Clinical trial NCT05951751: The TRIple Elimination Model Of Mother-to-child Transmission Program (TRI-MOM)
Official title: Integrated Antenatal Screening for HIV, Syphilis, and Hepatitis B Virus (HBV) in Pregnant Women in Burkina Faso and The Gambia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Syphilis
HBV
Keywords: maternal health
child health
HIV
Hepatitis B
Syphilis
prevention and control
pregnancy
Lead sponsor: Institut de Recherche pour le Developpement
Sponsor class: OTHER_GOV
Collaborators: name: Centre Muraz
name: Medical Research Council
name: Institut Pasteur
name: REVS PLUS Burkina Faso
name: Young Gambian Mums Fund
name: National AIDS Control Program Gambia
First posted: 2023-07-19
Enrollment: 2800
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Coverage of the strategy in the study maternities before its implementation
timeFrame: Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy)
measure: Coverage of the strategy in the study maternities after its implementation
timeFrame: Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)
Secondary outcomes:
measure: Knowledge of the targeted infections before the strategy implementation
timeFrame: Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy)
measure: Knowledge of the targeted infections after the strategy implementation
timeFrame: Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)
measure: Acceptability of the implemented strategy and PMTCT and preferences : screening refusal before the strategy implementation
timeFrame: Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy)
measure: Acceptability of the implemented strategy and PMTCT and preferences : screening refusal after the strategy implementation
timeFrame: Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)
measure: Acceptability of the implemented strategy and PMTCT and preferences : treatment refusal before the strategy implementation
timeFrame: Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy)
measure: Acceptability of the implemented strategy and PMTCT and preferences : treatment refusal after the strategy implementation
timeFrame: Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)
measure: Sensitivity of the hepatitis B core-related antigen rapid diagnostic test (HBcrAg-RDT) (PROTECT-B ancillary study)
timeFrame: Data collected at cohort inclusion
measure: Specificity of the HBcrAg-RDT (PROTECT-B ancillary study)
timeFrame: Data collected at cohort inclusion
measure: Positive predictive value of the HBcrAg-RDT (PROTECT-B ancillary study)
timeFrame: Data collected at cohort inclusion
measure: Negative predictive value of the HBcrAg-RDT (PROTECT-B ancillary study)
timeFrame: Data collected at cohort inclusion
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: Centre Muraz/INSP
city: Fajara
country: Gambia
facility: MRC The Gambia at LSHTM
Study officials:
affiliation: UMR 1252 SESSTIM
name: Sylvie Boyer, PhD
role: PRINCIPAL_INVESTIGATOR
References: