The TRIple Elimination Model Of Mother-to-child Transmission Program (TRI-MOM)
Study Details
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:
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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.
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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.
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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:
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Training of healthcare professionals in charge of maternal health (nurses, midwives and doctors in charge of maternal health services)
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Triple screening of HIV, Syphilis and HBV by rapid diagnostic tests
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Assessment and treatment of women positive for any of the 3 targeted infections
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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 :
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A quantitative and qualitative cross-sectional study before and after the implementation of the strategy.
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A cohort study of pregnant women positive for any of the three infections.
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Cost and cost-effectiveness analysis.
Study Design
Arms and Interventions
| 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:
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
|
Outcome Measures
Primary Outcome Measures
- Coverage of the strategy in the study maternities before its implementation [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
- Coverage of the strategy in the study maternities after its implementation [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
- Knowledge of the targeted infections before the strategy implementation [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
- Knowledge of the targeted infections after the strategy implementation [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
- Acceptability of the implemented strategy and PMTCT and preferences : screening refusal before the strategy implementation [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
- Acceptability of the implemented strategy and PMTCT and preferences : screening refusal after the strategy implementation [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
- Acceptability of the implemented strategy and PMTCT and preferences : treatment refusal before the strategy implementation [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
- Acceptability of the implemented strategy and PMTCT and preferences : treatment refusal after the strategy implementation [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
- Sensitivity of the hepatitis B core-related antigen rapid diagnostic test (HBcrAg-RDT) (PROTECT-B ancillary study) [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
- Specificity of the HBcrAg-RDT (PROTECT-B ancillary study) [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
- Positive predictive value of the HBcrAg-RDT (PROTECT-B ancillary study) [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)
- Negative predictive value of the HBcrAg-RDT (PROTECT-B ancillary study) [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
Criteria
Inclusion Criteria:
- Women attending a postnatal visit in one of the selected maternities (no maternal age limit)
Exclusion Criteria:
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Refusal to participate in the study
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Unable to provide consent
Contacts and Locations
Locations
No locations specified.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
- Principal Investigator: Sylvie Boyer, PhD, UMR 1252 SESSTIM