Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-04 @ 4:44 AM
Study NCT ID:
NCT05951751
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The TRIple Elimination Model Of Mother-to-child Transmission Program (TRI-MOM)
Sponsor:
Institut de Recherche pour le Developpement
Organization:
Study Overview
Official Title:
Integrated Antenatal Screening for HIV, Syphilis, and Hepatitis B Virus (HBV) in Pregnant Women in Burkina Faso and The Gambia
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRI-MOM
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: