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: the TRI-MOM project, phase 1

Introduction Mother-to-child transmission (MTCT) of HIV, syphilis, and hepatitis B virus (HBV) commonly observed in the WHO African region is associated with excess morbidity and mortality. Despite some progress, the coverage of interventions to prevent MTCT of these infections remains insufficient, particularly for syphilis and HBV. To fulfil these gaps and achieve the triple elimination of MTCT of these infections by 2030, the World Health Organization (WHO) advocates for integration of prevention of MTCT (PMTCT) activities for HBV with HIV and syphilis antenatal services. In partnership with the local governments, the TRI-MOM project, conducted in 2 phases, aims to evaluate a simplified (based on inexpensive rapid diagnostic tests), integrated (in maternal and child health services) and coordinated (between the various programs and health care workers) strategy for the triple elimination of HIV, syphilis and HBV MTCT in Burkina Faso and The Gambia.

and analysis The strategy will be implemented in 10 rural and urban health facilities in both countries including four activities: i) training sessions for healthcare workers working in maternal and child health services, ii) screening of pregnant women of the three infections using rapid diagnostic tests at the first antenatal visit, iii) clinical assessment and treatment of women tested positive for any of the 3 infections, and iv) raising awareness on HIV, Syphilis and HBV PMTCT among pregnant women and empowering those screened positive. 17,000 pregnant women are expected to be screened. The strategy will be evaluated through an interdisciplinary, mixed-methods approach comprising three studies: i) a quantitative and qualitative cross-sectional study conducted both before and after the implementation of the strategy to assess its impact on triple screening coverage in pregnant women; ii) a cohort study of pregnant women positive for any of the three infections to assess the coverage of PMTCT measures; and iii) a cost and cost-effectiveness analysis. Ethics and dissemination The study protocol has been approved by the competent authorities of the countries participating to the research (the LSHTM/MRCUG Scientific Coordinating Committee, the Gambia Government/MRC Joint Ethics Committee, the LSHTM ethics committee, the Burkinabe National Ethical Committee for Research in Health and the French Commission on Information Technology and Liberties). Results on the feasibility and acceptability of the triple elimination strategy will be disseminated using different media including policy briefs, posters and articles. Trial registration number NCT05951751 Strengths and limitations of the study Implementing the triple elimination strategy in close collaboration with the national health authorities and programs will ensure the sustainability of PMTCT of HIV, syphilis, and HBV in pregnant women. Promoting an interdisciplinary approach to evaluate the triple strategy, using both quantitative and qualitative methods, will provide a comprehensive understanding of the acceptability and feasibility of the strategy in both African countries. Including an economic evaluation will provide decision-makers with key information on the costs and cost-effectiveness of the triple elimination strategy compared to standard of care. Such information is essential for the nation-wide implementation of the strategy. Conducting the study in several urban and rural health facilities will provide stronger evidence of our findings across both countries. The first phase of the TRI-MOM project will only focus on the prenatal period until delivery and will therefore not provide information on the reduction of MTCT of the three infections. This outcome will be evaluated during a second phase of the project (2025-2028). Competing Interest Statement I have read the journal's policy and the authors of this manuscript have the following competing interests: GN, and YS report research funding and consultancy fees from Gilead Sciences. ML reports consultancy fees from Abbott USA and Gilead Sciences. All other authors declare no competing interests. Clinical Trial Trial registration number: NCT05951751 Funding Statement Yes Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study protocol has been approved by the competent authorities of the countries participating to the research (the LSHTM/MRCUG Scientific Coordinating Committee, the Gambia Government/MRC Joint Ethics Committee, the LSHTM ethics committee, the Burkinabe National Ethical Committee for Research in Health and the French Commission on Information Technology and Liberties). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability o datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.