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

Hiv Clinical Trial

— TRI-MOM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05951751
• Other study ID #: IRD_2023_SESSTIM_TRI-MOM
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Institut de Recherche pour le Developpement
• Contact: Lauren Perieres, PhD
• Phone: +33 4.91.32.46.00
• Email: lauren.perieres[@]inserm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2800
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• HBV
• Hiv
• Syphilis

Intervention

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

Locations

Country	Name	City	State
Burkina Faso	Centre Muraz/INSP	Bobo-Dioulasso
Gambia	MRC The Gambia at LSHTM	Fajara

Sponsors (7)

Lead Sponsor	Collaborator
Institut de Recherche pour le Developpement	Centre Muraz, Institut Pasteur, Medical Research Council, National AIDS Control Program Gambia, REVS PLUS Burkina Faso, Young Gambian Mums Fund

Countries where clinical trial is conducted

Burkina Faso,  Gambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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