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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hiv, Syphilis, HBV

Intervention / Treatment
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* Other: TRI-MOM intervention


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRI-MOM<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coverage of the strategy in the study maternities before its implementation | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maternal health, child health, HIV, Hepatitis B, Syphilis, prevention and control, pregnancy