollment (Estimated)

2800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Burkina Faso
      • Bobo-Dioulasso, Burkina Faso
        • Not yet recruiting
        • Centre Muraz/INSP
        • Contact:
          • Clarisse Gouem, MD
        • Principal Investigator:
          • Alice Nanelin Guingané, MD, PhD
  • Gambia
      • Fajara, Gambia
        • Recruiting
        • MRC The Gambia at LSHTM
        • Contact:
          • Gibril Ndow, MD, PhD
        • Principal Investigator:
          • Maud Lemoine, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy)
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
Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy)
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
Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)
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
Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy)
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
Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)
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
Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy)
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
Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)
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
Data collected at cohort inclusion
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
Data collected at cohort inclusion
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)
Data collected at cohort inclusion
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)
Data collected at cohort inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherche pour le Developpement

Collaborators

Medical Research Council
Institut Pasteur
Centre Muraz
REVS PLUS Burkina Faso
Young Gambian Mums Fund
National AIDS Control Program Gambia

Investigators

  • Principal Investigator: Sylvie Boyer, PhD, UMR 1252 SESSTIM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

July 10, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRD_2023_SESSTIM_TRI-MOM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

To be completed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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