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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05951751
Acronym
TRI-MOM
Enrollment
2800
Registered
2023-07-19
Start date
2024-03-18
Completion date
2025-05-31
Last updated
2024-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBV, Hiv, Syphilis

Keywords

maternal health, child health, HIV, Hepatitis B, Syphilis, prevention and control, pregnancy

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 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.

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.

Interventions

OTHERTRI-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

Sponsors

Centre Muraz
CollaboratorOTHER
Medical Research Council
CollaboratorOTHER_GOV
Institut Pasteur
CollaboratorINDUSTRY
REVS PLUS Burkina Faso
CollaboratorUNKNOWN
Young Gambian Mums Fund
CollaboratorUNKNOWN
National AIDS Control Program Gambia
CollaboratorUNKNOWN
Institut de Recherche pour le Developpement
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Coverage of the strategy in the study maternities before its implementationAssessed 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
Coverage of the strategy in the study maternities after its implementationAssessed 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

MeasureTime frameDescription
Acceptability of the implemented strategy and PMTCT and preferences : screening refusal before the strategy implementationAssessed 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
Acceptability of the implemented strategy and PMTCT and preferences : screening refusal after the strategy implementationAssessed 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
Acceptability of the implemented strategy and PMTCT and preferences : treatment refusal before the strategy implementationAssessed 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
Acceptability of the implemented strategy and PMTCT and preferences : treatment refusal after the strategy implementationAssessed 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
Knowledge of the targeted infections before the strategy implementationAssessed 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
Specificity of the HBcrAg-RDT (PROTECT-B ancillary study)Data collected at cohort inclusionPercentage 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)Data collected at cohort inclusionProportion 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)Data collected at cohort inclusionProportion of subjects with a negative HBcrAg test result who truly do not have a high viral load (≥200,000 IU/mL)
Sensitivity of the hepatitis B core-related antigen rapid diagnostic test (HBcrAg-RDT) (PROTECT-B ancillary study)Data collected at cohort inclusionPercentage of HBsAg-positive women with a high viral load (≥200,000 IU/mL) who are positive for HBcrAg-RDT
Knowledge of the targeted infections after the strategy implementationAssessed 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

Countries

Burkina Faso, The Gambia

Contacts

Primary ContactLauren Perieres, PhD
lauren.perieres@inserm.fr+33 4.91.32.46.00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026