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

NCT05951751 | Recruiting

• 1 other identifier: IRD_2023_SESSTIM_TRI-MOM
• Study Type: interventional
• Target: 2,800
• Locations: 2 countries
• Sites: 2

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. 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. 2.an "evaluation" component which will assess the impact of the TRI-MOM strategy on PMTCT services, reduction of HBV MTCT and women empowerment.

Conditions

Hiv; Syphilis; HBV

Keywords

maternal health; child health; HIV; Hepatitis B; Syphilis; prevention and control; pregnancy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Knowledge of the targeted infections before the strategy implementation

  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

  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

  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

  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

  Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy)

Study Arms (1)

TRI-MOM

EXPERIMENTAL

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

Interventions

TRI-MOM intervention OTHER

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

TRI-MOM

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women attending a postnatal visit in one of the selected maternities (no maternal age limit)

You may not qualify if:

• Refusal to participate in the study
• Unable to provide consent

Sponsors & Collaborators

• Institut de Recherche pour le Developpement: lead
• Centre Muraz: collaborator
• Medical Research Council: collaborator
• Institut Pasteur: collaborator
• REVS PLUS Burkina Faso: collaborator
• Young Gambian Mums Fund: collaborator
• National AIDS Control Program Gambia: collaborator

Study Sites (2)

Centre Muraz/INSP

Bobo-Dioulasso, Burkina Faso

NOT YET RECRUITING

MRC The Gambia at LSHTM

Fajara, The Gambia

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Syphilis; Hepatitis B

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Sylvie Boyer, PhD

  UMR 1252 SESSTIM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Perieres, PhD

CONTACT

+33 4.91.32.46.00; lauren.perieres@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 19, 2023
• Study Start: March 18, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

TH (1); BU (1)