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HivTRI-MOMNCT05951751

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

A study testing TRI-MOM intervention in people with Hiv and Syphilis, run by Institut de Recherche pour le Developpement at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Hiv, Syphilis, HBV
What is being tested?
TRI-MOM intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,800 participants
Where
2 sitesin 2 countries
Study dates
18 Mar 2024to May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

Lauren Perieres, PhD contact

+33 4.91.32.46.00

lauren.perieres@inserm.fr

2 sites in 2 countries

Burkina Faso1 site, 1 recruiting

  • Centre Muraz/INSP

    Bobo-Dioulasso

    Clarisse Gouem, MD

    Alice Nanelin Guingané, MD, PhD

    Not yet recruiting

Other trials in Burkina Faso

The Gambia1 site, 1 recruiting

  • MRC The Gambia at LSHTM

    Fajara

    Gibril Ndow, MD, PhD

    Maud Lemoine, MD, PhD

    Recruiting

Other trials in The Gambia

About this study

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

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.
Read the 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.
Conditions
Hiv, Syphilis, HBV
Being tested
TRI-MOM intervention
Keywords
maternal health, child health, HIV, Hepatitis B, Syphilis, prevention and control, pregnancy
Medical subject headings
Acquired Immunodeficiency Syndrome, Syphilis, Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRI-MOM interventionOther

    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
Study groups in NCT05951751
Study groupRoleWhat they receive
TRI-MOMExperimentalWomen attending their first postnatal visit in one of the selected maternities (no maternal age limit) will be eligible to participate in the study
Receives: Other: TRI-MOM intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Coverage of the strategy in the study maternities before its implementation

    Proportion of women screened for HIV, Syphilis and HBV during pregnancy

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

  2. Coverage of the strategy in the study maternities after its implementation

    Proportion of women screened for HIV, Syphilis and HBV during pregnancy

    Measured: Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)

Secondary outcomes (10)

  1. 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

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

  2. 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

    Measured: Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)

  3. 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

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

  4. 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

    Measured: Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)

  5. Acceptability of the implemented strategy and PMTCT and preferences : treatment refusal before the strategy implementation

    Proportion of positive pregnant women refusing treatment

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

  6. Acceptability of the implemented strategy and PMTCT and preferences : treatment refusal after the strategy implementation

    Proportion of positive pregnant women refusing treatment

    Measured: Assessed cross-sectionally using a questionnaire administered to women at 12 months (after the implementation of the TRI-MOM strategy)

  7. 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

    Measured: Data collected at cohort inclusion

  8. 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

    Measured: Data collected at cohort inclusion

  9. 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)

    Measured: Data collected at cohort inclusion

  10. 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)

    Measured: Data collected at cohort inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2023
  2. Study start18 Mar 2024
  3. Primary completionMay 2025 (estimated)
  4. Study completionMay 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05951751
Sponsor's protocol ID
IRD_2023_SESSTIM_TRI-MOM
Acronym
TRI-MOM
Status last verified
Jun 2024
First submitted
3 Jul 2023
Last updated
20 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: To be completed

Publications

  • Vo-Quang E, Guingane AN, Perieres L, Ndow G, Some V, Badjie S, Jobe A, Gouem C, Shimakawa Y, Kania D, Lemoine M, Boyer S; TRI-MOM study group. Towards triple elimination of HIV, syphilis and HBV mother-to-child transmission: Protocol of a simplified and integrated strategy in Burkina Faso and The Gambia: Protocol for the phase 1 of the TRI-MOM project. PLoS One. 2026 Feb 6;21(2):e0322670. doi: 10.1371/journal.pone.0322670. eCollection 2026.

    PubMed 41649980

Questions about this trial

What is this clinical trial studying?

A study testing TRI-MOM intervention in people with Hiv and Syphilis, run by Institut de Recherche pour le Developpement at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Burkina Faso, The Gambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lauren Perieres, PhD (+33 4.91.32.46.00, lauren.perieres@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coverage of the strategy in the study maternities before its implementation (time frame: Assessed cross-sectionally using a questionnaire administered to women at baseline (before the implementation of the TRI-MOM strategy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05951751, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.

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