An interventional study of TRI-MOM intervention in Hiv, Syphilis and HBV, sponsored by Institut de Recherche pour le Developpement. Recruiting at 2 sites in 2 countries. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by Institut de Recherche pour le Developpement · Not applicable, Interventional, and Health services research
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:
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:
Intervention component :
The TRI-MOM strategy includes 4 main activities:
Evaluation component :
The TRI-MOM program will include three studies :
126 studies on the registry are indexed under Syphilis; 34 are open to participants now.
This study's planned enrollment of 2,800 is above the median of 354 across 85 interventional studies indexed under Syphilis.
Browse Syphilis studies →Institut de Recherche pour le Developpement is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
Compared within Syphilis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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
Coverage of the strategy in the study maternities before its implementation
Proportion of women screened for HIV, Syphilis and HBV during pregnancy
Time frame: 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
Time frame: Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Data collected at cohort inclusion
Plan to share: Yes — To be completed
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